How Intuitive Is Exploring New Advancements in Robotics
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Safety Information | Robotic Surgical Company | Intuitive
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# Safety Information

This document provides a summary of the risks associated with surgery and is divided into three categories:

1\. Surgical risks—patient: Risks are listed and explained in a manner that is easier for patients to understand.

2\. Surgical risks—surgeon: Risks are listed in medical (or surgical) terms. [Go to the surgeon-facing section](#surgeon-facing).

3\. Risks associated with bronchoscopy: [Go to the Ion endoluminal system section](#ion).

## Surgical risks—patient

Serious complications may occur with any surgery, including surgery with the da Vinci system, up to and including death. In addition, there are risks that are specific to certain surgical procedures. Also, some medical conditions can increase the risks of any surgery. Patients should discuss pertinent surgical risks with their doctors.

This document provides a summary of the risks associated with surgery and includes four different sections.

- **Section I** includes the negative outcomes, risks, and complications of any type of surgery.
- **Section II** includes the negative outcomes, risks, and complications of minimally invasive surgical techniques.
- **Section III** includes the negative outcomes, risks, and complications of surgery with the da Vinci system.
- **Section IV** includes the negative outcomes, risks, and complications of representative, specific surgical procedures.

## I. Negative outcomes, risks, and complications of any surgical type

**This section covers potential negative outcomes, risks, and complications associated with any type of surgery.** Common approaches/methods of surgery include: open surgery (through a large incision), thoracotomy incision (through a large chest incision), transoral surgery (through the mouth), thoracoscopic or laparoscopic surgery (through a few small incisions or the belly button) with traditional laparoscopy or robotic-assisted laparoscopy with the da Vinci system.

**1\. During surgery**

- Loss of a large amount of blood (blood transfusion needed)
- Any inadvertent cut, tear, puncture, burn or injury to organ, structure, or tissue, including, but not limited to:


\- Major blood vessel


\- Hollow organ, such as the bowel or bladder


\- Solid organ, such as the spleen, kidney, heart , lungs or liver


\- Ureter (tubes that carry urine from the kidneys to the bladder)


\- Nerves
- Loss of a needle, piece of an instrument, particulate, or any other object used during surgery inside the patient’s body
- Anesthesia risks (anesthesia is medicine that allows patients to sleep deeply and not feel pain during surgery): heart attack, stroke, blocked lung artery, pneumonia (serious lung infection), dental injury, injury to the vocal cord and death
- Patient positioning injury: hemodynamic, intraocular pressure, neurologic, soft tissue injuries, blood clotting deep in the body
- Air/gas entering the bloodstream leading to abnormal heart function or stroke

**2\. After surgery**

The complications listed below may go away on their own, with standard treatment from a doctor, or may require: medicine, radiological intervention (allows doctors to see inside your body with imaging such as X-rays, CT or MRI scans or ultrasound), admission back into the hospital, extended hospital stay, and/or another operation.

- Bleeding
- Urinary tract infection and/or urine will not empty completely from the bladder
- Blocked intestine or small bowel, nausea/vomiting
- Heart attack or irregular heartbeat, inflammation of the sac covering the heart
- Blood clot in a vessel that breaks away and travels to another blood vessel (often in the brain, GI tract, kidneys or leg), blood clotting deep inside the body, or blocked lung artery (usually blocked by a blood clot)
- Collapsed lung, pneumonia (serious lung infection), buildup of fluid or blood between the layers of tissue lining the lungs and chest cavity, abnormal buildup of fluid in the air sacs of the lungs which leads to shortness of breath, need for re-intubation (tube inserted in the mouth to help support breathing), or prolonged intubation
- Infection, blood build-up outside of vessels, fluid build-up, pus build-up in the abdomen, pelvis or chest
- Infection of the cavity where organs like the stomach and colon lie leading to infection in the abdominal cavity and/or throughout the body
- Breakdown and release of muscle fiber into the blood stream which can cause kidney damage
- Injury to adjacent organs
- Surgical instrument or equipment injures to hollow or solid organ(s) or blood vessel(s)
- Large amount of drainage from wound, or drainage that lasts a long period of time
- Infection at the incision site
- Bursting of the wound at the incision site
- Infection and/or lack of bone healing of the sternum
- Hernia (bulging of organ or fatty tissue) at the incision site
- Sudden kidney failure
- Nerve disorder that causes weakness, numbness, tingling or pain (neuropathy)
- Loss of vision that lasts for a short period of time or does not go away
- Spread of cancer cells
- Major stroke or mini “warning” stroke
- Inability to work
- Symptoms or disease may return
- Death

## II. Negative outcomes, risks, and complications of minimally invasive surgery

**This section covers potential negative outcomes, risks, and complications of minimally invasive surgery (through one or a few small incisions), in addition to the risks above.** Examples include traditional laparoscopy, thoracoscopy, transoral endoscopy, and robotic-assisted laparoscopy using the da Vinci system.

**1\. During surgery**

- Injury of internal organs during placement of ports used for access into the abdominal or chest cavity
- Surgeon must switch from minimally invasive surgery to open surgery (through a large incision) or hand-assisted surgery. This is usually due to: patient anatomy/frame, severe scarring or swelling of tissues, injury during surgery, technical challenges, cancer or disease that can be seen in more places than first thought, or the patient cannot tolerate gas/air in abdomen (used to inflate the abdomen during minimally invasive surgery)
- Longer operating and anesthesia time
- Complications or injury to the eyes/vision, face or larynx (voice box) caused when the patient’s head is placed lower than his/her feet on the operating table
- Temporary swelling of tissue due to gas in the tissue
- Changes in heart rate, blood pressure or blood values due to absorption of the gas used during minimally invasive surgery
- Entry of gas or air into the bloodstream that may lead to abnormal heart function or stroke

**2\. After surgery**

- Shoulder pain from the gas used during the surgery

## III. Negative outcomes, risks, and complications of robotic–assisted surgery using the da Vinci system

In addition to the risks in I and II above, which are not unique to da Vinci, this section covers potential negative outcomes, risks, and complications of robotic-assisted surgery using the da Vinci system. Surgery using the da Vinci surgical system may be associated with longer operative and anesthesia times. As with any surgical device, there is also the risk that the da Vinci surgical system could malfunction or fail, leading to serious injury or the need to switch to another type of surgical approach. Switching to another surgical approach could also result in a longer procedure time, a longer time under anesthesia, and increased complications.

## IV. Negative outcomes, risks, and complications of representative, specific procedures

This section covers potential negative outcomes, risks, and complications of representative, specific procedures in addition to the risks listed in sections I, II and III. These risks are common to open surgery, traditional laparoscopy, or robotic-assisted laparoscopy using the da Vinci system (except TORS or Transoral Robotic Surgery, which is specific to surgery using the da Vinci system.)

Note: Not all procedures listed below are available for all da Vinci systems, instruments and accessories in all markets.

### **Urology**

**Radical prostatectomy (removal of prostate gland and some surrounding tissue)**: leaking of urine, urgent need to urinate, cannot get or keep an erection, rectal or bowel injury, narrowing of the urethra, pooling of lymph fluid in the pelvic area or legs.

**Pyeloplasty (surgery for a urinary blockage)**: infection of the kidney, leaking of urine, narrowing of the urethra, bowel injury, kidney stones, narrowing or movement of the stent, blood in the urine, prolonged leaking of urine.

**Cystectomy (removal of all/part of the bladder)**: leaking of urine, injury to the rectum, scar tissue that causes narrowing between two connected structures, fistula (abnormal bond of an organ, intestine or vessel to another part of the body), leaking of urine, urgent need to urinate, cannot get or keep an erection, abnormal pooling of lymph fluid.

**Nephrectomy (kidney removal) including partial nephrectomy (removing part of the kidney)**:  poor kidney function often due to limited blood flow, leaking of urine, cut or tear in the spleen, pancreas or liver, bowel injury, trapped air between the chest wall and lung, injury to diaphragm (muscle separating the chest from the abdomen), urinary fistula (abnormal connection of the urinary system to another body organ), abnormal pooling of urine, limited or cut off blood supply to kidney, abnormal pooling of lymph fluid.

**Ureteral reimplantation (repositions how ureter connects to bladder)**: urinary tract infection that affects one or both kidneys, damage to urethra that can cause urine to collect in other areas of the body, scar tissue that causes narrowing at the site of the repair abnormal flow of urine from the bladder backwards to the kidneys, leakage of urine, movement of the stent.

### **Gynecology**

**Hysterectomy, benign (removal of the uterus and possibly nearby organs)**: injury to the ureters (the ureters drain urine from the kidney into the bladder), vaginal cuff problems (scar tissue in vaginal incision, infection, bacterial skin infection, pooling/clotting of blood, incision opens or separates), injury to bladder (organ that holds urine), bowel injury, vaginal shortening, problems urinating (cannot empty bladder, urgent or frequent need to urinate, leaking urine, slow or weak stream), abnormal hole from the vagina into the urinary tract or rectum, vaginal tear or deep cut. Uterine tissue may contain unsuspected cancer and the cutting or morcellation of uterine tissue during surgery may spread cancer, and decrease the long-term survival of patients.

**Hysterectomy, cancer (removal of the uterus and possibly nearby organs)**: injury to the ureters (the ureters drain urine from the kidney into the bladder), vaginal cuff problem (scar tissue in vaginal incision, infection, bacterial skin infection, pooling/clotting of blood, incision opens or separates), injury to bladder (organ that holds urine), bowel injury, vaginal shortening, problems urinating (cannot empty bladder, urgent or frequent need to urinate, leaking urine, slow or weak stream), abnormal hole from the vagina into the urinary tract or rectum, vaginal tear or deep cut.

**Myomectomy (removal of fibroid tumors)**: tear or hole in uterus, split or bursting of the uterus, pre-term (early) birth, spontaneous abortion. Uterine tissue may contain unsuspected cancer. The cutting or morcellation of uterine or fibroid tissue during surgery may spread cancer, and decrease the long-term survival of patients.

**Sacrocolpopexy (pelvic prolapse surgery)**: mesh erosion/infection caused by mesh moving from vaginal wall into surrounding organs causing the need for another operation, injury to rectum/bowel, injury to bladder (organ that holds urine), injury to the ureters (the ureters drain urine from the kidney into the bladder), front wall of the rectum pushes into the back wall of the vagina, prolapsed bladder (bladder budges into vagina when supportive tissue weakens), vaginal incision opens or separates, loss of bladder control, pooling of blood between bladder and pubic bone, pooling of blood between the anus and vagina.

**Endometriosis resection (endometriosis surgery to remove implants)**: injury to the bowel, bladder (organ that holds urine) or ureters (the ureters drain urine from the kidney into the bladder).

### **General Surgery**

**Cholecystectomy (gallbladder removal)**: injury to the common bile duct (tube that carries bile from the gallbladder to the small intestine), injury to the liver, leaking bile, inflamed pancreas (pancreatitis), retained stones in the common bile duct.

**Nissen Fundoplication (acid reflux surgery)**: tear/hole in the stomach lining, tear in the small intestine or esophagus, injury to the spleen, the stomach wrap around the esophagus slips into the chest or down onto the stomach or breaks down, narrowing or tightening of the esophagus that makes swallowing difficult, collapsed lung, difficulty swallowing, bloating and discomfort from gas buildup, hiatal hernia that occurs when the stomach migrates into the chest through a hole in the diaphragm (muscle separating the chest from the abdomen).

**Heller Myotomy (swallowing disorder surgery)**: tear/hole in the stomach lining, or esophagus, muscle division that is inadequate to improve swallowing, the stomach wrap around the esophagus slips into the chest or down onto the stomach or breaks down, narrowing or tightening of the esophagus that makes swallowing difficult, collapsed lung, difficulty swallowing, heartburn, reflux, hiatal hernia that occurs when the stomach, colon, spleen and/or small bowel migrates into the chest through a hole in the diaphragm (muscle separating the chest from the abdomen).

**Paraesophageal hernia (stomach and/or other organs migrate into chest from the abdomen through the natural opening in the diaphragm that has enlarged)**: tear/hole in the stomach lining, tear in the esophagus, tear in the colon or small bowel, spleen injury, the stomach wrap around the esophagus slips into the chest or down onto the stomach or breaks down, narrowing or tightening of the esophagus that makes swallowing difficult, collapsed lung, difficulty swallowing, bloating and discomfort from gas buildup, heartburn, reflux, poor emptying of the stomach, another hiatal hernia that occurs when the stomach or other organs migrate into the chest through the naturally occurring opening in the diaphragm (muscle separating the chest from the abdomen) that has enlarged again, mesh erosion into another organ, mesh infection, mesh causing an abnormal narrowing of the esophagus.

**Bariatric surgery includes: gastric bypass (stomach reduction surgery), sleeve gastrectomy and duodenal switch**: leaking and/or narrowing where two parts of the digestive tract were reconnected (stomach to small intestine or small intestine to small intestine), leaking from where the bowel is cut, too large or small of a stomach pouch, internal trapping and/or narrowing of the bowel leading to blockage or compromised blood supply to a bowel segment, malnutrition, dumping syndrome (food moves too quickly into small intestine causing diarrhea), dehydration, need for supplementation of vitamins, minerals and protein.

**Gastrectomy (removal of all/part of the stomach)**: leaking and/or narrowing where two parts of the digestive tract were reconnected (stomach to small intestine, esophagus to small intestine, or small intestine to small intestine), leaking from where the bowel is cut, internal trapping and/or narrowing of the small intestine leading to blockage or compromised blood supply to a bowel segment, malnutrition, dumping syndrome (food moves too quickly into small intestine causing diarrhea), dehydration, need for supplementation of vitamins, minerals, and protein. Difficulty swallowing, collapsed lung, inflammation of the stomach lining.

**Donor nephrectomy (kidney removal in donor)**: poor kidney function, injury to the bowel, spleen, pancreas or liver, inflamed pancreas, collapsed lung, trapped air between the chest wall and lung, injury to the diaphragm( muscle separating chest from the abdomen), adrenal gland bleeding, urine leak into the abdominal cavity.

**Adrenalectomy (removal of one or both adrenal glands)**: injury to the spleen, inflamed and/or injured pancreas, pancreatic fluid leak, injury to the diaphragm (muscle separating chest from the abdomen), adrenal gland bleeding, injury to the kidney and/or its blood vessels.

**Splenectomy (removal of all/part of the spleen)**: injury to the pancreas, injury to the kidneys or adrenal glands, inflamed pancreas, leak of pancreatic juices, and blood clot in the portal and/or splenic vein (large vein that moves blood from the spleen and GI tract to the liver), reduced immune function due to absence of the spleen.

**Hernia repair (ventral, incisional, umbilical, inguinal)**: recurrence, bowel injury, infection of mesh, erosion of mesh into another organ, urinary retention, chronic pain. For inguinal hernia repair: injury to a blood vessel supplying the testicle and/or testicular injury, injury to tube that carries sperm.

**Pancreatic surgery (removal of all/part of the pancreas)**: inflamed pancreas, leak of pancreatic or bile juices, narrowing or leaking at the spot where the pancreas is connected to the bowel, injury to the spleen or bowel, insufficient pancreatic function (for example, diabetes), diarrhea, poor stomach emptying.

**Bowel resection and other colorectal procedures (removal of all/part of the intestine)**: leaking and/or narrowing at the spot where two sections of bowel were reconnected, colorectal or anal dysfunction (cannot empty bowel, frequent bowel movements, leakage, or constipation), internal trapping and/or narrowing of the bowel leading to obstruction or compromised blood supply to a bowel segment.

**Liver resection (removal of part of the liver)**: bleeding, abnormal clotting of blood, leak of bile (fluid produced by liver), infection in the liver, abdominal cavity or throughout the body, insufficient liver remaining for adequate liver function, injury to small bowel, colon or stomach, injury to diaphragm, blood clot in the portal vein (major vein draining blood from the bowel into the liver), loss of blood supply to a part of the liver being left behind, abnormal function of kidneys, abnormal electrolytes.

### **Cardiac surgery**

**Internal mammary (thoracic) artery mobilization for coronary artery bypass graft**: graft injury, graft narrowing, cardiac arrest (heart stops beating), a clot of fat, blood or air creates a block in the bloodstream, heart is not able to pump as much blood through the body, bleeding disorder in which blood cannot properly clot, sac-like cover around the heart becomes swollen and causes a low fever and chest pain for up to 6 months, irregular heartbeat, heart blockage, lengthy time on a breathing machine (ventilator) of 48 hours or more, blood flow to the breastbone and surrounding structures is reduced and leads to compromised healing, need to cut breastbone.

**Cardiac tissue ablation (abnormal heart rhythm procedure)**: blood vessel becomes blocked by a clot that moved from another part of the body, injury to a blood vessel to the heart, tear in the heart, injury to the esophagus, abnormal connection from heart to the swallowing tube (esophagus) leading to severe or lethal bleeding or stroke, need to cut breastbone.

**Mitral valve repair (surgery on an abnormal/leaking mitral valve)**: repair fails requiring another operation, leakage of blood flow through or around the repaired valve, stroke caused by a clot that gets stuck in smaller arteries of the brain, heart failure (heart cannot pump enough blood to the body), tear in the aortic wall causes it to separate, lengthy time on a breathing machine of 48 hours or more, lengthy time for a heart lung machine, extracorporeal membrane oxygenation (mechanical device that provides cardiac and respiratory support), intraaortic balloon pump (mechanical device to increase oxygen to cardiac muscles) or other cardiac assist systems, fluid in the lungs, sudden lack of blood flow to a limb due to a block in the bloodstream, valve infection, irregular heartbeat that requires a pacemaker, sac-like cover around the heart becomes swollen and causes a low fever and chest pain for up to 6 months, bleeding disorder in which the blood cannot properly clot, heart attack, headache, memory loss and/or loss of mental clarity, infections that may affect the kidneys, chest, valves or bladder cut in the major artery(ies) that sends blood to the pelvis and legs, pooling of blood between the chest wall and lung, pressure on the heart when blood/fluids build up between the heart muscle and its outer sac, injury to a coronary artery (blood vessels supplying the heart), inadequate closure of the chest wall, need to cut breastbone.

**Endoscopic ASD closure (surgery to close a hole between two chambers of the heart)**: failed closure of the hole, stroke caused by a clot that gets stuck in smaller arteries of the brain, heart failure (heart cannot pump enough blood to the body), tear in the aortic wall causes it to separate, lengthy time on a breathing machine of 48 hours or more, lengthy time for a heart lung machine, extracorporeal membrane oxygenation (a mechanical device that provides cardiac and respiratory support), intraaortic balloon pump (mechanical device to increase oxygen to cardiac muscles) or other cardiac assist systems, fluid in the lungs, sudden lack of blood flow to a limb due to a block in the bloodstream, irregular heartbeat that requires a pacemaker, sac-like cover around the heart becomes swollen and causes a low fever and chest pain for up to 6 months, bleeding disorder in which the blood cannot properly clot, heart attack, memory loss and/or loss of mental clarity, infections that may affect the kidneys, chest, valves or bladder, cut in the major artery(ies) that sends blood to the pelvis and legs, lung dysfunction, pooling of blood between the chest wall and lung, pressure on the heart when blood/fluids build up between the heart muscle and its outer sac, need to cut breastbone.

**Mammary to left anterior descending coronary artery anastomosis for cardiac revascularization with adjunctive mediastinotomy**: graft injury or narrowing, blood vessel connection fails requiring another operation, stroke caused by a clot that gets stuck in smaller arteries of the brain, heart failure (heart cannot pump enough blood to the body), tear in the aortic wall causes it to separate, lengthy time on a breathing machine of 48 hours or more, lengthy time for a heart lung machine, extracorporeal membrane oxygenation (a mechanical device that provides cardiac and respiratory support), intraaortic balloon pump (mechanical device to increase oxygen to cardiac muscles) or other cardiac assist systems, fluid in the lungs, sudden lack of blood flow to a limb due to a block in the bloodstream, valve infection, irregular heartbeat that requires a pacemaker, kidney or lung failure, sac-like cover around the heart becomes swollen and causes a low fever and chest pain for up to 6 months, bleeding disorder in which the blood cannot properly clot, heart attack, memory loss and/or loss of mental clarity, infections that may affect the kidneys, chest, valves or bladder cut in the major artery(ies) that sends blood to the pelvis and legs, pooling of blood between the chest wall and lung, pressure on the heart when blood/fluids build up between the heart muscle and its outer sac, need to cut breastbone.

### **Pediatric surgery**

The Intuitive Surgical Endoscopic Instrument Control System has been successfully used in the pediatric surgical procedures listed below, among others. **The complications and risks listed below are not specific to the pediatric population but apply to procedures under consideration.**

**Pyeloplasty (surgery for a urinary blockage)**: infection of the kidney, a leaking of urine, narrowing of the urethra, bowel injury, kidney stones, narrowing or movement of the stent, blood in the urine, prolonged leaking of urine.

**Ureteral reimplantation (repositions how ureter connects to bladder)**: urinary tract infection that affects one or both kidneys, damage to urethra that can cause urine to collect in other areas of the body, scar tissue that causes narrowing at the site of the repair abnormal flow of urine from the bladder backwards to the kidneys.

**Cholecystectomy (gallbladder removal)**: injury to the common bile duct (tube that carries bile from the gallbladder to the small intestine), leaking bile, inflamed pancreas (pancreatitis), retained common bile duct stones, liver injury.

**Nissen Fundoplication (acid reflux surgery)**: tear/hole in the stomach lining, tear in the small intestine or esophagus, the stomach wrap around the esophagus pushes into the chest or breaks down, narrowing or tightening of the esophagus that makes swallowing difficult, collapsed lung, difficulty swallowing, bloating and discomfort from gas buildup, hiatal hernia which occurs when the stomach bulges into the chest through a hole in the diaphragm (muscle separating the chest from the abdomen).

**Paraesophageal hernia (stomach bulges into chest through a hole in the diaphragm)**: tear/hole in the stomach lining, tear in the esophagus, tear in the colon or small bowel, spleen injury, the stomach wrap around the esophagus pushes into the chest or breaks down, narrowing or tightening of the esophagus that makes swallowing difficult, collapsed lung, difficulty swallowing, bloating and discomfort from gas buildup, heartburn, reflux, poor emptying of the stomach, hiatal hernia that occurs when the stomach bulges into the chest through a hole in the diaphragm (muscle separating the chest from the abdomen), mesh erosion into another organ, mesh infection, mesh narrowing the esophagus.

**Aortic ring ligation (surgery to repair abnormal aorta/tissue)**: respiratory system fails (difficult or unable to breathe).

**Patent ductus arteriosus (PDA) ligation (surgery to close/repair an opening in the ductus arteriosus blood vessel)**: abnormal breathing and heart rate, lung arteries stretch/widen, vocal cords do not work normally, narrowing or injury to the aorta (major blood vessel in the body), lymph fluid collects around the lungs, collapsed lung.

**Endoscopic ASD closure (surgery to close a hole between two chambers of the heart)**: failed closure of the defect, stroke caused by a clot that gets stuck in smaller arteries of the brain, heart failure (heart cannot pump enough blood to the body), tear in the aortic wall causes it to separate, lengthy time on a breathing machine of 48 hours or more, lengthy time for a heart lung machine, extracorporeal membrane oxygenation (outside body technique to provide cardiac and respiratory support), intraaortic balloon pump (mechanical device to increase oxygen to cardiac muscles) or other cardiac assist systems, fluid in the lungs, sudden lack of blood flow to a limb due to a block in the bloodstream, irregular heartbeat that requires a pacemaker, sac-like cover around the heart becomes swollen and causes a low fever and chest pain for up to 6 months, bleeding disorder in which the blood cannot properly clot, heart attack, memory loss and/or loss of mental clarity, infections that may affect the kidneys, chest, valves or bladder, cut in the major artery(ies) that sends blood to the pelvis and legs, lung dysfunction, pooling of blood between the chest wall and lung, pressure on the heart when blood/fluids build up between the heart muscle and its outer sac.

### **Thoracic surgery**

**Pulmonary resection (removal of part of lung)**: air leak from lungs, lung infection, inability to breathe sufficiently without extra oxygen or a breathing machine, abnormal/irregular heartbeat, breathing tube needs to be re-inserted, abnormal path for air between lung airways and pleural cavity (space around the lungs), lung failure, lymph fluid collects around lungs, difficulty breathing, remaining part of lung becomes twisted, collapsed lung, abnormal vocal cord function.

**Esophagectomy (removal of part of esophagus)**: leaking from the stomach and its connection to the esophageal remnant, lack of blood supply to the reconstructed esophagus, narrowing of the connection between esophagus and stomach, injury to the airway, lung infection, difficulty breathing heart attack, heart failure, abnormal/irregular heartbeat, abnormal vocal cord function with change in voice or speech, excess lymphatic fluid leaks in the pleural cavity (space around the lungs), migration of abdominal organs into the chest cavity through the natural opening in the diaphragm (muscle separating chest and abdomen).

**Mediastinal mass resection (chest tumor removal) including thymectomy (removal of thymus gland)**: lengthy time on a breathing machine of 48 hours or more, air leaks out of lungs, difficulty breathing, fluid buildup around the heart, respiratory failure, collapsed lung, injury to heart, abnormal vocal cord function leading to hoarseness, lymph fluid collects around lungs, need to cut breastbone, injury to nerve that controls diaphragm during breathing (muscle separating chest and abdomen) leading to shortness of breath.

### **Head and Neck Surgery**

**Thyroidectomy (thyroid gland removal)**: low levels of thyroid hormone, parathyroid hormone and calcium, larynx (voice box) nerve damage that lasts or returns, breathing tube needs to be re-inserted, deep cut in windpipe, abnormal vocal cord function, difficulty breathing, deformed appearance, lasting pain or numbness, bleeding from blood vessels or tissue in the neck, change in voice or speech. NOTE: Thyroidectomy is not cleared by the FDA in the USA.

**Transoral Robotic Surgery-TORS (head and neck surgery)**: bleeding that may be life-threatening, difficulty swallowing which could include the need for a permanent feeding tube without eating by mouth, breathing tube needs to be re-inserted, need to create breathing hole in the neck (tracheotomy and tracheostomy), need to use breathing tube and ventilator for a long time, changes to or loss of taste, tongue cannot move, difficulty opening mouth, broken teeth, narrowing of throat, changes in speech or voice quality, abnormal path from the gland that produces saliva, vocal cord damage, difficulty speaking, injury to teeth, difficulty breathing due to an airway blockage, loss of feeling in tongue, lip injury, injury to nerves in tongue and weak tongue. NOTE: TORS is intended for use only in benign and early-to-moderate stage cancerous tumors (classified as T1 or T2) and for benign base of tongue resection procedures.

## Surgical risks—surgeon

Serious complications may occur with any surgery, including surgery with the da Vinci system, up to and including death. In addition, there are risks that are specific to certain surgical procedures. Certain pre-existing medical conditions can also increase the risks of any surgery. Surgeons should discuss pertinent surgical risks with their patients.

- **Section I** includes the adverse events, risks, and complications of any type of surgery.
- **Section II** includes the adverse events, risks, and complications of minimally invasive surgical techniques.
- **Section III** includes the adverse events, risks, and complications of surgery with the da Vinci system.
- **Section IV** includes the adverse events, risks, and complications of representative, specific surgical procedures.

## I. Adverse events, risks, and complications of any surgical type

**This section covers potential adverse events, risks, and complications associated with all operative procedures in general and are NOT specific to the surgical method or approach used** (for example, abdominal/laparotomy incision (“open surgery”), thoracotomy incision, thoracoscopy, robotic-assisted laparoscopy using the da Vinci system, and conventional laparoscopy).

**1\. Intraoperative**

- Bleeding, excessive >500 mL, requiring blood transfusion or causing hemodynamic instability
- Injury (inadvertently caused by laceration, tear, perforation, puncture, electrocautery) to organ , structure, or tissue , including , but not limited to: major blood vessel, hollow viscous organs (e.g., bowel, bladder), solid organs (e.g., spleen, kidney, liver, heart, lung), ureter, nerve
- Loss of needle, instrument fragment or any foreign body during surgery in patient’s body
- Anesthesia risks (including heart attack, stroke, deep venous thrombosis, pulmonary embolism, pneumonia, dental injury, vocal cord injury, and death)
- Patient-positioning injury: hemodynamic, intraocular pressure, neurologic, soft tissue injuries

**2\. Postoperative**

These complications may resolve on their own with non-operative therapy, may require medical/pharmaceutical treatment such as antibiotics, may require radiological intervention such as drain placement or embolization, may require prolonged hospitalization, may require re-admission to the hospital, or may require additional procedures or surgical intervention such as re-operation.

- Bleeding
- Urinary: urinary tract infection, urinary retention
- Gastrointestinal: ileus, nausea/vomiting, small bowel obstruction
- Cardiac: myocardial infarction, arrhythmia, pericarditis
- Thromboembolic: deep venous thrombosis, pulmonary embolus
- Pulmonary: atelectasis, pneumonia, pleural effusion, pulmonary edema, need for re-intubation or prolonged intubation
- Infection / Hematoma / Fluid collection / Abscess (intra-abdominal, intra-pelvic, intra- thoracic)
- Peritonitis
- Rhabdomyolysis
- Injury to adjacent organs
- Serous drainage from wound, prolonged or excessive
- Wound infection: incisional
- Fascial dehiscence: incisional
- Hernia: incisional
- Renal: acute renal failure
- Neuropathy; persistent pain
- Visual loss, temporary or permanent
- Spread of cancer cells
- Cerebrovascular: transient ischemic attack, ischemic or hemorrhagic stroke
- Inability to work
- Recurrence of disease or symptoms
- Death

## II. Adverse events, risks, and complications of minimally invasive surgery

**This section covers potential adverse events, risks, and complications associated specifically with operative procedures performed minimally invasively through an endoscopic approach in addition to the above listed risks** (for example, conventional laparoscopy, transoral endoscopy and robotic-assisted laparoscopy using the da Vinci system).

**1\. Intraoperative**

- Conversion to open or hand-assisted surgery (typically due to patient anatomy, severe inflammation or adhesions, intraoperative injury, technical malfunction, extent of malignant invasion, extent of disease, or inability of patient to tolerate pneumoperitoneum)
- Veress needle or trocar injury to hollow viscous (e.g., bowel, bladder), solid organs (e.g., spleen, kidney, liver, heart, lung) or blood vessel(s)
- Longer operative and anesthesia time
- Air/gas entering the bloodstream leading to heart dysfunction or stroke
- Ocular or laryngeal-facial complications related to Trendelenburg position
- Subcutaneous emphysema
- Hemodynamic and physiologic changes from the pneumoperitoneum and gas used

**2\. Postoperative**

- Shoulder pain resulting from insufflated gas

## III. Adverse events, risks, and complications of robotic–assisted surgery using the da Vinci system

In addition to the risks in I and II above, which are not unique to da Vinci, this section covers potential negative outcomes, risks, and complications of robotic-assisted surgery using the da Vinci system. Surgery facilitated by the da Vinci surgical system may be associated with longer operative and anesthesia times than surgery with other approaches. As with any surgical device, there is also the risk that the da Vinci surgical system could malfunction or fail, leading to serious injury or the need to switch to another type of surgical approach. Switching to another surgical approach could also result in a longer procedure time, a longer time under anesthesia and increased complications.

## IV. Adverse events, risks, and complications of representative specific procedures

**This section covers potential adverse events, risks, and complications associated with specific operative procedures, not specific to the surgical method or approach used** (for example, abdominal/laparotomy incision, thoracotomy incision, robotic-assisted laparoscopy using the da Vinci system, and conventional laparoscopy—except for TORS or Transoral Robotic Surgery, which is specific to surgery with the da Vinci system). These procedural risks are in addition to the risks described under Sections I, II and III above.

Note: Not all procedures listed below are available for all da Vinci systems, instruments and accessories in all markets.

### **Urology**

**Radical prostatectomy**: surrounding nerve damage that can lead to urinary incontinence and/or erectile dysfunction, rectal or bowel injury, urethral stricture, lymphocele, lymphedema; bowel obstruction.

**Pyeloplasty**: pyelonephritis, anastomotic leak, ureteral stricture, bowel injury, urinoma, stone formation, stent migration or obstruction, hematuria, prolonged urinary leak.

**Cystectomy**: urine leak, rectal injury, anastomotic stricture, fistula formation, incontinence, impotence, pelvic lymphocele.

**Nephrectomy**:  renal insufficiency, urine leak, splenic, hepatic or pancreatic laceration, bowel injury, pneumothorax, diaphragmatic injury, urinary fistula, urinoma, renal infarction, lymphocele.

**Ureteral reimplantation**: pyelonephritis, urinary extravasation, anastomotic stricture, ureteral reflux.

### **Gynecology**

**Hysterectomy, benign**: urinary tract injury, vaginal cuff problem (separation, adhesions, granulation tissue, infection, cellulitis, hematoma), bladder injury, bowel injury, vaginal tear or laceration, vaginal shortening, voiding dysfunction, fistula formation: vesicovaginal, rectovaginal. Uterine tissue may contain unsuspected cancer. The cutting or morcellation of uterine tissue during surgery may spread cancer, and decrease the long-term survival of patients.

**Hysterectomy, malignant**: urinary tract injury, vaginal cuff problem (separation, adhesions, granulation tissue, infection, cellulitis, hematoma), bladder injury, bowel injury, vaginal tear or laceration, vaginal shortening, voiding dysfunction, fistula formation: vesicovaginal, rectovaginal.

**Myomectomy**: uterine perforation, uterine rupture, preterm birth, spontaneous abortion Uterine tissue may contain unsuspected cancer. The cutting or morcellation of uterine or fibroid tissue during surgery may spread cancer, and decrease the long-term survival of patients.

**Sacrocolpopexy**: mesh erosion/infection (if mesh used in repair) with need for re-operation, rectal injury, bladder injury, rectocele, cystocele, urinary tract injury, vaginal cuff dehiscence, urinary incontinence, hematoma (retropubic, perineal, or other).

**Endometriosis resection**: bowel injury, bladder injury, urinary tract injury.

### **General surgery**

**Cholecystectomy**: common bile duct injury; bile leak; pancreatitis, retained common bile duct stones, injury to liver or duodenum.

**Nissen Fundoplication**: gastric, duodenal or esophageal perforation, herniation of wrap, slipped wrap, dysphagia, pneumothorax, peri-esophageal abscess, esophageal stricture, hiatal hernia, vagal nerve injury resulting in gastroparesis, gas bloat syndrome, splenic injury.

**Paraesophageal and other hiatal hernia repairs**: gastric, duodenal, or esophageal perforation, herniation of wrap, dysphagia, pneumothorax, esophageal stricture, recurrent hiatal hernia, vagal nerve injury resulting in gastroparesis, gas bloat syndrome, heartburn, reflux, infection of mesh, and mesh erosion.

**Heller Myotomy**: gastric, duodenal or esophageal perforation, herniation of wrap, dysphagia, pneumothorax, esophageal stricture, hiatal hernia, heartburn, reflux, vagal nerve injury resulting in gastroparesis.

**Bariatric procedures (Sleeve Gastrectomy/ Roux-en-Y gastric bypass, Duodenal Switch)**: anastomotic/staple line leak, malnutrition, anastomotic stricture, dumping syndrome, dehydration, dysphagia, internal herniation, or bowel obstruction.

**Donor nephrectomy**: renal insufficiency, splenic, pancreatic or hepatic laceration, adrenal hematoma, pancreatitis, pneumothorax, diaphragmatic injury.

**Gastrectomy**: anastomotic/staple line leak, anastomotic stricture, dumping syndrome, dehydration, dysphagia, pneumothorax, internal herniation or bowel obstruction.

**Pancreatic procedures (Pancreatectomy and Whipple Procedure)**: pancreatitis, pancreatic leak, biliary leak, anastomotic leak, anastomotic stricture, splenic injury, pancreatic insufficiency, intestinal injury, delayed gastric emptying, diarrhea.

**Adrenalectomy**: splenic injury, pancreatitis, diaphragmatic injury, adrenal hematoma, adrenal insuffiency.

**Splenectomy**: pancreatic injury, kidney injury, adrenal injury, pancreatitis, pancreatic leak, portal vein thrombosis, compromised immune function.

**Hernia repair (ventral, incisional, umbilical, inguinal)**: recurrence, bowel injury, mesh infection, urinary retention. For inguinal hernia repair: testicular injury, chronic pain.

**Bowel resection and other colorectal procedures (Colectomy, Sigmoidectomy, Low Anterior Resection, Abdominopelvic resection (APR), Intersphincteric resection, Proctectomy, Rectopexy)**: anastomotic leak, anastomotic stricture, colorectal or anorectal dysfunction.

### **Cardiac surgery**

**Internal mammary artery mobilization**: graft injury, graft stenosis, cardiac arrest, embolism, low cardiac output syndrome, persistent coagulopathy, post-pericardiotomy syndrome, structural damage, arrhythmia, heart block, prolonged ventilation >48 hours, sternal de-vascularization.

**Cardiac tissue ablation**: thromboembolism, circumflex artery injury, cardiac perforation, esophageal injury.

**Mitral valve repair**: failed repair requiring replacement or repair, embolic stroke, ischemic heart failure, aortic dissection, prolonged ventilation >48 hours, prolonged time for: a heart-lung bypass, extracorporeal membrane oxygenation, intraaortic balloon pump or other cardiac assist systems, pulmonary edema, acute limb ischemia, valve infection, arrhythmia requiring pacemaker implantation, post-pericardiotomy syndrome (low grade fever and chest pain up to 6 months), pericarditis, persistent coagulopathy, heart attack, pericardial tamponade, memory loss and/or loss of mental clarity, arterial dissection, circumflex coronary artery injury, inadequate closure.

**Endoscopic ASD Closure**: failed closure of defect, embolic stroke, ischemic heart failure, aortic dissection, prolonged ventilation >48 hours, prolonged time for: a heart-lung bypass, extracorporeal membrane oxygenation, intraaortic balloon pump or other cardiac assist systems, pulmonary edema, acute limb ischemia, arrhythmia, heart block, cardiac arrest, hemothorax, pericardial tamponade, valve dysfunction, thromboembolism, thrombus formation, aortic dissection, arterial dissection, acute respiratory distress syndrome (ARDS), post-pericardiotomy syndrome, pericarditis, heart failure, persistent coagulopathy.

**Mammary to left anterior descending coronary artery anastomosis for cardiac revascularization with adjunctive mediastinotomy**: graft injury, graft stenosis, failed anastomosis, cardiac arrest, embolic stroke, aortic dissection, acute limb ischemia, heart attack, arrhythmias, prolonged ventilation >48 hours, prolonged time for: a heart-lung bypass, extracorporeal membrane oxygenation, intraaortic balloon pump or other cardiac assist systems, valve dysfunction, hemothorax, pericardial tamponade, persistent coagulopathy, post-pericardiotomy syndrome, memory loss and/or loss of mental clarity, kidney or lung failure, heart failure.

### **Pediatric surgery**

The Intuitive Surgical endoscopic instrument control system has been successfully used in the pediatric surgical procedures listed below, among others. **The complications / risks listed below are not specific to the pediatric population but are applicable for procedures under consideration.**

**Pyeloplasty**: pyelonephritis, anastomotic leak, ureteral stricture, bowel injury, urinoma, stone formation, stent migration or obstruction, hematuria, prolonged urinary leak

**Ureteral reimplantation**: pyelonephritis, urinary extravasation, anastomotic stricture, voiding dysfunction, vesicoureteral reflux.

**Cholecystectomy**: common bile duct injury; bile leak; pancreatitis, retained common bile duct stones.

**Nissen Fundoplication gastric**, duodenal or esophageal perforation, herniation of wrap, slipped wrap, dysphagia, pneumothorax, peri-esophageal abscess, esophageal stricture, hiatal hernia, gas bloat syndrome, splenic injury.

**Aortic Ring Ligation:** respiratory failure.

**Patent Ductus Arteriosus (PDA) ligation**: cardiorespiratory instability, ductal pseudoaneurysm, vocal cord dysfunction, pneumothorax, chylothorax, pulmonary arterial dilatation.

**Atrial Septal Defect Closure**: structural deterioration of repair, arrhythmia, heart block, cardiac arrest, prolonged ventilation >48 hours, prolonged time for: a heart-lung bypass, extracorporeal membrane oxygenation, intraaortic balloon pump or other cardiac assist systems, hemothorax, pericardial tamponade, valve dysfunction, thromboembolism, thrombus formation, aortic dissection, acute limb ischemia arterial dissection, acute respiratory distress syndrome (ARDS), post-pericardiotomy syndrome, pericarditis, heart failure, persistent coagulopathy.

### **Thoracic surgery**

**Pulmonary resection (Wedge Resection, Segmentectomy, Lobectomy)**: persistent air leak, pneumonia, prolonged mechanical ventilation >48 hours, atrial fibrillation, acute respiratory distress syndrome (ARDS), chylothorax, re-intubation, arrhythmias, bronchopleural fistula, phrenic nerve injury, esophageal injury, difficulty breathing, collapsed lung, pulmonary volvulus, recurrent laryngeal nerve injury leading to vocal cord dysfunction.

**Esophagectomy:** anastomotic leak, pneumonia, cardiac complications (infarction, failure, atrial fibrillation), recurrent laryngeal nerve injury, chyle leak.

**Mediastinal mass resection (including thymectomy)**: prolonged ventilation >48 hours, persistent air leak, pericardial effusion, mixed respiratory syndrome, chylothorax, pneumothorax, re-intubation, pneumonia, difficulty breathing, acute respiratory distress syndrome (ARDS), atrial fibrillation, cardiac injury, conversion to sternotomy, recurrent laryngeal nerve injury leading to vocal cord dysfunction, phrenic nerve injury.

### **Head and neck surgery**

**Thyroidectomy**: transient or permanent hypothyroidism, hypoparathyroidism/hypocalcemia, recurrent laryngeal nerve injury, re-intubation, tracheal laceration, vocal cord dysfunction, cosmetic deformity, persistent pain or numbness, transection of carotid sheath structures. NOTE: Thyroidectomy is not cleared by the FDA in the USA.

**Transoral Robotic Surgery (TORS)**: transoral bleeding that could include life threatening bleeds, difficulty swallowing that could include need for a permanent feeding tube with no eating by mouth, airway obstruction, re-intubation, need for tracheotomy, tracheostomy placement, prolonged intubation and need for ventilation, paralysis of tongue, difficulty opening mouth or trismus, broken teeth, pharyngeal stenosis, laryngeal stenosis, changes in speech or voice quality, salivary gland fistula, vocal cord damage, speech and swallowing dysfunction, dysphagia, dysphonia, lingual hypoesthesia, lip injury: abrasion, laceration, thermal trauma, dysguesia, hypoglossal nerve injury and tongue-weakness changes in taste sensitivity with loss of sense of taste. NOTE: TORS otolaryngology surgical procedures are restricted to benign and malignant tumors classified as T1 and T2 and for benign base of tongue resection procedures.

## Safety Statements

Surgeons should counsel their patients that serious complications may occur with any surgery, including surgery with a da Vinci system, up to and including death. Examples of serious and life-threatening complications, which may require prolonged and/or unexpected hospitalization and/or reoperation, include but are not limited to one or more of the following:

Injury to tissues and/or organs:

- Bleeding
- Infection
- Internal scarring that can cause long-lasting dysfunction or pain.

Surgeons should discuss these and all risks associated with surgery with their patients, including but not limited to the following:

- Potential for human error
- Potential for equipment failure
- Potential for anesthesia complications.

Risk specific to minimally invasive surgery, including surgery with a da Vinci system, include but are not limited to:

- Temporary pain or nerve injury associated with positioning
- A longer operative time
- The need to convert the procedure to an open approach.

Converting the procedure could mean a longer operative time, a longer time under anesthesia, and/or the need for additional or larger incisions and/or increased complications.

Surgeons should counsel their patients that there are other surgical approaches available. You should discuss your surgical experience and review these and all risks with your patients. Patients and physicians should review all available information on non-surgical and surgical options in order to make an informed decision. Clinical studies are available through the National Library of Medicine at [www.ncbi.nlm.nih.gov/pubmed](http://www.ncbi.nlm.nih.gov/pubmed). For complete important safety information, please refer to [www.intuitive.com/safety](https://www.intuitive.com/en-us/about-us/company/legal/safety-information). For a product’s intended use and/or indications for use, risks, full cautions, and warnings, please refer to the associated user manual(s).

Individuals' outcomes may depend on a number of factors—including but not limited to—patient characteristics, disease characteristics and/or surgeon experience.

**User Responsibilities**

There are several models of the da Vinci system. Be sure to read and understand all information in the applicable user manuals, including representative, specific procedures in the Professional Instructions for Use, contraindications, full cautions and warnings, before using da Vinci products. Failure to properly follow all instructions may lead to injury and result in improper functioning of the device.  Contraindications applicable to the use of conventional endoscopic instruments also apply to the use of all da Vinci instruments.

Training provided by Intuitive is limited to the use of the da Vinci surgical system and does not replace the necessary medical training and experience required to perform surgery. The da Vinci surgical system should be used only by surgeons who have received specific training in its use.

Before performing any da Vinci procedure, physicians are responsible for receiving sufficient training and proctoring to ensure that they have the skill and experience necessary to protect the health and safety of their patients.

Users of the da Vinci system must follow all instructions for use supplied with the system, instruments and accessories. Use of da Vinci instruments for tasks other than that for which they were designed may result in damage or breakage. Failure to properly follow instructions, notes, cautions, warnings and danger messages associated with this equipment may lead to serious injury or complications for the patient, including death.

In the event that the da Vinci system, instruments, or accessories do not work as expected or if you are aware of a product deficiency or adverse event, please contact Intuitive Customer Service immediately. Please refer to the Customer Service contact information in the product Instructions for Use.

## Ion endoluminal system

**Risks associated with bronchoscopy**

Risks associated with bronchoscopy through an endotracheal tube and under general anesthesia are infrequent and typically minor and may include but are not limited to: sore throat, hoarseness, respiratory complications including dyspnea or hypoxemia, airway injury, bronchospasm, laryngospasm, fever, hemoptysis, chest, or lung infection including pneumonia, lung abscess, or an adverse reaction to anesthesia. Although rare, the following complications may also occur: bleeding, pneumothorax (collapsed lung), cardiovascular complications including but not limited to myocardial infarction (heart attack) and cerebrovascular accidents (strokes), respiratory failure, air embolism, or death. As with other medical procedures, there may be additional risks associated with the use of general anesthesia and/or endotracheal intubation which are not listed above; you should consult a healthcare professional regarding these and other potential risks.

Procedures using the Ion endoluminal system may be associated with longer procedure and/or longer anesthesia time.

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