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 THE PATIENT UNDERWENT A HEMICOLECTOMY PROCEDURE ON (B)(6) 2012 IN WHICH TRADITIONAL LAPAROSCOPIC TECHNIQUES AND THE DA VINCI SI SYSTEM WERE USED. AN UNRECOGNIZED BOWEL PERFORATION OCCURRED WHILE PERFORMING TRADITIONAL LAPAROSCOPIC TECHNIQUES DURING ADHESIOLYSIS. THE PATIENT EXPIRED ON (B)(6) 2012.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI ROBOTICALLY-ASSISTED MINI TVR (TRICUSPID VALVE REPAIR) PROCEDURE VIA RIGHT THORACOTOMY ON (B)(6) 2012. THE LEGAL DOCUMENT PROVIDED CLAIMS THAT AS A RESULT OF THE SURGICAL PROCEDURE, THE PATIENT EXPERIENCED COMPLICATIONS AND DAMAGES INCLUDING BUT NOT LIMITED TO RESPIRATORY FAILURE AND HD INSTABILITY, PORTAL VEIN THROMBOSIS WITH ELEVATED BILIRUBIN, AND EVENTUALLY, DEATH. ISI WAS NOT PROVIDED WITH THE OPERATIVE REPORT OR THE PATIENT'S MEDICAL RECORDS. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED DURING SURGERY.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AFTER A DA VINCI PARTIAL NEPHRECTOMY WAS COMPLETED, IT WAS DETERMINED THAT THE PATIENT REQUIRED ANOTHER PROCEDURE. THE PATIENT THEN UNDERWENT AN OPEN PROCEDURE, FOR A TOTAL NEPHRECTOMY. AFTERWARDS, THE PATIENT WAS TRANSFERRED TO (B)(6), WHERE THE PATIENT EXPIRED ON AN UNKNOWN DATE. THE DELAY IN REPORTING IS DUE TO AN ADMINISTRATIVE OVERSIGHT WHERE THE AWARE DATE WAS INADVERTENTLY NOT UPDATED BY A CUSTOMER SERVICE REPRESENTATIVE.

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 UNDERGOING A DA VINCI SI CHOLECYSTECTOMY PROCEDURE ON (B)(6) 2012, THE PATIENT LATER EXPIRED ON (B)(6) 2012. DURING THE SURGICAL PROCEDURE, THE SURGEON DECIDED TO REMOVE THE PATIENT'S GALL BLADDER USING TRADITIONAL LAPAROSCOPIC TECHNIQUES AND WITHOUT USING A BAG. AN ISI REPRESENTATIVE IN ATTENDANCE DURING THE SURGICAL PROCEDURE INDICATED THAT NO SYSTEM MALFUNCTIONS OCCURRED DURING THE CASE AND THE PLANNED PROCEDURE WAS COMPLETED WITHOUT ANY ISSUES.

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 RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI HYSTERECTOMY SURGICAL PROCEDURE ON (B)(6) 2012. INTUITIVE SURGICAL WAS NOT PROVIDED WITH THE OPERATIVE REPORT OR MEDICAL RECORDS. THERE WAS NO REPORT THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. PER THE LEGAL DOCUMENT, THE PATIENT SUFFERED A PERFORATED BOWEL AND DIED. NO FURTHER CLINICAL INFORMATION WAS PROVIDED ABOUT THIS EVENT.

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 SUSTAINED AN INJURY TO HER MESENTERIC VEIN PRIOR TO THE START OF A PLANNED DA VINCI SI BILATERAL PELVIC AND PARA-AORTIC LYMPHADENECTOMY PROCEDURE ON (B)(6), 2012. ACCORDING TO THE PROCEDURE NOTE, THE INJURY OCCURRED DURING TROCAR PLACEMENT FOR AN EXPLORATORY LAPAROTOMY FOR STAGING OF UTERINE CANCER. THE PATIENT HAD NOT YET BEEN DOCKED TO THE DA VINCI SI SURGICAL SYSTEM AT THE TIME THE INJURY OCCURRED. THE PATIENT'S MEDICAL HISTORY INCLUDED RECENT TOTAL VAGINAL HYSTERECTOMY ((B)(6) 2012) THAT REVEALED STAGE IB ENDOMETRIAL CARCINOMA THAT REQUIRED SURGICAL STAGING. PRIOR TO THE START OF THE PLANNED SURGICAL PROCEDURE, THE PATIENT WAS INFORMED OF THE RISKS, BENEFITS, PERIOPERATIVE COMPLICATIONS, AND CONVALESCENCE RELATED TO THE PROCEDURE AND SURGICAL CONSENT WAS SIGNED. ACCORDING TO THE OPERATIVE REPORT, AT THE BEGINNING OF THE PLANNED SURGICAL PROCEDURE, A 12 MM TROCAR WAS PLACED SUPRAUMBILICALLY. THE PATIENT WAS NOTED TO HAVE MASSIVE OMENTAL ADHESIONS TO THE PELVIS, SMALL BOWEL, DESCENDING COLON, AND ANTERIOR ABDOMINAL WALL. UPON DIRECT INSERTION

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 RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI POLYP REMOVAL PROCEDURE ON (B)(6) 2012. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: 'SURGERY TOOK 5 1/2 HOURS INSTEAD OF 2 DUE TO SCAR TISSUE , HAD TO INTUBATE HIM BECAUSE HE COULD NOT BREATHE, A TEAR IN HIS INTESTINE, DEVELOPED A RASH WHOLE BACK TURNED BACK DOCTORS DID NOTHING, PASSED AWAY FOLLOWING MORNING AUTOPSY SHOWS AN INFECTION.'

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 1 DAY AFTER A DA VINCI S HYSTERECTOMY PROCEDURE WAS SUCCESSFULLY PERFORMED, THE PATIENT EXPIRED.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: TEXT FROM PATIENT IDENTIFIER = (B)(6), MFR REPORT 2955842-2013-04055: 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. 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

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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI HYSTERECTOMY PROCEDURE ON (B)(6) 2011. THE LEGAL COMPLAINT INDICATES THAT EVENTUALLY, THE ROBOTIC ASSISTANCE WAS COMPLETED AND THE PATIENT WAS RETURNED TO THE TABLE, UPON WHICH TIME THE MORCELLATION PROCESS WAS BEGUN TO REMOVE THE UTERUS, OVARIES, FALLOPIAN TUBES, AND FIBROIDS. THE LEGAL COMPLAINT ALSO INDICATES THAT APPROXIMATELY HALFWAY THROUGH THE MORCELLATION PROCESS, THE PATIENT, HAD NO BLOOD PRESSURE OR PULSE. DUE TO ASYSTOLE, A CODE WAS CALLED AT 2:41 PM. THE PATIENT SUBSEQUENTLY PASSED AWAY AT 2:55 PM THAT SAME DAY. ISI WAS NOT PROVIDED WITH THE OPERATIVE REPORT OR THE PATIENT'S MEDICAL RECORDS. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING SURGERY. ON (B)(4) 2014, ISI CONTACTED THE CLINICAL SALES REPRESENTATIVE (CSR). THE CSR INDICATED THAT HE WAS PRESENT DURING A PORTION OF THE REPORTED DA VINCI SURGICAL PROCEDURE. THE CSR STATED THAT AFTER THE EVENT OCCURRED, HE SPOKE TO THE SURGEON, THE SITE'S CHAIR OF THE ROBOTICS COMMITTEE, THE SITE'S CHAIR OF THE GYN COMMITTEE, AND THE ANESTHESIOLOGI

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 HYSTERECTOMY PROCEDURE, THE PATIENT EXPIRED FROM A PULMONARY EMBOLISM.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2011, A PATIENT UNDERWENT A DA VINCI S HYSTERECTOMY PROCEDURE. IT WAS REPORTED THAT THE PROCEDURE TOOK 5 HOURS AND 25 MINUTES TO COMPLETE, WITH THE PATIENT IN STEEP TRENDELENBURG POSITION DURING THE CASE. 6-8 HOURS POST-OP, THE PATIENT SUFFERED SUDDEN BILATERAL PNEUMOTHORAX (TENSION) WHICH RENDERED HER COMATOSE AND IN A PERSISTENT VEGETATIVE STATE. LIFE SUPPORT WAS REMOVED ON (B)(6) 2011, AND THE PATIENT EXPIRED.

da Vinci Surgical System — Death 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 PROSTATECTOMY PROCEDURE ON (B)(6)2011 AND ALLEGED TO HAVE INJURIES INCLUDING POSTOPERATIVE TRAUMA, CAPILLARY LEAK SYNDROME, SEPSIS, AND DEATH. THE DATE OF DEATH WAS NOT PROVIDED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT SEVERAL DAYS AFTER A SUCCESSFUL DA VINCI SI TONGUE BASE RESECTION (TORS) PROCEDURE AND AFTER BEING DISCHARGED HOME, THE PATIENT EXPERIENCED BLEEDING FROM THE OPERATIVE AREA AND EXPIRED. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED; HOWEVER, THE SITE HAS BEEN CONTACTED AND ADDITIONAL INFORMATION IS EXPECTED.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI ROBOTIC-ASSISTED LEFT PARTIAL NEPHRECTOMY FOR LEFT RENAL MASS ON (B)(6) 2011. ISI WAS PROVIDED WITH THE OPERATIVE (OP) REPORT AND ALLEGATIONS OF PATIENT COMPLICATIONS. THE PATIENT ALLEGEDLY HAD TO UNDERGO ABDOMINAL EXPLORATION, LEFT COLECTOMY AND DIVERTING LOOP ILEOSTOMY ON (B)(6) 2011, APPROXIMATELY ONE MONTH AFTER HIS ROBOTIC PARTIAL NEPHRECTOMY TO REPAIR PERFORATED LEFT COLON WITH ABSCESS. PRIOR TO THE SECOND SURGERY, THE PATIENT WENT TO THE HOSPITAL ON (B)(6) 2011 WITH COMPLAINTS OF ABDOMINAL PAIN ASSOCIATED WITH NAUSEA AND VOMITING. AT THE TIME, HE WAS FOUND TO HAVE PERINEPHRIC ABSCESS WITH POSSIBLE PERFORATION OF THE DESCENDING COLON. FURTHER EVALUATION REVEALED A WIDE BORE FISTULA FROM THE COLON INTO THE ABSCESS CAVITY. THE PATIENT DIED ON (B)(6) 2012 DUE TO ACUTE MYOCARDIAL INFARCTION. PER THE OP REPORT OF (B)(6) 2011, THE PATIENT'S LEFT RENAL MASS WAS FOUND INCIDENTALLY. THE MASS MEASURED 4 CM, LOCATED ON THE POSTEROLATERAL ASPECT OF THE UPPER POLE OF THE KIDNEY. PER THE OP REPORT, ALTERNATIVES, RISKS, AND BENEFITS WERE DISCUSSED WITH THE PATIENT AND

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI BOWEL SURGERY PROCEDURE ON (B)(6) 2011. ACCORDING TO THE LEGAL DOCUMENT, THE PATIENT SUFFERED A SEVERE INFECTION WHICH RESULTED IN A SECOND HOSPITALIZATION, A HIGH TEMPERATURE, WHICH LEAD TO A STROKE AND HER PASSING AWAY. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT AND DISCHARGE SUMMARY. BASED ON THE OPERATIVE REPORT, THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING SURGERY. THERE WAS ALSO NO INDICATION THAT AN INTRA-OPERATIVE COMPLICATION OCCURRED. THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION AFTER COMPLETION OF THE SURGICAL PROCEDURE. THE PATIENT WAS DISCHARGED HOME ON POST-OPERATIVE DAY 1 ((B)(6) 2011). ACCORDING TO THE DISCHARGE SUMMARY, THE OPERATIVE AND POST OPERATIVE COURSE WAS UNCOMPLICATED. ON (B)(4) 2014, ISI CONTACTED THE RISK MANAGEMENT DEPARTMENT FROM THE SITE. THE RISK MANAGER REVIEWED THE OPERATIVE REPORT AND CONFIRMED THAT THERE WERE NO REPORTS THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM OCCURRED. THE RISK MANAGER ALSO DID NOT FIND ANY ADDITIONAL

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 COLON RESECTION PROCEDURE ON (B)(6) 2011 AND SUBSEQUENTLY EXPIRED ON AN UNSPECIFIED DATE. ISI WAS PROVIDED WITH THE DA VINCI OPERATIVE REPORT AND ADDITIONAL HOSPITAL 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 INTRA-OPERATIVE COMPLICATION ALTHOUGH THE OPERATION HAD TO BE CONVERTED TO AN OPEN PROCEDURE DUE TO THE SIZE OF THE TUMOR. THE PATIENT WAS ADMITTED TO THE HOSPITAL FROM (B)(6) 2011. NO FURTHER MEDICAL RECORDS WERE PROVIDED. A LETTER FROM AN ATTORNEY INDICATES THAT THE PATIENT SUSTAINED A BOWEL PERFORATION, UNDERWENT ADDITIONAL SURGERIES, AND THEN PASSED AWAY. THE PATIENT'S DATE AND CAUSE OF DEATH WERE NOT PROVIDED. ISI HAS MADE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE ATTORNEY AND THE SITE'S RISK MANAGEMENT GROUP; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT. A FOLLOW-UP MDR WILL BE IF ADDITIONAL INFORMATION IS RECEIVED.

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 ALLEGEDLY SUSTAINED AN INJURY DURING A DA VINCI SURGICAL PROCEDURE ON (B)(6), 2008 AT AN UNSPECIFIED HOSPITAL AND SUBSEQUENTLY EXPIRED ON AN (B)(6) 2008. NO OTHER INFORMATION REGARDING THE REPORTED ALLEGATION WAS PROVIDED.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI HYSTERECTOMY BILATERAL SALPINGO-OOPHORECTOMY FOR ABNORMAL UTERINE BLEEDING, MENORRHAGIA, UTERINE HYPERTROPHY, UTERINE FIBROIDS, AND COMPLEX ENDOMETRIAL HYPERPLASIA WITH ATYPICAL ON (B)(6) 2011. ISI WAS PROVIDED WITH THE PATIENT OPERATIVE (OP) REPORT PERTAINING TO HER DA VINCI HYSTERECTOMY BILATERAL SALPINGO-OOPHORECTOMY PROCEDURE, MEDICAL DOCUMENTATION PERTAINING HER PRE-SURGICAL CONDITION, AND CARDIAC CLEARANCE. ISI WAS ALSO PROVIDED MEDICAL DOCUMENTATION PERTAINING TO HER HOSPITALIZATION FROM (B)(6) 2011, THE DATE THE PATIENT DIED AND HER CERTIFICATE OF DEATH. THE PATIENT'S RECORDS HAVE BEEN EXTENSIVELY REVIEWED. ACCORDING TO THE INFORMATION PROVIDED IN THE PATIENT'S OP REPORT FOR HER DA VINCI SURGICAL PROCEDURE ON (B)(6) 2011, THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS AND/OR ACCESSORIES; HOWEVER, IT WAS INDICATED THAT THE SURGERY WAS COMPROMISED BY THE PATIENT'S HABITUS AND HER EXTREME OBESITY, WHICH REQUIRED ADDITIONAL OPERATING TIME IN PRE-HYSTERECTOMY AND HYSTERECTOMY PORTIONS OF THE PROCEDURE. ON (B)(6) 2011,

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AFTER A DA VINCI SI BILATERAL SALPINGO-OOPHORECTOMY (BSO) WAS COMPLETED, THE PATIENT RETURNED TO THE HOSPITAL THE NEXT DAY OR TWO DAYS POST PROCEDURE COMPLAINING OF PAIN. A GENERAL SURGEON SAW THE PATIENT AND MADE THE DECISION TO OPEN THE PATIENT FOR EXPLORATORY SURGERY WHICH RESULTED IN A DIAGNOSIS OF SEPSIS. IT IS UNKNOWN HOW THE PATIENT WAS TREATED. THE PATIENT EXPIRED ON (B)(6) 2011. SINCE RECEIVING THIS INITIAL REPORT, THE SITE HAS BEEN CONTACTED TO REQUEST 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: IT WAS REPORTED THAT 56 HOURS AFTER A DA VINCI SI TORS (TRANSORAL ROBOTIC SURGERY) PROCEDURE WAS SUCCESSFULLY PERFORMED, THE PATIENT EXPERIENCED HEAVY BLEEDING AND CARDIOPULMONARY ARREST ENSUED. CPR WAS PERFORMED IN EXCESS OF 20 MINUTES BEFORE THE PATIENT'S PULSE WAS RESTORED AND AS A RESULT, IRREVERSIBLE ANOXIC BRAIN INJURY OCCURRED. ON (B)(6) 2011, THE PATIENT EXPIRED. AT THE TIME OF THE REPORT, THE CAUSE OF THE PATIENT BLEEDING WAS UNDETERMINED. IT WAS ALSO REPORTED THAT DURING THE SURGICAL PROCEDURE, THERE WERE NO SYSTEM FAILURES, NO INJURY TO THE PATIENT, AND NO COMPLICATIONS EXPERIENCED.

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 S OVARIAN CYSTECTOMY PROCEDURE, THE SURGEON ENCOUNTERED EXCESSIVE ADHESIONS WITHIN THE PATIENT'S ANATOMY WHICH MADE IT DIFFICULT TO PERFORM THE PROCEDURE LAPAROSCOPICALLY. AT THIS TIME, THE SURGEON MADE THE DECISION TO CONVERT TO TRADITIONAL OPEN TECHNIQUES TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH NO ISSUES NOTED. APPROXIMATELY TWO TO THREE WEEKS POST PROCEDURE, THE PATIENT RETURNED TO THE HOSPITAL AND WAS DIAGNOSED WITH ILEUS. IT IS UNKNOWN HOW THE PATIENT WAS TREATED; HOWEVER, THE PATIENT EXPIRED AFTER BEING DIAGNOSED. THE SITE'S RISK MANAGEMENT DEPARTMENT HAS BEEN CONTACTED SEVERAL TIMES TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, OUR ATTEMPTS HAVE BEEN UNSUCCESSFUL. THE DELAY IN REPORTING IS DUE TO AN ISI EMPLOYEE'S MISUNDERSTANDING OF COMPLAINT REPORTING CRITERIA. THE SITE ADVISED THAT THERE WAS NOT CORRELATION BETWEEN OUR SYSTEM AND THE EVENT AND OUR ISI REPRESENTATIVE UNDERSTOOD THE SITE'S FEEDBACK AS NOT REQUIRING THE INITIATION OF A COMPLAINT RECORD. SINCE THIS MISUNDERSTANDING WAS DISCOVERED, RETRAINING HAS BEEN PERFORMED WITH THE ISI REPRESENTATIVE TO MITIGATE FUTURE OCCURRENCES.

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 SURGICAL PROCEDURE ON (B)(6) 2011 FOR LOWER ANTERIOR RESECTION FOR OBSTRUCTING RECTOSIGMOID CANCER WHO SUBSEQUENTLY PASSED AWAY ON (B)(6) 2011. ISI WAS NOT PROVIDED WITH THE DA VINCI SURGICAL OPERATIVE REPORT. ADDITIONAL INFORMATION WAS PROVIDED BUT THEY ARE ALL RELATED TO SUBSEQUENT HOSPITALIZATIONS AND NON-ROBOTIC PROCEDURE. ULTIMATELY, THE PATIENT WAS FOUND TO HAVE EXPIRED AT HOME BY HIS SPOUSE ON (B)(6) 2011 AND AN AUTOPSY REPORT WAS INCLUDED. 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 HOSPITAL AUTOPSY'S CLINICAL SUMMARY PROVIDED THE FOLLOWING INFORMATION: THE PATIENT HAD BEEN IN RELATIVELY GOOD HEALTH UNTIL (B)(6) 2011 AT WHICH TIME HE PRESENTED WITH MULTIPLE SYMPTOMS THAT INCLUDED GASTROINTESTINAL BLEEDING, ANEMIA, HYPONATREMIA, HYPERGLYCEMIA, AND FEBRILE ILLNESS. DURING HIS WORKUP, HE WAS ULTIMATELY FOUND TO HAVE NEARLY OBSTRUCTING RECTOSIGMOID MASS, AND UNDERWENT ROBOTIC LOW ANTERIOR RESECTION ON (B)(6) 2011, WITH SPLENIC

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 ON (B)(6), 2011 A PATIENT PASSED AWAY 18 MONTHS AFTER A DA VINCI S PROCEDURE TO REMOVE THE LOWER LOBE OF THEIR LEFT LUNG DUE TO BRONCHIOLOALVEOLAR CARCINOMA. ACCORDING TO THE PATIENT'S HUSBAND, DURING THE PROCEDURE, THE PATIENT'S STOMACH AND DIAPHRAGM WERE PUNCTURED RESULTING IN SEPSIS. THE PATIENT UNDERWENT A 5 MONTH HOSPITAL STAY AND EIGHTEEN MONTHS AS A NEAR INVALID. TO DATE, (B)(6) HAS NOT PROVIDED THE PATIENT'S HUSBAND WITH INFORMATION REGARDING THIS EVENT. INTUITIVE HAS CONTACTED THE SITES RISK MANAGEMENT DEPARTMENT, WHO ADVISED THAT THEY WOULD INVESTIGATE THIS EVENT AND RESPOND BACK TO INTUITIVE WITHIN THE UPCOMING WEEKS.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON APRIL 4, 2012 INTUITIVE SURGICAL WAS CONTACTED BY THE PATIENT'S GRAND-DAUGHTER THAT THE PATIENT UNDERWENT A KIDNEY BIOPSY PROCEDURE USING THE DA VINCI S SURGICAL SYSTEM ON (B)(6) 2011. REPORTEDLY, DURING THE BIOPSY PROCEDURE, THE PATIENT'S RENAL ARTERY WAS DAMAGED. THE PLANNED PROCEDURE WAS CONVERTED TO OPEN SURGICAL TECHNIQUES TO REPAIR THE AFFECTED VESSEL AND THE PATIENT REQUIRED A PARTIAL NEPHRECTOMY AS A RESULT OF THE DAMAGE. THE PATIENT LOST 13 PINTS OF BLOOD. ON (B)(6) 2012, THE PATIENT EXPIRED DUE TO PNEUMONIA, MULTIPLE ORGAN FAILURE AND RENAL FAILURE.

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

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

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

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

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

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

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