da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) RECEIVED VOLUNTARY REPORT (B)(4) WITH THE FOLLOWING EVENT DESCRIPTION: I HAD MY PROSTATE REMOVED THE DA VINCI ROBOT AND DURING MY SURGERY, MY SURGEON ATTEMPTED TO FUSE TOGETHER SOME BLOOD VESSELS AND THE ROBOT FAILED TO FUSE SOME OF MY BLOOD VESSELS TOGETHER THUS CAUSING ME TO BLEED INTERNALLY. INSTEAD OF BEING IN THE HOSPITAL ONE NIGHT, I WAS IN THE HOSPITAL FOR OVER THIRTY DAYS. ALSO, ONE OF MY SURGEON'S INTERNS TOLD ME THAT WHEN MY SURGEON WAS ATTEMPTING TO REMOVE THE ROBOT FROM MY BODY THAT THE ROBOT STARTED UP ON ITS OWN AND DID CUT OTHER BLOOD VEINS. NO WHERE IN MY MEDICAL RECORDS WAS ANY OF WHAT HAPPENED TO ME WAS IN THE MEDICAL RECORDS THAT I OBTAINED FROM THE HOSPITAL. THE HOSPITAL HAD TO GIVE ME OVER 8 PINTS OF BLOOD AND I HAD TO STAY IN THE HOSPITAL FOR OVER 30 DAYS. THE OPERATION USING THE DA VINCI ROBOT ALMOST CAUSED ME THE LOSS OF MY LIFE AND I AM NOW BEING TREATED FOR SEVERE ANXIETY AND DEPRESSION OVER WHAT HAPPENED TO ME WHILE I WAS OPERATED ON VIA DA VINCI ROBOT. NONE OF WHAT I HAVE SAID WAS REPORTED ON ANY MEDICAL RECORDS THAT I PAID TO GET. MY SURGEON AND THE HOSPITAL COVERED UP WHAT ACTUALLY HAPPENED TO ME WHEN I HA

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 DA VINCI GASTROSTOMY PROCEDURE, APPROXIMATELY 1.5 DAYS AFTER THE PATIENT WAS DISCHARGED FROM THE HOSPITAL; THE PATIENT DEVELOPED A PULMONARY EMBOLISM AND SUBSEQUENTLY EXPIRED. ON (B)(6) 2014, THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) WHO REPORTED THIS COMPLAINT REPORTED THAT SHE WAS PRESENT AT THE BEGINNING OF THE PLANNED SURGICAL PROCEDURE. ACCORDING TO THE CSR SHE WAS TOLD BY THE SITE'S ROBOTICS COORDINATOR THAT THE PATIENT WAS VERY SICK PRIOR TO UNDERGOING THE ROBOTIC PROCEDURE AND THAT DURING THE SURGICAL PROCEDURE, THERE WAS NO MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS AND/OR ACCESSORIES THAT CAUSED OR CONTRIBUTED TO THE PATIENT'S DEMISE. THE ROBOTICS COORDINATOR ALSO INDICATED THAT THE PATIENT'S DEMISE WAS UNRELATED TO THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS AND/OR ACCESSORIES. THE PATIENT'S SPECIFIC PRE-EXISTING CONDITIONS WERE NOT PROVIDED TO THE CSR. 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 AFTER COMPLETION OF A DA VINCI HYSTERECTOMY PROCEDURE, THE PATIENT EXPIRED. THE INITIAL REPORTER OF THIS COMPLAINT INDICATED THAT THE PATIENT HAD A HISTORY OF DRUG ABUSE, BLOOD PRESSURE ISSUES, AND WAS OBESE. ON (B)(6) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INITIAL REPORTER. THE INITIAL REPORTER WAS NOT PRESENT DURING THE DA VINCI SURGICAL PROCEDURE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON POST-OPERATIVE DAY 1. THE PATIENT REPORTEDLY PASSED AWAY THE FOLLOWING DAY ON POST-OPERATIVE DAY 2. THE INITIAL REPORTER INDICATED THAT HE SPOKE TO THE SURGEON REGARDING THE REPORTED EVENT AND THERE WERE NO REPORTS THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE DA VINCI HYSTERECTOMY PROCEDURE. ALSO, THERE WERE NO REPORTS THAT ANY INTRA-OPERATIVE COMPLICATIONS OCCURRED. ON (B)(6) 2014, THE INITIAL REPORTER SPOKE TO THE SURGEON AND WAS INFORMED THAT THE AUTOPSY REPORT WAS STILL NOT COMPLETED AT THE TIME. ON (B)(6) 2014, ISI CONTACTED THE SITE'S OR DIRECTOR. SHE STATED THAT THERE WERE NO REPORTS THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM OCCURRED DURING THE SURGICAL PROC

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 PRIOR TO STARTING A DA VINCI SURGICAL PROCEDURE, A NURSE INJURED HER HAND WHILE ATTEMPTING TO MOVE THE PATIENT SIDE CART (PSC). ACCORDING TO THE INITIAL REPORTER OF THIS COMPLAINT, THE PSC WAS ABOUT 1 INCH FROM THE WALL AND WAS IN NEUTRAL WHEN THE NURSE GRABBED THE HANDLE OF THE PSC IN AN AWKWARD POSITION. AT THAT SAME TIME, A SURGICAL TECHNICIAN SWITCHED THE PSC FROM NEUTRAL TO DRIVE. AT THAT POINT, THE PSC REPORTEDLY LURCHED BACKWARDS AND CRUSHED THE NURSE'S HAND BETWEEN THE PSC AND WALL. THE NURSE DID NOT BELIEVE THAT SHE ACTIVATED THE HAND CONTROL OF THE PSC. THE NURSE HAD TO GO TO THE EMERGENCY ROOM (ER) AND AN X-RAY WAS PERFORMED. NO BONE FRACTURES WERE FOUND. THE NURSE WAS FOUND TO HAVE SOFT TISSUE DAMAGE AND SWELLING. NO BRUISING WAS OBSERVED. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INITIAL REPORTER. THE INITIAL REPORTER STATED FROM WHAT HE RECALLS, THE NURSE WAS GIVEN A BAG OF ICE FROM THE ER TO TREAT THE SWELLING. NO DRESSINGS OR BANDAGES WERE GIVEN TO TREAT THE NURSE. AT THIS TIME, THE INITIAL REPORTER STATED THAT THE NURSE IS BACK AT WORK AND IS DOING FINE. ON (B)(4) 2014, ISI ALSO CONTACTED THE FIELD SERVICE ENGINEER (FSE). ACC

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 COMPLETION OF A DA VINCI URETERAL REIMPLANTATION PROCEDURE, THE PATIENT DEVELOPED SEPSIS ROUGHLY AROUND POST-OPERATIVE DAY 2. AN EXPLORATORY LAPAROTOMY WAS PERFORMED AND THE PATIENT WAS FOUND TO HAVE SUSTAINED A PERFORATED COLON. THE PATIENT SUBSEQUENTLY PASSED AWAY ON (B)(6) 2014. ACCORDING TO THE ROBOTICS COORDINATOR FROM THE SITE, AN INTERNAL INVESTIGATION WAS BEING PERFORMED IN RELATION TO THE REPORTED EVENT. THE CAUSE OF THE PATIENT'S BOWEL PERFORATION WAS UNKNOWN. HOWEVER, THE ROBOTICS COORDINATOR INDICATED THAT THE SITE BELIEVES THE BOWEL INJURY MIGHT HAVE OCCURRED DURING INTRODUCTION OF A CAMERA PORT. REPORTEDLY, THE CAMERA PORT WAS NOT CREATED UNDER DIRECT VISUALIZATION. ON (B)(6) 2014, ISI CONTACTED THE ROBOTICS COORDINATOR AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. TO HER KNOWLEDGE, NO MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. SHE REITERATED THAT THE SITE BELIEVES THE CAUSE OF THE PATIENT'S INJURY WAS DUE TO CAMERA TROCAR INSERTION.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(4) 2014, INTUITIVE SURGICAL INC. (ISI) REVIEWED A JOURNAL ARTICLE BY RUPA SEETHARAMAIAH ET AL. TITLED ROBOTIC REPAIR OF GIANT PARAESOPHAGEL HERNIAS. ACCORDING TO THE REPORTED ARTICLE, A (B)(6) HEALTHY WOMAN CAME TO THE EMERGENCY DEPARTMENT WITH SHORTNESS OF BREATH. PEH WAS DIAGNOSED, AND THE PATIENT WAS TAKEN TO THE OPERATING ROOM. DURING THE PROCEDURE, A GPEH WAS FOUND AND THE STOMACH WAS STRONGLY ADHERED TO BOTH THE RIGHT AND LEFT CRUS. DURING THE DISSECTION, A PLEURAL INJURY WAS NOTICED. REDUCTION WAS COMPLETED, THE PLEURAL INJURY WAS REPAIRED WITH NO. 3-0 VICRYL (ETHICON), AND THE HERNIA WAS CLOSED WITH NONABSORBABLE SUTURE. NO PLEURAL TUBE WAS USED. A BIOLOGICAL MESH WAS PLACED AND A NISSEN FUNDOPLICATION PERFORMED. THE TOTAL PROCEDURE WAS COMPLETED IN 258 MINUTES, AND THE PATIENT WAS DISCHARGED 3 DAYS LATER. THE HOSPITAL NAME AND THE DA VINCI SERIAL NUMBER INVOLVED WITH THIS PATIENT WAS NOT PROVIDED IN THE ARTICLE.

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 NISSEN FUNDOPLICATION PROCEDURE, THE PATIENT'S STOMACH WAS PUNCTURED. THE SURGICAL PROCEDURE WAS COMPLETED. ACCORDING TO THE INITIAL REPORTER OF THIS COMPLAINT, THE PATIENT UNDERWENT MULTIPLE PROCEDURES FOR REPAIR OF THE REPORTED INJURY.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI PROSTATECTOMY PROCEDURE, THE SURGEON COULD NOT GET THE HARMONIC ACE CURVED SHEARS INSTRUMENT OR MARYLAND BIPOLAR FORCEPS INSTRUMENT TO ENERGIZE. DUE TO THE REPORTED ISSUE, THE INITIAL REPORTER INDICATED THAT THE PATIENT LOST 1300 CC OF BLOOD. ON (B)(4) 2014, AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) CONTACTED THE SITE'S ROBOTICS COORDINATOR. ACCORDING TO THE ROBOTICS COORDINATOR, THE HOSPITAL HAD LOST POWER TO THE ENTIRE OR IN THE MORNING AND THE SURGICAL STAFF HAD UNPLUGGED AND RE-PLUGGED THE CABLES IN ORDER TO GET THEIR SYSTEMS ALL TURNED BACK ON FOR THE DA VINCI SURGICAL PROCEDURE. DURING THE DA VINCI SURGICAL PROCEDURE, THE SURGEON ATTEMPTED TO ACTIVATE THE HARMONIC ACE CURVED SHEARS INSTRUMENT AND MARYLAND BIPOLAR FORCEPS INSTRUMENT BUT NOTICED THAT THEY WOULD NOT WORK. AFTER THE ROBOTICS COORDINATOR UNPLUGGED AND RE-PLUGGED THE INSTRUMENT CABLES LEADING TO THE ELECTROSURGICAL UNIT (ESU), THE INSTRUMENTS BEGAN TO WORK PROPERLY FOR THE REST OF THE PROCEDURE. LATER THAT SAME DAY, THE FSE PERFORMED A FIELD EVALUATION AT THE SITE. THE FSE CHECKED THE SENSOR STATUS FOR FOOT PEDAL ACTIVATION ON THE SYSTEM WHICH PASSED. THE

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI PROSTATECTOMY ON AN UNSPECIFIED DATE. ISI WAS NOT PROVIDED WITH THE OPERATIVE REPORT OR ANY MEDICAL RECORDS. ACCORDING TO THE LEGAL DOCUMENT PROVIDED, THE PATIENT HAD PROSTATE SURGERY. DURING SURGERY, THE MACHINE BROKE DOWN. HE SPENT 12 DAYS IN THE HOSPITAL. IN ADDITION, THE LEGAL DOCUMENT NOTED THE PATIENT INJURY AS COMPARTMENT SYNDROME.

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 COMPLETION OF A DA VINCI SINGLE-SITE CHOLECYSTECTOMY PROCEDURE, THE PATIENT EXPIRED ON POST-OPERATIVE DAY 2. NO ISSUES WERE REPORTED TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. ON (B)(6) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE RISK MANAGEMENT DEPARTMENT AT THE SITE. THE RISK MANAGER REVIEWED THE PATIENT'S MEDICAL RECORDS AND THE OPERATIVE REPORT. ACCORDING TO THE RISK MANAGER, THE PATIENT HAD A HISTORY OF CARDIAC DISEASE AND CORONARY ARTERY DISEASE. HE WAS A 2 PACK/DAY SMOKER. ON (B)(6) 2014, THE PATIENT WAS SEEN IN THE HOSPITAL FOR COMPLAINTS OF ABDOMINAL PAIN AND CHEST PAIN. IMAGING WAS PERFORMED AND IT WAS DETERMINED AT THE TIME THAT THE PATIENT NEEDED A CHOLECYSTECTOMY. THE PATIENT REPORTEDLY TOLD THE SURGEON THAT HE HAD KNOWN THAT HE HAD GALL STONES FOR 3 YEARS. BASED ON THE OPERATIVE REPORT, THERE WERE NO REPORTS OF ANY INTRA-OPERATIVE COMPLICATIONS OR MALFUNCTIONS OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY. THE DA VINCI SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT WAS DISCHARGED HOME IN STABLE CONDITION ON POST-OPERATIVE DAY 1 ((B)(6) 2014). THE RISK MANAGER INDICATED THAT AT THE TIME OF DISCHARGE, THE PA

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(4) 2014, INTUITIVE SURGICAL INC. (ISI) REVIEWED A JOURNAL ARTICLE BY TAKAHRIO YASUI ET AL TITLED, IMPACT OF PROSTATE WEIGHT ON PERIOPERATIVE OUTCOMES OF ROBOT-ASSISTED LAPAROSCOPIC PROSTATECTOMY WITH A POSTERIOR APPROACH TO THE SEMINAL VESICLE. ACCORDING TO THE REPORTED ARTICLE, FIVE PATIENTS EXPERIENCED INTRAOPERATIVE COMPLICATIONS, INCLUDING 3 PATIENTS WITH POSTERIOR BLADDER INJURY, 1 PATIENT WITH RECTAL INJURY, AND 1 PATIENT WITH ILEUM INJURY. IN ALL THESE PATIENTS, THE INJURY WAS REPAIRED DURING A ROBOTIC OPERATION. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THE REPORTED EVENTS. THE HOSPITALS NAME, DA VINCI SYSTEM SERIAL NUMBERS AND TYPE OF PROCEDURES INVOLVED WITH ALL FIVE COMPLAINTS WERE NOT INCLUDED IN THIS ARTICLE.

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 COMPLETION OF A DA VINCI SIGMOID COLECTOMY PROCEDURE, THE PATIENT WAS FOUND TO HAVE SUSTAINED AN ANASTOMOTIC LEAK. ACCORDING TO THE INITIAL REPORTER OF THIS COMPLAINT, THE SURGEON BELIEVES THE INFERIOR MESENTERIC ARTERY (IMA) WAS NOT FULLY SEALED DURING THE SURGICAL PROCEDURE AND THEREFORE A LEAK OCCURRED. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE INITIAL REPORTER WAS PRESENT DURING THE DA VINCI SIGMOID COLECTOMY PROCEDURE. HE DID NOT OBSERVE ANY ISSUES WITH THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY DURING THE SURGICAL PROCEDURE. THE INITIAL REPORTER ALSO STATED THAT HE DID NOT WITNESS ANY INTRA-OPERATIVE COMPLICATIONS OTHER THAN SLIGHT BLEEDING THAT THE SURGEON WAS ABLE TO CONTROL AND SEAL WITHOUT ANY ISSUES. THE INITIAL REPORTER DID NOT KNOW THE CURRENT STATUS OF THE PATIENT. ON (B)(4) 2014, ISI ALSO CONTACTED THE SURGEON WHO PERFORMED THE DA VINCI SIGMOID COLECTOMY PROCEDURE. THE SURGEON INDICATED THAT POST-OPERATIVELY, THE PATIENT DEVELOPED A LARGE HEMATOMA IN THE MESENTERY THAT REQUIRED SURGICAL INTERVENTION FOR CLOT EVACUATION. THE SUR

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 ENDOMETRIOSIS RESECTION PROCEDURE, PATIENT SIDE MANIPULATOR 3 (PSM3) HAD UNINTENDED MOVEMENT AND THE PATIENT WAS FOUND TO HAVE SUSTAINED TWO 1 PUNCTURE WOUNDS TO THE SIGMOID COLON. THE PSM IS AN INSTRUMENT ARM LOCATED ON THE PATIENT SIDE CART (PSC) THAT PROVIDES STERILE INTERFACE FOR THE ENDOWRIST INSTRUMENT. ACCORDING TO THE INITIAL REPORTER OF THIS COMPLAINT, THE SURGEON STATED THAT THE CLUTCH BUTTON FROM PSM3 HAD BEEN PUSHED TO MOVE THE INSTRUMENT TO THE END OF THE CANNULA TIP. AT THE TIME OF THE EVENT, IT IS UNCLEAR WHAT INSTRUMENT WAS INSTALLED ON PSM3. AT AN UNSPECIFIED TIME DURING THE SURGICAL PROCEDURE, THE SURGEON STATED THAT PSM3 WENT SPASTIC. THE SURGEON THEN REMOVED THE INSTRUMENT INSTALLED ON PSM3 AND FOUND TWO PUNCTURE WOUNDS TO THE SIGMOID COLON. THE SURGEON REPAIRED THE PUNCTURE WOUNDS AND INDICATED THAT THE PATIENT WAS DOING WELL. ON (B)(4) 2014, AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) PERFORMED A FIELD EVALUATION AT THE SITE. THE FSE TEST DROVE THE DA VINCI SURGICAL SYSTEM AND VERIFIED THAT THE SYSTEM WAS READY FOR USE. HE WAS UNABLE TO REPLICATE THE REPORTED ISSUE WITH PSM3. ON (B)(4) 2014, ISI CONTACT

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ATTORNEYS HAVE ALLEGED THAT THEIR CLIENTS SUFFERED INJURIES ASSOCIATED WITH DA VINCI SURGICAL PROCEDURES. THESE CLAIMS DO NOT INVOLVE DEATHS. THESE ALLEGATIONS WERE FIRST RECEIVED BY INTUITIVE SURGICAL DURING THE TIME PERIOD OF (B)(4) 2013 TO (B)(4) 2014. FOR THOSE CLAIMS WHERE PROCEDURE DATES ARE PROVIDED, THE DATES RANGE FROM (B)(6) 2004 THROUGH (B)(6) 2014.

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 GASTRECTOMY SURGICAL PROCEDURE, IT WAS IDENTIFIED THAT THE HARMONIC ACE INSERT WAS SUDDENLY BROKEN. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE CUSTOMER TO ASK FOR ADDITIONAL INFORMATION, THE CUSTOMER INDICATED THAT A FRAGMENT FELL INTO THE PATIENT AND IT WAS RETRIEVED DURING THE SAME PROCEDURE. AN X-RAY WAS PERFORMED AND NO FRAGMENTS WERE SEEN TO REMAIN IN THE PATIENT. THERE WAS NO PATIENT HARM, ADVERSE OUTCOME OR INJURY 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: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI SURGICAL PROCEDURE ON AN UNSPECIFIED DATE IN 2010. INTUITIVE SURGICAL WAS NOT PROVIDED WITH THE OPERATIVE REPORT OR ANY PATIENT 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 INTERNAL BLEEDING DURING SURGERY. PATIENT WAS IN A COMA FOR 2 WEEKS AND THEN DIED.

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 PROSTATECTOMY PROCEDURE AND SUBSEQUENTLY EXPIRED ON (B)(6) 2012. INTUITIVE SURGICAL WAS NOT PROVIDED WITH THE OPERATIVE REPORT. NO SUPPLEMENTAL INFORMATION WAS PROVIDED. THE DA VINCI SERIAL OR MODEL IS UNKNOWN. IN (B)(6) 2012, THE PATIENT UNDERWENT A DA VINCI ROBOTIC-ASSISTED PROSTATECTOMY FOR UNKNOWN REASON. ALLEGATIONS OF PATIENT COMPLICATIONS WERE AS FOLLOWS: PER ROBOTIC SURGERY CLAIM FORM, THE PATIENT HAD SURGERY IN (B)(6) 2012 AND PASSED AWAY (B)(6) 2012. HE SUSTAINED A STROKE AND KNICKED BLADDER. 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.

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 PROSTATECTOMY PROCEDURE ON (B)(6) 2011 AND SUBSEQUENTLY EXPIRED ON (B)(6) 2011. INTUITIVE SURGICAL WAS NOT PROVIDED WITH THE OPERATIVE REPORT. NO SUPPLEMENTAL INFORMATION WAS PROVIDED. ACCORDING TO THE MEDIATION COVER SHEET, ON (B)(6) 2011, THE PATIENT HAD A PROSTATECTOMY PROCEDURE. THE PATIENT'S ABDOMEN BECAME DISTENDED; CT REVEALED URINE POOLING IN ABDOMEN; ER SURGERY TO REPAIR TORN BLADDER; PASSED AWAY AFTER COMPLICATIONS FROM SUBSEQUENT SURGERY ON (B)(6) 2011.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2014, THE REPORTER INFORMED INTUITIVE SURGICAL, INC. (ISI) OF A PATIENT WHO REPORTEDLY EXPERIENCED A SIMILAR POST DA VINCI COURSE AS THE PATIENT WHO SUSTAINED NEURO-SOMATIC SYMPTOMS FOLLOWING A DA VINCI MYOMECTOMY PROCEDURE REPORTED IN MFR REPORT 2955842-2013-04307 (PATIENT IDENTIFIER (B)(6)). THE REPORTER WAS UNWILLING TO PROVIDE ANY ADDITIONAL DETAILS. THERE WAS NO ALLEGATION OF A MALFUNCTION WITH THE DA VINCI SYSTEM, INSTRUMENTS, AND/OR ACCESSORIES. THE PATIENT'S AGE/WEIGHT, DA VINCI SYSTEM SERIAL , PROCEDURE TYPE, EVENT DATE, AND POST DA VINCI COURSE DETAILS WERE NOT PROVIDED. ADDITIONAL ATTEMPTS HAVE BEEN MADE TO CONTACT THE REPORTER FOR MORE INFORMATION; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN 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 POST A DA VINCI HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY AND PARA AORTIC NODE DISSECTION PROCEDURE PERFORMED ON (B)(6) 2014 THE PATIENT UNDERWENT A SECOND SURGICAL PROCEDURE DUE TO INFARCTION OF THE RIGHT COLON. THE DATE OF THE PATIENT'S DEMISE WAS NOT REPORTED AND IT IS THE SURGEON'S BELIEF THAT THE PATIENT'S DEMISE WAS UNRELATED TO THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS AND/OR ACCESSORIES. ON (B)(6) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON WHO PERFORMED THE SURGICAL PROCEDURE. ACCORDING TO THE SURGEON THERE WAS NO MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS AND/OR ACCESSORIES THAT CAUSED OR CONTRIBUTED TO THE PATIENT'S DEMISE. THE PATIENT HAD UTERINE CANCER AND BOWEL ISCHEMIA. THE SURGEON INDICATED THAT THE PATIENT'S DEMISE WAS UNRELATED TO THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS AND/OR ACCESSORIES, BUT WAS CAUSED BY THE PATIENT'S BOWEL ISCHEMIA. DUE TO HIPPA REGULATIONS, THE SURGEON DECLINED TO PROVIDE ANY OTHER INFORMATION REGARDING 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: IT WAS REPORTED THAT DURING A DA VINCI HYSTERECTOMY WITH BILATERAL PELVIC AND PARA-AORTIC LYMPHADENECTOMY PROCEDURE FOR ENDOMETRIAL CANCER STAGING, THE PATIENT SUSTAINED A URETERAL INJURY. THERE WERE NO REPORTS THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. ACCORDING TO THE CLINICAL FELLOW, THE DA VINCI FLUORESCENCE IMAGING VISION SYSTEM WAS BEING USED DURING AN INSTITUTIONAL REVIEW BOARD (IRB) APPROVED RESEARCH PROTOCOL IN WHICH A PATIENT RECEIVED A CERVICAL INTERSTITIAL INJECTION OF INDOCYANINE GREEN (ICG) FOR THE PURPOSE OF SENTINEL LYMPH NODE MAPPING. DURING DISSECTION OF A SENTINEL LYMPH NODE FROM THE LEFT PARA-AORTIC LYMPH NODE CHAIN AND WHILE THE SURGEON WAS OPERATING IN THE FLUORESCENCE IMAGING MODE, A 2MM THERMAL INJURY TO THE LEFT URETER AT THE LEVEL OF THE INFERIOR MESENTERIC ARTERY OCCURRED. THE CLINICAL FELLOW INDICATED THAT THE INJURY OCCURRED BECAUSE VISUALIZATION WAS POOR DUE TO BLEEDING (CONTAMINATING THE SURGICAL FIELD) AND BECAUSE THE LEFT URETER, WHICH HAD ORIGINALLY BEEN IDENTIFIED AND RETRACTED BY THE 3RD ARM, SLIPPED OUT FROM ITS RETRACTION INTO THE SURGICAL FIELD. AT THE TIME THE INJURY OCCUR

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 COMPLETION OF A DA VINCI SACROCOLPOPEXY PROCEDURE, THE PATIENT PRESENTED WITH AN UNSPECIFIED SMALL BOWEL INJURY POST-OPERATIVELY. ACCORDING TO THE INITIAL REPORTER OF THIS COMPLAINT, THERE WERE NO REPORTS FROM THE SURGICAL STAFF THAT ANY INTRA-OPERATIVE COMPLICATIONS OCCURRED DURING THE DA VINCI SURGICAL PROCEDURE. IN ADDITION, THERE WERE NO REPORTS THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. ON (B)(6) 2014, THE PATIENT RETURNED TO THE HOSPITAL AND UNDERWENT AN EXPLORATORY LAPAROTOMY. DURING THE PROCEDURE, THE PATIENT UNDERWENT REPAIR OF THE SMALL BOWEL INJURY. 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: IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI TOTAL COLECTOMY PROCEDURE, THE PATIENT WAS FOUND TO HAVE SUSTAINED A POSSIBLE THERMAL BURN TO THE SMALL BOWEL POST-OPERATIVELY. ACCORDING TO THE INITIAL REPORTER OF THIS COMPLAINT, THE POST-OPERATIVE COMPLICATION WAS IDENTIFIED ON POST-OPERATIVE DAY 11. ON (B)(6) 2015, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. ACCORDING TO THE CSR, HE WAS PRESENT DURING THE DA VINCI SURGICAL PROCEDURE. THERE WERE NO INTRA-OPERATIVE COMPLICATIONS OBSERVED AND NO REPORTS OF ANY ARCING OF ENERGY FROM AN INSTRUMENT. ON (B)(6) 2015, ISI CONTACTED THE SITE'S ROBOTICS COORDINATOR. SHE INDICATED THAT SHE WAS IN AND OUT OF THE DA VINCI SURGICAL PROCEDURE. THERE WERE NO REPORTS OF ANY INTRA-OPERATIVE COMPLICATIONS OR ISSUES WITH THE DA VINCI SYSTEM, INSTRUMENTS, OR ACCESSORIES. TO HER KNOWLEDGE, THE PATIENT WAS TAKEN BACK TO THE OR ON AN UNSPECIFIED DATE FOR REPAIR OF A POSSIBLE THERMAL INJURY TO THE SMALL BOWEL. THE ROBOTICS COORDINATOR DID NOT KNOW WHAT THE SUSPECTED CAUSE WAS FOR THE THERMAL INJURY. AFTER THE THERMAL INJURY WAS REPAIRED, THE PATIE

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 HYSTERECTOMY PROCEDURE, WHILE THE SURGEON WAS UTILIZING A MONOPOLAR CURVED SCISSORS INSTRUMENT AND A FENESTRATED BIPOLAR FORCEPS INSTRUMENT, THE PATIENT SUSTAINED A THERMAL INJURY TO HER RECTUM. THE SURGEON CONSULTED A GENERAL SURGEON TO EVALUATE THE DEFECT. AFTER EXAMINING THE PATIENT'S RECTUM, THE GENERAL SURGEON DETERMINED THAT THE AFFECTED AREA DID NOT REQUIRE ANY TREATMENT. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED. APPROXIMATELY 5 DAYS POST-OP AND DURING THE PATIENT'S HOSPITALIZATION, THE PATIENT COMPLAINED OF PAIN. EXAMINATION OF THE PATIENT FOUND THAT THE PATIENT HAD DEVELOPED A RECTAL CERVICAL FISTULA. ON (B)(6) 2014, INTUITIVE SURGICAL, INC. (ISI) RECEIVED ADDITIONAL INFORMATION FROM THE SURGEON WHO PERFORMED THE DA VINCI HYSTERECTOMY PROCEDURE. ACCORDING TO THE SURGEON THE PATIENT UNDERWENT A DA VINCI HYSTERECTOMY PROCEDURE DUE TO FIBROIDS, MENORRHAGIA AND ANEMIA. THE PATIENT'S UTERUS WEIGHED 615 GRAMS AND WAS 20 WEEKS IN SIZE. THE SURGEON INDICATED THAT AFTER THE PATIENT'S UTERUS HAD BEEN MORCELLATED AND REMOVED, HE IDENTIFIED A WHITE SPOT ON THE PATIENT'S SIGMOID COLON THAT WAS CLOSE TO THE UTERINE CERVIX JUNCTION. WHILE THE GE

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 COMPLETION OF A DA VINCI HYSTERECTOMY PROCEDURE, THE PATIENT WAS SENT HOME AND THEN LATER PRESENTED WITH A POSSIBLE BOWEL INJURY. THERE WERE NO REPORTS THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI OVARIAN CYSTECTOMY PROCEDURE, THE PATIENT'S BOWEL WAS INJURED. ACCORDING TO THE INITIAL REPORTER, THE INSTRUMENTS WERE INSTALLED IN THE PATIENT WITH THE SURGEON AT THE PATIENT SIDE CONSOLE (PSC) UNDER SCOPE VISUALIZATION. WHEN THE SURGEON SAT DOWN AT THE SURGEON SIDE CONSOLE (SSC), SHE WAS UNABLE TO SEE THE SCISSORS INSTALLED ON PATIENT SIDE MANIPULATOR (PSM1) 1. THE SURGEON MOVED THE CAMERA TO LOOK FOR THE SCISSOR TIPS. THE INITIAL REPORTER INDICATED THAT THE SURGEON FOUND THAT THE SCISSORS HAD NICKED/PUNCTURED THE PATIENT'S BOWEL. THE INITIAL REPORTER ALSO INDICATED THAT THEY WERE COMPLETING THE DA VINCI SURGICAL PROCEDURE AND ANOTHER SURGEON WAS GOING TO PERFORM THE BOWEL REPAIR USING THE DA VINCI SYSTEM. AT AN UNSPECIFIED TIME DURING THE EVENT, THE SURGICAL STAFF NOTICED THAT THE CANNULA ON PSM1 HAD BECOME DISCONNECTED.

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 06/02/2016, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF THE (B)(4) BLOG TITLED, (B)(4). ACCORDING TO THE INTERNET BLOG, THE PATIENT ALLEGED THAT SHE EXPERIENCED MULTIPLE POST-OPERATIVE COMPLICATIONS AFTER UNDERGOING A DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE PERFORMED ON (B)(6) 2014. THE INTERNET BLOG DOES NOT CONTAIN ANY ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED OR CAUSED/CONTRIBUTED TO THE OPERATIVE COMPLICATIONS. REFER TO THE FOLLOWING INTERNET LINK FOR ACCESS TO THE INTERNET BLOG: (B)(4). BASED ON THE INTERNET BLOG, THE FOLLOWING INFORMATION WAS PROVIDED: THE PATIENT INDICATED THAT SHE WAS SENT HOME THE SAME DAY AFTER UNDERGOING A DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE. POST-OPERATIVELY, THE PATIENT CLAIMED THAT SHE EXPERIENCED BLADDER AND PELVIC PAIN. AFTER CONSULTING WITH HER SURGEON, THE PATIENT INDICATED THAT SHE WAS INSTRUCTED TO GO TO THE ER ON POST-OPERATIVE DAY 4 OR 5. WHILE IN URGENT CARE, THE PATIENT WAS FOUND TO HAVE A BLADDER INFECTION. SINCE UNDERGOING THE DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PATIENT INDICATED THAT SHE HAS HAD MULTIPLE EXAMS AND RADIOLOGIC TESTS PERFORMED ON HER PELVIS AND BLADDER. A YEAR AND

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 SURGICAL PROCEDURE, THE PATIENT'S RECTUM WAS DAMAGED AND AS A RESULT OF THE INJURY TO THE PATIENT, THE SURGEON MADE THE DECISION TO CONVERT THE SURGICAL PROCEDURE TO OPEN SURGICAL TECHNIQUES TO REPAIR AND COMPLETE THE PROCEDURE. REPORTEDLY, THE INJURY TO THE PATIENT WAS DUE TO THE PATIENT'S ANATOMY. THERE WAS NO REPORT OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES. THE PATIENT HAD CANCER, WHICH MADE IT DIFFICULT FOR THE SURGEON TO DELINEATE THE SURGICAL PLANES. 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) 2014, AN INTUITIVE SURGICAL, INC. (ISI) SALES REPRESENTATIVE BECAME AWARE OF AN INJURY THAT OCCURRED DURING A DA VINCI RIGHT UPPER LOBECTOMY PROCEDURE THAT TOOK PLACE ON (B)(6) 2014 FROM A DOCTOR WHO WAS PRESENT DURING THE CASE. THE DOCTOR INDICATED THAT THE SURGEON PERFORMING THE DA VINCI SURGICAL PROCEDURE ENCOUNTERED AN INJURY TO A BRANCH OF THE PULMONARY ARTERY, WHICH BLED UNCONTROLLABLY. THE DA VINCI PROCEDURE WAS CONVERTED TO AN OPEN SURGICAL PROCEDURE AND THE PATIENT WAS GIVEN AN EMERGENCY HEART AND LUNG BYPASS. THE PATIENT LOST >40 UNITS OF BLOOD AND WAS GIVEN A BLOOD TRANSFUSION. THE PATIENT ALSO DEVELOPED ABDOMINAL COMPARTMENT SYNDROME AND WAS REOPENED AT THE SAME PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED AT THE TIME. ON (B)(6) 2014, ISI CONTACTED THE SITE'S RISK MANAGEMENT. THE RISK MANAGER INDICATED THAT THE PATIENT'S INJURY WAS NOT RELATED TO ANY ISSUES OR MALFUNCTIONS OF THE DA VINCI SYSTEM. SHE DECLINED TO PROVIDE ANY OTHER INFORMATION.

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 SACROCOLPOPEXY PROCEDURE, THE PATIENT'S ILIAC VESSEL WAS INJURED AND THE PATIENT EXPIRED.

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 NEPHRECTOMY PROCEDURE, THE SURGEON NICKED AN UNSPECIFIED VESSEL RESULTING IN THE PATIENT RECEIVING A BLOOD TRANSFUSION. ON (B)(6) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SITE'S ROBOTICS COORDINATOR. THE ROBOTICS COORDINATOR STATED THAT THE INJURY TO THE PATIENT'S VESSEL WAS DUE TO SURGEON ERROR. SHE STATED THAT NO MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. ACCORDING TO THE ROBOTICS COORDINATOR, THE SURGEON REPAIRED THE VESSEL INJURY AND THE DA VINCI SURGICAL PROCEDURE WAS COMPLETED. THE PATIENT WAS DISCHARGED HOME ON POST-OPERATIVE DAY 3 AND THERE WERE NO REPORTS OF ANY POST-OPERATIVE COMPLICATIONS.

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 CHOLECYSTECTOMY ON (B)(6) 2014 AND SUSTAINED AN INTRA-OPERATIVE PERFORATION. ACCORDING TO THE LEGAL DOCUMENT PROVIDED, THE PATIENT PASSED AWAY ON (B)(6) 2014 DUE TO COMPLICATIONS OF BACTERIAL SEPSIS. ISI WAS NOT PROVIDED WITH THE OPERATIVE REPORT OR THE PATIENT'S MEDICAL RECORDS.

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 COMPLETION OF A DA VINCI HYSTERECTOMY PROCEDURE, THE PATIENT RETURNED TO THE HOSPITAL WITH COMPLAINTS OF ABDOMINAL PAIN. THE PATIENT WAS EVALUATED IN AN EMERGENCY ROOM (ER), TREATED WITH AN ANTIBIOTIC, AND SENT HOME. ON (B)(4) 2013, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE CLINICAL SALES REPRESENTATIVE (CSR). THE CSR WAS NOT PRESENT DURING THE SURGICAL PROCEDURE. THERE WAS NO REPORT THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. THE CSR STATED THAT AFTER THE EVENT OCCURRED, AN ISI FIELD SERVICE ENGINEER (FSE) PERFORMED A FIELD EVALUATION AT THE SITE ON AN UNSPECIFIED DATE. ACCORDING TO THE CSR, THE FSE AND THE SITE'S BIOMED DEPARTMENT EVALUATED THE DA VINCI SYSTEM INVOLVED WITH THIS COMPLAINT AND NO ISSUES WERE FOUND. THE CSR WAS UNABLE TO PROVIDE THE DATE OF THE SURGICAL PROCEDURE INVOLVED WITH THIS COMPLAINT.

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 COMPLETION OF A DA VINCI NISSEN FUNDOPLICATION AND PARA-ESOPHAGEAL REPAIR PROCEDURE, THE PATIENT RETURNED TO THE ICU ON POST-OPERATIVE DAY 3. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2014. HOWEVER, THE PATIENT SUBSEQUENTLY PASSED AWAY ON (B)(6) 2014. THERE WAS NO REPORT THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. ON (B)(6) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INITIAL REPORTER OF THIS COMPLAINT. THE INITIAL REPORTER INDICATED THAT HE WAS PRESENT DURING THE SURGICAL PROCEDURE AND NO MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY WAS OBSERVED. ACCORDING TO THE INITIAL REPORTER, THE PATIENT RETURNED TO THE HOSPITAL ON POST-OPERATIVE DAY 3 AND A PERFORATION OF HER STOMACH WAS FOUND. THE INJURY WAS REPAIRED AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL 8 DAYS LATER. THE DAY AFTER BEING DISCHARGED FROM THE HOSPITAL, THE PATIENT PASSED AWAY. THE INITIAL REPORTER DID NOT KNOW THE CAUSE OF THE PATIENT'S DEMISE. HE STATED THAT THE PATIENT HAD COMPROMISED HEALTH PRIOR TO UNDERGOING THE DA VINCI SURGICAL PROCEDURE. NO ADDITIONAL INFORMATION

CyberKnife — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A PATIENT CONTACTED ACCURAY AND PROVIDED THE FOLLOWING INFORMATION: HAD CYBERKNIFE TREATMENT IN 2014 AT (B)(6) HOSPITAL. SHORTLY AFTER THE TREATMENT THE I HAD URINARY INCONTINENCE FOLLOWED BY LATER FECAL INCONTINENCE. BOTH ARE UNCONTROLLABLE. THERE ARE SURGERIES TO HELP CORRECT THIS PROBLEM HOWEVER I DO NOT WISH TO GO THIS ROUTE AND VERY DISSATISFIED WITH THE OUTCOME.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY AND BILATERAL SALPINGO-OOPHORECTOMY ON (B)(6) 2012 FOR DYSFUNCTIONAL UTERINE BLEEDING AND ENLARGING UTERINE FIBROIDS. ISI WAS PROVIDED WITH THE PATIENT'S OPERATIVE REPORT (OP) AND THE OP REPORT FOR THE FOLLOWING LAPAROTOMY. NO MEDICAL HISTORY WAS PROVIDED. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING SURGERY. THE HYSTERECTOMY WAS PERFORMED WITH SEQUENTIAL CAUTERY AND TRANSECTION OF THE INFUNDIBULOPELVIC VESSELS, THE ROUND LIGAMENTS, AND THE BROAD LIGAMENTS. IT WAS NOTED DURING THE DISSECTION OF THE BLADDER FLAP THAT THERE WAS MINIMAL SCAR TISSUE FROM HER CESAREAN SECTION. THE CARDINAL LIGAMENTS AND UTERINE VESSELS WERE CAUTERIZED WITH PK CAUTERY AND CUT, AND THE COLPOTOMY MADE TO THE LEVEL OF THE KOH BASKET. THE UTERUS WAS REMOVED VAGINALLY AND THE VAGINAL CUFF CLOSED WITH VLOCK SUTURES. SURGERY WAS COMPLETED WITH NO COMPLICATIONS. ON (B)(6) 2013 PATIENT PRESENTED WITH FEELINGS OF WEAKNESS, PERSISTENT PAIN AND NAUSEA AND LOW GRADE TEMPERATURE AND RLQ MILD TENDERNESS. PATIENT WAS STA

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 PROSTATECTOMY PROCEDURE, THE PATIENT LOST 3500 CC'S OF BLOOD. ACCORDING TO THE INITIAL REPORTER OF THIS COMPLAINT, THE DA VINCI SURGICAL PROCEDURE TOOK 10 HOURS. THE PATIENT WAS TAKEN TO THE ICU AND THEN PASSED AWAY THE FOLLOWING DAY ON (B)(6) 2013. ON (B)(6) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SITE'S RISK MANAGER. THE RISK MANAGER INDICATED THAT THE SURGEON INVOLVED WITH THIS COMPLAINT WAS NO LONGER EMPLOYED BY THE SITE. ACCORDING TO THE RISK MANAGER, NO MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. THE RISK MANAGER STATED THAT AN AUTOPSY HAS BEEN PERFORMED AND THE CAUSE OF THE PATIENT'S DEATH WAS CARDIAC ARREST AND BLEEDING. THE RISK MANAGER INDICATED THAT THE SITE IS CURRENTLY REVIEWING THE CASE AND THE CAUSE OF THE INTRA-OPERATIVE BLEEDING IS UNDER INVESTIGATION. THE RISK MANAGER WAS UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION REGARDING THE PATIENT OR REPORTED 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: ON (B)(4) 2014, AN INTUITIVE SURGICAL, INC. (ISI) REPRESENTATIVE BECAME AWARE OF A PATIENT WHO PASSED AWAY 11 DAYS AFTER UNDERGOING A DA VINCI HYSTERECTOMY PROCEDURE, HERNIA REPAIR, AND LAPARATOMY PROCEDURE. THE FOLLOWING INFORMATION WAS OBTAINED FROM THE SURGEON WHO PERFORMED THE DA VINCI SURGERY. ON (B)(6) 2013, A PATIENT UNDERWENT A DA VINCI HYSTERECTOMY WITH NODES DISSECTION PROCEDURE AND WAS DISCHARGED FROM THE HOSPITAL THE FOLLOWING DAY ON (B)(6) 2013. THE PATIENT REPORTEDLY DID NOT SUSTAIN ANY BOWEL INJURIES DURING THE DA VINCI SURGERY. ON (B)(6) 2013, THE SURGEON WHO PERFORMED THE DA VINCI SURGERY PERFORMED A HERNIA REPAIR ON THE PATIENT AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2014. ON (B)(6) 2014 MORNING, THE PATIENT RETURNED TO THE HOSPITAL WITH PAIN. SHE HAD AN UNSPECIFIED CT SCAN (RESULTS WERE NOT PROVIDED) AND AN ARTERIOGRAM (VESSELS WERE NORMAL). THE PATIENT UNDERWENT 2 CT SCANS AND LATER WENT INTO RENAL FAILURE AND BECAME SEPTIC THE SAME DAY. THE PATIENT WAS TAKEN BACK TO SURGERY ON (B)(6) 2014 FOR A LAPAROTOMY, WHICH WAS WHEN THE INCARCERATED DISTAL ILEUM AND CECUM WERE IDENTIFIED. ON (B)(6) 2014 MIDNIGHT, THE PATIENT CODED AND WAS RESUSCITATED. A

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 HYSTERECTOMY PROCEDURE, THE SURGEON MADE AN INCISION INTO THE PATIENT'S BLADDER WHICH WAS ADHERED. THE INITIAL REPORTER OF THIS COMPLAINT INDICATED THAT THE INCISION WAS CREATED WHILE THE SURGEON WAS PERFORMING A COLPOTOMY. THE BLADDER INJURY WAS RECOGNIZED AND REPAIRED BY A UROLOGIST. THE UROLOGIST NOTED NORMAL FUNCTION OF BOTH URETHRAL SPHINCTERS WITH THE USE OF DYE AND THE BLADDER DEFECT WAS CLOSED WITH SUTURES. THE INITIAL REPORTER INDICATED THAT THE PATIENT WAS DOING OK POST-OPERATIVELY. ON (B)(6) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INITIAL REPORTER. THE INITIAL REPORTER STATED THAT THE BLADDER INJURY WAS DUE TO A SURGICAL ERROR. ACCORDING TO THE INITIAL REPORTER, THE SURGEON DID NOT REALIZE THAT THE BLADDER WAS STILL ADHERED AND INADVERTENTLY CREATED A NICKEL SIZED INCISION IN THE PATIENT'S BLADDER. THE INITIAL REPORTER ALSO STATED THAT NO MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. THE INITIAL REPORTER INDICATED THAT A DRAIN WAS PLACED DURING THE REPAIR AND WAS REMOVED ON POST-OP DAY 1 OR 2. THE PATIENT WAS DISCHARGED AND NO POST-OPERATIVE COMPLICATIONS WERE R

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: I UNDERWENT A ROUTINE BLADDER SLING SURGERY APPROX (B)(6), 2013 AT (B)(6) HOSPITAL IN (B)(6). (B)(6) USED THE DA VINCI ROBOT TO PERFORM THE SURGERY. AS THE ROBOTIC ARM WAS RE-POSITIONING MY SMALL INTESTINE, THE ROBOT SLICED MY SMALL INTESTINE WITHOUT THE SURGEON KNOWING IT. ACCORDING TO THE SURGEON, THE ROBOT STOPPED VIDEO TAPING THE PROCEDURE HALF WAY THROUGH SO HE WAS UNABLE TO DETERMINE WHAT HAD HAPPENED. EMERGENCY LIFE SAVING SURGERY WAS PERFORMED ON (B)(6), 2013 BY THE RESIDENT SURGEON TO REPAIR THE TEAR. IT IS NOW 3 MONTHS POST PROCEDURE AND I STILL HAVE NOT BEEN ABLE TO RETURN TO WORK AS I STILL HAVE AN OPEN ABDOMINAL WOUND. PLEASE, I RESPECTFULLY ASK THAT YOU TAKE THE DA VINCI ROBOT OFF THE MARKET AND NOT LET IT HARM ANY FURTHER PEOPLE. MY HOSPITAL BILLS ARE NEARING (B)(6).

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 DIED AFTER UNDERGOING A DA VINCI RIGHT UPPER LOBE WEDGE RESECTION PROCEDURE FOR A LUNG MASS ON (B)(6) 2013. ACCORDING TO THE LEGAL DOCUMENTS, IT WAS ALLEGED THAT DUE TO A DEFECTIVE DESIGN OF THE DA VINCI SURGICAL SYSTEM, THE PATIENT SUSTAINED AN ARTERY INJURY TO THE RIGHT INTERNAL JUGULAR VEIN. AS A RESULT, THE PATIENT WENT INTO VENTRICULAR FIBRILLATION AND DETERIORATED TO ASYSTOLE, AND SUBSEQUENTLY PASSED AWAY AT THE END OF THE PROCEDURE. ISI RECEIVED THE PATIENT'S DA VINCI OPERATIVE REPORT AND ADDITIONAL MEDICAL RECORDS. ACCORDING TO THE MEDICAL RECORDS, THE PATIENT WAS PREVIOUSLY TREATED WITH CHEMOTHERAPY AND RADIATION IN THE LEFT LOWER LOBE FOR STAGE III LUNG CANCER AND WAS PRESENTED WITH A NEW ENLARGING LESION IN THE UPPER MEDIASTINUM/RIGHT UPPER LOBE. AFTER THE DA VINCI SYSTEM WAS DOCKED TO THE PATIENT, THE PATIENT'S CHEST WAS EXPLORED AND NO METASTATIC TISSUE WAS FOUND. A MASS WAS IDENTIFIED IN THE RIGHT UPPER LOBE FIRMLY ADHERENT TO THE MEDIASTINUM, AT THE APEX OF THE CHEST, AT THE SUPERIOR MEDIASTINUM. THE PLEURA OVER THIS AREA WAS INCISED WITH BIPOLAR CAUTERY. DURING TH

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 TOTAL HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY, BILATERAL PELVIC LYMPHADENECTOMY, AND PARA-AORTIC LYMPHADENECTOMY FOR OVARIAN CANCER ON (B)(6) 2013. ISI WAS PROVIDED WITH THE DA VINCI SURGERY OPERATIVE REPORT AND ADDITIONAL MEDICAL RECORDS. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT AND/OR ACCESSORY DURING THE DA VINCI SURGERY. PER THE SURGICAL NOTE, THE ABDOMEN WAS FIRST ENTERED BY SCOPE AT THE LEVEL OF THE LEFT UPPER QUADRANT RIGHT BELOW THE RIB CAGE IN ORDER TO OBSERVE IF THERE WERE ADHESIONS FROM THE PREVIOUS CHOLECYSTECTOMY IN THE UPPER ABDOMEN CLOSE TO THE UMBILICUS, BECAUSE SHE PRESENTED A LARGE SCAR. ADHESIONS WERE SEEN AND LYSED BY ENDO SHEARS AND MONOPOLAR CURRENT OVER A 10-15 MINUTE TIME BEFORE THE CAMERA COULD BE INSERTED. SURGICAL FINDINGS ALSO NOTED ENLARGED LYMPH NODES SUSPICIOUS FOR MALIGNANCY AND AN ENLARGED FIBROID UTERUS THAT REQUIRED MORCELLATION FOR REMOVAL. THE PATIENT WAS DISCHARGED ON (B)(6) 2013. SHE WAS INSTRUCTED TO FOLLOW UP WITH THE SURGEON IN 7-10 DAYS. AROUND (B)(6) 2013,

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AFTER A DA VINCI HYSTERECTOMY PROCEDURE A PROBLEM WAS IDENTIFIED AND THE PATIENT WAS TAKEN BACK INTO SURGERY FOR AN EXPLORATORY LAPAROTOMY TO LOOK FOR A BOWEL INJURY.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(4) 2013, AN INTUITIVE SURGICAL, INC. (ISI) REPRESENTATIVE REPORTED A TRANSVERSE COLON INJURY THAT WAS OBSERVED AFTER A PATIENT WHO UNDERWENT A DA VINCI CHOLECYSTECTOMY SURGICAL PROCEDURE ON (B)(6) 2013. THE PATIENT UNDERWENT ANOTHER UNSPECIFIED SURGERY ON AN UNKNOWN DATE. NO OTHER DETAILS WERE PROVIDED AT THE TIME. ON (B)(4) 2014, ISI OBTAINED THE FOLLOWING ADDITIONAL INFORMATION FROM THE INITIAL REPORTER: THE PATIENT WAS A MALE WHO WAS (B)(6) (WEIGHT=UNKNOWN). THE INITIAL REPORTER SPOKE WITH THE SITE AND WAS NOT INFORMED OF ANY INTRA-SURGICAL COMPLICATIONS OR MALFUNCTIONS OF THE DA VINCI SYSTEM AND/OR INSTRUMENT/ACCESSORIES. ON AN UNSPECIFIED DATE FOLLOWING THE DA VINCI SURGICAL PROCEDURE, THE PATIENT STARTED TO FEEL SICK. TWO DAYS POST DA VINCI SURGERY ((B)(6) 2013), THE SAME DA VINCI SURGEON PERFORMED AN OPEN EXPLORATORY SURGERY AND FOUND THE PATIENT'S TRANSVERSE COLON WAS CUT. THE INJURY WAS REPAIRED AND THE PATIENT WAS HOSPITALIZED FOR A COUPLE WEEKS. PATIENT WAS DISCHARGED AROUND (B)(6) 2014 TO A REHAB FACILITY FOR AN UNDETERMINED TIME PERIOD. THE SURGEON DOES NOT KNOW WHEN THE INJURY OCCURRED AND HOW IT HAPPENED BUT BELIEVES THE INJURY MAY BE RELATED TO USE ERROR (INS

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 COMPLETION OF A DA VINCI SURGICAL PROCEDURE, A NURSE'S FINGERS WERE INJURED WHILE MANEUVERING THE PATIENT SIDE CART (PSC). ACCORDING TO THE INITIAL REPORTER, THE NURSE WAS HAVING DIFFICULTY CONTROLLING THE ACCELERATION OF PSC AND THE NURSE'S FINGERS WERE INJURED BECAUSE THE PSC DID NOT STOP AS THE CUSTOMER HAD EXPECTED. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) WAS CONTACTED DUE TO THE REPORTED EVENT. THE TSE ADVISED THE SITE NOT TO THROTTLE FULLY WHEN MANEUVERING THE PSC BACKWARDS. THE TSE ALSO ADVISED THE SITE TO STOP THE PSC WHEN THE PSC IS CLOSE TO THE END OF A WALL. ON (B)(6) 2013 AND (B)(6) 2014, ISI CONTACTED THE INITIAL REPORTER. THE INITIAL REPORTER EXPLAINED THAT THE NURSE'S FINGER GOT STUCK BETWEEN A HANDLE ON THE PSC AND A WALL WHILE TRYING TO MOVE THE PSC AGAINST THE WALL. HE ALSO INDICATED THAT THE NURSE UNDERWENT AN X-RAY AND NO FRACTURES WERE FOUND. ACCORDING TO THE INITIAL REPORTER, ONE OF THE NURSE'S FINGERS WAS FOUND TO BE BRUISED AND WRAPPED IN A BANDAGE. THE NURSE WAS ADDITIONALLY TREATED WITH 3 ANTIBIOTIC PILLS.

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 CHOLECYSTECTOMY PROCEDURE, THE SURGEON EXPERIENCED REPEATED INTERMITTENT DELAY AND NON-INTUITIVE MOTION WITH PATIENT SIDE MANIPULATOR ARM 2 (PSM2). THE PSM IS AN INSTRUMENT ARM LOCATED ON THE PATIENT SIDE CART (PSC) THAT PROVIDES STERILE INTERFACE FOR THE ENDOWRIST INSTRUMENT. IT WAS REPORTED THAT THE PATIENT'S COMMON BILE DUCT WAS NICKED. HOWEVER, THE SURGEON STATED THAT THE INJURY TO THE PATIENT'S COMMON BILE DUCT WAS NOT RELATED TO THE PSM2 ISSUES. ON (B)(4) 2013, AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER(FSE) PERFORMED A FIELD EVALUATION AT THE SITE. THE FSE TESTED THE PSM INVOLVED WITH THIS COMPLAINT AND FOUND THE PSM SENSORS WERE FUNCTIONING PROPERLY. THE FSE WAS UNABLE TO REPLICATE THE REPORTED ISSUE. THE FSE REVIEWED THE SYSTEM LOGS AND FOUND MULTIPLE 282 AND 31009 ERROR CODES. AN ERROR CODE 282 INDICATES THAT A TOOL WAS DETERMINED TO BE INVALID BY THE SYSTEM. AN ERROR CODE 31009 INDICATES TOOL WAS FULLY DETECTED, AND THEN ONE OR MORE (BUT NOT ALL) OF THE TOOL SENSORS WERE NOT DETECTED FOR 3 SECONDS. THE FSE EXPLAINED THAT THE REPORTED PSM ISSUES WERE MOST LIKELY RELATED TO AN ISSUE WITH THE STERILE ADAPTER. HOWEVER THE

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI SIGMOID COLECTOMY PROCEDURE, THE DA VINCI SYSTEM WAS UNDOCKED FROM THE PATIENT WHEN THE SURGEON REALIZED HE DID NOT GET ALL THE DISEASED PORTIONS FROM THE PATIENT. THE SURGEON DECIDED TO PERFORM A TRADITIONAL OPEN SURGICAL PROCEDURE TO REMOVE THE DISEASED ANATOMY. AT THE TIME THE SURGEON MADE THE DECISION TO PERFORM THE OPEN SURGICAL PROCEDURE, THE INITIAL REPORTER WAS NO LONGER IN THE OPERATING ROOM (OR), HOWEVER IT WAS INDICATED THAT THE ENTIRE SURGERY LASTED A COUPLE OF HOURS. ON AN UNSPECIFIED DATE, THE PATIENT WAS RELEASED FROM THE HOSPITAL, HOWEVER, THE PATIENT LATER NOTIFIED THE SURGEON OF COMPLAINTS OF NUMBNESS TO HIS LEFT ARM. ON (B)(4) 2013, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON. THE SURGEON INDICATED THAT THE ARM NUMBNESS WAS IN THE DISTRIBUTION OF THE MEDIAN NERVE AND HAD SINCE BEEN RESOLVED. THERE WERE NO OTHER REPORTED POST-OPERATIVE COMPLICATIONS. THE SURGEON REPORTEDLY ORDERED A CERVICAL SPINE MRI WHICH SHOWED THAT THE PATIENT HAD A CERVICAL DISK BULGING IN C4 THROUGH C7, BUT THERE WAS NO DIRECT NERVE IMPINGEMENT. ACCORDING TO THE SURGEON, THE SURGICAL PROCEDURE LASTED 6-7 HOURS AND THE PATIENT WAS N

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 COMPLETION OF A DA VINCI PROSTATECTOMY PROCEDURE, A PATIENT RETURNED TO THE HOSPITAL 3 DAYS LATER AND WAS FOUND TO HAVE SUSTAINED A COLON INJURY. THE INITIAL REPORTER OF THIS COMPLAINT, THE ROBOTICS COORDINATOR, INDICATED THAT THE PATIENT UNDERWENT A DIVERTING COLOSTOMY PROCEDURE. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ROBOTICS COORDINATOR FROM THE SITE. THE ROBOTICS COORDINATOR STATED THAT THERE WERE NO REPORTS THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE DA VINCI PROSTATECTOMY PROCEDURE. ACCORDING TO THE ROBOTICS COORDINATOR, THE PATIENT RETURNED TO THE HOSPITAL 3 DAYS POST-OPERATIVELY WITH COMPLAINTS OF ABDOMINAL PAIN AND FEVER. THE PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY PROCEDURE AND WAS FOUND TO HAVE SEPSIS AND AN UNSPECIFIED COLON INJURY. THE ROBOTIC COORDINATOR STATED THAT A TEMPORARY COLOSTOMY WAS PLACED AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ACCORDING TO THE ROBOTICS COORDINATOR, THE PATIENT WAS TO RETURN TO THE HOSPITAL AT A LATER DATE FOR FURTHER EVALUATION AND POSSIBLE PLACEMENT OF A BOWEL ANASTOMOSIS.

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 COMPLETION OF A DA VINCI MYOMECTOMY PROCEDURE, THE PATIENT WAS FOUND TO HAVE A SMALL BOWEL INJURY. ACCORDING TO THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR), A SURGEON FOUND THE SMALL BOWEL INJURY DURING A SUBSEQUENT OPEN PROCEDURE TO PERFORM A RESECTION OF THE BOWEL. THE SURGEON INDICATED THAT IT WAS HIS BELIEF THAT THE SMALL BOWEL INJURY WAS CLEARLY A THERMAL INJURY. THE CSR ALSO INDICATED THAT THE PATIENT EXPERIENCED FURTHER UNSPECIFIED POST-OPERATIVE COMPLICATIONS AFTER UNDERGOING THE OPEN BOWEL RESECTION PROCEDURE. ON (B)(4) 2013, ISI CONTACTED THE CSR. THE CSR WAS NOT PRESENT DURING THE SURGICAL PROCEDURE. HOWEVER, THE CSR INDICATED THAT THE DA VINCI MYOMECTOMY PROCEDURE WENT SMOOTHLY AND THERE WERE NO REPORTS THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. THE CSR STATED THAT THE PATIENT HAS SINCE BEEN DISCHARGED FROM THE HOSPITAL AND IS DOING FINE. THE CSR ALSO STATED THAT AFTER THE EVENT OCCURRED, AN ISI FIELD SERVICE ENGINEER (FSE) PERFORMED A FIELD EVALUATION AT THE SITE ON AN UNSPECIFIED DATE. ACCORDING TO THE CSR, THE FSE AND THE SITE'S BIOMED DEPARTME

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 PROSTATECTOMY PROCEDURE ON (B)(6) 2013. DURING THE SURGICAL PROCEDURE, THE PLAINTIFF'S ATTORNEY CLAIMS THAT THE PATIENT SUSTAINED A PROBABLE BURN INJURY TO HIS BOWEL WHICH LATER CAUSED HIS DEATH. ISI WAS NOT PROVIDED WITH THE DA VINCI-ASSISTED OPERATIVE REPORT OR ANY MEDICAL RECORDS. NO FURTHER CLINICAL INFORMATION WAS PROVIDED.