da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AFTER A DA VINCI S MITRAL VALVE REPAIR PROCEDURE, THE PATIENTS BLOOD PRESSURE HAD DROPPED, THE SURGEON PERFORMED A MINI THORACOTOMY TO IDENTIFY THE SOURSE OF THE BLOOD PRESSURE LOSS. A LEAK IN THE MITRAL VALVE WAS FOUND AND A STERNOTOMY WAS PERFORMED TO REPAIR OF THE VALVE; HOWEVER, THE PATIENT EXPIRED BEFORE THE VALVE COULD BE REPAIRED. THE SITE HAS BEEN CONTACTED FOR ADDITIONAL INFORMATION RELATED TO THIS EVENT; HOWEVER, NO NEW INFORMATION HAS BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(4) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED A LEGAL COMPLAINT WITH THE FOLLOWING ALLEGATION: IT WAS REPORTED THAT SHORTLY AFTER A DA VINCI SI NISSEN FUNDOPLICATION PROCEDURE PERFORMED ON (B)(6) 2011, THE PATIENT REPORTEDLY DEVELOPED GASTROPARESIS. THE PATIENT CONSULTED WITH A GASTROENTEROLOGIST WHO CONCLUDED THAT THE PATIENT'S GASTROPARESIS ALLEGEDLY DEVELOPED BECAUSE HER VAGUS NERVE WAS DAMAGED. NO FURTHER CLINICAL INFORMATION WAS PROVIDED.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT EIGHT DAYS AFTER A DA VINCI SI TONGUE BASE RESECTION (TORS) PROCEDURE WAS SUCCESSFULLY PERFORMED, THE PATIENT EXPIRED DUE TO UNCONTROLLABLE POST OPERATIVE BLEEDING.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT POST A SUCCESSFUL DA VINCI SI HYSTERECTOMY PROCEDURE THE PATIENT SUFFERED A PERIOPERATIVE LEFT HEMISPHERE CEREBROVASCULAR ACCIDENT (CVA) SECONDARY TO COMPLETE OCCLUSION OF LEFT CAROTID ARTERY (EMBOLIC). POSTOPERATIVELY NOTED TO BE COMPLETELY APHAGIC AND RIGHT HEMIPLEGIC. A CLOT WAS IDENTIFIED VIA MRA IMAGING FROM BIFURCATION OF AORTA. NO H/O HYPERCOAGULABILITY. FIBROMUSCULAR HYPERPLASIA (FMH) SIGNIFICANT FOR MOTHER SUFFERING FATAL CEREBROVASCULAR ACCIDENT (CVA). REPORTEDLY, THE PATIENT'S DEMISE WAS UNRELATED TO THE DA VINCI S SURGICAL SYSTEM.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY ON (B)(6) 2011 DUE TO ENDOMETRIOSIS, AND CHRONIC PELVIC PAIN. ISI WAS PROVIDED WITH THE PATIENT'S OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES OTHER HOSPITAL REPORTS THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY THE SURGICAL PROCEDURE AND THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. ON THE DAY OF SURGERY, THE PATIENT DEVELOPED INCREASING ABDOMINAL PAIN AND WAS FOUND TO HAVE A LOW HEMATOCRIT. AN INTRABDOMINAL HEMATOMA WAS DIAGNOSED AND TREATED WITH A BLOOD TRANSFUSION OF PACKED RED BLOOD CELLS.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI HYSTERECTOMY FOR PELVIC PAIN AND MENORRHAGIA PROCEDURE ON (B)(6) 2011. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. ON (B)(6) 2011 THE PATIENT PRESENTED WITH A 1CM AREA AT THE TOP OF THE VAGINA THAT WAS BLEEDING AND CAUSING PAINFUL INTERCOURSE. THIS AREA WAS REVISED IN SURGERY AND FOUND TO BE AN AREA OF ADHESION OF THE SIGMOID COLON INCLUDING SIGMOID EPIPLOICA TO THE TOP OF THE CUFF. THIS AREA WAS DISSECTED OUT AND THE EDGES OF THE VAGINA REFRESHED AND CLOSED. NO FURTHER CLINICAL INFORMATION WAS PROVIDED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL MEDIATION EFFORT ON (B)(4) 2013 INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION INCLUDING MEDICAL RECORDS OF A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY PROCEDURE ON (B)(6) 2011 DUE TO ABNORMAL UTERINE BLEEDING. ON (B)(6) 2011, THE PATIENT RETURNED TO THE HOSPITAL'S EMERGENCY ROOM (ER) COMPLAINING OF ABDOMINAL PAIN AND SWELLING. ACCORDING TO THE OPERATIVE (OR) REPORT REGARDING THE SURGERY ON (B)(6) 2011 THE SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT'S UTERUS WAS REMOVED VAGINALLY AND WITHOUT DIFFICULTY. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SURGICAL SI SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED AND THERE WAS NO INDICATION THAT THE PATIENT EXPERIENCED ANY INTRAOPERATIVE COMPLICATIONS. IT WAS STATED THAT THE PATIENT WAS AWAKENED AND TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2011. DURING THE PATIENT'S ER VISIT ON (B)(6) 2011, THE PATIENT REPORTED ABDOMINAL PAIN, BLOOD SPOTTING AND THAT SEXUAL INTERCOURSE WAS PAINFUL. ACCORDING TO AN OP REPORT DATED (B)(6) 2011, THE PATIENT HAD TO UNDERGO A SURGICAL PROCEDURE FOR VAGINAL CUFF REVISION AND SMALL BOWEL SEROSAL

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL MEDIATION EFFORT ON (B)(4) 2013 INTUITIVE SURGICAL RECEIVED INFORMATION INCLUDING MEDICAL RECORDS OF A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY PROCEDURE WITH BILATERAL-OOPHORECTOMY AND CYSTOSCOPY PROCEDURE ON (B)(6) 2011. ON (B)(6) 2011 THE PATIENT WAS ADMITTED INTO THE EMERGENCY ROOM OF ANOTHER HOSPITAL DUE TO WHAT THE PATIENT REPORTED AS EXPERIENCING ABDOMINAL PAIN. THE ATTENDING SURGEON SUSPECTED POSSIBLE ACUTE ABDOMINAL INFECTION AND DETECTED HERNIA AT THE TROCAR SITE. DURING PELVIC EXPLORATION THE SURGEON NOTED A LARGE AMOUNT OF FLUID AND SUSPECTED A URETERAL INJURY. THE PATIENT REQUIRED AN EXPLORATORY LAPAROTOMY, A CYSTOSTOMY, URETERAL AND BLADDER EXPLORATION, PLACEMENT OF BILATERAL URETERAL STENTS, AND AN APPENDECTOMY. THE PATIENT UNDERWENT THIS PROCEDURE WITHOUT ANY COMPLICATIONS AND SHE WAS NOTED TO HAVE REMARKABLE POST-OPERATIVE RECOVERY WITH NORMAL RETURN OF ALL BLADDER FUNCTION. THE PATIENT'S OPERATIVE REPORT (OP) REGARDING THE SURGERY DATE OF (B)(6) 2011 INDICATES THAT THE PATIENT'S PREOPERATIVE DIAGNOSIS NOTED TP HAVE UTERINE FIBROIDS AND PELVIC PAIN. DURING THE SURGICAL PROCEDURE IT WAS DISCOVERED THAT THE PATIENT UTERUS WAS ATTACHED TO TH

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL, INC. RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI SI RADICAL PROSTATECTOMY FOR HI-RISK PROSTATE CANCER ON (B)(6) 2011. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES OTHER NOTES FROM THE PATIENT'S HOSPITALIZATION. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS AN ALLEGATION OF AN INTRAOPERATIVE COMPLICATION SINCE THE PATIENT HAD TO RETURN TO THE OR WITHIN 24 HOURS. ON THE DAY OF THE SURGERY THE PATIENT PRESENTED WITH HYPOTENSION IN THE RECOVERY ROOM AND WAS TRANSFERRED TO THE ICU. ATTEMPTS TO MAINTAIN NORMAL BLOOD PRESSURE WERE UNSUCCESSFUL AND THE PATIENT WAS TAKEN BACK TO SURGERY FOR AN EXPLORATORY LAPAROTOMY. THE PATIENT WAS FOUND TO HAVE ACTIVE BLEEDING FROM A SMALL ARTERIOLE IN THE AREA OF THE PRIOR LYMPH NODE DISSECTION. THIS WAS EASILY CONTROLLED AND THE PATIENT'S OPERATION WAS CONCLUDED

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT ON (B)(6) 2011, THE PATIENT UNDERWENT A SUCCESSFUL DA VINCI S FUNDECTOMY PROCEDURE, HOWEVER, 3 HOURS POST PROCEDURE, A PANCREATIC FISTULA WAS FOUND. DRAINAGE WAS PERFORMED AND AMYLASE LEVELS WERE TESTED. ON (B)(6) 2011, THE DOCTOR DETERMINED THAT THE INSERTS USED FOR DRAINAGE WAS NOT ALLOWING SUFFICIENT DRAINAGE AND AS A RESULT THE SURGEON CLEANED THE PATIENT ENDOSCOPICALLY AND A DRAINAGE TUBE WAS PLACED. ON (B)(6) 2011, THE PATIENT'S RESPIRATORY STATUS BECAME WORSE AND A CT SCAN SHOWED AN ABSCESS INSIDE THE MEDIASTINUM AND THE CHEST CAVITY. IT WAS FOUND THAT THE PATIENT ALSO EXPERIENCED MEDIASTINITIS AND EMPYEMA. DRAINAGE WAS PERFORMED AND THE PATIENT WAS PUT ON A RESPIRATOR. AS OF (B)(6) 2011, THE SITE REPORTED THAT THE PATIENT IS RECOVERING WITH NO FEVER. THE PATIENT IS SAID TO BE RECOVERING WELL WITH ALL SYMPTOMS IMPROVING.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI TOTAL HYSTERECTOMY AND RIGHT SALPINGECTOMY FOR PELVIC PAIN, ABNORMAL UTERINE BLEEDING, UTERINE FIBROIDS, AND RIGHT HYDROSALPINX ON (B)(6) 2011. ISI WAS PROVIDED WITH THE OPERATIVE REPORT. ACCORDING TO THE OPERATIVE REPORT, THERE WAS A REPORT OF AN INTRAOPERATIVE COMPLICATION OF A RIGHT URETERAL INJURY. AFTER RELEASE OF THE V RING OF THE VCARE UTERINE MANIPULATOR, THERE WAS NOTED TO BE A PERFORATING BLEEDING VESSEL THAT APPEARED TO BE PART OF THE DESCENDING BRANCHES OF THE UTERINE ARTERY. THE SURGEON REPORTS, UPON DESICCATING THAT A SPARK WAS NOTED TO SPARK TO THE RIGHT URETER AND A PINPOINT HOLE WAS NOTED IN THE RIGHT URETER. UROLOGY WAS CALLED IN TO THE OPERATING ROOM TO CONSULT AND REPAIR THE URETEROTOMY DEFECT. ACCORDING TO THE UROLOGIST'S NOTES, THE AREA OF INJURY WAS CONSISTENT WITH A THERMAL INJURY. THE UROLOGIST PERFORMED A CYSTOSCOPY, ROBOTIC-ASSISTED RIGHT URETERAL REIMPLANTATION AND PLACEMENT OF A DOUBLE-J STENT. THE REMAINDER OF THE HYSTERECTOMY PROCEDURE WAS PERFORMED WITHOUT INCIDENT. THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL MEDIATION EFFORT ON AUGUST 16, 2013 INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION INCLUDING MEDICAL RECORDS OF A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY AND BILATERAL SALPINGECTOMY PROCEDURE ON (B)(6) 2011. REPORTEDLY, DURING THE SURGICAL PROCEDURE AN INADVERTENT CYSTOTOMY OCCURRED. THE OPERATIVE REPORT FINDING INDICATED THAT THE PATIENT HAD EXTENSIVE ANTERIOR ABDOMINAL WALL ADHESIONS AND SCARRING. THE PATIENT'S UTERUS WAS FOUND TO BE ENLARGED DUE TO UTERINE FIBROIDS. THE PATIENT ALSO HAD RIGHT AND LEFT OVARIAN FOLLICULAR CYSTS THAT WERE NOT ADJUSTED. REPORTEDLY, THERE WERE ALSO EXTENSIVE FILMY ADHESIONS ALONG THE ANTERIOR ASPECT OF THE BLADDER TO THE ANTERIOR ABDOMINAL WALL. THERE WAS NO REPORT IN THE PATIENT'S OPERATIVE (OP) REPORT THAT A MALFUNCTION OF THE DA VINCI SI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED. THE OP REPORT INDICATED AN INADVERTENT CYSTOTOMY OCCURRED AND WAS REPAIRED INTRA-OPERATIVELY. A CYSTOSCOPY WAS PERFORMED TO CONFIRM THE INTACTNESS OF THE URETERS. THE PATIENT WAS TAKEN TO THE POST-ANESTHESIA CARE UNIT AWAKE AND IN STABLE CONDITION. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2011. REPORTEDLY, THE PATI

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI S SACROCOLPOPEXY POSTERIOR COLPORRHAPHY AND SLING PROCEDURE ON (B)(6) 2011. THE LEGAL DOCUMENT ALLEGES THAT THE PATIENT SUSTAINED A PUNCTURED BOWEL DUE TO A THERMAL BURN. NO SPECIFIC ALLEGATION OF A MALFUNCTION WITH THE DA VINCI S SYSTEM, INSTRUMENTS, OR ACCESSORIES WAS REPORTED. NO OTHER INFORMATION WAS PROVIDED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI S DAVINCI HYSTERECTOMY FOR FIBROIDS AND SEVERE ENDOMETRIOSIS WITH LEFT TUBE AND OVARY EXTENSIVELY INVOLVED BY LEFT ENDOMETRIOMA, CUL-DE SAC AND BLADDER SEROSAL DISEASE ON (B)(6) 2011. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES: UROLOGIC CONSULTATION (B)(6) 2011. HISTORY AND PHYSICAL (B)(6) 2011. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. THE SURGERY WAS COMPLICATED BY A LOT OF OLD INFLAMMATORY ADHESIONS OF THE TUBES AND OVARIES BILATERALLY. THE LEFT WAS MUCH GREATER THAN THE RIGHT WITH DENSE ADHESIONS IN THE CUL-DE SAC CONSISTENT WITH OLD ENDOMETRIOSIS AND STUCK ON THE COLON. BOTH URETERS WERE IDENTIFIED. BLEEDING FROM THE RIGHT LOWER UTERINE VESSEL WAS CAUTERIZED AT THE LEVEL OF THE CERVIX. AFTER CIRCUMFERENTIAL COLPOTOMY WAS PERFORMED, THE SPECIMENS WERE DELIVERED TRANSVAGINALLY AND THE CUFF CLOSED WITH 2 QUILL 0 LATERO-MEDIAL RUNNING SUTURES. THE BLADDER WAS FILLED AND INSPECTED FOR LEAKA

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(4) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION FROM AN ATTORNEY REPRESENTING A PATIENT WHO UNDERWENT A DA VINCI SI PROSTATECTOMY PROCEDURE ON (B)(6) 2011 AND ALLEGED TO HAVE INJURIES INCLUDING PUNCTURED BLADDER AND LACERATED RECTUM. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI-ASSISTED ROBOTIC PROCEDURE - SMALL BOWEL RESECTION FOR FOREIGN BODY (CAMERA) OF SMALL BOWEL, POSSIBLE INFLAMMATORY MASS ON (B)(6) 2011. PER THE MEDICAL RECORDS, THE PATIENT HAD PERSISTENT ANEMIA, HAD HAD NEGATIVE WORKUP, AND THEN UNDERWENT INGESTION OF A VIDEOCAMERA IN (B)(6) 2009, BUT WAS UNABLE TO PASS THE CAMERA. AFTER SEVERAL ATTEMPTS AT THIS, SHE ELECTED TO HAVE OPERATIVE INTERVENTION. ADDITIONAL RECORDS STATE THAT THE PATIENT WAS UNABLE TO PASS THE CAPSULE AND WAS FOUND TO HAVE A SMALL AREA OF ULCERATION AND FIBROSIS. ISI WAS PROVIDED WITH THE DA VINCI SURGERY OPERATIVE REPORT AND OTHER MEDICAL RECORDS. A CAREFUL REVIEW OF THE MEDICAL DOCUMENTATION WAS CONDUCTED. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT, AND/OR ACCESSORY DURING THE OPERATION. THERE WERE NO INTRAOPERATIVE COMPLICATIONS. PERTINENT FINDINGS INCLUDE MULTIPLE AREAS OF THICKENED MESENTERY. THE SURGEON'S DICTATED OPERATIVE REPORT STATES, NEAR THE ILEOJEJUNAL JUNCTION, THERE WAS AN AREA OF SMALL BOWEL THAT HAD THICKENED MESENTERY AND FELT 2 OR 3 AREAS

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL MEDIATION EFFORT ON AUGUST 16, 2013, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION INCLUDING MEDICAL RECORDS OF A PATIENT WHO SUSTAINED A SMALL LACERATION TO THE SIGMOID COLON DURING A DA VINCI S LEFT OOPHORECTOMY PROCEDURE ON (B)(6) 2011. THERE WAS NO REPORT IN THE PATIENT'S OPERATIVE (OP) REPORT THAT A MALFUNCTION OF THE DA VINCI SI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED DURING THE SURGICAL PROCEDURE. THE RISKS AND BENEFITS OF THE SURGERY WERE EXPLAINED TO THE PATIENT. ACCORDING TO THE INFORMATION PROVIDED IN THE OP REPORT, DURING THE SURGICAL PROCEDURE, THE SURGEON ENCOUNTERED SEVERE PELVIC ADHESIONS. REPORTEDLY, WHILE THE SURGEON WAS PERFORMING LYSIS OF ADHESIONS, A VERY SMALL LACERATION 1.5CM TO THE ANTIMESENTERIC BORDER OF THE SIGMOID COLON WITH MINIMAL SPILL OCCURRED. THE PLANNED SURGICAL PROCEDURE WAS CONVERTED TO OPEN SURGICAL TECHNIQUES. THE PATIENT UNDERWENT A COLORRHAPHY FOR REPAIR OF THE COLON. THE AFFECTED AREA WAS REPAIRED USING SILK SUTURES. THIS PROVIDED AN EXCELLENT CLOSURE AND NO COMPROMISE OF THE LUMEN. IT WAS REPORTED THAT THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSFERRED FROM THE OPERATING ROOM IN STABLE CONDIT

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI ROBOTIC HYSTERECTOMY; LYSIS OF PELVIC ADHESIONS FOR MENORRHAGIA, FIBROID UTERUS, RIGHT OVARIAN CYST AND PELVIC PAIN ON (B)(6) 2011. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. PER OPERATIVE REPORT, ON (B)(6) 2011, THE PATIENT HAD A LARGE MULTILOBULAR FIBROID UTERUS. NO ADNEXAL MASSES. UTERUS APPX 10 EM. LEFT OVARIAN FALLOPIAN TUBE APPEARED NORMAL; THE RIGHT OVARY SOMEWHAT ADHERENT TO THE RIGHT PELVIC SIDE WALL, BUT NO EVIDENCE OF OVARIAN CYSTS. THERE WAS SOME SCARRING OF THE RIGHT OVARY ON THE RIGHT SIDE. LYSIS OF THE ADHESIONS TO FREE UP TO RIGHT OVARY AND PELVIC SIDE WALL. URETER WAS IDENTIFIED. ON (B)(6) 2011, RADIOLOGY FINAL REPORT NOTES INDICATE A CT SCAN ABDOMEN AND PELVIS WITH CONTRAST WAS PERFORMED. FLUID COLLECTION WITH AIR MIXED WITHIN IT IN THE DEPENDENT PORTION OF THE PELVIS IS LIKELY TO REPRESENT EITHER HEMATOMA OR ABSCESS. ON (B)(6) 2011, RADIOLOGY FINAL REPORT NOTES, INDICATE CT SCAN OF ABDOMEN WITHOUT INTRAVENOUS CONTRAST AND CT SCAN OF PELVIS WITHOUT INTRAVENOUS CONTRAST WAS PERFORMED. PELVIC FLUID COLLECTION IN THE SETTING OF RECENT HYSTE

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT 10 DAYS AFTER A DA VINCI SI TRANSORAL RESECTION PROCEDURE WAS SUCCESSFULLY PERFORMED, THE PATIENT EXPERIENCED BLEEDING IN THE SURGICAL AREA AND EXPIRED. THE DATE OF THE SURGICAL PROCEDURE AND DATE OF DEATH WERE NOT RECEIVED. PRE SURGERY, THE PATIENT'S CANCER WAS THOUGHT TO BE AT STAGE T2, HOWEVER, DURING THE PROCEDURE, IT WAS DISCOVERED THAT THE CANCER WAS AT STAGE T3. THERE WERE NO SYSTEM MALFUNCTIONS DURING THE PROCEDURE AND THE SURGEON INDICATED THAT THE PATIENT'S DEMISE WAS UNRELATED TO THE DA VINCI SI SURGICAL SYSTEM. THE SURGEON BELIEVES THAT THE POST SURGICAL BLEEDING MAY HAVE BEEN RELATED TO A DELAY IN HEALING AND THAT A SCAB MAY HAVE COME OFF. THE DELAY IN REPORTING IS DUE TO A MISUNDERSTANDING ABOUT WHEN INTUITIVE SURGICAL FIRST BECAME AWARE OF THE EVENT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI RADICAL TOTAL HYSTERECTOMY, BILATERAL SALPINGO OOPHORECTOMY, PELVIC AND PERI-AORTIC LYMPH NODE DISSECTION WITH NERVE SPARING PROCEDURE ON (B)(6) 2011, FOR STAGE 1, B-1 SQUAMOUS CELL CARCINOMA OF THE CERVIX. ISI WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES FOLLOW UP PROCEDURE AND OPERATIVE NOTES THAT ENTAIL THE DIAGNOSIS AND TREATMENT OF A LEFT URETEROVAGINAL FISTULA AND LEFT URETERAL STRICTURE. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. ON (B)(6) 2011, THE PATIENT HAD LEFT SIDED PAIN. SHE WAS FOUND TO HAVE A LEFT URETEROVAGINAL FISTULA. ON (B)(6) 2011, A PERCUTANEOUS LEFT NEPHROSTOMY TUBE WAS PLACED TO DECOMPRESS THE KIDNEY. ON (B)(6) 2011, THE NEPHROSTOMY TUBE WAS CHANGED. ON (B)(6) 2011, A LEFT URETERAL REIMPLANTATION WAS PERFORMED. THE PATIENT'S CURRENT CONDITION INCLUDES FREQUENT URINARY TRACT INFECTIONS WITH BLADDER SPASMS AND REPORTS PAINFUL INTERCOURSE. THE PATIENT CURRENTLY IS NO LONGER ABLE

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI SI TOTAL HYSTERECTOMY FOR PELVIC PAIN AND DYSMENORRHEA ON (B)(6) 2011. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT . ADDITIONAL INFORMATION PROVIDED INCLUDES HOSPITAL OPERATIVE AND RADIOLOGY REPORTS THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY]. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. ON (B)(6) 2011 THE PATIENT RETURNED TO SURGERY TO DRAIN APPROXIMATELY 300 CC'S OF BLOOD FROM A PELVIC HEMATOMA. A SMALL OPENING OF THE VAGINAL CUFF WAS SEEN AND THIS WAS HELPFUL FOR HEMATOMA DRAINAGE. THE VAGINAL CUFF WAS ALSO RESUTURED AT THIS TIME. SHE WAS DISCHARGED ON (B)(6) 2011.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL MEDIATION EFFORT ON (B)(4) 2013 INTUITIVE SURGICAL, INC. RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY ON (B)(6) 2011 DUE TO PERSISTENT ABNORMAL UTERINE BLEEDING. THE PATIENT'S OPERATIVE REPORT DOES NOT CONTAIN INFORMATION REGARDING ANY MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED AND THERE WAS NO INDICATION THAT THE PATIENT EXPERIENCED ANY INTRA-OPERATIVE COMPLICATIONS. THE PATIENT'S OPERATIVE REPORT STATED THAT THE PATIENT'S VAGINAL CUFF WAS CLOSED WITH NO DIFFICULTY AND THE CUFF WAS FOUND TO BE HEMOSTATIC. THE PROCEDURE WAS COMPLETED AND THE PATIENT TOLERATED THE PROCEDURE WELL. THE PATIENT WAS AWAKENED AND TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. ON (B)(6) 2011, THE PATIENT UNDERWENT A VAGINAL CUFF CLOSURE PROCEDURE DUE TO VAGINAL CUFF DEHISCENCE. PER PATIENT'S OPERATIVE REPORT, DURING EXAMINATION IT WAS DISCOVERED THAT THE PATIENT'S VAGINAL CUFF WAS OPEN IN THE MIDPORTION ABOUT 2 CM IN LENGTH. BOWEL CONTENT WAS VISIBLE THROUGH THE CUFF OPENING. THE EDGES OF THE CUFF WERE FOUND TO BE INTACT. THE CUFF WAS CLOSED USING SUTURE AND WAS CLOSED WITHOUT DIFFICULTY. A SECOND LAYER OF

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL MEDIATION EFFORT ON (B)(4) 2013 INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT WHO EXPERIENCED POST-SURGICAL COMPLICATIONS AFTER UNDERGOING A DA VINCI SI HYSTERECTOMY FOR ENDOMETRIAL CANCER ON (B)(6) 2011. PER THE INFORMATION PROVIDED, THERE WERE NO SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT DURING DA VINCI HYSTERECTOMY PROCEDURE. INTRA OPERATIVE BLOOD LOSS WAS REPORTED TO BE 50CC. REPORTEDLY, THE PATIENT'S VAGINAL CUFF WAS CLOSED WITH RUNNING VICRYL SUTURE. POST OPERATIVELY THE PATIENT HAD HYPONATREMIA, WHICH REQUIRED SOME INTRAVENOUS FLUID HYDRATION, BUT OTHERWISE THE PATIENT DID WELL AND WAS DISCHARGED HOME IN GOOD CONDITION. ON (B)(6) 2011 THE PATIENT WAS SEEN BY HER DOCTOR, AND DURING HER FOLLOW -UP VISIT IT WAS INDICATED THAT HER VAGINAL CUFF WAS WELL SUPPORTED AND INTACT WITH NO TENDERNESS. THE PATIENT WAS ASKED TO FOLLOW UP IN WITH HER DOCTOR IN SIX MONTHS. ON (B)(6) 2011 THE PATIENT COMPLAINED OF VAGINAL PRESSURE AND SHE WENT TO EMERGENCY ROOM. THE PATIENT WAS NOT DIAGNOSED WITH ANY SIGNIFICANT ISSUES AND WAS DISCHARGED HOME WITH A RECOMMENDATION OF FOLLOW UP. ALLEGEDLY, WHILE ON VACATION, ON (B)(6) 2011 WHILE THE PATIENT WAS WALKING

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL MEDIATION EFFORT, ON (B)(4) 2013 INTUITIVE SURGICAL RECEIVED INFORMATION INCLUDING MEDICAL RECORDS, OF A PATIENT WHO HAD A BLADDER INJURY DURING DA VINCI SI HYSTERECTOMY AND BILATERAL SALPINGO-OOPHORECTOMY PROCEDURE THAT WAS PERFORMED ON (B)(6) 2011. DURING THE PROCEDURE, THE SURGEON NOTICED A 1.5-2CM RENT (CYSTOTOMY) IN THE POSTERIOR ASPECT OF THE BLADDER. THE SURGEON MADE THE DECISION TO CONVERT THE PROCEDURE TO OPEN SURGICAL PROCEDURE IN ORDER TO GET FULL EXPOSURE. THE SURGEON ORDERED A UROLOGICAL CONSULTATION TO ADDRESS THE BLADDER INJURY. THE CONSULTING SURGEON THEN PERFORMED A REPAIR OF THE BLADDER RENT. THE SURGEON IRRIGATED THE ABDOMEN AND HEMOSTASIS WAS ASSURED. A DRAIN WAS PLACED IN THE POSTERIOR CUL-DE-SAC. NO FURTHER COMPLICATIONS WERE NOTED. THE PATIENT WAS DISCHARGED ON (B)(6) 2011 WITH A JP DRAIN FOR WOUND DRAINAGE AND A FOLEY CATHETER FOR URINARY DRAINAGE, BOTH WHICH WERE REMOVED BY (B)(6) 2011. A CYSTOGRAM ON (B)(6) 2011 SHOWED NO VISUALIZED BLADDER LEAK. AT THE PATIENT'S RECORDED LAST POST-OP VISIT ON (B)(6) 2011, THE SURGEON CLEARED THE PATIENT AND STATED THAT NO FURTHER FOLLOW UP WAS NECESSARY. THE PATIENT HAS NOT HAD ANY ADDITIONAL MEDICAL TR

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON SEPTEMBER 5, 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION FROM AN ATTORNEY REPRESENTING A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY PROCEDURE ON (B)(6) 2011, AND ALLEGED TO HAVE INJURIES INCLUDING A PUNCTURED BLADDER DUE TO A THERMAL BURN. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY AND CYSTOSCOPY FOR DYSMENORRHEA AND MENORRHAGIA ON (B)(6) 2011. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING THE SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. FOR THE ABDOMINAL PART OF THE OPERATION A PNEUMOPERITONEUM WAS ESTABLISHED USING A VERESS NEEDLE, AND AFTER PLACEMENT OF TROCARS AND DOCKING OF THE ROBOT, FLIMSY ADHESIONS WERE TAKEN DOWN IN THE MID-LOWER ABDOMEN. BILATERAL UTERO-OVARIAN PEDICLES AND LATERAL LIGAMENTS WERE TRANSECTED USING BIPOLAR CAUTERY AND MONOPOLAR CAUTERY SCISSORS. ANTERIOR BLADDER FLAP ADHESIONS WERE NOTED AND RELATED TO A PREVIOUS C-SECTION. THESE ADHESIONS WERE DISSECTED UNEVENTFULLY USING MONOPOLAR AND BIPOLAR INSTRUMENTS. UTERUS AND CERVIX WERE DELIVERED VAGINALLY AND THE CUFF CLOSED WITH 0 VICRYL. NO COMPLICATIONS WERE NOTED DURING SURGERY. (BLOOD LOSS, 25CC) NO ORIGINAL RECORDS: ACCORDING TO THE CLAIM FORM, ON (B)(6) 2011 (POSTOPERATIVE DAY, POD 2), A CONSULTANT SAW THE PATIENT FOR POSTOPERATIVE ILEUS AND GILBERT SYNDROME. THE

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2011 (B)(4) REPORTED THAT POST A DA VINCI S HYSTERECTOMY PROCEDURE, WHICH TOOK PLACE ON (B)(6) 2011, THE PATIENT RETURNED TO THE HOSPITAL WITH COMPLICATIONS AND WAS FOUND TO HAVE A BOWEL PERFORATION.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL MEDIATION EFFORT ON JULY 25TH, 2013 INTUITIVE SURGICAL RECEIVED INFORMATION INCLUDING MEDICAL RECORDS OF A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY ON (B)(6) 2011. ACCORDING TO THE SURGEON'S OPERATIVE REPORT, THERE WERE ADHESIONS OF THE SMALL BOWEL TO THE ABDOMINAL WALL. LYSIS OF ADHESIONS WAS PERFORMED. THE PATIENT RETURNED TO THE HOSPITAL'S EMERGENCY ROOM ON (B)(6) 2011 WITH COMPLAINTS OF ABDOMINAL DISTENTION, NAUSEA AND VOMITING. A CT SCAN OF THE PATIENT'S PELVIS WAS PERFORMED FOUND THAT THE PATIENT HAD AN ORGANIZED CLOT. A NEEDLE BIOPSY WAS PERFORMED AND NO SIGN OF ABSCESS FORMATION OR INFECTION WAS NOTED. X-RAYS PERFORMED WERE CONSISTENT WITH ILEUS. ON (B)(6) 2011 A PELVIC EXAM UNDER ANESTHESIA WAS PERFORMED. THE CUFF WAS INTACT; HOWEVER, UPON OPENING THE CUFF, FLUID CONSISTENT WITH LYSING HEMATOMA WAS DISCOVERED AND DRAINED. THERE WAS NO EVIDENCE OF FISTULA OR FOREIGN BODY, THERMAL ENERGY OR DAMAGE TO THE PATIENT'S BLADDER. FOLLOWING THE SURGICAL PROCEDURE, THE PATIENT DID EXPERIENCE IMPROVEMENT. OVER THE COURSE OF THE PATIENT'S HOSPITALIZATION, THE PATIENT HAD CLINICALLY IMPROVED AND THE PATIENT WAS DISCHARGED F

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI S TOTAL HYSTERECTOMY AND DRAINAGE OF LEFT OVARIAN CYST FOR SEVERE MENORRHAGIA, SEVERE DYSMENORRHEA, AND FAILED ENDOMETRIAL ABLATION ON (B)(6) 2008. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT FOR THE PRIMARY PROCEDURE, THE EMERGENT LAPAROTOMY AND THE LAPAROSCOPIC HERNIOPLASTY. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING SURGERY. THE PORTS WERE PLACED, AND AFTER INCISION AND DRAINAGE OF THE LEFT OVARIAN CYST, THE OVARIAN SUSPENSORY LIGAMENTS, PROXIMAL BROAD LIGAMENTS AND ROUND LIGAMENTS WERE SERIALLY CLAMPED, CAUTERIZED AND TRANSECTED. THE BLADDER FLAP WAS DEVELOPED, THE CARDINAL LIGAMENTS AND UTERINE VESSELS SEALED AND TRANSECTED, AND THE COLPOTOMY PERFORMED AGAIN THE COLPOTOMY RING. THE UTERUS WAS DELIVERED THROUGH THE VAGINA AND THE VAGINAL CUFF CLOSED WITH V-LOC SUTURE. SEPRAFILM SLURRY WAS PLACED OVER THE VAGINAL DOME TO TRY TO PREVENT ADHESION FORMATION, AND THE SURGERY COMPLETED WITHOUT COMPLICATION. ON (B)(6) 2011 PATIENT PRESENTED WITH RLQ AND FEVER. CT IMAGING SHOWED INFLAMMATORY CHANG

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI SI TOTAL ROBOTIC HYSTERECTOMY FOR MULTIPLE LEIOMYOMATA UTERI, MENORRHAGIA AND DYSPAREUNIA ON (B)(6) 2011. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT IN ADDITION TO A PATHOLOGY REPORT, OFFICE VISIT REPORTS ((B)(6) 2011), RADIOLOGIC FINDINGS OF PYELOGRAMS AND CLINICAL LAB REPORT OF (B)(6) 2011. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. THE UTERUS WAS 225 GRAMS AND 9-10 WEEK IN SIZE. TWO LARGE SUBSEROSAL FUNDAL MYOMAS PLUS A SMALLER SUBSEROSAL POSTERIOR MYOMA WERE FOUND AT THE TIME OF SURGERY. A DIFFICULT DISSECTION OCCURRED AROUND THE BLADDER DUE TO ANTERIOR FIBROIDS. THE UTERUS WAS MORCELLATED DUE TO ITS LOBULATED SIZE. HEMOSTASIS WAS CONFIRMED. THE PATIENT WAS TAKEN TO THE PACU IN GOOD CONDITION. THE PATIENT DEVELOPED VAGINAL LEAKING AFTER SURGERY AND AN EXAMINATION ON (B)(6) 2011 REVEALED A VAGINAL FISTULA WITH URINE DRAINAGE. ON (B)(6) 2011, A VAGINOSCOPY REVEALED SUTURES DRAINING SLIGHTLY PURULENT FLUID BUT NO DISCRETE FISTULA.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI PROSTATECTOMY PROCEDURE ON (B)(6) 2011. THE LEGAL DOCUMENT ALLEGES THAT AS A DIRECT AND PROXIMATE RESULT OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY, OR ITS IMPROPER AND / OR UNLAWFUL USE, THE PATIENT SUFFERED A BLADDER AND BLOOD VESSELS INJURY.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED A JOURNAL ARTICLE BY COOPER ET AL TITLED, UNDERREPORTING OF ROBOTIC SURGERY COMPLICATIONS. IN THIS ARTICLE, THE AUTHORS REPORTED COMPLICATIONS REPORTED IN MAUDE DATABASE OR LEXISNEXIS, AND PACER (PUBLIC ACCESS TO COURT ELECTRONIC RECORDS) FROM (B)(6) 2000 TO (B)(6) 2012. ACCORDING TO THE ARTICLE, IT WAS REPORTED THAT AN UNSPECIFIED PATIENT INJURY OCCURRED IN RELATION TO DEVICE ASSEMBLY OF AN UNSPECIFIED DA VINCI SURGICAL PROCEDURE PERFORMED ON (B)(6) 2011. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THE REPORTED EVENT. THE HOSPITAL NAME, DA VINCI SYSTEM SERIAL, AND TYPE OF PROCEDURE INVOLVED WITH THIS COMPLAINT WERE NOT INCLUDED IN THE ARTICLE. ARTICLE INFORMATION: TITLE: UNDERREPORTING OF ROBOTIC SURGERY COMPLICATIONS AUTHORS: MICHOL A. COOPER, ANDREW IBRAHIM, HEATHER LYU, MARTIN A. MAKARY PUBLISHED DATE: 08/27/2013 LINK: HTTP://ONLINELIBRARY.WILEY.COM/DOI/10.1111/JHQ.12036/ABSTRACT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL MEDIATION EFFORT ON SEPTEMBER 4, 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION FROM AN ATTORNEY REPRESENTING A PATIENT WHO UNDERWENT A DA VINCI NEPHRECTOMY PROCEDURE ON (B)(6) 2011 AND ALLEGED TO HAVE INJURIES TO THEIR KIDNEYS. NO FURTHER INFORMATION IS PROVIDED AT THIS TIME.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI HYSTERECTOMY PROCEDURE ON (B)(6) 2011. THE LEGAL DOCUMENT ALLEGES THAT AS A DIRECT AND PROXIMATE RESULT OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY, OR ITS IMPROPER AND / OR UNLAWFUL USE, THE PATIENT SUFFERED VAGINAL ABSCESS.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2012, ISI RECEIVED A LEGAL COMPLAINT CONCERNING A PATIENT WHO UNDERWENT A DA VINCI SI MITRAL VALVE REPAIR PROCEDURE THAT WAS CONVERTED TO ANOTHER TECHNIQUE. THE LEGAL COMPLAINT ALLEGED THAT DURING THE SURGERY THE ROBOTIC ARMS HAD TOO MUCH PRESSURE APPLIED TO THEM CAUSING THE MACHINE TO JOLT. THE LEGAL COMPLAINT ALSO ALLEGED THAT THE PATIENT EXPERIENCED 15 HOURS OF INTERNAL BLEEDING BEFORE DETERMINING THAT EXPLORATORY SURGERY WAS NEEDED, AND THE SURGERY DISCOVERED THAT THE ROBOTIC ARMS SPLICED AND PUNCTURED THE PATIENT'S LIVER AND SPLEEN. DUE TO THE REPORTED INJURIES SUSTAINED BY THE PATIENT DURING THE DA VINCI ROBOTIC SURGICAL PROCEDURE, THE LEGAL COMPLAINT ALLEGED THAT THE PATIENT HAD TO HAVE MULTIPLE ADDITIONAL MEDICAL TESTS AND PHYSICIAN CONSULTATIONS, AND HAD SUFFERED PAIN, LOSS OF FUNCTION, EMOTIONAL DISTRESS, AND PERMANENT INJURY. THE LEGAL COMPLAINT ALLEGED THAT DESPITE ADDITIONAL TREATMENT, THE PATIENT CONTINUED TO SUFFER FROM ABDOMINAL PAIN, FATIGUE, AND DECREASED ENERGY AND STAMINA.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON 26-NOV-2020, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF THE GENERAL THORACIC AND CARDIOVASCULAR SURGERY ARTICLE TITLED, ¿IS LEFT-SIDE DAVINCI PROCEDURE CHALLENGING? INITIAL EXPERIENCES OF A SINGLE INSTITUTE.¿ WITHIN THE ARTICLE, THE FOLLOWING IS NOTED: CASE #1 INVOLVED A 48-YEAR OLD FEMALE PATIENT WITH STAGE 1B CANCER WHO UNDERWENT A DA VINCI-ASSISTED LEFT UPPER LOBECTOMY PROCEDURE ON AN UNSPECIFIED DATE. THE CAUSE OF THE CONVERSION PER TABLE 3 IN THE ARTICLE WAS AN ¿INJURY OF PA¿ (PULMONARY ARTERY).¿IN CASE 1, THE CAUSE OF CONVERSION WAS UNCONTROLLABLE BLEEDING FROM AN INJURY TO THE LINGUAL SEGMENTAL PULMONARY ARTERY DURING STAPLING OF THE INCOMPLETE INTERLOBAR FISSURE.¿ FURTHERMORE, IT WAS NOTED IN REFERENCE TO CASE #1 (AND CASE #2) "IN BOTH CASES, CONVENTIONAL ENDOSCOPIC STAPLING DEVICES WERE EMPLOYED." ADDITIONALLY, THE ARTICLE STATES THE FOLLOWING: "WE EXPERIENCED TWO CONVERSIONS IN STAPLING THE FISSURE OF THE LEFT UPPER LOBE. BOTH CONVERSIONS WERE CAUSED BY FAILURE TO CONFIRM THAT THE TIP OF THE STAPLER WAS FREE FROM THE ADJACENT STRUCTURES. THIS IS PARTLY ATTRIBUTABLE TO THE SPECIFIC CHARACTERISTICS OF THE 30 DEGREE ANGLED SCOPE: IT IS DIFFICULT TO OBSERVE LATERALLY U

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL MEDIATION EFFORT, INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION INCLUDING MEDICAL RECORDS CONCERNING A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY PROCEDURE WITH CYSTOSCOPY ON (B)(6) 2010. THE MEDICAL RECORDS INDICATE THAT THE PATIENT DEVELOPED POST-OPERATIVE COMPLICATIONS. BASED ON THE MEDICAL RECORDS PROVIDED, THE PATIENT HAD A PREOPERATIVE DIAGNOSIS OF A DYSPAREUNIA, HISTORY OF ENDOMETRIOSIS, POSTCOITAL BLEEDING, AND UTERINE FIBROIDS. ACCORDING TO THE OPERATIVE REPORT, THE RISK AND BENEFITS WERE EXPLAINED AND THE PATIENT AGREED TO UNDERGO THE PROCEDURE. THE DA VINCI SI HYSTERECTOMY PROCEDURE WAS COMPLETED WITHOUT ANY COMPLICATIONS. AFTER THE UTERUS WAS REMOVED AND THE VAGINAL CUFF WAS CLOSED, GOOD HEMOSTASIS WAS NOTED. AT THE CONCLUSION OF THE SURGICAL PROCEDURE, THE PATIENT WAS TAKEN TO THE PACU IN GOOD CONDITION. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2011, AFTER RECEIVING TREATMENT FOR POST-OPERATIVE ACUTE ANEMIA FROM INTRA-ABDOMINAL BLOOD LOSS. AT THE TIME OF DISCHARGE, THE PATIENT WAS TOLERATING A REGULAR DIET, AND PASSING FLATUS WITH NO SIGNS AND SYMPTOMS OF ANEMIA. ON (B)(6) 2011, THE PATIENT WAS EVALUATED IN A HOSPITAL FOR ABD

On December 27, 2010, an employee of the restaurant El Pollo Loco was working in its food preparation area to make a salsa. He was using a Robot Coupe, bowl cutter mixer to cut cilantro. During the cutting process, the lid was not attached. When he loaded the vegetables to the blender, both his hands were caught by the blade. The tip of the middle finger on his right hand was amputated. Emergency medical technicians were called, and he was transported to a hospital.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON JULY 25TH, 2013 INTUITIVE SURGICAL RECEIVED A LEGAL COMPLAINT INCLUDING MEDICAL RECORDS OF A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY AND BILATERAL SALPINGO-OOPHORECTOMY WITH PELVIC AND PARAAORTIC LYMPH NODE DISSECTION ON (B)(6) 2010. THE PATIENT HAD A DIAGNOSIS OF GRADE II ENDOMETRIAL CANCER AND FIBROID UTERUS. THE SURGICAL PROCEDURE WAS COMPLETED AS PLANNED WITH THE REMOVAL OF UTERUS, TUBES AND OVARIES THROUGH VAGINA WITH PERIAORTIC LYMPHNODE DISSECTION. THE VAGINAL CUFF WAS CLOSED USING INTERRUPTED STITCHES WITHOUT ANY DIFFICULTY. THE SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED AND THE PATIENT WAS EXTUBATED AND TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2010 IN GOOD CONDITION WITH A NORMAL HEMATOCRIT LEVEL WITHOUT COMPLICATIONS AS PER THE MEDICAL RECORDS. AFTER ARRIVING HOME THE PATIENT BEGAN TO DEVELOP NAUSEA AND ABDOMINAL PAIN. THIS PERSISTED TO DEHYDRATION AND SHE PRESENTED TO HOSPITAL'S ER REMARKABLY DEHYDRATED ON (B)(6) 2010. A CT-SCAN PERFORMED SHOWED FINDINGS CONSISTENT WITH A POSSIBLE PELVIC ABSCESS. SHE WAS ADMITTED AND UNDERWENT A CT GUIDED CATHETER PLACEMENT IN AN ATTEMPT TO DRAIN THE ABSCE

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI HYSTERECTOMY AND BILATERAL SALPINGO-OOPHORECTOMY AND CYSTOSCOPY ON (B)(6) 2010 FOR MENORRHAGIA. ISI WAS PROVIDED WITH THE OPERATIVE REPORTS. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. DURING A STANDARD HYSTERECTOMY PROCEDURE, EXCELLENT HEMOSTASIS WAS NOTED. PICTURES WERE TAKEN. NO BLADDER PERFORATIONS WERE NOTED AFTER CYSTOSCOPY. THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. ON (B)(6) 2011, PATIENT UNDERWENT A CYSTOSCOPY, LEFT RETROGRADE PYELOGRAM AND STENT PLACEMENT TO REPAIR A LEFT URETERAL VAGINAL FISTULA. THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. ON (B)(6) 2011, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR AN URETEROVAGINAL FISTULA AND UNDERWENT CYSTOSCOPY, BILATERAL RETROGRADE PYELOGRAMS, BOARI FLAP, LEFT URETERONEOCYSTOSTOMY AND INSERTION OF A LEFT URETERAL STENT. A URETEROCELE WAS NOTED IN THE RIGHT URETER AND IT WAS EASILY INTUBATED WITH A CATHETER. THE PREVIOUSLY PLACED LEFT URETERAL ST

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI SI LEFT OVARIAN CYSTECTOMY WITH EXTENSIVE LYSIS OF ADHESIONS ON (B)(6) 2010. ISI WAS PROVIDED WITH THE OPERATIVE REPORT. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THE PATIENT HAD EXTENSIVE, DENSE, SEVERE ADHESIONS FROM BOWEL TO BOWEL, BOWEL TO ANTERIOR ABDOMINAL WALL, BOWEL TO BLADDER AND TO OVARY. MONOPOLAR AND BIPOLAR ENERGY WERE USED TO LYSE THE ADHESIONS. THE ADHESIOLYSIS TOOK 150 MINUTES. THE PATIENT HAD CHRONIC ABDOMINAL PAIN. ON (B)(6) 2011 PATIENT PRESENTED WITH SEVERE ABDOMINAL PAIN. CT SCAN WAS CONCERNING FOR PERFORATED SMALL BOWEL. THE PATIENT WAS TAKEN TO THE OPERATING ROOM WHERE SHE WAS FOUND TO HAVE 2 ENTEROTOMIES. ONE WAS FELT TO BE IATROGENIC, OCCURRING DURING THE DISSECTION OF THE OPERATION. THE OTHER WAS FELT TO BE THE CAUSE OF THE LEAK. THE PATIENT UNDERWENT A SMALL BOWEL RESECTION AND ILEOSTOMY. ON (B)(6) 2011 SHE UNDERWENT DELAYED PRIMARY CLOSURE OF HER WOUND. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2011 IN GOOD CONDITION. THE PATIENT UNDERWENT AN ILEOSTOMY TAKEDOWN

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT APPROXIMATELY 2 HOURS DURING A DA VINCI SI RECTOPEXY PROCEDURE, WHILE AN INSTRUMENT CHANGE WAS IN PROGRESS, THE SURGEON REMOVED HIS HANDS FROM THE MASTER TOOL MANIPULATORS (MTM); HOWEVER; LEFT HIS HEAD IN THE SURGEON SIDE STEREO VIEWER. THIS CAUSED THE INSTRUMENT BEING EXCHANGED IN THE GUIDED TOOL CHANGE MODE, TO MOVE SLIGHTLY FORWARD AND BUMP THE PATIENT'S COLON. SLIGHT BLEEDING OF THE PATIENT'S COLON OCCURRED; HOWEVER, NO REPAIR, BLOOD TRANSFUSION OR INTERVENTION WAS NECESSARY. THE PLANNED PROCEDURE WAS COMPLETED AND NO ADVERSE OUTCOME WAS REPORTED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL MEDIATION EFFORT ON (B)(6) 2013 INTUITIVE SURGICAL RECEIVED A LEGAL COMPLAINT REGARDING A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY PROCEDURE ON AN UNKNOWN DATE. THE LEGAL COMPLAINT ALLEGES THAT DURING THE SURGICAL PROCEDURE, THE PATIENT SUSTAINED BOWEL PERFORATION. AS A RESULT OF HER BOWEL INJURY THE PATIENT DEVELOPED SEPSIS, EXPERIENCED SEPTIC SHOCK, RENAL FAILURE, HYPOXIC BRAIN INJURY, THYROID INJURY, GALLBLADDER DAMAGE, COGNITIVE DEFICITS, AND URINARY AND BOWEL INCONTINENCE. PER THE INFORMATION IN THE LEGAL COMPLAINT, THE PATIENT HAS SUFFERED SEVERE AND PERMANENT INJURIES INCLUDING SEVERE INTERNAL INJURIES, PAIN, DISABILITY, PHYSICAL IMPAIRMENT, MENTAL IMPAIRMENT, DISFIGUREMENT, MENTAL ANGUISH, INCONVENIENCE AND LOSS OF CAPACITY FOR THE ENJOYMENT OF LIFE, ALL OF WHICH ARE CONTINUING AND ARE PERMANENT IN NATURE. NO OTHER INFORMATION WAS PROVIDED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ACCORDING TO ALLEGATIONS MADE IN A LAWSUIT, THE PATIENT EXPERIENCED INTRA-ABDOMINAL BLEEDING, THERMAL BURNING, SEVERE INFECTION WITH INTRA-ABDOMINAL ABSCESSES, AND SEPTIC SHOCK AFTER A DA VINCI HYSTERECTOMY PROCEDURE. THE PATIENT CONTINUES TO SUFFER FROM CHRONIC ABDOMINAL PAIN AND SEVERE BOWEL ISSUES. THE PATIENT HAS BEEN UNABLE TO MAINTAIN INTIMATE RELATIONSHIPS AND SUFFERS EMOTIONAL DISTRESS. ALLEGEDLY, THE PATIENT UNDERWENT MULTIPLE ADDITIONAL MEDICAL TESTS/PROCEDURES AND SURGERY.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL MEDIATION EFFORT, ON (B)(6) 2013 INTUITIVE SURGICAL RECEIVED INFORMATION INCLUDING MEDICAL RECORDS OF A PATIENT WHOSE BLADDER WAS REPORTEDLY INJURED DURING A DA VINCI SI HYSTERECTOMY AND BILATERAL OOPHORECTOMY ON (B)(6) 2010. THE INADVERTENT DAMAGE TO THE PATIENT'S BLADDER WAS REPAIRED AND THE SURGICAL PROCEDURE WAS COMPLETED. THE OPERATIVE REPORT FOR THE PATIENT'S FOR THE SURGERY DATE OF (B)(6) 2010 INDICATED THAT AN INADVERTENT CYSTOTOMY APPROXIMATELY 2 CM WAS CREATED AND WAS INSTANTLY RECOGNIZED AND REPAIRED WITH SUTURES. INDIGO CARMINE WAS ADMINISTERED TO THE PATIENT AND THERE WAS NO PASSAGE OF DYE INTO THE PERITONEAL CAVITY NOTED AFTER THE COMPLETING THE REPAIR. REPORTEDLY, THE VAGINAL CUFF WAS COMPLETED AND WAS OVERSEWN WITH A GOOD SEAL. HEMOSTASIS WAS CHECKED AND ASSURED. THE PATIENT'S URETERS WERE INSPECTED AND NOTED TO BE IN THEIR NORMAL ANATOMICAL POSITIONS BILATERALLY. THE PROCEDURE WAS COMPLETED A LEAF OF INTERCEED WAS PLACED OVER THE VAGINAL CUFF. THE PATIENT WAS CLOSED, EXTUBATED AND TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. THERE WERE NO OTHER COMPLICATIONS NOTED. THE PATIENT'S HISTORY AND PHYSICAL REPORT STATED THAT DURING A POST-OP FOLLOW U

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT WHILE REMOVING TISSUE DURING A DA VINCI S TRANSORAL RESECTION PROCEDURE PERFORMED ON (B)(6) 2010, THE SURGEON ENCOUNTERED AN UNUSUAL GROUP OF VEINS AND PATIENT BLEEDING OCCURRED. THE SURGEON WAS ABLE TO STOP THE BLEEDING AND THE PLANNED SURGICAL PROCEDURE WAS COMPLETED. THERE WERE NO SYSTEM MALFUNCTIONS DURING THE PROCEDURE. FIVE DAYS POST-OP, THE PATIENT EXPERIENCED BLEEDING AND EXPIRED ON (B)(6) 2010.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI HYSTERECTOMY PROCEDURE ON (B)(6) 2010. THE PROVIDED INFORMATION ALLEGES THAT THE PATIENT SUSTAINED BLADDER SUTURE AND URETHRAL OBSTRUCTION INJURIES. NO SPECIFIC ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY WAS REPORTED. NO OTHER INFORMATION WAS PROVIDED.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT AN ATTEMPTED DA VINCI-ASSISTED ROBOTIC HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY AND ABDOMINAL COMPLETION OF HYSTERECTOMY FOR ATYPICAL ENDOMETRIAL HYPERPLASIA ON (B)(6) 2010. THE PATIENT ALSO UNDERWENT SEROMUSCULAR REPAIR OF THE BLADDER AND SEROMUSCULAR REPAIR OF THE SIGMOID COLON. ISI WAS PROVIDED WITH THE OPERATIVE REPORT, OTHER MEDICAL RECORDS, AND A DEATH CERTIFICATE. ACCORDING TO THE OPERATIVE REPORT, THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT, AND/OR ACCESSORY. PERTINENT FINDINGS INCLUDED: THE PATIENT WAS NOTED TO HAVE DENSE ADHESIONS OF THE BLADDER TO THE ANTERIOR UTERUS AND ANTERIOR CERVIX. THE OPERATIVE REPORT ALSO STATES, THE PATIENT HAD THE PROCEDURE INITIALLY STARTED ROBOTICALLY, DESPITE MULTIPLE ATTEMPTS TO TRY AND SWEEP THE BOWEL OUT OF THE PELVIS, IT WAS DIFFICULT KEEPING THE SIGMOID COLON AND TO A LESSER DEGREE THE CECUM AND SMALL BOWEL AWAY FROM THE SURGICAL FIELD. DURING MOBILIZATION AND DISSECTION OF THE BLADDER, THE SURGEON NOTED, I WAS USING THE THIRD ARM OF THE ROBOT TO KEEP TRACTION UP ON THE BLADD

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI SI PROSTATECTOMY PROCEDURE ON (B)(6) 2010. THE LEGAL DOCUMENT ALLEGES THAT AS A DIRECT AND PROXIMATE RESULT OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY, OR ITS IMPROPER AND / OR UNLAWFUL USE, THE PATIENT SUFFERED IMPOTENCE AND INCONTINENCE. ACCORDING TO THE INFORMATION PROVIDED IN THE LEGAL COMPLAINT, REPORTEDLY, THE PATIENT UNDERWENT RECONSTRUCTIVE SURGERY TO CONTROL HIS CONTINENCE; HOWEVER, THE SURGERY WAS UNSUCCESSFUL. REPORTEDLY, THE PATIENT HAS SUFFERED CONSTANT PAIN. THE PATIENT ALSO UNDERWENT AN ARTIFICIAL PENILE IMPLANT TO CONTROL HIS IMPOTENCE. REPORTEDLY, THE PROCEDURE FAILED. NO OTHER INFORMATION REGARDING THE PATIENT WAS PROVIDED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI LAP BAND PROCEDURE ON (B)(6) 2010. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: EXTREME BURNS IN BODY.