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 PANCREATIC SURGICAL PROCEDURE WITH THE DA VINCI SURGICAL SYSTEM ON (B)(6) 2009. REPORTEDLY, THE PATIENT EXPERIENCED BLEEDING AND SUBSEQUENTLY DIED. NO OTHER INFORMATION WAS PROVIDED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A CYSTOSCOPY WITH BILATERAL URETERAL TEMPORARY STENT PLACEMENT, DA VINCI RADICAL HYSTERECTOMY WITH RIGHT SALPINGO-OOPHORECTOMY, BILATERAL PELVIC LYMPHADENECTOMY AND LEFT OVARIAN SUSPENSION FOR AN INDICATION OF ADENOCARCINOMA OF THE CERVIX STATUS POST CONIZATION AND RIGHT ADNEXAL MASS PROCEDURE ON (B)(6) 2009. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT AND TWO SUBSEQUENT PROCEDURE REPORTS. NO MEDICAL HISTORY WAS AVAILABLE. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING SURGERY. BEFORE SURGERY, THE SURGEON PERFORMED A CYSTOSCOPY AND TEMPORARY URETERAL STENT PLACEMENT. DURING SURGERY, THE SURGEON USED HOT SHEARS, FENESTRATED BIPOLAR GRASPER AND A PK DISSECTOR TO FIRST PERFORM A LYMPHADENECTOMY FROM THE COMMON ILIAC ARTERY TO THE CIRCUMFLEX VEIN AND THE OBTURATOR SPACE. THE UTERINE ARTERIES WERE ISOLATED, BIPOLAR CAUTERIZED, DIVIDED AND DISSECTED OVER THE URETERS, AND THE URETERS DISSECTED OFF OF THE MEDIAL PERITONEAL LEAVES, AND THE URETERAL TUNNELS BIPOLAR CAUTERIZED AND OPENED WITH COLD SCISSORS. THE UTEROSA

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI TOTAL ABDOMINAL HYSTERECTOMY PROCEDURE ON (B)(6) 2009 FOR PELVIC PAIN AND ENDOMETRIOSIS. ISI WAS PROVIDED WITH THE OPERATIVE REPORT IN ADDITION TO THE SURGICAL PATHOLOGY REPORT AND VARIOUS LAB RESULTS. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. UPON INITIAL EXAMINATION OF THE PELVIC CONTENTS IMMEDIATELY FOLLOWING ENDOSCOPE PLACEMENT, THE UTERUS APPEARED TO BE ENLARGED AND A DEFECT IN THE RIGHT CORNEAL REGION WAS NOTED, THROUGH WHICH THE BALLOON WAS VISIBLE. SAID DEFECT WAS CONFIRMED IN THE SURGICAL PATH REPORT. MINIMAL BLOOD LOSS OCCURRED DURING THE PROCEDURE, WHICH THE PATIENT TOLERATED WELL AND WAS TAKEN BACK TO THE RECOVERY ROOM IN SATISFACTORY CONDITION. ON (B)(6) 2009, THE PATIENT PRESENTED WITH PELVIC PAIN AFTER INTERCOURSE. A CT SCAN FOUND A SMALL AMOUNT OF PNEUMOPERITONEUM AND NONSPECIFIC FREE FLUID IN THE PELVIS. A CONFLICTING REPORT FROM THE PHYSICIAN STATES THAT ALTHOUGH SHE TOLD THE ER STAFF THAT SHE HAD INTERCOURSE, IT WAS NOT TRUE. A VAGINAL EVALUATION WAS PERFORMED AND 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 MEDIATION EFFORT, INTUITIVE SURGICAL, INC. (ISI)RECEIVED INFORMATION OF A PATIENT WHO UNDERWENT A DA VINCI PROSTATECTOMY ON 05/01/2009 AND SUFFERED INJURIES AND DAMAGES. NO FURTHER CLINICAL INFORMATION WAS PROVIDED.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI ASSISTED RADICAL HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY, BILATERAL PELVIC LYMPHADENECTOMY, BILATERAL PERIAORTIC LYMPHADENECTOMY, AND OMENTECTOMY ON (B)(6) 2009 FOR CLINICAL STAGE II UTERINE SEROUS CARCINOMA. ISI WAS PROVIDED WITH THE DA VINCI SURGERY OPERATIVE REPORT. PER THE OPERATIVE REPORT, THERE WAS NO INDICATION THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, AN INSTRUMENT, AND/OR AN ACCESSORY OCCURRED DURING THE DA VINCI SURGERY. NO INTRA-OPERATIVE COMPLICATIONS WERE NOTED. AT THE CONCLUSION OF THE SURGICAL PROCEDURE, THE PATIENT WAS AWAKENED, EXTUBATED, AND BROUGHT TO THE RECOVERY ROOM IN STABLE CONDITION. THE ESTIMATED BLOOD LOSS FROM THE SURGICAL PROCEDURE WAS 50 ML. ON (B)(6) 2009, THE PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY WITH SMALL BOWEL RESECTION AND ANASTOMOSIS. PER THE OPERATIVE REPORT, THE PATIENT HAD DEVELOPED RIGHT LOWER LOBE PNEUMONIA AFTER UNDERGOING THE DA VINCI SURGICAL PROCEDURE ON (B)(6) 2009 AND WAS NOTED TO BE CLINICALLY SEPTIC WITH INCREASING ABDOMINAL DISTENSION AND DISCOMFORT SUSPICIOUS FOR AN UNDERLYING ABDO

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused 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 RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI TOTAL HYSTERECTOMY FOR MENORRHAGIA AND DYSMENORRHEA PROCEDURE ON (B)(6) 2009. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT FOR THE PRIMARY SURGERY AND SECONDARY REVISION SURGERY. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING SURGERY. AFTER PORT PLACEMENT, THE ROUND LIGAMENTS, UTEROOVARIAN VASCULAR PEDICLES COAGULATED AND DIVIDED. THE BLADDER FLAP WAS CREATED, THE UTERINE ARTERIES COAGULATED AND DIVIDED AND THE COLPOTOMY PERFORMED OVER THE VCARE CUP. THE UTERUS WAS DELIVERED THROUGH THE VAGINA, SMALL BLEEDERS CONTROLLED ON THE VAGINAL CUFF WITH CAUTERY, AND THE VAGINAL CUFF CLOSED WITH POLYSORB AND A LAPRA-TY. A SHEET OF INTERCEED WAS PLACED OVER THE VAGINAL CUFF, AND THE PROCEDURE COMPLETED WITHOUT COMPLICATION. ON (B)(6) 2009, ON A POSTOPERATIVE VISIT PATIENT WAS DOING WELL WITH NO TENDERNESS, AND A WELL HEALED INCISION CITE. ON (B)(6) 2009, PATIENT PRESENTED WITH HISTORY OF PAIN WITH INTERCOURSE SINCE (B)(6) 2009. VAGINAL EXAM SHOWED ABSENT CERVIX, HEALED VAGINAL CUFF, ADNEXAL TENDERNESS. AN U/S

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI S PROSTATECTOMY PROCEDURE, THE PATIENT WAS VERY SICK AND THE CASE WAS DIFFICULT. THE PATIENT WAS ALSO LARGE AND THE PROSTATE WAS LOCATED DEEP INSIDE THE PATIENT'S PELVIS. IT WAS THE SURGEON'S FIRST PROSTATECTOMY PROCEDURE USING THE DA VINCI S SURGICAL SYSTEM AND THE PROCEDURE WAS GOING SLOWLY, WITH THE SURGEON FIGHTING BOWEL THE ENTIRE CASE. NO SYSTEM MALFUNCTION OCCURRED AND ALL SURGICAL TASKS HAD BEEN PERFORMED CORRECTLY, HOWEVER, THE SURGEON MADE THE DECISION TO CONVERT TO TRADITIONAL OPEN SURGICAL TECHNIQUES TO COMPLETE THE PLANNED PROCEDURE DUE TO THE LENGTH OF TIME IT WAS TAKING TO COMPLETE THE PROCEDURE. TWO DAYS POST-OP, 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: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI PROSTATECTOMY PROCEDURE ON (B)(6) 2009. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: DUE TO INCONTINENCE AND SURGICAL CORRECTION.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI S PROSTATECTOMY PROCEDURE (B)(6) 2009. THE LEGAL DOCUMENT ALLEGES THAT AS A DIRECT AND PROXIMATE RESULT OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY, OR ITS IMPROPER AND / OR UNLAWFUL USE, THE PATIENT SUFFERED AN INJURY TO HIS OBTURATOR NERVE AND REQUIRED 4 UNITS OF BLOOD. ACCORDING TO THE INFORMATION PROVIDED, THE PATIENT WAS HOSPITALIZED FOR 21 DAYS. REPORTEDLY, POST-OPERATIVELY THE PATIENT IS IMPOTENT AND INCONTINENT. NO OTHER 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: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI PROSTATE CANCER PROCEDURE ON (B)(6) 2009. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: 'INCONTINENT & IMPOTENT AFTER SURGERY, HAD FOLLOW UP SURGERY 1 YEAR LATER WHERE THEY IMPLANTED AND ARTIFICIAL SPHINCTER, PAIN AFTER SURGERY'.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT POST A DA VINCI S SACROCOLPOPEXY PROCEDURE, THE PT DEVELOPED DEEP VIN THROMBOSIS (DVT). NO ADDITIONAL PT HARM OR ADVERSE OUTCOME WAS REPORTED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION INCLUDING A MEDICAL RECORD REGARDING A PATIENT THAT UNDERWENT A DA VINCI PROSTATECTOMY PROCEDURE ON (B)(6) 2009. THE OPERATIVE REPORT FOR THE DA VINCI PROSTATECTOMY PROCEDURE WAS NOT PROVIDED; HOWEVER, AN OPERATIVE REPORT FOR THE REPAIR OF ENTEROTOMY AND SMALL BOWEL RESECTION WAS PROVIDED. ACCORDING TO THE PROVIDED OPERATIVE REPORT, THE SURGEON PERFORMING THE DA VINCI PROSTATECTOMY CONSULTED WITH ANOTHER SURGEON DURING THE PROSTATECTOMY DUE TO AN INTRA-OPERATIVE INJURY TO THE PATIENT'S SMALL BOWEL. IT WAS NOTED THAT THE PATIENT SUSTAINED THE SMALL BOWEL INJURY (ENTEROTOMY X2) DUE TO SEVERE ADHESIONS OF THE PELVIS FROM PREVIOUS TRANSABDOMINAL SURGERY. THE PATIENT RECEIVED A SMALL BOWEL RESECTION OF MID TO DISTAL ILEUM, ABOUT A 12 CM SEGMENT, WITH PRIMARY ANASTOMOSIS. THE PATIENT TOLERATED THE SMALL BOWEL REPAIR WELL AND THE REMAINDER OF THE PROSTATECTOMY WAS LEFT UNDER THE CARE OF THE INITIAL DA VINCI SURGEON. THERE WAS NO SPECIFIC ALLEGATION OF ANY MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY IN THE PROVIDED DOCUMENT. NO OTHER INFORMATION WAS PROVIDED. SINCE THE DA VINCI PROSTATECTOMY OPERATIVE REPORT

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED A JOURNAL ARTICLE BY COOPER ET AL TITLED, UNDERREPORTING OF ROBOTIC SURGERY COMPLICATIONS. IN THIS ARTICLE, THE AUTHORS REPORTED COMPLICATIONS REPORTED IN MAUDE DATABASE OR LEXISNEXIS, AND PACER (PUBLIC ACCESS TO COURT ELECTRONIC RECORDS) FROM JANUARY 1, 2000 TO AUGUST 1, 2012. ACCORDING TO A REPORTED INJURY IN THE ARTICLE, A FAILURE OF BAND AND CLIP DURING A PATIENT'S DA VINCI MITRAL VALVE REPAIR PROCEDURE ON (B)(6) 2009 LED TO THE PATIENT'S CONGESTIVE HEART FAILURE AND SUBSEQUENT OPEN HEART REPAIR. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THE REPORTED EVENT. THE HOSPITAL NAME, PATIENT INFORMATION, AND DA VINCI SYSTEM SERIAL INVOLVED WITH THIS COMPLAINT WERE NOT INCLUDED IN THE ARTICLE. ARTICLE INFORMATION: TITLE: UNDERREPORTING OF ROBOTIC SURGERY COMPLICATIONS AUTHORS: MICHOL A. COOPER, ANDREW IBRAHIM, HEATHER LYU, MARTIN A. MAKARY PUBLISHED DATE: 08/27/2013 LINK: (B)(4).

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 NEPHRECTOMY PROCEDURE, WHILE THE SURGEON WAS PERFORMING THE HILAR DISSECTION TECHNIQUE, THE PATIENT BEGAN TO HEMORRHAGE. THE SURGEON DECIDED TO CONVERT THE PROCEDURE TO TRADITIONAL OPEN SURGICAL TECHNIQUE. DESPITE EFFORTS FROM THE SURGICAL STAFF, THE PATIENT HEMORRHAGING WAS NOT ABLE TO BE CONTROLLED AND THE PATIENT EXPIRED. BASED ON THE INFORMATION PROVIDED BY THE SITE, IT WAS DETERMINED THAT THE DA VINCI S SURGICAL SYSTEM DID NOT MALFUNCTION AND DID NOT CONTRIBUTED TO THE PATIENT'S DEATH.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI S SACRAL COLPOPEXY FOR TOTAL VAGINAL PROLAPSE ON (B)(6) 2009. THE PROCEDURE WAS CONVERTED TO AN OPEN SACRAL COLPOPEXY. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES: ADMISSION NOTES, POST-OP NOTES, DISCHARGE SUMMARY, UROLOGY CLINIC NOTES (B)(6) 2009 PRIOR TO THE PROCEDURE, THE RISKS AND BENEFITS OF SURGERY WERE DISCUSSED WITH THE PATIENT. THE PATIENT CHOSE TO UNDERGO A ROBOT-ASSISTED LAPAROSCOPIC SACRAL COLPOPEXY. THERE WAS INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS A REPORT OF AN INTRAOPERATIVE COMPLICATION. PNEUMOPERITONEUM WAS ACHIEVED USING A DIRECT VISION TROCAR IN THE MIDLINE WITHOUT DIFFICULTY. THE CAMERA WAS THEN PLACED AND NO SIGNS OF A BOWEL INJURY WERE OBSERVED. FOUR OTHER PORTS WERE THEN PLACED AND THE TROCARS WERE PLACED UNDER DIRECT VISION AND LAPAROSCOPICALLY. THE ADHESIONS WERE TAKEN DOWN. THE ROBOT WAS THEN DOCKED. DURING TAKE DOWN OF DENSE ADHESIONS IN THE BOWEL AREA, A SMALL HOLE WAS MADE IN THE BLADDER. THE HOLE WAS SUTURE CLOSED U

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(4) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED A LEGAL COMPLAINT WITH THE FOLLOWING ALLEGATION: IT WAS REPORTED THAT AFTER A DA VINCI SI NEPHRECTOMY PROCEDURE WAS PERFORMED ON (B)(6) 2009, BLEEDING WAS NOTED FROM THE PATIENT'S AORTA. NO FURTHER CLINICAL INFORMATION WAS PROVIDED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON 09/04/2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED A JOURNAL ARTICLE BY COOPER ET AL TITLED, UNDERREPORTING OF ROBOTIC SURGERY COMPLICATIONS. IN THIS ARTICLE, THE AUTHORS REPORTED COMPLICATIONS REPORTED IN MAUDE DATABASE OR LEXISNEXIS, AND PACER (PUBLIC ACCESS TO COURT ELECTRONIC RECORDS) FROM JANUARY 1, 2000 TO AUGUST 1, 2012. ACCORDING TO A REPORTED INJURY IN THE ARTICLE, A PATIENT SUSTAINED A PERFORATED VISCOUS INJURY AND REQUIRED MULTIPLE SUBSEQUENT SURGERIES AFTER UNDERGOING A DA VINCI LEFT SALPINGO OOPHORECTOMY PROCEDURE ON (B)(6) 2009 . NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THE REPORTED EVENT. THE HOSPITAL NAME, PATIENT INFORMATION, AND DA VINCI SYSTEM SERIAL INVOLVED WITH THIS COMPLAINT WERE NOT INCLUDED IN THE ARTICLE. ARTICLE INFORMATION: TITLE: UNDERREPORTING OF ROBOTIC SURGERY COMPLICATIONS AUTHORS: MICHOL A. COOPER, ANDREW IBRAHIM, HEATHER LYU, MARTIN A. MAKARY PUBLISHED DATE: 08/27/2013 LINK: HTTP://ONLINELIBRARY.WILEY.COM/DOI/10.1111/JHQ.12036/ABSTRACT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI SI VAGINAL VAULT REPAIR ON (B)(6) 2009. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. MULTIPLE PRE-OP AND POST-OP REPORTS ARE INCLUDED. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS A REPORT OF AN INTRAOPERATIVE COMPLICATION - NAMELY A TEAR OF THE INFERIOR VENA CAVA. UPON ENTERING THE ABDOMEN EXTENSIVE ADHESIONS WERE NOTED AND ONE HOUR WAS SPENT LYSING THEM PRIOR TO THE ROBOTIC INSTRUMENTS BEING PLACED. ALL WERE RELEASED EXCEPT FOR ONE, WHICH WAS HERNIATED THROUGH A PREVIOUS INCISION SITE. FURTHER ENTEROLYSIS WAS PERFORMED AFTER THE ROBOT WAS DOCKED. THE LOOP OF SMALL BOWEL THAT WAS ATTACHED THROUGH THE ANTERIOR ABDOMINAL WALL HERNIATION SITE WAS RELEASED USING THE ROBOT. THE SMALL BOWEL WHICH WAS INVOLVED IN THIS PART WAS EXAMINED AND THE SEROSA NOTED TO BE SOMEWHAT DENUDED. THIS AREA IS OVERSEWN WITH SUTURE. SHORTLY AFTER THE SACRAL PROMONTORY WAS IDENTIFIED AND EXPOSED BLEEDING WAS NOTED FROM THE INFERIOR PORTION OF THE VENA CAVA. VASCULAR SURGEONS WERE BROUGHT IN AND CLIPS WERE

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED A JOURNAL ARTICLE BY COOPER ET AL TITLED, UNDERREPORTING OF ROBOTIC SURGERY COMPLICATIONS. IN THIS ARTICLE, THE AUTHORS REPORTED COMPLICATIONS REPORTED IN MAUDE DATABASE OR LEXISNEXIS, AND PACER (PUBLIC ACCESS TO COURT ELECTRONIC RECORDS) FROM JANUARY 1, 2000 TO AUGUST 1, 2012. ACCORDING TO A REPORTED INJURY THE ARTICLE, A PATIENT SUSTAINED A URETERAL INJURY AND RENAL INSUFFICIENCY AFTER UNDERGOING A DA VINCI HYSTERECTOMY PROCEDURE ON (B)(6) 2009. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THE REPORTED EVENT. THE HOSPITAL NAME AND DA VINCI SYSTEM SERIAL INVOLVED WITH THIS COMPLAINT WERE NOT INCLUDED IN THE ARTICLE. ARTICLE INFORMATION: TITLE: UNDERREPORTING OF ROBOTIC SURGERY COMPLICATIONS AUTHORS: MICHOL A. COOPER, ANDREW IBRAHIM, HEATHER LYU, MARTIN A. MAKARY PUBLISHED DATE: 08/27/2013 LINK: (B)(6).

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT POST A DA VINCI S PROSTATECTOMY PROCEDURE, THE PATIENT DEVELOPED BILATERAL LEG NERVE PALSY. NO ADDITIONAL PATIENT HARM OR ADVERSE OUTCOME WAS REPORTED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI PROSTATECTOMY PROCEDURE ON (B)(6) 2009. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: IMPOTENCE, INCONTINENCE, URINARY PROBLEMS, BLEEDING, SCARRING, RECTAL BLEEDING, FOUL SMELLING DISCHARGE.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI SI PROSTATECTOMY PROCEDURE ON (B)(6) 2009. THE LEGAL DOCUMENT ALLEGES THAT AS A DIRECT AND PROXIMATE RESULT OF THE DA VINCI SI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY, OR ITS IMPROPER AND/OR UNLAWFUL USE, THE PATIENT SUFFERED INJURIES AND DAMAGES.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL MEDIATION EFFORT, ON JULY 25TH, 2013 INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION INCLUDING MEDICAL RECORDS CONCERNING A PATIENT WHO UNDERWENT A DA VINCI S HYSTERECTOMY PROCEDURE ON (B)(6) 2009. THE PATIENT'S MEDICAL HISTORY SUMMARY WAS PROVIDED. THE INFORMATION RECEIVED STATED THAT DURING THE SURGICAL PROCEDURE, A FAILURE OF THE THREE-DIMENSIONAL OPTICAL SYSTEM OCCURRED WHILE THE SURGEON WAS SUTURING THE VAGINAL CUFF AND THE PATIENT SUSTAINED A VAGINAL CUFF DEHISCENCE. THE PATIENT'S MEDICAL RECORDS INDICATE THAT THE PATIENT UNDERWENT THE DA VINCI SI HYSTERECTOMY ON (B)(6) 2009 FOR CHRONIC ABDOMINAL PAIN, CHRONIC MENOMETRORRHAGIA, CHRONIC PELVIC PAIN, DYSMENORRHEA, AND SYMPTOMATIC LEIOMYOMA. THE MEDICAL SUMMARY INDICATES THAT EQUIPMENT FAILURE OCCURRED PRESUMED DIGITIZER ON THE LEFT 3D EYE SYSTEM ON THE CONSOLE AT THE POINT OF SUTURING. BOTH 2D AND 3D VISUAL SYSTEMS WERE THEN UTILIZED TO COMPLETE THE CASE IN A VERY SAFE MANNER WITHOUT COMPLICATIONS TO THE PATIENT. THE PATIENT EXPERIENCED POST-OPERATIVE NAUSEA FOR 2 DAYS BEFORE SHE WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2009. THE PATIENT INDICATED THAT SHE WAS SENSITIVE TO NARCOTIC MEDICATIONS AND THAT T

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 ENDOSCOPE TIP BECAME VERY HOT AND BURNT THE PATIENT'S BOWEL. SURGICAL INTERVENTION WAS NOT REQUIRED, AND THE PLANNED PROCEDURE WAS COMPLETED WITHOUT ANY FURTHER ISSUES.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL MEDIATION EFFORT, ON (B)(6) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION INCLUDING MEDICAL RECORDS CONCERNING A PATIENT WHO UNDERWENT A DA VINCI S PROSTATECTOMY PROCEDURE ON (B)(6) 2009. THE DOCUMENTATION PROVIDED STATES THAT THE PATIENT DEVELOPED AN ABSCESS AS A RESULT OF UNDERGOING THE SURGICAL PROCEDURE AND WAS HOSPITALIZED. THE PATIENT'S OPERATIVE REPORT FOR (B)(6) 2009, INDICATED THAT HE UNDERWENT A RADICAL PROSTATECTOMY, FOLLOWED BY A BILATERAL PELVIC LYMPH NODE DISSECTION. THE PATIENT HAD BEEN DIAGNOSED WITH ADENOCARCINOMA OF THE PROSTATE. NO INTRA-OPERATIVE COMPLICATIONS WERE REPORTED ON THE OPERATIVE REPORT. THE OPERATIVE REPORT ALSO NOTED THAT THE PATIENT TOLERATED THE PROCEDURE WELL. THE PATIENT WAS DISCHARGED HOME THE FOLLOWING DAY ON (B)(6) 2009, AND WAS REPORTED TO BE DOING FINE. THE DISCHARGE SUMMARY INDICATED THAT THE PATIENT WAS AFEBRILE, HIS URINE WAS CLEAR, WITH MINIMAL DRAINAGE. HE WAS DISCHARGED WITH A FOLEY CATHETER. ON (B)(6) 2009, THE PATIENT HAD A POST-OPERATIVE FOLLOW-UP APPOINTMENT WITH THE SURGEON. THE PATIENT'S CATHETER WAS REMOVED. THE PATIENT'S PORT SITES LOOKED GOOD. DURING A FOLLOW UP VISIT ON (B)(6) 2009 THE PATIENT 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: PER LEGAL SUMMONS RECEIVED ON (B)(4) 2012, IT WAS ALLEGED THAT THE PATIENT HAD A DA VINCI S HYSTERECTOMY SURGERY ON (B)(6) 2009 TO REMOVE OVARIAN FIBROID TUMORS. FIVE WEEKS AFTER SURGERY, THE PATIENT BEGAN FEELING FEVERISH AND NAUSEOUS AND HAD DIARRHEA. IT WAS ALLEGED THE PATIENT HAD NOT ENGAGED IN SEXUAL INTERCOURSE SINCE THE SURGERY. AT THAT TIME, IT WAS ALLEGED THE PATIENT ENGAGED IN SEXUAL INTERCOURSE WITH HER HUSBAND AND EXPERIENCED LIGHT BLEEDING. WHEN THE PATIENT USED THE BATHROOM THEREAFTER, THE PATIENT HEARD A POP AND ALLEGEDLY SAW APPROXIMATELY AN INCH OF INTESTINES COMING OUT OF HER VAGINA. THE PATIENT WAS ADMITTED AT THAT TIME TO (B)(6). A DIFFERENT SURGEON PERFORMED EMERGENCY OPEN LAPAROTOMY SURGERY. WHILE OPERATING, A MASSIVE INFECTION WITH CYSTS AND ADHESIONS ENCAPSULATING THE FALLOPIAN TUBE AND OVARY WAS FOUND AND THE RIGHT OVARY HAD TO BE REMOVED AS A RESULT. ADDITIONALLY, THE INFECTION DETERIORATED THE VAGINAL CUFF TISSUE THAT HAD BEEN SEWN DURING THE DA VINCI S HYSTERECTOMY CAUSING THE CUFF TO TEAR LEADING TO A SMALL BOWEL EVISCERATION. THE INFECTED TISSUE WAS REMOVED AND VAGINAL CUFF RE-SEWN. THE PATIENT STAYED IN THE HOSPITAL FIVE DAYS.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: I WAS TOLD BY THE SURGEON THAT I HAD PROSTATE CANCER AND HE SUGGESTED THE DA VINCI ROBOT. HE SAID THAT I WOULD NOT EVEN KNOW THAT I HAD BEEN OPERATED ON AND THAT I WOULD LEAVE THE HOSPITAL THE NEXT DAY. HOWEVER, I REMAINED A PT IN THE HOSPITAL FOR 33 DAYS, I WAS BLEEDING INTERNALLY AND I WAS GIVEN 18 PINTS OF BLOOD. I LOST OVER 45 LBS AND I COULD NOT WALK, EAT, OR DRINK ANYTHING BY MYSELF. I WAS FINALLY RELEASED AFTER 33 DAYS IN THE HOSPITAL AND 12 HOURS AFTER I WAS DISCHARGED, I HAD TO BE READMITTED BECAUSE OF PAIN, BLEEDING AND NAUSEA. SINCE THE DA VINCI SURGERY, I HAVE HAD TO HAVE SEVEN MORE OPERATIONS. THE SURGEON THAT PERFORMED THE ORIGINAL DA VINCI ROBOTIC SURGERY NEVER EVER CAME TO SEE ME OR TO CHECK ON ME WHILE I WAS HOSPITALIZED FOR APPROX 5 WEEKS.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI ROBOTIC SACROCOLPOPEXY FOR VAGINAL PROLAPSE ON (B)(6) 2009. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. ON (B)(6) 2009, THE PATIENT UNDERWENT ROBOTIC SACROCOLPOPEXY, LYSIS OF ADHESIONS AND SLING PROCEDURE WITH CYSTOSCOPY. DURING PROCEDURE IT WAS NOTED THAT THERE WAS MULTIPLE ADHESIONS AND A GENERAL SURGEON CAME AND TOOK DOWN ADHESIONS. IN RECOVERY, THE PATIENT DEVELOPED SEVERE HYPOTENSION, HAD LARGE BLOODY EMESIS AND WAS FOUND TO HAVE AN ACTIVELY BLEEDING STOMACH ULCERATION. THE PATIENT DEVELOPED ACUTE TUBULAR NECROSIS (ATN), HAD A COAGULOPATHY, BECAME SEPTIC, BUT ULTIMATELY WAS TREATED AND STABILIZED IN ICU. ON (B)(6) 2009, ADDITIONALLY THE PATIENT UNDERWENT A RIGHT HEMICOLECTOMY FOR ISCHEMIC BOWEL INJURY. THE PATIENT WAS DISCHARGED ON (B)(6) 2009. NO FURTHER CLINICAL INFORMATION WAS PROVIDED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL MEDIATION EFFORT, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION, INCLUDING BRIEF MEDICAL RECORDS,OF A PATIENT WHO UNDERWENT A ROBOTIC HYSTERECTOMY ON (B)(6) 2009. PER MEDICAL RECORDS THE PATIENT TOLERATED THE SURGICAL PROCEDURE WELL AND WAS DISCHARGED THE FOLLOWING DAY, (B)(6) 2009. ON (B)(6) 2009, THE PATIENT WAS ADMITTED TO THE HOSPITAL AND UNDERWENT A VAGINAL CUFF REPAIR ON (B)(6) 2009. PER DISMISSAL SUMMARY HER POSTOPERATIVE COURSE WAS UNCOMPLICATED. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2009. PER BRIEF DISCHARGE SUMMARY, THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2009 DUE TO VAGINAL BLEEDING. SHE UNDERWENT EXAMINATION UNDER ANESTHESIA AND CYSTOSCOPY. AS EXAM REVEALED VAGINAL CUFF ABSCESS, NO VAGINAL CUFF DEHISCENCE. THE PATIENT WAS TREATED WITH IV ANTIBIOTICS, AND SHE WAS THEN DISMISSED HOME WITH ORAL ANTIBIOTICS. NO FURTHER CLINICAL INFORMATION WAS PROVIDED ABOUT THE PATIENT'S CURRENT STATUS.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL MEDIATION EFFORT ON (B)(6) 2013 INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION, INCLUDING MEDICAL RECORDS, OF A PATIENT WHO UNDERWENT A DA VINCI HYSTERECTOMY PROCEDURE ON (B)(6) 2009 FOR SYMPTOMATIC FIBROID UTERUS. ACCORDING TO THE OPERATIVE REPORTS, THE SURGEON EVALUATED THE PATIENT'S PELVIS DURING THE DA VINCI SURGICAL PROCEDURE AND INDICATED THERE WAS A MARKEDLY ENLARGED MULTI-FIBROID UTERUS. AFTER THE VAGINAL CUFF WAS CLOSED, THE SURGEON NOTED A SMALL AMOUNT OF WELLING OF METHYLENE BLUE FROM THE LEFT PELVIC BRIM. THE SURGEON SUSPECTED A BLADDER OR URETHRAL INJURY AND UROLOGY WAS CONSULTED. WHEN UROLOGY ARRIVED, A CYSTOSCOPY WITH RETROGRADE PLACEMENT OF A GUIDEWIRE WAS PERFORMED AND REVEALED THERE WAS A LEFT URETERAL TRANSECTION CLOSE TO THE BLADDER NECK. THE FOLEY CATHETER WAS REPLACED IN THE URINARY BLADDER AND THE PATIENT WAS THEN UNDOCKED FROM THE DA VINCI SYSTEM. THE UROLOGIST EXAMINED THE PATIENT'S PELVIS THROUGH A SMALL AMOUNT OF DISSECTION IN THE CAMPER'S FASCIA. THE SMALL AMOUNT OF DISSECTION REVEALED THE TRANSECTED LEFT URETER AND CHARRING WAS OBSERVED AT THE END OF THE URETER. THE UROLOGIST REPAIRED THE URETERAL INJURY BY DIRECTLY IMPLANTING TH

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI TOTAL BENIGN HYSTERECTOMY PROCEDURE IN 2009. THE LEGAL DOCUMENT ALLEGES THAT AS A DIRECT AND PROXIMATE RESULT OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY, OR ITS IMPROPER AND / OR UNLAWFUL USE, THE PATIENT SUFFERED INJURIES AND DAMAGES.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT DA VINCI S SACROCOLPOPEXY PROCEDURE FOR VAGINAL PROLAPSE AND STRESS INCONTINENCE ON (B)(6) 2008. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES FOLLOW UP OPERATIVE REPORTS AND CONSULTATIONS. ON (B)(6) 2008 THE PATIENT UNDERWENT ROBOTIC LAPAROSCOPIC SACROCOLPOPEXY AND LYSIS OF ADHESIONS AND LEFT OVARIAN CYSTECTOMY WITH TRANSVAGINAL TAPE AND CYSTOSCOPY. PROCEDURE TOOK SEVEN HOURS TO COMPLETE (LARGER BMI). THE PATIENT DEVELOPED PLEURAL EFFUSIONS AND EDEMA OF HEAD AND NECK POST OP. THE PATIENT WAS IN ICU ON VENTILATOR FOR SEVERAL DAYS AND WAS DISCHARGED HOME ON (B)(6) 2009. 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) 2009, THE PATIENT PRESENTED WITH RECTOVAGINAL FISTULA. THE PATIENT UNDERWENT DIVERTING LOOP COLOSTOMY (SIGMOID) ON (B)(6) 2009. ON (B)(6) 2009, THE PATIENT WAS ADMITTED FOR EXCISION OF RECTOVAGINAL FISTULA WITH END COLOSTOMY AS PROBLEMS PERSISTED, SOME AS A RESULT OF ROBOTIC SURGERY AND S

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL MEDIATION EFFORT, INTUITIVE SURGICAL, INC., (ISI) RECEIVED INFORMATION, INCLUDING MEDICAL RECORDS AND OPERATIVE REPORTS OF A PATIENT WHO UNDERWENT A ROBOTIC HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY, PELVIC AND PERIAORTIC LYMPHADENECTOMY AND SUFFERED POST-SURGICAL COMPLICATIONS AFTER UNDERGOING A DA VINCI SI SURGICAL PROCEDURE ON (B)(6) 2008. BASED ON THE OPERATIVE REPORTS,THE DA VINCI PROCEDURE WAS WELL TOLERATED BY THE PATIENT AND THERE WAS NO MALFUNCTION THAT OCCURRED WITH THE DA VINCI SYSTEM AND OR INSTRUMENTS. POSTOPERATIVELY, THE PATIENT WAS NOTED TO HAVE ABDOMINAL DISTENTION AND NAUSEA AND WAS KEPT IN THE HOSPITAL AN EXTRA NIGHT AND WAS DISCHARGED ON (B)(6) 2008. ON (B)(6) 2008, THE PATIENT WAS SEEN IN THE ER FOR ABDOMINAL PAIN. CT SCAN SHOWED SMALL AMOUNT OF FLUID IN THE PELVIS WITH NO SIGNS OF PERITONITIS. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND WAS SENT HOME AFTER ABOUT 4 DAYS OF HOSPITALIZATION. SHE RETURNED TO THE HOSPITAL ON (B)(6) 2009 WITH WORSENING SYMPTOMS AND A CT SCAN WAS PERFORMED. THE CT SCAN SHOWED DILATED LOOPS OF SMALL BOWEL WITH AIR FLUID LEVELS AND SOME PELVIC FLUID. ON (B)(6) 2009, THE PATIENT WENT INTO THE OPERATING ROOM FOR 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: AS PART OF A LEGAL MEDIATION EFFORT, INTUITIVE SURGICAL, INC., (ISI) RECEIVED INFORMATION INCLUDING MEDICAL RECORDS AND OPERATIVE REPORT OF A PATIENT WHO SUFFERED POST- SURGICAL COMPLICATIONS AFTER UNDERGOING A RIGHT HEMI COLECTOMY WITH RIGHT ILEAL REVISION DA VINCI SURGICAL PROCEDURE. THE PATIENT WAS REFERRED TO GENERAL SURGERY CLINIC AFTER SHE WAS FOUND TO HAVE A LONG ILEAL SEGMENT OF CROHN'S AND WORSENING ABDOMINAL PAIN. THE PATIENT WAS ADMITTED TO THE HOSPITAL. AFTER EXPLAINING THE RISK AND BENEFITS OF THE PROCEDURE INCLUDING RISK OF INTERNAL HERNIA, BLEEDING, LEAK, RECURRENCE, NEED FOR REOPERATION THE PATIENT CONTINUED TO UNDERGO A DA VINCI RIGHT HEMICOLECTOMY WITH EXTENDED RIGHT ILEAL RESECTION WITH TWO- LAYER HAND SEWN ANASTOMOSIS ON (B)(6) 2012. IN THE OPERATIVE REPORT THERE IS NO EVIDENCE THAT THE DA VINCI SYSTEM OR INSTRUMENT MALFUNCTIONED. THE CROHN'S DISEASE RESECTION TOOK PLACE AT MID BOWEL LEVEL, ANASTOMOSIS WAS CREATED USING STAPLES WHICH DID NOT SHOW ANY EVIDENCE OF BLEEDING. THE MESENTERIC DEFECTS WERE CLOSED USING RUNNING 2.0 SILK AND THE ABDOMEN WAS WELL IRRIGATED. THERE WAS NO EVIDENCE OF FRANK PUS AND ALL DISSECTED AREAS WERE FOUND TO BE HEMOSTATIC. 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: IN 2009, INTUITIVE SURGICAL WAS FORWARDED VOLUNTARY REPORT BY THE FDA FOR A PT DEATH AT HOSPITAL. THE REPORT DETAILS ARE PROVIDED BELOW: CDRH MAUDE EVENT REPORT 2009. REPORT OUTCOME ATTRIBUTED TO EVENT: DEATH. DATE RECEIVED: 2009. EVENT DATE: 2009. EVENT DESCRIPTION THE FOLLOWING MONTH: HEALTHY FEMALE FOR OVARIAN CYSTECTOMY USING THE DAVINCI ROBOT. PT SUFFERED FATAL CARDIAC ARREST IN THE MIDDLE OF THE PROCEDURE. HISTORY OF HTN, BUT OTHER WISE HEALTHY. NO AUTOPSY DONE. DEVICE INFORMATION: BRAND: DAVINCI ROBOT. DEVICE OPERATOR: HEALTH PROFESSIONAL. DEVICE AVAILABLE FOR EVALUATION: Y. EXPIRATION DATE: IS REPORTER A HEALTH PROFESSIONAL?: Y.

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 HEART VALVE REPAIR PROCEDURE ON (B)(6) 2008. THE LEGAL DOCUMENT ALLEGES THAT DURING THE SURGERY, THE PATIENT EXPERIENCED INTERNAL BLEEDING AND INTERNAL BURNS OCCURRED. THE LEGAL DOCUMENT ALSO ALLEGES THAT THE PATIENT SUBSEQUENTLY EXPIRED ON AN UNSPECIFIED DATE AFTER BLOOD VESSELS WERE DAMAGED. INTUITIVE SURGICAL, INC. (ISI) WAS NOT PROVIDED WITH THE OPERATIVE REPORT OR ANY PATIENT MEDICAL RECORDS. BASED ON THE LEGAL DOCUMENT PROVIDED, THERE WAS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL 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: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO REPORTEDLY UNDERWENT A DA VINCI-ASSISTED ROBOTIC PROCEDURE - NEPHRECTOMY FOR RENAL MASS ON (B)(6) 2008. ISI WAS NOT PROVIDED WITH THE DA VINCI SURGERY OPERATIVE REPORT. ISI WAS ONLY PROVIDED A LEGAL CLAIM FORM. THE LEGAL DOCUMENT STATES THAT ON (B)(6) 2008, THE PATIENT UNDERWENT ROBOTIC SURGERY FOR REMOVAL OF A RENAL MASS. DURING THE ROBOTIC SURGERY THE ROBOT PERFORATED THE PATIENT'S ARTERY LEADING TO IS [SIC] OTHER KIDNEY. IN ADDITION, THE LEGAL DOCUMENT CLAIMS THAT AS A RESULT, THE PATIENT WAS NOT A CANDIDATE TO RECEIVE THE CANCER TREATMENT, INTERLEUKIN II, TO FIGHT HIS KIDNEY CANCER. THE PATIENT PASSED AWAY ON (B)(6) 2013 FROM METASTATIC RENAL CANCER. NO FURTHER INFORMATION WAS PROVIDED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AFTER A DA VINCI HYSTERECTOMY PROCEDURE, DURING THE CYSTOSCOPY, IT WAS FOUND THAT THE PATIENT'S URETER HAD BEEN DAMAGED. THE URETER WAS REPAIRED VIA A URETERONEOCYSTOTOMY PROCEDURE, AND THE PATIENT WAS DISCHARGED TWO DAYS LATER. NO ADDITIONAL PATIENT HARM OR ADVERSE OUTCOME WAS REPORTED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI SI TOTAL LAPAROSCOPIC HYSTERECTOMY (>250G), ENTEROLYSIS, CYSTOURETHROSCOPY FOR MENORRHAGIA, FIBROIDS (18 WEEKS SIZE) AND PELVIC PAIN ON (B)(6) 2008. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES: GYN CONSULTATION IN ER ON (B)(6) 2008, OR REPORT ON (B)(6) 2008 AFTER PLACEMENT OF THE UTERINE MANIPULATOR AND INSTALLATION OF A PNEUMOPERITONEUM THROUGH A VERESS NEEDLE ADDITIONAL TROCARS WERE PLACED AND THE DAVINCI ROBOT DOCKED. ADHESIONS FROM THE SIGMOID COLON TO THE LEFT OVARY, POSTERIOR FUNDUS AND LEFT ABDOMINAL WALL WERE TAKEN DOWN SHARPLY AND FUNDAL ATTACHMENTS TO THE UTERUS, FALLOPIAN TUBES, UTERO-OVARIAN LIGAMENT AND ROUND LIGAMENTS WERE ELECTROCOAGULATED AND CUT. THE LEFT PEDICLE AND SIGNIFICANT BLADDER ADHESIONS WAS DISSECTED. THEN TRANSECTION OF THE BROAD LIGAMENT AND UTERINE VESSELS WAS PERFORMED. A SIMILAR PROCEDURE WAS PERFORMED ON THE OPPOSITE SIDE AND IDENTIFICATION OF A MASS THAT APPEARED AS A PEDUNCULATED FIBROID WAS NOTED. THIS WAS LATER ON RESECTED TRANSPERITONEALLY. AFTER BLADDER DISSECTION DOWN TO THE V

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI S PROSTATECTOMY PROCEDURE ON (B)(6) 2008. THE LEGAL DOCUMENT ALLEGES THAT AS A DIRECT AND PROXIMATE RESULT OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY, OR ITS IMPROPER AND / OR UNLAWFUL USE, THE PATIENT SUFFERED AN ANASTOMOTIC LEAK. NO OTHER INFORMATION WAS PROVIDED. ACCORDING TO THE INFORMATION PROVIDED IN THE LEGAL DOCUMENT THE PATIENT'S ANASTOMOTIC LEAK WAS DISCOVERED ON (B)(6) 2008 DURING A FOLLOW-UP VISIT. REPORTEDLY, THE PATIENT HAS EXPERIENCED INCONTINENCE AS A RESULT OF THE ANASTOMOTIC LEAK AND REQUIRED RECONSTRUCTIVE SURGERY TO IMPLANT A BLADDER SLING TO CONTROL HIS INCONTINENCE. 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: IT WAS REPORTED THAT 8 DAYS AFTER A DA VINCI S HYSTERECTOMY PROCEDURE, THE PT UNDERWENT AN EXPLORATORY LAPAROSCOPY PROCEDURE WHERE A BOWEL PERFORATION WAS DISCOVERED. THE PERFORATION WAS REPAIRED, HOWEVER, THE PT BECAME SEPTIC DUE TO A BILIOUS FLUID LEAKAGE. THE PT WAS IN CRITICAL CARE FOR 2 WEEKS AND WAS THEN TRANSFERRED TO LONG TERM CARE. NO ADD'L PT HARM OR ADVERSE OUTCOME WAS REPORTED.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI S SURGICAL PROCEDURE TO REMOVE A PELVIC MASS, THE CONSOLE SURGEON UNINTENTIONALLY CLIPPED THE PT'S SUPERIOR MESENTERIC ARTERY. AFTER THE PROCEDURE WAS COMPLETED, THE PT WENT INTO ORGAN FAILURE WHILE ON THE FLOOR AND EXPIRED. NO ADDITIONAL INFO 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 AFTER A DA VINCI S MITRAL VALVE REPAIR SURGICAL PROCEDURE AND WHILE RE-INFLATION OF THE PT'S RIGHT LUNG, THE SURGICAL STAFF NOTICED A VERY LOW OXYGEN (O2) SATURATION. AS A RESULT OF THE LOW O2 SATURATION, THE SURGICAL STAFF DECIDED TO PUT THE PT ON BYPASS IN ORDER TO SCOPE THE LUNGS. THE SURGICAL STAFF FOUND THAT FLUID HAD ACCUMULATED IN THE PT'S RIGHT LUNG. DESPITE EFFORTS, THE PT WAS NOT ABLE TO REGAIN FUNCTION OF THE RIGHT LUNG AND WAS TRANSFERRED TO THE ICU. THE PT EXPIRED DUE TO MULTI-ORGAN FAILURE, HYPOXIA, AND ACUTE PULMONARY EDEMA OF THE RIGHT LUNG.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI PROSTATECTOMY ON (B)(6) 2008. THE LEGAL DOCUMENT ALLEGES THAT AS A DIRECT AND PROXIMATE RESULT OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY, OR ITS IMPROPER AND / OR UNLAWFUL USE, THE PATIENT SUFFERED URINARY INCONTINENCE AND ERECTILE DYSFUNCTION RESULTING IN INJURIES AND DAMAGES.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI PROSTATECTOMY PROCEDURE ON (B)(6) 2008. THE LEGAL DOCUMENT ALLEGES THAT AS A DIRECT AND PROXIMATE RESULT OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY, OR ITS IMPROPER AND / OR UNLAWFUL USE, THE PATIENT SUFFERED URINARY INCONTINENCE AND ERECTILE DYSFUNCTION.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION FROM AN ATTORNEY REPRESENTING A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY PROCEDURE ON (B)(6) 2008, AND ALLEGED TO HAVE INJURIES INCLUDING A PERFORATED URETER LEADING TO HYDROURETERONEPHROSIS. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI ESOPHAGOGASTRECTOMY FOR ESOPHAGEAL ADENOCARCINOMA ON (B)(6) 2008. A COMBINATION OF STANDARD LAPAROSCOPIC AND ROBOTIC ASSISTED LAPAROSCOPY WAS PERFORMED. THE SURGEON WENT BACK AND FORTH BETWEEN ROBOTIC ASSISTED AND NON-ROBOTIC LAPAROSCOPIC TECHNIQUE DEPENDING UPON WHICH TASKS WERE BEING ACCOMPLISHED. ISI WAS PROVIDED WITH THE DA VINCI SURGERY OPERATIVE REPORT (S) AND SUPPLEMENTAL HOSPITAL 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 ANY PORTION OF THE OPERATION. THERE WERE NO INTRAOPERATIVE COMPLICATIONS. PERTINENT FINDINGS INCLUDE BARRETT'S ESOPHAGUS CHANGES. THE SURGEON'S DICTATED OPERATIVE REPORT STATES, THERE WERE ADHESIONS IN THE UPPER ABDOMEN, LEFT ABDOMEN AND RIGHT ABDOMEN. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING SURGERY. THE SURGERY WAS COMPLETED WITH NO REPORTED INTRA-OPERATIVE COMPLICATIONS. AT THE CONCLUSION OF THE SURGICAL PROCEDURE, THE PATIENT UN

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION FROM AN ATTORNEY REPRESENTING A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY PROCEDURE ON (B)(6) 2008, AND ALLEGED TO HAVE INJURIES INCLUDING A URETERAL INJURY, VESICOVAGINAL FISTULA, POST-OPERATIVE TRAUMA, SEROMA, AND AN ABSCESS. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION FROM AN ATTORNEY REPRESENTING A PATIENT WHO UNDERWENT A DA VINCI PROSTATECTOMY PROCEDURE ON (B)(6) 2008, AND ALLEGED TO HAVE INJURIES INCLUDING POSTOPERATIVE TRAUMA, HEMORRHAGING, AND A SEROMA. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.