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 PROSTATECTOMY PROCEDURE ON (B)(6) 2012 FOR HIGH RISK ADENOCARCINOMA OF THE PROSTATE AND SUBSEQUENTLY EXPIRED ON (B)(6) 2012. ISI WAS PROVIDED WITH THE DA VINCI OPERATIVE REPORT AND ADDITIONAL INFORMATION INCLUDING READMISSION NOTES AND LAB WORK. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS NO REPORT OF AN INTRA-OPERATIVE COMPLICATION; HOWEVER, THE SURGEON EXPERIENCED DIFFICULTY CONTROLLING BLEEDING FROM THE DORSAL VENOUS COMPLEX SO THE DA VINCI SURGICAL PROCEDURE WAS CONVERTED TO AN OPEN LAPAROTOMY. TRANSFUSIONS WERE REQUIRED WITH RBC AND PLATELETS. THE PATIENT'S HEMATOCRIT WAS LOW (27%). SUPERFICIAL VENOUS THROMBOSIS WAS NOTED ON THE RIGHT LESSER SAPHENOUS VEIN. THE PATIENT WAS DISCHARGED ON (B)(6) 2012. ON (B)(6) 2012, THE PATIENT RETURNED TO THE EMERGENCY ROOM AND REPORTED URINE LEAKING AFTER MANIPULATION OF THE CATHETER AT HOME. ON (B)(6) 2012, A DRAINAGE CATHETER WAS PLACED IN ABDOMEN. ON (B)(6) 2012, THE PATIENT DEVELOPED PULSELESS ELECTRICAL ACTIVITY AND COULD NOT BE RESUSC

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 CHRONIC PELVIC PAIN AND ENLARGED UTERUS ON (B)(6) 2012. FINDINGS INCLUDED ENDOMETRIOSIS AND FIBROIDS. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDED CERTAIN MEDICAL RECORDS REGARDING POSTOPERATIVE CARE. 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 OTHER THAN THE FINDING OF EXTENSIVE ADHESIONS, HOWEVER AFTER REVIEWING THE FOLLOW UP RECORDS, IT IS CLEAR THAT THE PATIENT'S LEFT URETER WAS TRANSECTED DURING THE INITIAL OPERATION, BUT THIS WENT UNRECOGNIZED UNTIL A FEW DAYS LATER ON (B)(6) 2012 THE PATIENT PRESENTED WITH INCREASING URINARY DIFFICULTY, BLOATING, ABDOMINAL PAIN AND NAUSEA. WORK UP INCLUDED CHEST X-RAY, URINALYSIS, CT SCAN OF THE PELVIS AND ABDOMEN. A 14 CM FLUID COLLECTION WAS FOUND. ON (B)(6) 2012 THE PATIENT RETURNED TO THE OR WHERE SHE UNDERWENT EXPLORATORY LAP, CYSTOSCOPY, RE-IMPLANTATION OF L URETER. THE ABDOMEN COULD NOT BE CLOSED DUE TO SWELLING

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 INCLUDING MEDICAL RECORDS OF A PATIENT WHO UNDERWENT LOWER ANTERIOR RESECTION FOR RECTOSIGMOID CANCER ON (B)(6) 2012. THE PATIENT'S OPERATIVE (OP) REPORT FOR THE DA VINCI LOW ANTERIOR RESECTION PROCEDURE INDICATES THAT THE PATIENT WAS FOUND TO HAVE A LARGE FRIABLE BLOODY MASS AND MASS IN THE RECTOSIGMOID. IN ADDITION THERE WERE LESIONS IN THE LIVER CONSISTENT WITH CYSTS. PER THE MEDICAL RECORDS, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT COMPLICATIONS. THE ABDOMEN WAS COPIOUSLY IRRIGATED, CLEAN AND DRIED. THE OP REPORTS DO NOT CONTAIN ANY INDICATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. DURING THE POST-OP RECOVERY PHASE, THE PATIENT DEVELOPED SEPSIS ,INTRABDOMINAL INFECTION. THE PATIENT WAS SENT BACK TO THE OPERATING ROOM FOR AN EMERGENCY EXPLORATORY LAPAROTOMY, DRAINAGE OF PELVIS AND ABDOMINAL ABSCESSES, ABDOMINAL WASHOUT AND PLACEMENT OF A DIVERTING LOOP ILEOSTOMY. PER THE MEDICAL RECORDS, TURBID FLUID WAS ENCOUNTERED CONSISTENT WITH ABSCESS. THE ABDOMEN WAS COPIOUSLY IRRIGATED. 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: ON (B)(6) 2012, INTUITIVE SURGICAL WAS PROVIDED A LETTER SENT TO (B)(6) FROM (B)(6), ALLEGING PROLONGED PROCEDURES UP TO 11 HOURS CAN RESULT IN AFFECTS TO THE PATIENT SUCH AS THROMBOSIS, EMBOLISM, COMPARTMENTAL SYNDROME AND HEMATOMAS. ADDITIONALLY, AN ALLEGATION WAS MADE THAT A PATIENT EXPERIENCED AN ABSCESS AFTER A PROCEDURE. THE LETTER ALSO ALLEGED GENERAL PROBLEMS WITH PROPER STERILIZATION OF INSTRUMENTS. NO SITE SPECIFIC INFORMATION WAS PROVIDED WITHIN THE BODY OF THIS LETTER. SEVERAL ATTEMPTS HAVE BEEN MADE TO CONTACT THE AUTHOR OF THE LETTER, (B)(6) AND STAFF, BOTH VIA EMAIL AND PHONE; HOWEVER, AS OF THE DATE OF THIS REPORT NO RETURNED COMMUNICATION HAS BEEN RECEIVED.

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 S HYSTERECTOMY PROCEDURE WITH BILATERAL SALPINGO-OOPHORECTOMY, EXTENSIVE LYSIS OF ADHESIONS AND RIGHT URETEROLYSIS ON (B)(6) 2012. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2012. THE PATIENT'S OPERATIVE REPORT (OP) FOR THE SURGICAL PROCEDURE ON (B)(6) 2012 INDICATED THAT THE PATIENT UNDERWENT THE DA VINCI HYSTERECTOMY PROCEDURE WITH BILATERAL SALPINGO-OOPHORECTOMY DUE TO UTERINE FIBROIDS, MENOMETRORRHAGIA AND MILD CERVICAL DYSPLASIA. BASED ON THE INFORMATION IN THE PATIENT'S OP, THERE WAS NO REPORT THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED DURING THE PROCEDURE. THE SURGEON DESCRIBES IN THE OP THAT THERE WERE EXTENSIVE ADHESIONS AND HE DECIDED TO PERFORM EXTENSIVE LYSIS OF ADHESIONS BETWEEN THE BLADDER AND THE ANTERIOR PART OF THE LOWER UTERINE SEGMENT. THE SURGEON STATES IN THE OP THAT THE RIGHT URETER WAS VERY CLOSE TO THE LEVEL OF DISSECTION. THE SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED AND THE PATIENT WAS TAKEN TO THE RECOVERY ROOM WITH STABLE VITAL SIGNS AND IN

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 DURING A DA VINCI SI BILATERAL SALPINGO-OOPHORECTOMY PROCEDURE, DURING PLACEMENT OF THE UTERINE MANIPULATOR, THE PATIENT'S BOWEL WAS RUPTURED. THE SURGEON REPAIRED THE PATIENT'S BOWEL, WHICH TOOK APPROXIMATELY 3 HOURS TO REPAIR. TWO DAYS POST OP THE PATIENT EXPERIENCED CARDIOVASCULAR COMPLICATIONS AND COMPLICATIONS AND EXPIRED. THE SURGEON IS ATTRIBUTING THE PATIENT'S DEMISE TO A T-BERG. 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, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI ANTERIOR EXENTERATION, INCLUDING CYSTECTOMY, HYSTERECTOMY AND BILATERAL SALPINGO-OOPHORECTOMY PROCEDURE ON (B)(6) 2012 FOR CHRONIC PYOCYSTIS AND NEUROGENIC BLADDER. 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. AN OPEN HASSON TECHNIQUE WAS USED TO ENTER THE PERITONEAL CAVITY. EXTENSIVE ADHESIONS WERE SEEN UPON INSERTION OF THE LAPAROSCOPE. THESE WERE MOSTLY IN THE MIDLINE AND ADJACENT TO THE ILEAL CONDUIT IN THE RIGHT LOWER QUADRANT. THEY WERE TAKEN DOWN USING COLD SHEARS PRIOR TO DOCKING THE DA VINCI SYSTEM. THE BLADDER, UTERUS AND OVARIES WERE COMPLETELY DISSECTED AND DELIVERED THROUGH THE VAGINAL APEX. HEMOSTASIS IN THE PELVIS WAS CONFIRMED. THE ILEAL CONDUIT WAS CAREFULLY INSPECTED AND IRRIGATED TO CONFIRM NO INJURY. CAREFUL INSPECTION OF THE BOWEL UNDERNEATH THE PRIOR ADHESIONS NOTED NO INJURY. AN ON-Q PAIN PUMP WAS PUT INTO PLACE SUBCUTANEOUSLY. ESTIMATED BLOOD LOSS WAS 900 ML. THE PATIEN

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 ONE YEAR AGO, A PATIENT EXPIRED AFTER UNDERGOING A DA VINCI SI GYNECOLOGICAL PROCEDURE.

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 DURING A DA VINCI S PROSTATECTOMY PROCEDURE, MINOR BLEEDING OCCURRED. THE BLEEDING WAS REGARDED AS NORMAL BLEEDING FROM MINOR VESSELS. THE SURGERY WAS COMPLETED SUCCESSFULLY AND THE PATIENT WENT INTO RECOVERY. THE PATIENT SEEMED FINE DURING RECOVERY; HOWEVER, AT AN UNKNOWN TIME AFTER THE SURGERY, THE PATIENT EXPIRED. NO FURTHER 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 HYSTERECTOMY PROCEDURE ON (B)(6) 2012 FOR MENOMETRORRHAGIA. ISI WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES A HANDWRITTEN LIMITED HISTORY AND PHYSICAL RECORD FROM (B)(6) 2012 AND SEVERAL RADIOLOGIC REPORTS. ACCORDING TO THE MEDICAL RECORDS, 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. AFTER INTRAVAGINAL PLACEMENT OF THE ROOMY UTERINE MANIPULATOR, A PNEUMOPERITONEUM WAS CREATED USING A VERESS NEEDLE THROUGH THE UMBILICUS AND PORTS WERE PLACED UNDER DIRECT VISUALIZATION. THE UTERO-OVARIAN AND ROUND LIGAMENTS WERE CAUTERIZED WITH THE PK DEVICE AND TRANSECTED WITH MONOPOLAR SCISSORS. THE BLADDER WAS SHARPLY TAKEN OF THE UTERUS AND THE BLADDER FLAP CREATED WHILE THE VESSELS AND TISSUE WAS CAUTERIZED AND TRANSECTED IN A SIMILAR FASHION. SOME BLEEDING WAS NOTED ON THE LEFT SIDE FROM A RESIDUAL VESSEL COMING OF THE UTERINE ARTERY. AFTER COLPOTOMY, THE UTERUS WAS REMOVED THROUGH THE CUFF AND THE COLPOTOMY CLO

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 GALL BLADDER PROCEDURE ON (B)(6) 2012. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: A GALL STONE GOT STUCK IN THE BILE DUCT AND THEY TRIED TO PUSH IT OUT. THEY RUPTURED THE BILE DUCT SHE THEN BLED INTERNALLY. HER SCAR STILL REMAINS.

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, A CYSTOSCOPY AND LYSIS OF ADHESION PROCEDURE ON (B)(6) 2012. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2012 IN STABLE CONDITION. ON (B)(6) 2012, THE PATIENT RETURNED TO THE HOSPITAL'S EMERGENCY ROOM COMPLAINING OF ABDOMINAL PAIN. THE PATIENT'S OPERATIVE (OP) REPORT FOR THE SURGICAL PROCEDURE DATED (B)(6) 2012 INDICATED THAT THE PATIENT'S PREOPERATIVE DIAGNOSIS WAS CHRONIC PAIN AND ABNORMAL VAGINAL BLEEDING. THE OP REPORT DID NOT ALLEGE THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED DURING THE SURGICAL PROCEDURE AND THERE WERE NO ANOMALIES NOTED. PER THE INFORMATION IN THE OP REPORT, THE SURGICAL PROCEDURE WAS COMPLETED AND THE PATIENT TOLERATED THE PROCEDURE WELL. THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. THE PATIENT CALLED THE DOCTOR'S OFFICE ON (B)(6) 2012 COMPLAINING OF NAUSEA AND VOMITING. AN E-SCRIPT FOR ZOFRAN WAS SENT IN FOR HER. ON (B)(6) 2012, THE PATIENT UNDERWENT A CYSTOSCOPY, BILATERAL RETROGRADE URETEROGRAM, B

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 OF A PATIENT WHO UNDERWENT A DA VINCI A HYSTERECTOMY PROCEDURE ON (B)(6) 2012 AND ALLEGEDLY SUFFERED AN URETERAL INJURY. 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: IT WAS REPORTED THAT APPROXIMATELY 45 MINUTES INTO A DA VINCI SI PROCEDURE WHEN THE ASSISTANT AT THE PATIENT SIDE CART (PSC) PERFORMED A TOOL CHANGE TO SWITCH THE INSTRUMENTS IN THE PATIENT SIDE MANIPULATOR (PSM) ARMS, THE PATIENT'S AORTA WAS PUNCTURED. THE SURGEON MADE THE DECISION TO CONVERT TO TRADITIONAL OPEN SURGICAL TECHNIQUES TO COMPLETE THE PLANNED SURGICAL PROCEDURE. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION RIGHT AFTER THE OPEN SURGICAL PROCEDURE, HOWEVER, THE PATIENT EXPIRED THE FOLLOWING DAY. THE SITE HAS BEEN CONTACTED FOR ADDITIONAL INFORMATION, HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN FORTHCOMING.

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 CORONARY ARTERY BYPASS PROCEDURE FOR STENT STENOSIS ON (B)(6) 2012. ISI WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDED THE PATIENT'S HOSPITAL RECORDS. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. BASED ON THE OPERATIVE REPORT THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR AN ELECTIVE CORONARY ARTERY BYPASS PROCEDURE ON (B)(6) 2012. THE PATIENT WAS INFORMED OF THE RISK, BENEFITS, AND ALTERNATIVES TO THE PROCEDURE. THE PATIENT UNDERSTOOD, AGREED, AND WISHED TO PROCEED WITH THE PROCEDURE. ACCORDING TO THE OPERATIVE REPORT, DURING AN INSTRUMENT CHANGE FOR THE SUPERIOR ROBOTIC PORT AN INADVERTENT AORTIC INJURY WAS CREATED. THIS APPEARED TO SELF TAMPONADE, HOWEVER, PRUDENCE DICTATED CONVERSION TO OPEN AT THIS POINT. THEREFORE, THE ROBOT WAS REMOVED FROM THE FIELD. THE LEFT ANTERIOR THORACOTOMY WAS MADE TO INCLUDE THE THORACOSCOPIC PORT. IN ADDITION IT WAS NOTED THAT, A SMALL LINEAR RENT ON THE OUTER SURFACE OF THE DESCENDING AORTA SUPERIOR TO THE PULMONARY ARTERY WA

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 2 DAYS POST-OP A DA VINCI SI GASTRIC BYPASS PROCEDURE, THE PATIENT DEVELOPED SEPTIC SHOCK AFTER THE JEJUNUM (JJ) AND GASTROJEJUNUM (GJ) STAPLE LINES AND SUTURE CLOSURES OPENED. THERE WAS NO REPORT OF A MALFUNCTION OF THE DA VINCI SYSTEM, INSTRUMENTS AND/OR ACCESSORIES AND IT IS THE SURGEON'S BELIEF THAT OPENING OF THE JJ AND GS STAPLE LINES AND SUTURE CLOSURES WAS RELATED TO THE PATIENT'S ANATOMY. 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 THAT UNDERWENT A DA VINCI S TOTAL HYSTERECTOMY WITH LYMPHADENECTOMY FOR ADENOCARCINOMA OF THE ENDOMETRIUM (B)(6) 2012. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT . ADDITIONAL INFORMATION PROVIDED INCLUDES OFFICE AND HOSPITAL NOTES REGARDING FOLLOW UP CARE. 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 UNDERWENT RADICAL HYSTERECTOMY WITH BSO, RIGHT PELVIC LYMPH NODE BIOPSY AND APPENDECTOMY ON. DISCHARGED ON (B)(6) 2012. RE-ADMISSION ON (B)(6) 2012 FOR EXPLORATORY LAPAROTOMY FOR PELVIC ABSCESS WITH SEPTIC SHOCK. LARGE 8-10 CM POSTERIOR ABSCESS NOTED. NO INTESTINAL PERFORATION OR OTHER INJURY WAS NOTED. UNFORTUNATELY, FOLLOWING SURGERY, SHE EXPIRED DUE TO SEPTIC 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 DISPUTE INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY WITH BSO, UTEROSACRAL LIGAMENT SUSPENSION AND CYSTOSCOPY FOR PELVIC PRESSURE AND THICKENING OF THE ENDOMETRIAL LINING ON (B)(6) 2012. REPORTEDLY, THE PATIENT SUSTAINED A BOWEL INJURY. ISI WAS NOT PROVIDED WITH ANY ORIGINAL MEDICAL RECORDS INCLUDING OPERATIVE REPORT OR DISCHARGE SUMMARIES. ACCORDING TO THE INFORMATION PROVIDED, ON (B)(6) 2012, WHEN IT WAS DISCOVERED THAT THE PATIENT WAS STILL NOT GETTING BETTER GI AND SURGERY WERE CONSULTED. A SECOND CT WAS OBTAINED AND SHE WAS NOTED TO HAVE A POSSIBLE ENTEROTOMY IN THE LOWER COLON. ON (B)(6) 2012, SHE WAS TAKEN BACK TO THE OPERATING ROOM. THE SURGEON DID NOTE A RECTAL INJURY AND THIS WAS REPAIRED AND A PROTECTIVE DIVERTING COLOSTOMY WAS PLACED. POST OPERATIVELY THE PATIENT NEEDED TO BE IN THE ICU FOR SEVERAL DAYS. AN ACUTE MYOCARDIAL INFARCT WAS DIAGNOSED DURING THIS EPISODE. AFTER BEING TREATED WITH IV ANTIBIOTICS HER WHITE COUNT DID DIMINISH. A REHAB FACILITY WAS THEN CONSULTED ON (B)(6) FOR LONG TERM MANAGEMENT. THE PATIENT CONTINUED TO IMPROVE SLOWLY AND WAS ADVANCED IN HER DIET IN A VERY S

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 HIATAL HERNIA REPAIR PROCEDURE ON (B)(6) 2012. ACCORDING TO THE LEGAL DOCUMENT PROVIDED, THE SURGEON SUSPECTED DURING THE DA VINCI SURGERY THAT HE HAD INJURED THE PATIENT'S BOWEL AND DECIDED TO CONVERT TO AN OPEN PROCEDURE. DURING THE OPEN PROCEDURE, THE SURGEON REPORTEDLY DISCOVERED A BOWEL PERFORATION (HOLE IN HER BOWELS). HE ALSO IDENTIFIED MULTIPLE TEARS IN THE MEMBRANE AROUND THE PATIENT'S BOWELS. ACCORDING TO THE LEGAL DOCUMENT, THE SURGEON BELIEVED THIS BOWEL DAMAGE WAS CAUSED BY A GRASPER ON THE DA VINCI ROBOT HE USED. AFTER IDENTIFYING THE BOWEL DAMAGE, THE SURGEON REMOVED PART OF THE PATIENT'S COLON AND THEN REPAIRED THE PATIENT'S HERNIA. THE LEGAL DOCUMENT CLAIMS THAT AFTER THE SURGERY WAS COMPLETED, THE PATIENT REMAINED HOSPITALIZED AND HER MEDICAL CONDITION DECLINED DUE TO COMPLICATIONS FROM THE BOWEL SURGERY. ON (B)(6) 2012 THE SURGEON DECIDED TO PERFORM AN EXPLORATORY SURGERY AFTER A BUILDUP OF GAS WAS OBSERVED IN THE PATIENT'S ABDOMEN. THE EXPLORATORY SURGERY REVEALED THAT THE PATIENT'S SMALL AND LARGE BOWEL WERE FOUND TO BE DEAD. 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) 2012, A PATIENT POSTED THE FOLLOWING INFORMATION ON ISI'S SOCIAL NETWORK SITE VIA (B)(6): "I HAD THE DAVINCI SURGERY 8 MONTHS AGO. I STILL HAVE SOME NUMBNESS IN ONE AREA AND I STILL HAVE SOME PAIN. DO YOU KNOW WHY I WOULD STILL HAVE PAIN AFTER THIS LONG? I WILL BE SEEING MY DOCTOR ON (B)(6). I HAVE ASKED HER BEFORE WHY IT STILL HURT; SHE TOLD ME SINCE I HAD PROBLEMS WITH MY LEFT SIDE BEFORE MY SURGERY THAT IS WHY IT STILL HURTS. IT DOES NOT MAKE SENSE AT ALL TO ME. AND ALSO ABOUT A WEEK AGO I STARTED TO SPOT. IT LASTED FOR A DAY AND A HALF."

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, AND ALLEGED A BOWEL PERFORATION 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 WHO UNDERWENT DA VINCI TOTAL HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY AND CYSTOSCOPY FOR HISTORY OF MENOMETRORRHAGIA, DYSMENORRHEA, AND UTERINE FIBROIDS 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, INSTRUMENTS OR ACCESSORIES DURING SURGERY. THE OPERATIVE FINDINGS WERE A (B)(6) UTERUS WITH MULTIPLE FIBROIDS. SEQUENTIAL IDENTIFICATION, CAUTERIZATION AND TRANSECTION OF THE INFUNDIBULO PELVIS LIGAMENTS, THE ROUGNON LIGAMENTS, THE BROAD LIGAMENTS. THE ARTERIAL DISSECTION AND CULPOTOMY WERE NOTABLE FOR A DIFFICULT DISSECTION DUE TO THE PRESENCE OF EXTENSIVE ADHESIONS, AND AN ABNORMALLY HIGH ROUTE FOR THE UTERINE ARTERY ON THE RIGHT SIDE. THE ARTERY WAS CAUTERIZED, AND AFTER DISSECTION IT WAS NOTED THAT THE URETER HAD BEEN IN CLOSE PROXIMITY DURING COAGULATION, AND THERE WAS CONCERN FOR THERMAL INJURY. THE REMAINDER OF THE OPERATION WAS COMPLETED, AND A UROLOGIC CONSULT WAS CALLED TO EVALUATE THE STATE OF THE URETER. THE CONSULT SURGEON PERFORMED A URETEROLYSIS FROM THE PELVIC BRIM TO THE INSERT

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 GASTRIC BYPASS PROCEDURE THE SURGEON WAS UNABLE TO MOVE PATIENT SIDE MANIPULATOR (PSM) ARM 2 FROM THE SURGEON CONSOLE. AFTER RESTARTING THE SYSTEM, PSM ARM 2 WORKED FINE. AFTER 15 MINUTES OF OPERATION THE SURGEON LOST CONTROL OF PSM ARM 1, RESULTING IN DAMAGE TO THE PATIENT'S STOMACH. NO FURTHER INJURIES WERE 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 DURING A DA VINCI SI OVARIAN TRANSPOSITION PROCEDURE, A COMPLICATION OCCURRED AND THE PATIENT STARTED TO BLEED. THE SURGEON ATTEMPTED TO CONTROL BLEEDING BY APPLYING PRESSURE WITH AN INSTRUMENT GRASPER AND APPLYING LAPAROSCOPIC LIGACLIPS. THE LIGACLIPS FAILED TO CONTROL THE BLEEDING AND THE SURGEON ATTEMPTED TO SUTURE THE VESSEL, BUT THIS WAS ALSO UNSUCCESSFUL AT CONTROLLING BLEEDING. THE SURGEON MADE THE DECISION TO CONVERT TO TRADITIONAL OPEN SURGICAL TECHNIQUES. THE SURGICAL STAFF UNDOCKED THE CAMERA ARM AND ONE OF THE INSTRUMENT ARMS FROM THE PATIENT BUT KEPT THE OTHER TWO ARMS WITH THE INSTRUMENTS IN THE PATIENT. THE INSTRUMENTS ARMS WERE APPLYING PRESSURE TO THE SITE OF BLEEDING. THE SURGEON ATTEMPTED TO FIND THE SOURCE OF BLEEDING. IT IS UNCLEAR ON THE SEQUENCE OF EVENTS AFTER THIS. THE PATIENT WAS CONFIRMED TO HAVE EXPIRED. IT IS UNKNOWN WHETHER THE PATIENT EXPIRED DURING OR AFTER THE PROCEDURE. NO FURTHER 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: IT WAS REPORTED THAT DURING A DA VINCI SI PULMONARY LOBECTOMY PROCEDURE, THE PATIENT'S PULMONARY ARTERY WAS LACERATED, REQUIRING HEMOSTASIS OF THE AFFECTED VESSEL USING A CADIERE FORCEPS INSTRUMENT TO ALLOW FOR COMPLETION OF THE PLANNED SURGICAL PROCEDURE USING OPEN SURGICAL TECHNIQUES. AFTER OBTAINING ADEQUATE EXPOSURE, THE SITE ATTEMPTED TO MANUALLY OPEN THE GRIPS ON THE CADIERE FORCEPS INSTRUMENT USING SEVERAL DIFFERENT ALLEN WRENCHES, HOWEVER, THE INSTRUMENT GRIPS WOULD NOT RELEASE. THE SITE THEN ATTEMPTED TO RELEASE THE INSTRUMENT USING THE MASTER TOOL MANIPULORS (MTM), HOWEVER, THE ERROR MESSAGE UNABLE TO ALIGN MASTERS WAS OBSERVED. UNABLE TO RESOLVE THE ISSUE, THE SITE CONTACTED ISI TECHNICAL SUPPORT ENGINEERING (TSE) FOR TROUBLESHOOTING ASSISTANCE. AFTER PERFORMING AN EMERGENCY STOP/RECOVER OF THE SYSTEM, THE GRIPS ON THE CADIERE FORCEPS INSTRUMENT OPENED. NO OTHER INFORMATION CONCERNING 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: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI SI HYSTERECTOMY FOR MENORRHAGIA AND UTERINE FIBROIDS ON (B)(6) 2012. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT ADDITIONAL INFORMATION PROVIDED INCLUDES FOLLOW-UP OPERATIVE AND RADIOLOGY REPORTS THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY]. THERE WAS A REPORT OF AN INTRAOPERATIVE COMPLICATION, NAMELY AN INCIDENTAL CYSTOTOMY WHICH WAS REPAIRED DURING THE INITIAL OPERATION BY A UROLOGIST. THE PATIENT WAS DISCHARGED HOME WITH A FOLEY CATHETER IN 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 DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI S HYSTERECTOMY, ASPIRATION OF LEFT OVARIAN CYST FOR CHRONIC PELVIC PAIN AND ADENOMYOSIS 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 AND GOOD HEMOSTASIS WAS REPORTED. THE PROCEDURE WAS UNREMARKABLE EXCEPT FOR THE PRESENCE OF A HEMORRHAGIC LEFT OVARIAN CYST WHICH WAS DRAINED. THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. ON POSTOP DAY 2, (B)(6) 2012, THE PATIENT'S BLOOD PRESSURE HAD FALLEN AND SHE HAD EPISODES OF DIAPHORESIS. AS HER HEMOGLOBIN COUNTS FELL, THE DECISION WAS MADE TO PERFORM AN EXPLORATORY LAPAROTOMY. HEMOPERITONEUM WAS RECOGNIZED, AND 2300ML OF CLOTS ENCOUNTERED AND IRRIGATED OUT. THE UTERO-OVARIAN PEDICLES WERE FOUND TO BE HEMOSTATIC AS WERE THE PELVIC SIDEWALL, PORT SITES, BOTH OVARIES AND TUBES. A SMALL AREA IN THE POSTERIOR RIGHT VAGINAL CUFF WAS OOZING, AND IT WAS CLOSED. THE PATIENT WAS TRANSFERRED TO THE ICU ON A VENTILATOR. SHE WAS DISCH

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 TRANSORAL ROBOTIC SURGERY WITH PARTIAL PHARYNGECTOMY, RADICAL TONSILLECTOMY, AND PARTIAL GLOSSECTOMY FOR SQUAMOUS CELL CARCINOMA OF THE RIGHT OROPHARYNX ON (B)(6) 2012. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES: HISTORY AND PHYSICAL (H&P) (B)(6) 2012, DISCHARGE SUMMARY (B)(6) 2012, NURSING ASSESSMENT OF PT. DISCHARGE READINESS (B)(6) 2012, 2 HANDWRITTEN POSTOPERATIVE PROCEDURE NOTES (B)(6) 2012, PROGRESS NOTE (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. A MCGIVER MOUTH PROP WAS PLACED AND SUSPENDED FROM THE SUSPENSION ARM, THE ROBOT DOCKED WITH THE CAMERA ARM AND 2 OPERATING ARMS POSITIONED APPROPRIATELY, LOADED WITH THE MARYLAND GRASPER, THE MONOPOLAR CAUTERY, AND THE 8MM CAMERA. THE TUMOR WAS IMMEDIATELY VISUALIZED AND REVEALED A > 2CM ENDOPHYTIC TUMOR FROM THE RIGHT TONSIL, COMPLETELY CONFINED TO TONSIL. THE RESECTION WAS THEN INITIATED BY USING THE MONOPOLAR CAUTERY AT THE T

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 HYSTERECTOMY PROCEDURE ON (B)(6) 2012 FOR ENDOMETRIAL ADENOCARCINOMA. ACCORDING TO THE LEGAL DOCUMENT, THE PATIENT REPORTEDLY SUSTAINED A PUNCTURE TO HER BLADDER AND INTESTINES DURING THE DA VINCI SURGERY AND SUBSEQUENTLY DIED ON AN UNSPECIFIED DATE. IN ADDITION TO THE LEGAL DOCUMENT, ISI WAS PROVIDED WITH THE OPERATIVE REPORTS OF THE PRIMARY DA VINCI HYSTERECTOMY PROCEDURE AND A SECONDARY OPERATION THAT OCCURRED ON (B)(6) 2012. NO ADDITIONAL INFORMATION WAS PROVIDED. ACCORDING TO THE (B)(6) 2012 DA VINCI SURGERY OPERATIVE REPORT, THERE WAS AN INTRAOPERATIVE COMPLICATION, NAMELY A SMALL INADVERTENT CYSTOTOMY, WHICH WAS RECOGNIZED AND REPAIRED BY A UROLOGIST DURING THE INITIAL OPERATION. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT AND/OR ACCESSORY DURING SURGERY IN THE OPERATIVE REPORT. IT IS UNKNOWN WHEN THE PATIENT WAS DISCHARGED AFTER THE DA VINCI SURGERY. ON (B)(6) 2012, THE PATIENT RETURNED TO SURGERY FOR ACUTE ABDOMINAL PAIN. PERFORATED VISCUS WAS SEEN. RESECTION OF TERMINAL ILEUM AND ILEOSTOMY WERE PERFORMED BY

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 PARTIAL HYSTERECTOMY PROCEDURE ON (B)(6) 2012. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY:LARGE HEMATOMA CAUSING HEAVY BLEEDING, STITCH USED IN OPERATION WAS NOT DONE PROPERLY, INTERNAL BLEEDING, HERNIATED APPENDIX.

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, ISI RECEIVED A LEGAL COMPLAINT ALLEGING THAT A PATIENT WHOM UNDERWENT A DA VINCI SI GYNECOLOGICAL PROCEDURE ON (B)(6) 2012 AT (B)(6) MEDICAL CENTER IN (B)(6), EXPERIENCED PAIN, SUFFERING AND BLEEDING POST THE SURGICAL PROCEDURE. THE LEGAL COMPLAINT ALLEGES THAT UPON THE PATIENT'S FOLLOW UP WITH HER TREATING PHYSICIAN, THE PHYSICIAN INDICATED TO HER THAT THE POST-SURGICAL COMPLICATIONS SHE WAS EXPERIENCING WERE A NORMAL PART OF THE RECOVERY FROM HER SURGERY. THE LEGAL COMPLAINT ALLEGED THAT ON (B)(6) 2012 THE PATIENT MET WITH HER TREATING PHYSICIAN DUE TO EXTENSIVE GYNECOLOGICAL BLEEDING. IT WAS ALLEGED THAT THE TREATING PHYSICIAN DIRECTED THE PATIENT TO THE EMERGENCY ROOM AT (B)(6) MEDICAL CENTER. IT WAS DISCOVERED THAT THE PATIENT REQUIRED AN EMERGENCY SURGICAL PROCEDURE TO CORRECT A SURGICAL DEFECT THAT WAS CAUSED BY THE SITE'S DA VINCI SI SURGICAL SYSTEM. THIS WAS NOT DISCOVERED DURING THE PATIENT'S SURGICAL PROCEDURE PERFORMED ON (B)(6) 2012. REPORTEDLY, FOLLOWING THE EMERGENCY SURGICAL PROCEDURE, THE PATIENT WAS HOSPITALIZED AND CONFINED TO HER BED FOR MANY DAYS.

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 21, 2013, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION INCLUDING MEDICAL RECORDS OF A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY PROCEDURE ON (B)(6) 2012 WITH A PRE-OPERATIVE DIAGNOSIS OF MENORRHAGIA, PELVIC PAIN AND THE DESIRED DEFINITIVE THERAPY. THE PATIENT'S MEDICAL RECORDS STATE THAT THE RISKS, BENEFITS AND ALTERNATIVES TO ROBOTIC SURGERY AND HYSTERECTOMY WERE DISCUSSED WITH THE PATIENT, AND THE PATIENT UNDERSTOOD AND CONSENTED. ACCORDING TO THE PATIENT'S OPERATIVE (OP) REPORT, A 10MM INCISION AT THE UMBILICUS WAS CREATED, AND A CAMERA PORT WAS INSERTED UNDER DIRECT VISION WITH A 10MM LAPAROSCOPE. UPON ENTRY, THE OP REPORT STATES THERE APPEARED TO BE SOME OMENTAL GRAZING, WITH NO EVIDENCE OF ANY INJURIES. UPON REPEAT INSPECTION OF THE BOWEL, NO EVIDENCE OF ANY INJURY WAS OBSERVED. THEN THE ROBOT WAS DOCKED AND THE PROCEDURE WAS PERFORMED. THERE WAS NO REPORT THAT A MALFUNCTION OF THE DA VINCI SI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED DURING THE PROCEDURE. THE PLANNED SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED. IT WAS STATED IN THE OP REPORT THAT AFTER THE SYSTEM WAS

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 UNDERWENT A DAVINCI PROSTATECTOMY AND EXTENSIVE LYSIS OF ADHESIONS FOR ADENOCARCINOMA IN WHICH 1000ML OF BLOOD LOSS WHICH OCCURRED 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. UPON INSERTION OF THE ENDOSCOPE, MULTIPLE LOOPS OF BOWEL WERE NOTED TO BE ADHERED TO THE POSTERIOR ABDOMINAL WALL. MULTIPLE ADHESIONS WERE TAKEN DOWN WITH LAPAROSCOPIC SHEARS PRIOR TO ROBOT DOCKING. AFTER DOCKING, MUCH FAT WAS NOTED IN THE ENDOPELVIC FASCIA SURFACE. EXCISING THE BLADDER NEXT ADJACENT TO THE MEDIAN LOBE OF THE PROSTATE WAS A VERY CHALLENGING PORTION OF THE PROCEDURE DUE TO THE SIZE OF THE PROSTATE MEDIAN LOBE. BLADDER NECK RECONSTRUCTION WAS ALSO PARTICULARLY CHALLENGING AND IT WAS NOTED THAT THE ENTIRE SURGERY REQUIRED MUCH MORE SKILL THAN THE NORMAL PROSTATECTOMIES PERFORMED AT THIS INSTITUTION. THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. ON (B)(6), THE PATIENT PRESENTED WITH SEVERE ABDOMI

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: ARTERY CUT DURING SURGERY, EMERGENCY SURGERY, RECEIVED 3 BLOOD TRANSFUSIONS, RIGHT LEG ACHES SOMETIMES

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 WHO DEVELOPED POST- SURGICAL COMPLICATIONS AFTER HAVING A DA VINCI SI HYSTERECTOMY WITH LEFT SALPINGO-OOPHORECTOMY PROCEDURE ON (B)(6) 2012. IT WAS NOTED THAT A 360 DEGREE CIRCUMFERENTIAL CUTTING OF THE CERVIX FROM THE VAGINA WAS PERFORMED USING MONOPOLAR HOT SHEARS. A SMALL LACERATION WAS DETECTED AT THE VAGINAL CUFF; HOWEVER, THE LACERATION WAS CLOSED WITH SUTURES. THE PELVIS WAS IRRIGATED AND FOUND TO BE COMPLETELY HEMOSTATIC BEFORE THE PROCEDURE WAS COMPLETED. THE PATIENT WAS DISCHARGED HOME ON POST- OPERATIVE DAY ONE. THE PATIENT WENT IN TO THE OFFICE FOR A FOLLOW-UP VISIT ON (B)(6) 2012 AND THE ABDOMINAL INCISIONS WERE DESCRIBED AS HEALING WELL. THE PATIENT WENT TO THE EMERGENCY ROOM ON (B)(6) 2012 WITH COMPLAINTS OF ABDOMINAL PAIN. PATIENT WAS EXAMINED AND A CT SCAN OF THE ABDOMEN AND PELVIS REVEALED A SMALL FLUID COLLECTION IN THE CUL-DE-SAC NEAR THE CUFF WITH A FLECK OF AIR MEASURING 2 CM. DIFFERENTIAL DIAGNOSES INCLUDE A SMALL ABSCESS OR SEROMA. THE PATIENT SUBSEQUENTLY SAW ANOTHER SURGEON ON (B)(6) 2012 AND HIS EXAMINATION REVEALED AN EXTREM

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE FOLLOWING PATIENT STORY CONCERNING A DA VINCI GALL BLADDER PROCEDURE WAS FOUND POSTED ON THE (B)(6) BY INTUITIVE SURGICAL ON (B)(6) 2012: (B)(6), MY SON WAS ALMOST KILLED AFTER A SURGEON USED THE DA VINCI MACHINE TO REMOVE HIS GALL BLADDER. NO OTHER DETAILS WERE PROVIDED. ISI WAS UNABLE TO CONTACT THE AUTHOR OF THE POST CONCERNING THE REPORTED EVENT, AS THE AUTHOR HAS BLOCKED THEIR (B)(6) ACCOUNT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE FOLLOWING PATIENT STORY CONCERNING A DA VINCI SI HYSTERECTOMY PROCEDURE WAS FOUND POSTED ON THE DA VINCI STORIES ONLINE. HAD POP LEVEL 4 AND HYSTERECTOMY, LEAVING CERVIX ONLY, DONE ROBOTICALLY. STILL HAVE MAJOR ABDOMINAL PAIN AND BOWEL ISSUES. HE REMAINS TO TELL ME EVERYTHING OK. HAD CT SCAN SHOWING 9 MM KIDNEY STONE; SAID THIS IS REASON FOR PAIN. I'M HAVING THE SAME PAIN EXPERIENCED BEFORE SURGERY AND AFTER VAGINAL EXAMS. I FEEL BAD ALL THE TIME; NO ENERGY, BLOATING, AND WEIGHT GAIN. IF I TAKE FOUR ADVIL, IT HELPS, BUT IF ON MY FEET AWHILE, IT GETS WORSE... SO I SIT! I'M TIRED OF COMPLAINING TO DR AND FAMILY... NOT IN MY HEAD; THIS IS REAL. I'M FRUSTRATED WITH EVERYONE. WITH THE HOLIDAYS COMING, WILL HAVE COMPANY FOR 1 WEEK. DREADING THIS. I USUALLY LOOK FORWARD TO IT. EVERYONE THINKS I SHOULD BE OK, BUT I'M NOT! WENT TO FAMILY DOCTOR; NO ANSWER. HAS ANYONE ELSE FELT LIKE THIS? I ALSO HAVE DIVERTICULOSIS, BUT SYMPTOMS ARE DIFFERENT. I PUT POP AS DIAGNOSIS, BUT WAS A TOTAL VAGINAL PROLAPSE; UTERUS WAS OUT. SO HAD MESH FOR BLADDER, RECTOCELE PLUS ALL AFOREMENTIONED. CAN'T STAND PAIN AND BEING TIRED ANYMORE. I'M NOW (B)(6), BUT FEEL OLDER, FATTER, AND LAZY. I USED TO LOVE WORKING

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 DA VINCI SI SURGICAL PROCEDURE, THE PATIENT WAS FOUND TO HAVE A BURN LOCATED AT PORT INCISION SITE. INTUITIVE SURGICAL TECHNICAL SERVICE ENGINEER (TSE) PROVIDED THE CUSTOMER WITH POTENTIAL CAUSES THAT MAY CONTRIBUTED TO THE BURNS AT THE PORT INCISION SITE. NO ADDITIONAL PATIENT HARM, ADVERSE OUTCOME, OR INJURY 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 RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI PROSTATECTOMY PROCEDURE ON (B)(6) 2012. 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 URINARY INCONTINENCE AND ERECTILE DYSFUNCTION.

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.