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, A PATIENT UNDERWENT A DA VINCI SI SURGICAL PROCEDURE ON HIS STOMACH AT (B)(6) MEDICAL CENTER, WHICH REPORTEDLY TOOK 6.5 HOURS TO COMPLETE. THE PATIENT ALSO HAD HIS HIATAL HERNIA REPAIRED. THE PATIENT ALLEGES THAT POST SURGERY, HE CONTINUES TO HAVE PAIN IN HIS STOMACH AND ISSUES WITH KEEPING HIS FOOD DOWN. LATE SUBMISSION OF THIS REPORT IS DUE TO A DATA ENTRY OVERSIGHT BY CUSTOMER SERVICE.

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) 2012, ALLEGING INJURIES INCLUDING A THERMAL BURN TO THE ABDOMINAL AREA LEADING TO PERFORATION IN THE PELVIC AREA. 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 THAT UNDERWENT A DA VINCI SI PROSTATECTOMY FOR PROSTATE CANCER ON (B)(6) 2012. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES FOLLOW UP NOTES AND 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. ROBOTIC PROSTATECTOMY ON (B)(6) 2012. ON (B)(6) 2012, HE DEVELOPED A FISTULA BETWEEN RECTUM AND URETHRA. VISITS TO PHYSICIAN NOTE CONSERVATIVE TREATMENT WAS TRIED INITIALLY. ON (B)(6) 2012, HE WAS ADMITTED AND UNDERWENT A TRANSANAL RECTOURETHRAL FISTULA REPAIR AND A LAPAROSCOPIC DIVERTING COLOSTOMY. FOLLOWING SURGERY HAD POSSIBLE PERI-ABDOMINAL INFECTION AND WAS MAINTAINED ON IV ANTIBIOTICS. ON (B)(6) 2012, HE HAD TO UNDERGO A SECOND ATTEMPTED FISTULA REPAIR. ULTIMATELY DISCHARGED, AND HAD SUBSEQUENT REVERSAL OF COLOSTOMY.

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 APPROXIMATELY 1 DAY POST-OP, A SUCCESSFUL DA VINCI SI LYSIS OF ADHESIONS PROCEDURE, THE PATIENT EXHIBITED SIGNS OF CELLULITIS AT ONE OF THE TROCAR SITES AND EXPERIENCED DECREASED URINE OUTPUT. A CT SCAN PERFORMED SHOWED THE PATIENT HAD NORMAL GASTROINTESTINAL AND GENITOURINARY TRACT, HOWEVER, WITHIN A FEW HOURS, THE PATIENT'S HEALTH BEGAN TO DETERIORATE AND WAS TAKEN TO THE ICU. SEVERAL SPECIALISTS CONSULTED SUSPECTED THAT THE PATIENT HAD NECROTIZING FASCIITIS AND THE PATIENT WAS THEN TAKEN TO THE OPERATING ROOM. THE GENERAL SURGEON CONSULTED FOUND THAT THE PATIENT'S SMALL BOWEL HAD A PERFORATION. THE PATIENT HAD DEVELOPED SEPTIC SHOCK, ACIDOSIS AND EXPIRED. IT IS THE SURGEON'S BELIEF THAT THE INFECTION DEVELOPED BY THE PATIENT WAS VERY ATYPICAL PRESENTATION FOR PERITONITIS AND PERFORATION AND THAT MAYBE THE PATIENT'S IMMUNOSUPPRESSIVE STATUS CAUSED THE EVENT, AS DAMAGE TO THE PATIENT'S BOWEL WAS NOT THERMAL DAMAGE AND WAS NOT CAUSED BY THE TROCAR AS SHE PERFORMED AN OPEN ENTRY. THE DELAY IN REPORTING IS DUE TO AN OVERSIGHT IN INITIAL CAPTURING OF THE COMPLAINT BY ISI CUSTOMER SERVICE.

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 LAPAROSCOPIC HYSTERECTOMY WITH LEFT SALPINGO-OOPHORECTOMY PROCEDURE ON (B)(6) 2012. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES A DISCHARGE SUMMARY FROM A SUBSEQUENT HOSPITALIZATION FOR VAGINAL BLEEDING ON (B)(6) 2012 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) 2012 PATIENT PRESENTED WITH VAGINAL BLEEDING. THE PATIENT WAS OBSERVED IN THE HOSPITAL WHERE AN EXAMINATION SHOWED AN AREA OF BLEEDING ON THE VAGINAL CUFF. SIMPLE PRESSURE WAS APPLIED WITH A 4X4 SPONGE AND THE BLEEDING STOPPED. THE PATIENT WAS DISCHARGED ON THE SAME DAY TO HER HOME IN GOOD CONDITION. NO ADDITIONAL INFORMATION WAS PROVIDED AFTER THE DATE OF DISCHARGE.

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 DISCOVERY ACTIVITY, ON (B)(4) 2015, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY ISI WAS PROVIDED WITH A COPY OF THE HOSPITAL'S RISK OCCURRENCE REPORT FROM THE HOSPITAL'S RISK MANAGEMENT DEPARTMENT. THE RISK OCCURRENCE REPORT INDICATED THAT DURING THE SURGICAL PROCEDURE, THE CERTIFIED REGISTERED NURSE ANESTHETIST(CRNA) NOTED THAT THE PATIENT'S FOLEY CATHETER CONTAINED A SMALL AMOUNT OF BLOOD. THE HOSPITAL'S UROLOGIST WAS CONSULTED AND UPON EXAMINATION OF THE PATIENT'S BILATERAL URETERS, HE DISCOVERED THAT THE MIDDLE OF THE PATIENT'S BLADDER WALL WAS WEAK. THE UROLOGIST PLACED A STITCH TO THE AFFECTED AREA. ACCORDING TO THE INFORMATION IN THE RISK OCCURRENCE REPORT, THERE WAS NO HARM TO THE PATIENT AND THE PATIENT WAS IN STABLE CONDITION. NO ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT 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: ON (B)(6) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION FROM AN ATTORNEY REPRESENTING A PATIENT WHO UNDERWENT A DA VINCI SI CARDIAC PROCEDURE ON (B)(6) 2012, AND ALLEGED TO HAVE SUSTAINED A NERVE INJURY. 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 RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI PROSTATECTOMY PROCEDURE ON (B)(6) 2012. THE PROVIDED INFORMATION ALLEGES THAT THE PATIENT SUSTAINED INJURIES INCLUDING BLOOD VESSEL AND NERVE DAMAGE AND SEVERE INCONTINENCE. THERE WAS NO SPECIFIC ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY 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: ON (B)(6) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION FROM AN ATTORNEY REPRESENTING A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY PROCEDURE ON (B)(6) 2012 AND ALLEGED TO HAVE INJURIES INCLUDING URETER INJURY. 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 MEDIATION EFFORT ON (B)(6) 2013, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION INCLUDING MEDICAL RECORDS OF A PATIENT WHO EXPERIENCED POST-SURGICAL COMPLICATIONS AFTER UNDERGOING A DA VINCI TOTAL HYSTERECTOMY WITH RIGHT SALPINGO-OOPHORECTOMY, LYSES OF ADHESIONS, AND A VIDEO PELVISCOPY ON (B)(4) 2012. THE PATIENT'S OPERATIVE (OP) REPORT FOR THE SURGICAL PROCEDURE OF (B)(6) 2012 STATES THAT DURING THE DA VINCI TOTAL HYSTERECTOMY WITH RIGHT SALPINGO-OOPHORECTOMY, SHE WAS NOTED TO HAVE ADHESIONS ON THE RIGHT LOWER QUADRANT FROM PREVIOUS SURGERIES. THE INITIAL PELVIC EXAM REVEALED AN AREA OF SMALL BOWEL THAT WAS ADHERENT TO THE MIDLINE UPPER VAGINAL CUFF, WHICH WAS TAKEN DOWN WITH METICULOUS SHARP DISSECTION WITHOUT CAUSING ANY INJURIES TO THE SMALL BOWEL. THE PATIENT'S BILATERAL TUBES AND OVARIES WERE REMOVED. THE OPERATIVE REPORTS DO NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. THIS PATIENT WITH UNKNOWN ETIOLOGY, WAS PRESENTED TO THE EMERGENCY ROOM WITH ABDOMINAL PAIN APPROXIMATELY 1 MONTH AFTER THE DA VINCI SURG

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 AFTER REMOVING THE CANNULA ACCESSORIES AFTER A DA VINCI SI HYSTERECTOMY PROCEDURE WAS COMPLETED, CHARRING WAS OBSERVED AT ONE OF THE PORT INCISION SITES. NO ADDITIONAL HARM 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)(4) 2013 INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION INCLUDING MEDICAL RECORDS OF A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY, A LEFT SALPINGECTOMY, CYSTOTOMY REPAIR AND CYSTOSCOPY. THE PATIENT HAD A PRE-DIAGNOSIS OF MENOMETRORRHAGIA, FIBROID UTERUS AND A HISTORY OF ANEMIA. ACCORDING TO THE PATIENT'S OPERATIVE (OP) REPORT DATED (B)(4) 2012, THERE WAS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED; HOWEVER, THE PATIENT SUSTAINED A SMALL CYSTOMY DURING THE SURGICAL PROCEDURE. REPORTEDLY, AFTER THE SURGEON HAD DISSECTED THE BLADDER FREE FROM THE PATIENT'S CERVIX A SMALL CYSTOTOMY WAS IDENTIFIED APPROXIMATELY 5MM IN SIZE. THE DEFECT TO THE PATIENT'S BLADDER WAS REPAIRED WITH SUTURES. AFTER CLOSURE OF THE PATIENT'S VAGINAL CUFF WAS COMPLETED, THE SURGICAL AREA WAS IRRIGATED AND GOOD HEMOSTASIS WAS NOTED. A CYSTOSCOPY WAS THEN PERFORMED AND THE PATIENT WAS ADMINISTERED INDIGO CARMINE. A GOOD EXTRUSION OF URINE FROM BOTH URETERAL ORIFICES WAS NOTED. THE BLADDER REPAIR WAS ALSO VISUALIZED AND NOTED TO BE INTACT. THE PATIENT WAS AWAKENED IN STABLE CONDITION FOLLOWING THE SURGICAL

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 AFTER A DA VINCI S PROSTATECTOMY SURGICAL PROCEDURE THE PATIENT DEVELOPED A POSTSURGICAL COMPLICATION. THE PATIENT HAD ABSCESS IN THE PELVIS. THE SITE HAS ADVISED AN ANASTOMOSIS INSUFFICIENCY CAUSED THE PATIENT INJURY. THE DELAY IN REPORTING IS DUE TO VAGUE EVENT DESCRIPTION AND ROOT CAUSE DETERMINATION BY THE USER FACILITY. AS INDICATED, AN INVESTIGATION IS ONGOING, AND UNTIL FURTHER ROOT CAUSE DETERMINATION CAN BE CONFIRMED, THIS EVENT SHALL BE REPORTED.

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 A PATIENT EXPIRED 5 DAYS AFTER UNDERGOING A DA VINCI SI TONGUE BASE RESECTION PROCEDURE ON (B)(6), 2012. NO ISSUES OCCURRED DURING THE SURGICAL PROCEDURE AND THE PATIENT WAS RELEASED 3 DAYS POST-OP. THE PATIENT WAS DOING WELL AT THE TIME OF DISCHARGE, HOWEVER, HE WAS DISCOVERED TO HAVE PASSED AWAY TWO DAYS LATER AT HIS HOME.

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 AND MEDICAL RECORDS OF A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY PROCEDURE ON (B)(6) 2012. THE PATIENT HAS HAD A LONG HISTORY OF HEAVY MENSES, COMPLAINTS OF MENORRHAGIA, AND ANEMIA. ON (B)(6) 2012, THE PATIENT WAS RECOMMENDED TO HAVE HYSTERECTOMY FOR DEFINITIVE TREATMENT OF HER MENORRHAGIA PROBLEM. THE PATIENT ELECTED TO PROCEED WITH THE ROBOTIC-ASSISTANT HYSTERECTOMY. THE MEDICAL RECORD INDICATED THAT THE PATIENT UNDERSTOOD THAT DUE TO HER SMALL STATURE AND SIZE OF THE UTERUS THAT IT WAS POSSIBLE THAT THE SURGICAL PROCEDURE MAY NOT BE COMPLETED WITH THE DA VINCI SYSTEM AND IT MAY CONVERT TO OPEN PROCEDURE. RISKS WERE ALSO DISCUSSED WITH HER REGARDING BLEEDING, INFECTION, DAMAGE TO ADJACENT STRUCTURES, AND DEATH. THE DA VINCI HYSTERECTOMY OPERATIVE REPORT WAS NOT PROVIDED; HOWEVER, THE PATIENT'S MEDICAL RECORDS INDICATED THAT THE PATIENT'S PRE AND POST-OPERATIVE DIAGNOSES WERE SYMPTOMATIC UTERINE FIBROIDS. THE DISCHARGE SUMMARY INDICATED THAT THE PATIENT HAD TEMPORARY INABILITY TO VOID SECONDARY TO URETHRAL SWELLING AND WAS SENT HOME WITH A FOLEY CATHETER ON (B)(6) 2012. THE MEDICAL RE

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 OOPHORECTOMY PROCEDURE ON (B)(6) 2012, AND ALLEGED TO HAVE SUSTAINED A PERFORATED BOWEL INJURY. 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: ON (B)(6) 2014, ISI RECEIVED (B)(4) FROM THE FDA WITH THE FOLLOWING EVENT DESCRIPTION: DURING THE COURSE OF DISSECTION, THERE DID APPEAR TO BE A SMALL RENT WITHIN THE MUCOSA OF THE SIGMOID COLON ABOUT 3 CM IN DIAMETER. GIVEN THIS RENT AND CONTINUED DIFFICULTY IN CLEARLY IDENTIFYING THE URETERS AS NECESSARY TO FREE THE OVARIES, THE PHYSICIAN WAS CONSULTED AND CAME TO THE OR AND ASSISTED IN COMPLETING THE BSO, LYSIS OF ADHESIONS AND URETEROLYSIS AND REPAIRED THE RENT IN THE SEROSA OF THE SIGMOID COLON.

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 PROSTATECTOMY WITH EXTENSIVE LAPAROSCOPIC ADHESIOLYSIS AND LAPAROSCOPIC BILATERAL PELVIC LYMPH NODE DISSECTION FOR PROSTATE CANCER ON (B)(6) 2012. ISI WAS PROVIDED WITH THE PATIENT'S OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDED A FOLLOW-UP REPORT WITH H&P DATED (B)(6) 2012. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING SURGICAL PROCEDURE. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION; HOWEVER, THE SURGERY WAS COMPLICATED BY AN EXTENSIVE AMOUNT OF FLIMSY ADHESIONS OF BOWEL AND OMENTUM OF THE ANTERIOR ABDOMINAL WALL REQUIRING LAPAROSCOPIC ADHESIOLYSIS WITH MONOPOLAR CAUTERY USED SPARINGLY. DURING THE REMAINING DISSECTION THE SPACE BETWEEN THE RECTUM AND PROSTATE WAS DEVELOPED WITHOUT DIFFICULTY; HOWEVER, THERE WAS NOTED TO BE A SIGNIFICANT AMOUNT OF ADHESION LEFT INSIDE, SO WIDE DISSECTION WAS TAKEN USING BIPOLAR CAUTERY ON THE LEFT. THE RIGHT SIDE DID NOT HAVE A SIMILAR AMOUNT OF ADHESION; THEREFORE, NERVE SPARRING WAS ATTEMPTED ON THE RIGHT. A LYMPHADENECTOMY WAS CARRIED OU

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 VOLUNTARY REPORT (B)(4) WITH THE FOLLOWING EVENT DESCRIPTION: ON (B)(6) 2012, I HAD A DA VINCI ASSISTED LAVH, BEING RELEASED THE FOLLOWING DAY ON (B)(6) 2012. I FELT AS THOUGH I WAS RECOVERING WELL FOR THE FIRST FEW DAYS. BEGAN HAVING ABDOMINAL PAIN ON (B)(6) 2012. RETURNED TO SURGEON ON (B)(6) 2012 BECAUSE I WAS NOT FEELING WELL. PUT ON ANTIBIOTIC AND SENT HOME. ON (B)(6), WENT TO ER AND WAS ADMITTED BECAUSE IT WAS DISCOVERED THAT MY RIGHT URETER HAD SUFFERED A THERMAL INJURY DURING MY HYSTERECTOMY AND MY CONTINUED DECLINE THE DAYS PRIOR WERE DUE TO THE INJURED URETER LEAKING URINE INTO MY ABDOMINAL CAVITY. AFTER TWO FAILED ATTEMPTS AT TREATING THE INJURY CONSERVATIVELY, I HAD TO BE OPENED UP, REOPERATED ON, AND MY BLADDER RECONSTRUCTED TO REACH MY NOW SHORTER URETER.

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 INFORMATION FROM AN ATTORNEY REPRESENTING A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY PROCEDURE ON (B)(6) 2012, AND ALLEGED TO HAVE INJURIES INCLUDING POST-OPERATIVE TRAUMA, HEMORRHAGING, AND BOWEL OBSTRUCTION. 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 MEDIATION EFFORT ON AUGUST 16, 2013, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION INCLUDING MEDICAL RECORDS OF A PATIENT WHO UNDERWENT A DA VINCI S PELVIC AND PERI-AORTIC LYMPHNODE DISSECTION, OMENTECTOMY, AND STAGING FOR GRADE IV OVARIAN CANCER ON (B)(6) 2012 DUE TO CANCER OF THE OVARY. ACCORDING TO THE PATIENT'S OPERATIVE (OP) REPORT THERE WAS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI S SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED AND THERE WAS NO INDICATION THAT THE PATIENT EXPERIENCED ANY INTRA-OPERATIVE COMPLICATIONS. THE SURGICAL PROCEDURE WAS COMPLETED AND THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN GOOD CONDITION. THE PATIENT'S POST-OP COURSE WAS UNCOMPLICATED AND ON (B)(6) 2012 THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. REPORTEDLY, ON (B)(6) 2012, THE PATIENT WAS ADMITTED INTO THE EMERGENCY ROOM OF ANOTHER AREA HOSPITAL COMPLAINING OF ABDOMINAL PAIN ASSOCIATED WITH FEVER. THE PATIENT WAS TRANSFERRED BACK TO THE HOSPITAL WHERE THE INITIAL SURGICAL PROCEDURE WAS PERFORMED AND UNDERWENT A CT SCAN AND AN EXPLORATORY LAPAROTOMY. THE CT SCAN REVEALED A PELVIC ABSCESS AND DURING THE LAPAROTOMY PROCEDURE IT WAS DISCOVERED THAT 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. (ISI) RECEIVED A LEGAL DOCUMENT REGARDING A PATIENT THAT UNDERWENT AN ATTEMPTED DA VINCI HYSTERECTOMY PROCEDURE ON (B)(6) 2012 FOR ABNORMAL UTERINE BLEEDING AND DYSMENORRHEA. THE LEGAL DOCUMENT ALLEGES THAT THE PATIENT SUSTAINED INJURIES DURING TROCAR PLACEMENT. ACCORDING TO THE LEGAL DOCUMENT, THE PATIENT HAS A HISTORY OF ABNORMAL UTERINE BLEEDING AND DYSMENORRHEA. HER CONDITION WAS INITIALLY TREATED CONSERVATIVELY BUT DUE TO HER CONTINUED SYMPTOMS, SHE OPTED TO PROCEED WITH A DA VINCI HYSTERECTOMY PROCEDURE ON (B)(6) 2012. UPON TROCAR PLACEMENT FOR THE DA VINCI HYSTERECTOMY PROCEDURE, BLOOD BEGAN POURING OUT OF A PORT SITE. IT WAS NOT SPECIFIED IF THE TROCAR WAS AN ISI PRODUCT. A VASCULAR SURGEON WAS CONTACTED FOR AN EMERGENT MANAGEMENT OF A SUSPECTED AORTIC INJURY. THE VASCULAR SURGEON ADVISED THE SURGICAL STAFF TO HOLD PRESSURE ON THE AORTA UNTIL HE ARRIVED. THE PATIENT REPORTEDLY BECAME EXTREMELY HYPOTENSIVE (BLOOD PRESSURE=60/44 MM HG) DUE TO THE MASSIVE BLOOD LOSS. MULTIPLE BLOOD TRANSFUSIONS WERE GIVEN IN AN ATTEMPT TO STABILIZE HER CONDITION. THE VASCULAR SURGEON ARRIVED 25 MINUTES LATER AND MADE A MIDLINE ABDOMINAL INCIS

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, I HAD A DA VINCI ASSISTED LAVH, BEING RELEASED THE FOLLOWING DAY ON (B)(6) 2012. I FELT AS THOUGH I WAS RECOVERING WELL FOR THE FIRST FEW DAYS. BEGAN HAVING ABDOMINAL PAIN ON (B)(6) 2012. RETURNED TO SURGEON ON (B)(6) 2012 BECAUSE I WAS NOT FEELING WELL. PUT ON ANTIBIOTIC AND SENT HOME. ON (B)(6) 2012, WENT TO ER AND WAS ADMITTED BECAUSE IT WAS DISCOVERED THAT MY RIGHT URETER HAD SUFFERED A THERMAL INJURY DURING MY HYSTERECTOMY AND MY CONTINUED DECLINE THE DAYS PRIOR WERE DUE TO THE INJURED URETER LEAKING URINE INTO MY ABDOMINAL CAVITY. AFTER TWO FAILED ATTEMPTS AT TREATING THE INJURY CONSERVATIVELY, I HAD TO BE OPENED UP, REOPERATED ON, AND MY BLADDER RECONSTRUCTED TO REACH MY NOW SHORTER URETER.

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, 2013 INTUITIVE SURGICAL RECEIVED INFORMATION INCLUDING MEDICAL RECORDS OF A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY PROCEDURE ON (B)(6) 2012 DUE TO MENOMETRORRHAGIA, SEVERE DYSMENORRHEA AND CHRONIC BACKACHE. THE PATIENT'S MEDICAL RECORDS REPORT THAT THE RISKS, BENEFITS AND ALTERNATIVES WERE DISCUSSED WITH THE PATIENT. ACCORDING TO THE PATIENT'S OPERATIVE (OP) REPORT, THERE WERE NO ANOMALIES NOTED. THE SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED AND GOOD AND COMPLETE HEMOSTASIS WAS NOTED. PELVIC HEMOSTASIS WAS RE-AFFIRMED BY DROPPING THE GAS PRESSURES. AT THE CONCLUSION OF THE SURGICAL PROCEDURE, A CYSTOSCOPY WAS PERFORMED. THE PATIENT'S BLADDER WAS FOUND TO BE NORMAL, AND BILATERAL URETERIC OPENINGS NOTED. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORIES OCCURRED AND THERE WAS NO INDICATION THAT THE PATIENT EXPERIENCED ANY INTRA-OPERATIVE COMPLICATIONS. REPORTEDLY, THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSFERRED TO RECOVERY IN STABLE CONDITION. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2012. PER THE MEDICAL RECORDS, ON (B)(6) 2012 THE PATIENT

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 LEGAL COMPLAINT, WHICH INDICATED THAT A PATIENT ALLEGEDLY EXPERIENCED POST-OPERATIVE COMPLICATIONS AFTER A DA VINCI S SURGICAL PROCEDURE IN (B)(6) 2012. ACCORDING TO THE LEGAL COMPLAINT, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR MEDICAL SERVICES AND CARE INCLUDING DIAGNOSTIC PROCEDURES AND MEDICAL TREATMENT (DETAILS WERE NOT PROVIDED) ON OR ABOUT (B)(6) 2012. ON OR ABOUT (B)(6) 2012, THE PATIENT UNDERWENT A DA VINCI SI SURGICAL PROCEDURE FOR ENDOMETRIOSIS RESECTION, OVARIAN CYSTECTOMY, AND EXTENSIVE LYSIS OF ADHESIONS INCLUDING ENTEROLYSIS. THE LEGAL COMPLAINT ALLEGES THAT THE PATIENT POST-OPERATIVELY EXPERIENCED AN INFECTION RESULTING FROM A BOWEL PERFORATION, WHICH LED TO THE PATIENT UNDERGOING SURGERY FOR SIGMOID COLECTOMY ON AN UNSPECIFIED DATE. NO MEDICAL REPORTS, CHARTS, OR OPERATIVE REPORTS WERE 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 SI HYSTERECTOMY PROCEDURE ON (B)(6) 2012. THE LEGAL DOCUMENT ALLEGES THAT THE PATIENT SUSTAINED A THERMAL BURN TO THE BLADDER.

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 REGARDING A PATIENT WHO UNDERWENT A DA VINCI SI CYSTIC RIGHT SALPINGO OOPHORECTOMY AND CYSTECTOMY PROCEDURE ON (B)(6) 2012. IN LATE (B)(6) 2012, A CT SCAN WAS PERFORMED SHOWED THAT THE PATIENT HAD A COMPLEX CYSTIC LESION ON HER RIGHT OVARY. IN LATE (B)(6) 2012 THE PATIENT EXPERIENCED NAUSEA AND BACK PAIN. A CT SCAN WAS ORDERED, WHICH SHOWED A VERY MARKED HYDRONEPHROSIS. THE SURGEON NOTED THAT THE PATIENT'S URETER WAS VERY DILATED DOWN TO THE PELVIC BRIM IN THE REGION WHERE THE PRIOR OVARIAN CYST WAS. THE SURGEON MADE THE DECISION TO PROCEED WITH A CYSTOSCOPY RIGHT RETROGRADE PYELOGRAM AND POSSIBLE STENT INSERTION. ON (B)(6) 2012 THE PATIENT UNDERWENT A RIGHT RETROGRADE PYELOGRAM URETEROSCOPY AND INSERTION OF A DOUBLE J STENT. THE URETEROSCOPY DEMONSTRATED A PROBABLE SCARRED AREA WITH A SMALL CALIBER. THE STENT WAS PLACED WITH SOME DIFFICULTY. DURING THE PROCEDURE, THE URETEROSCOPY ALSO SHOWED A HIGH GRADE OBSTRUCTION WITH A PALE AREA OF THE URETER, WHICH WAS FELT TO REPRESENT AN AREA OF ISCHEMIA. A FOLLOW UP CT SCAN WAS PERFORMED ON (B)(6) 2012 AND SHOWED HYDRONEPHROSIS WITH A MALPOSITION

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 LEGAL COMPLAINT. THE LEGAL COMPLAINT ALLEGES THAT DURING A DA VINCI SI MITRAL VALVE REPAIR PROCEDURE, THE PATIENT'S CORONARY ARTERY WAS INADVERTENTLY OBSTRUCTED, CAUSING SEVERE PERMANENT HEART DAMAGE. THE LEGAL COMPLAINT ALLEGES THAT THE PATIENT EXPERIENCED CARDIAC ARREST THREE TIMES.

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 AFTER REMOVING THE CANNULA ACCESSORIES AFTER A DA VINCI SI GYNECOLOGICAL PROCEDURE WAS COMPLETED, THE PHYSICIAN ASSISTANT FOUND THAT THE PATIENT'S PORT INCISIONS EXHIBITED MILD BURNS. 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 ROBOTIC HYSTERECTOMY FOR PELVIC PAIN, PELVIC CONGESTION SYNDROME, BILATERAL OVARIAN CYSTS ON (B)(6) 2012. 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) 2012, THE PATIENT HAD THE FOLLOWING PROCEDURE LAPAROSCOPIC-ASSISTED VAGINAL HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY WITH DA VINCI ROBOTIC ASSIST. ON (B)(6) 2012, THE PATIENT WENT TO THE ER SINCE THE PATIENT WAS GOING TO THE BATHROOM, WENT TO HAVE A BOWEL MOVEMENT AND THEN AN OBJECT DROPPED OUT OF HER VAGINA. PATIENT WAS IN SEVERE PAIN. GYNECOLOGIC EXAMINATION: VAGINAL AREA REVEALS PROLAPSED OF ABOUT 6 INCHES OF SMALL INTESTINE WITH MESENTERY THROUGH THE VAGINA EXTERNALLY. THE PATIENT HAD THE FOLLOWING PROCEDURE: VAGINAL EXPLORATION, REDUCTION OF BOWEL EVISCERATION, CLOSURE OF VAGINAL CUFF, CYTOSCOPY, INSERTION OF DOUBLE-J STENT OF THE RIGHT URETER. IT WAS NOTED THAT THERE WAS A POSSIBLE URETERAL INJURY. CIEAR EFFLUX OF METHYLEN

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 AFTER REMOVING THE CANNULA ACCESSORIES AFTER A DA VINCI SI SACROCOLPOPEXY PROCEDURE WAS COMPLETED, CHARRING WAS OBSERVED AT TWO OF THE PORT INCISION SITES. THE SURGEON EXCISED THE BURNT SKIN AT ONE OF THE PORT LOCATIONS PRIOR TO CLOSING THE INCISION AND THE OTHER INCISION WAS CLOSED PRIMARILY. NO ADDITIONAL HARM 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 DISPUTE INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI S TOTAL HYSTERECTOMY FOR FIBROIDS ON (B)(6) 2012. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES MEDICAL REPORTS, OPERATIVE NOTES, AND EXAMINATIONS FOR FURTHER CARE. THERE WAS NOT AN 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) 2012 THE PATIENT PRESENTED WITH FLUID LEAKING FROM VAGINA. A RIGHT URETEROVAGINAL FISTULA WAS DIAGNOSED. SHE UNDERWENT A CYSTOSCOPY, RETROGRADE PYELOGRAM AND RIGHT URETERAL SENT PLACEMENT. SHE WAS DISCHARGED ON (B)(6) 2012. ON (B)(6) 2012, SHE PRESENTED WITH COMPLAINTS OF RIGHT SIDED FLANK PAIN. CT UROGRAM SHOWED MILD R HYDRONEPHROSIS ON (B)(6) 2012, THE PATIENT HAD A R URETERAL RE-IMPLANTATION. SHE HAS HAD SUBSEQUENT VISITS FOR CONTINUED R FLANK PAIN AND A STENT WAS PLACED IN THE R URETER.

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 POST A SUCCESSFUL DA VINCI SI PARTIAL NEPHRECTOMY PROCEDURE, THE PATIENT RETURNED TO THE HOSPITAL FOR A FASCIOTOMY TO REPAIR COMPARTMENT SYNDROME. PER THE ROBOTICS COORDINATOR PRESENT FOR THE CASE, THE DA VINCI SI SYSTEM DID NOT MALFUNCTION IN ANY WAY NOR CONTRIBUTE TO THE PATIENT'S OUTCOME, HOWEVER THE PATIENT WAS OBESE AND THE PROCEDURE TOOK LONGER THAN NORMAL. THE ROBOTICS COORDINATOR STATED THAT THE PATIENT'S POSITIONING AND DURATION OF THE PROCEDURE LIKELY CAUSED THE COMPARTMENT SYNDROME.

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) 2012. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: DOCTOR NICKED BLADDER

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 TWO WEEKS AFTER COMPLETION OF A DA VINCI SI HYSTERECTOMY PROCEDURE, IT WAS DISCOVERED DURING A POST-SURGICAL CHECK-UP THAT THE PATIENT DEVELOPED ERYTHEMA AT TWO OF THE PORT SITE INCISIONS. THE AFFECTED PORT SITES WERE LOCATED AT THE UPPER LEFT AND UPPER RIGHT QUADRANTS. REPORTEDLY, A PK DISSECTOR INSTRUMENT WAS INSTALLED IN THE UPPER LEFT QUADRANT PORT SITE AND A MONOPOLAR CURVED SHEARS (MCS) INSTRUMENT WAS INSTALLED IN THE UPPER RIGHT QUADRANT DURING THE SURGICAL PROCEDURE.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: WHILE DISSECTING THE RIGHT SIDE PELVIC LYMPH NODES, WITH THE ARM OF THE DA VINCI, AN ARC OCCURRED AT THE SITE OF THE TIP COVER ("TIP COVER ACCESSORY") CAUSING A SMALL HOLE IN THE PATIENT'S VESSEL. THE SURGEON REPAIRED THE INJURY WITH A STITCH. ELECTRICAL SURGICAL UNIT WAS SET AT 40 AND THEN TURNED DOWN TO 35. THE ESU APPEARS TO BE WORKING FINE - PER THE CLINICAL ENGINEER.

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 DEVELOPED A POST-OPERATIVE COMPLICATION AFTER UNDERGOING A DA VINCI SI TOTAL HYSTERECTOMY PROCEDURE ON (B)(6), 2012 WITH A PREOPERATIVE DIAGNOSIS OF A SYMPTOMATIC FIBROID UTERUS. NO INTRA-OPERATIVE COMPLICATIONS WERE DOCUMENTED ON THE OPERATIVE REPORT FOR THE DA VINCI SI TOTAL HYSTERECTOMY PROCEDURE. AT THE END OF THE PROCEDURE, THE SURGEON STATED THAT THE PATIENT TOLERATED THE PROCEDURE WELL AND THE PATIENT'S URINE WAS NOTED TO BE CLEAR. THE PATIENT WAS BROUGHT TO THE RECOVERY ROOM IN STABLE CONDITION. ON (B)(6) 2012, THE PATIENT WAS EVALUATED IN AN EMERGENCY ROOM (ER) FOR REPORTED COMPLAINTS OF ABDOMINAL AND FLANK PAIN. A CT SCAN REVEALED MULTIPLE PELVIC COLLECTIONS. A FOLLOW-UP CT SCAN ON (B)(6) 2012, REVEALED AN UNCHANGED LEFT PELVIC FLUID COLLECTION, MODERATE TO HIGH-GRADE OBSTRUCTION OF THE LEFT URETER, AND NEW ASCITES. TWO DAYS LATER, THE PATIENT PRESENTED WITH SYMPTOMS OF ABDOMINAL PAIN AND SOME NAUSEA. SHE DENIED HAVING DIFFICULTY URINATING, FLANK PAIN, DYSURIA, OR HEMATURIA. ON (B)(6) 2012, THE PATIENT UNDERWENT A CYSTOSCOPY, LEFT RETR

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, MEDWATCH UF/IMPORTER REPORT (B)(4) WAS RECEIVED: EVENT DESC: THE PATIENT SAFETY CONCERN REGARDING THE DAVINCI ROBOT IS A POSSIBLE DESIGN ISSUE. THE PATIENT SUFFERED A COMPARTMENT SYNDROME OF THE RIGHT LOWER EXTREMITY (RLE) AFTER THE ROBOTIC-ASSISTED LAPAROSCOPY (WITH PROCEDURES). IT IS FELT THAT THE ROBOTIC ARM, WHILE DOCKED ON THE RIGHT SIDE OF THE PATIENT, EITHER BUMPED AND/OR RESTED ON THE PATIENT'S RLE. THIS WAS A 7 HOUR PROCEDURE. THE PATIENT REQUIRED EMERGENCY, 4-COMPARTMENT FASCIOTOMY FOLLOWED BY ANOTHER SURGERY FOR SKIN GRAFT (PLUS WOUND VAC) AND WOUND CLOSURE. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? DA VINCI ROBOTIC-ASSISTED LAPAROSCOPY WITH LYSIS OF ADHESIONS, RESECTION OF ENDOMETRIOSIS, BILATERAL SALPINGECTOMY, CYSTOSCOPY, AND PELVIC FLOOR BOTOX INJECTION.

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 THAT UNDERWENT A DA VINCI NISSEN FUNDOPLICATION AND HIATAL HERNIA REPAIR PROCEDURE ON (B)(6) 2012. THE PATIENT REPORTEDLY SUSTAINED A LACERATION TO THE PORTAL VEIN DURING THE SURGICAL PROCEDURE AND SUBSEQUENTLY PASSED AWAY ON (B)(6) 2012. ISI WAS NOT PROVIDED WITH THE OPERATIVE REPORT OR THE PATIENT'S MEDICAL RECORDS. ACCORDING TO THE LEGAL DOCUMENT PROVIDED, WHILE THE SURGEON WAS DISSECTING AWAY MESENTERY IN THE AREA OF THE LESSER CURVATURE OF THE STOMACH, SIGNIFICANT BLEEDING WAS ENCOUNTERED AND A LATERAL LACERATION TO THE MEDIAL ASPECT OF THE PORTAL VEIN WAS THEN IDENTIFIED. AFTER RECOGNIZING THE VESSEL INJURY, THE SURGEON MADE THE DECISION TO CONVERT TO AN OPEN PROCEDURE AND ENTERED THE PATIENT'S ABDOMEN THROUGH A VERTICAL MIDLINE INCISION. VASCULAR SURGERY WAS THEN CONTACTED FOR ASSISTANCE. WHILE VASCULAR SURGERY WAS EN ROUTE, THE SURGEON CROSS CLAMPED THE PORTAL VEIN, PROCEEDED WITH THE NISSEN FUNDOPLICATION PROCEDURE, AND COMPLETED THE ORIGINALLY INTENDED PROCEDURE. UPON ARRIVING IN THE OPERATING ROOM, A VASCULAR SURGEON IDENTIFIED A LATERAL LACERATION TO THE MEDIAL ASPECT OF

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 MEDIATION EFFORT, INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION INCLUDING MEDICAL RECORDS CONCERNING A PATIENT WHO EXPIRED AT THE BEGINNING OF A PLANNED DA VINCI SI HYSTERECTOMY PROCEDURE ON (B)(6) 2012. AT THE TIME OF THE EVENT, THE DA VINCI SI SYSTEM HAD NOT YET BEEN DOCKED TO THE PATIENT. BASED ON THE MEDICAL RECORDS PROVIDED, THE PATIENT HAD PREOPERATIVE DIAGNOSIS OF UTERINE LEIOMYOMA, REFRACTORY TO MEDICAL MANAGEMENT. ACCORDING TO THE OPERATIVE NOTE, THE GENERAL ENDOTRACHEAL ANESTHESIA WAS ESTABLISHED PRIOR TO STARTING THE SURGICAL PROCEDURE. THE SURGEON MADE A HORIZONTAL INCISION IN THE PATIENT'S UMBILICUS WITH A SCALPEL AND A VERESS NEEDLE WAS USED TO ACCESS THE ABDOMINAL CAVITY. AFTER THE PATIENT'S ABDOMEN WAS INSUFFLATED WITH APPROXIMATELY 3 L OF CARBON DIOXIDE GAS, THE VERESS NEEDLE WAS REMOVED AND A 12 -MM TROCAR WAS PLACED. THE SURGEON STATED THAT AN EXPLORATION OF THE ABDOMEN AND PELVIS WAS PERFORMED AND NO EVIDENCE OF ANY INJURY AT THE SITE OF ENTRY WAS FOUND. THE PATIENT WAS THEN PLACED IN TRENDELENBURG POSITION. DURING REPOSITIONING, THE PATIENT WAS NOTED TO HAVE INTERMITTENT HYPOTENSION AND HYPERTENSION. HOWEVER, THE SURGEON STATED THAT IT W

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 TWO DAYS AFTER A SUCCESSFUL DA VINCI SI TONGUE BASE RESECTION PROCEDURE AND WHILE STILL ADMITTED, THE PATIENT EXPERIENCED BLEEDING FROM THE OPERATIVE AREA AND EXPIRED. IT WAS REPORTED THAT THE PATIENT DID EXPERIENCE BLEEDING FROM THE LINGUAL ARTERY DURING THE PROCEDURE; HOWEVER, THE BLEEDING WAS CONTROLLED WITH CAUTERY. THE SITE HAS BEEN CONTACTED FOR ADDITIONAL INFORMATION WITHOUT SUCCESS.

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 THAT UNDERWENT A DA VINCI-ASSISTED ROBOTIC CORONARY ARTERY BYPASS GRAFT PROCEDURE FOR CORONARY ARTERY DISEASE ON (B)(6) 2012. ISI WAS PROVIDED WITH THE DA VINCI SURGERY OPERATIVE REPORT (S) AND SUBSEQUENT MEDICAL RECORDS INCLUDING AUTOPSY REPORTS. 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 INTRA-OPERATIVE COMPLICATIONS. THE PATIENT'S IMMEDIATE POST-OP RECOVERY IN THE HOSPITAL WAS EXCELLENT. AFTER THE DA VINCI SURGERY WAS COMPLETED, THE PATIENT PRESENTED WITH THE FOLLOWING: ON (B)(6) 2012, THE PATIENT DEVELOPED FEVER AND SHORTNESS OF BREATH. AN EKG TEST WAS PERFORMED AND THE PATIENT WAS FOUND TO HAVE A RIGHT BUNDLE BRANCH HEART BLOCK. ON (B)(6) 2012, A CARDIAC MRI REVEALED THAT THE PATIENT HAD MYOCARDITIS. THE PATIENT CONTINUED TO BE FEBRILE AND SUBSEQUENTLY BECAME HYPOTENSIVE AND HYPOXIC. ON (B)(6) 2012, THE PATIENT WAS TRANSFERRED TO THE CCU FOR ICU TREATMENT. THAT SAME DAY WHILE IN THE CATH LAB FOR PULMONARY ARTERY (PA) CATHETE

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, RESECTION OF ENDOMETRIOSIS AND CYSTOSCOPY ON (B)(6) 2012. ISI WAS PROVIDED WITH THE PATIENT'S OPERATIVE (OP) REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDED FOLLOW-UP HOSPITAL RECOVERY NOTES: ACCORDING TO THE INFORMATION IN THE PATIENT'S OP REPORT, 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. ON (B)(6) 2012 THE PATIENT PRESENTED TO THE ER WITH ABDOMINAL PAIN, VAGINAL BLEEDING, AND REPORTS OF FEVER. THE PATIENT WAS GIVEN PACKED RED BLOOD CELLS TRANSFUSION. NOTES FROM THE HOSPITAL REPORT THAT THE PATIENT WAS AFEBRILE ON MULTIPLE DETERMINATIONS. A CT SCAN SHOWED 7/8CM PELVIC FLUID COLLECTION POSSIBLY RESOLVING A HEMATOMA. THE PATIENT'S COMPLETE BLOOD COUNT SHOWED THAT THE PATIENT HAD A NORMAL WHITE BLOOD COUNT AND HEMATOCRIT. THE PATIENT WAS TREATED WITH IV UNASYN DESPITE LACK OF EVIDENCE OF INFECTION OR DOCUMENTED FEVER. THE PATIENT WAS DISCHARGED TO HOME ON PERCOCET AND AUGMENTIN.

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 SLEEP NASAL ENDOSCOPY, UVULOPALATOPHARYNGOPLASTY AND TONGUE BASE REDUCTION WITH DA VINCI TRANSORAL ROBOTIC SURGERY (TORS) PROCEDURE ON (B)(6) 2012 FOR SEVERE OBSTRUCTIVE SLEEP APNEA AND CPAP INTOLERANCE. ISI WAS PROVIDED WITH THE OPERATIVE REPORT AND THE PATIENT'S MEDICAL RECORDS. THE OPERATIVE REPORT DOES NOT CONTAIN ANY ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. PER THE OPERATIVE REPORT, THE PATIENT WAS FOUND TO HAVE PROFOUND LINGUAL TONSIL HYPERPLASIA WHICH LED TO IMMEDIATE UPPER AIRWAY OBSTRUCTION UPON LOW DOSE ADMINISTRATION OF PROPOFOL. TO A LESSER EXTENT, THE PATIENT HAD UVULA AND SOFT PALATAL COLLAPSE. A TOTAL OF 19 ML OF TONGUE BASE WAS REMOVED. AS HEMOSTATIC AGENT WAS BEING APPLIED, BRISK BLEEDING WAS NOTED IN THE LEFT HYPOPHARYNX AND A THROAT PACK WAS PLACED. AFTER ALLOWING ADEQUATE TIME FOR HEMOSTASIS, THE THROAT PACK WAS GRADUALLY ADVANCED OUT OF THE HYPOPHARYNX AND EXPOSURE WAS ACHIEVED WITH A MOUTH GAG AND ROBOTIC CAMERA. THE SURGEON NOTED THAT THE LIKELY SOURCE OF BLEEDING WAS A SMALL BRANCH OF THE LINGUAL AR

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 NERVE SPARING RADICAL HYSTERECTOMY TYPE III, BILATERAL PELVIC LYMPHADENECTOMY, BILATERAL SALPINGECTOMY, BILATERAL OOPHOROPEXY FOR CERVICAL CANCER ON (B)(6) 2012. 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. THE PATIENT WAS DISCHARGED HOME IN GOOD CONDITION ON (B)(6) 2012. ON (B)(6) 2012 PATIENT PRESENTED WITH SMALL BOWEL PROLAPSING THROUGH THE VAGINA. SHE WAS DIAGNOSED WITH VAGINAL CUFF DEHISCENCE, TAKEN TO THE OPERATING ROOM FOR REPAIR.

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 4 HOURS INTO A DA VINCI S PROSTATECTOMY PROCEDURE, IT WAS NOTED BY THE ANESTHESIOLOGIST THAT THE PATIENT'S HEALTH WAS DECLINING. SEVERAL ATTEMPTS BY THE SURGICAL TEAM WERE MADE TO REVERSE THE PATIENT'S CONDITION, HOWEVER, THE ATTEMPTS WERE UNSUCCESSFUL AND THE PATIENT EXPIRED. NO OTHER ADDITIONAL 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, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI PROSTATECTOMY PROCEDURE ON (B)(6) 2012 FOR ADENOCARCINOMA OF THE PROSTATE. 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. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. VISUALIZATION OF THE INTRA-PERITONEAL CAVITY REVEALED SOME INTRA-ABDOMINAL ADHESIONS IN THE RIGHT UPPER QUADRANT AND IN THE PERIUMBILICAL REGION. SHARP DISSECTION WAS USED TO TAKE DOWN THE OMENTAL ADHESIONS AND A FEW SMALL BOWEL ADHESIONS. INSPECTION OF THE INTESTINES REVEALED NO INJURY. THE PATIENT WAS VERY THIN, SO THE TROCARS WERE PLACED CLOSER TO EACH OTHER THAN NORMAL. A MINIMAL NERVE SPARING PROCEDURE WAS PERFORMED BILATERALLY SECONDARY TO HIS AGGRESSIVE CANCER. OOZING FROM THE DORSAL VENOUS COMPLEX WAS NOTED AND LIGATED WITH SUTURES. GOOD HEMOSTASIS WAS NOTED THROUGHOUT THE PROCEDURE. A BILATERAL LYMPH NODE DISSECTION WAS PERFORMED FROM THE LEVEL OF THE ILIAC VESSELS TO THE OBTURATOR NERVE AND VESSELS POSTERIORLY TO THE PELVIC SIDEWALL, TO THE BLADDER MEDIALLY. NO INJU

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 DURING A DA VINCI SI HYSTERECTOMY PROCEDURE, THE PATIENT WAS NOT SECURELY VELCROED TO THE OPERATING TABLE, CAUSING THE PATIENT TO SLIDE. THE SYSTEM CAMERA ARM THAT WAS DOCKED TO THE PATIENT WAS ABLE TO HOLD THE PATIENT ON THE TABLE AND PREVENT THEM FROM FULLY SLIDING OFF. DUE TO THE SLIDING, TEARING OCCURRED AT THE TROCAR PORT INCISION LOCATION. THE TEAR WAS REPAIRED AT THE END OF THE SURGICAL PROCEDURE. NO ADDITIONAL PATIENT HARM WAS REPORTED. AFTER THE EVENT OCCURRED, THE SURGEON INDICATED THAT THE CAMERA ARM WAS DIFFICULT TO MOVE AND FELT LIKE IT WAS PULSATING DURING MANUAL MOVEMENT.

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 PROCEDURE ON (B)(6) 2012 FOR AN ENLARGED BOGGY UTERUS. ISI WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES A HISTORY AND PHYSICAL EXAM FOR WHEN THE PATIENT DEVELOPED VAGINAL BLEEDING AFTER SURGERY. 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 PATIENT HAD AN UNEVENTFUL OPERATION. ON (B)(6) 2012, THE PATIENT CALLED THE DOCTOR'S OFFICE COMPLAINING OF A FOUL DISCHARGE. SHE BEGAN FLAGYL TREATMENT FOR A VAGINAL INFECTION. ON (B)(6) 2012, THE PATIENT WAS SEEN IN THE DOCTOR'S OFFICE WITH PAIN AND BLEEDING AFTER INTERCOURSE. SHE RETURNED TO OUTPATIENT SURGERY TO HAVE A BROKEN SUTURE REPLACED. THE UPPER VAGINA WAS RE-SUTURED WITH 5 SUTURES OF 1 VICRYL.

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 AN UNCOMPLICATED DA VINCI HYSTERECTOMY PROCEDURE WAS SUCCESSFULLY COMPLETED, THE PATIENT EXPIRED LATER THAT NIGHT.