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Important Safety Information

Serious complications may occur with any surgery, including da Vinci Surgery, 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.

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 da Vinci Surgery.
• Section IV includes the negative outcomes, risks and complications of representative, specific surgical procedures.

I. Adverse Events, Risks, and Complications of Any Surgical Type

This section covers 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, da Vinci system robotic-assisted laparoscopy, and conventional laparoscopy).

1. Intraoperative
• Bleeding, excessive >500 mL, requiring blood transfusion
• 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 (bowel, bladder), solid organs (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 and death)

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 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
• 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 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 da Vinci system robotic-assisted laparoscopy).

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, or inability of patient to tolerate
pneumoperitoneum)
• Veress needle or trocar injury to hollow viscous (bowel, bladder), solid organs (spleen, kidney, liver, heart, lung) or blood
vessel
• Longer operative and anesthesia time
• Neuropraxia related to patient positioning
• Ocular or laryngeal-facial complications related to trendelenberg position

2. Postoperative
• Shoulder pain
• Gas pain

III. Adverse Events, Risks and Complications of da Vinci robotic –assisted surgery

In addition to the risks in I and II above, which are not unique to da Vinci, this section covers negative outcomes, risks and complications of da Vinci robotic-assisted surgery. 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 robotic surgical system could malfunction or fail leading to serious injury or the need to switch to another type of procedure. Switching to another procedure type 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 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, da Vinci system robotic-assisted laparoscopy, and conventional laparoscopy). These procedural risks are in addition to the risks described under Sections I, II and III above.

Urology

Radical Prostatectomy: surrounding nerve damage which 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 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. Patients undergoing a hysterectomy for presumed benign disease who have an undiagnosed cancer may be at risk of having cancer cells spread if the uterus is cut into pieces for removal.

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. Patients undergoing a myomectomy who have an undiagnosed cancer may be at risk of having cancer cells spread through the abdomen if the uterus is cut into pieces for removal.

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). Patients undergoing a hysterectomy for presumed benign disease who have an undiagnosed cancer may be at risk of having cancer cells spread if the uterus is cut into pieces for removal.

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

General Surgery

Cholecystectomy: common bile duct injury; bile leak; pancreatitis

Nissen Fundoplication: gastric, duodenal or esophageal perforation, herniation of wrap, dysphagia, pneumothorax, peri-esophageal abscess, esophageal stricture, hiatal hernia

Paraesophageal and Other Hiatal Hernia Repairs: gastric, duodenal or esophageal perforation, herniation of wrap, dysphagia, pneumothorax, esophageal stricture, hiatal hernia

Heller Myotomy: gastric, duodenal or esophageal perforation, herniation of wrap, dysphagia, pneumothorax, esophageal stricture, hiatal hernia

Bariatric Procedures (Sleeve Gastrectomy/ Roux-en-y gastric bypass, Duodenal Switch): anastomotic/staple line leak, malnutrition, anastomotic stricture, dumping syndrome, dehydration, dysphagia

Donor Nephrectomy: renal insufficiency, splenic laceration, adrenal hematoma, pancreatitis, pneumothorax, diaphragmatic injury

Gastrectomy: anastomotic or duodenal leak, anastomotic stricture, dysphagia, pneumothorax

Pancreatic Procedures (Pancreatectomy and Whipple Procedure): pancreatitis, pancreatic leak, anastomotic leak, anastomotic stricture, splenic injury, pancreatic insufficiency, intestinal injury

Adrenalectomy: splenic injury, pancreatitis, diaphragmatic injury, adrenal hematoma

Splenectomy: pancreatic injury, kidney injury, adrenal injury, pancreatitis, pancreatic leak, portal vein thrombosis

Bowel Resection and Other Colorectal Procedures (Colectomy, Sigmoidectomy, Low Anterior Resection, APR, Intersphincteric Resection, Proctectomy, Rectopexy): anastomotic leak, anastomotic stricture, 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 Atrial Septal Defect 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, postpericardiotomy 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,

Cholecystectomy: common bile duct injury; bile leak; pancreatitis

Nissen Fundoplication: pneumothorax, gastric or duodenal perforation, wrap herniation/ breakdown, esophageal stricture, dysphagia, enterocutaneous fistula, hiatal hernia, para-esophageal hernia

Aortic Ring Ligation: respiratory failure

Patent Ductus Arteriosus 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 ventilation >48 hours, atrial fibrillation,, acute respiratory distress syndrome (ARDS), chylothorax, re-intubation, arrhythmias, bronchopleural fistula, phrenic nerve injury, esophageal injury, recurrent laryngeal nerve injury leading to vocal cord dysfunction

Mediastinal Mass Resection: prolonged ventilation >48 hours, persistent air leak, pericardial effusion, mixed respiratory syndrome, chylothorax, pneumothorax, re-intubation, pneumonia, 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 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 considered an off-label procedure in the US.

Transoral Robotic Surgery (TORS): transoral bleeding which could include life threatening bleeds, difficulty swallowing which 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: Transoral Robotic otolaryngology surgical procedures are restricted to benign and malignant tumors classified as T1 and T2