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.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THIS REPORT IS BEING FILED BASED AN ISI INVESTIGATION CONCLUDING 08/08/2008. (B)(4) WAS RECEIVED ON 08/01/2008 FROM THE (B)(6). IT WAS REPORTED THAT DURING DA VINCI S BILATERAL INTERNAL MAMMARY ARTERIES REVASCULARIZATION PROCEDURE, THE CUSTOMER EXPERIENCED A SYSTEM ERROR CODE #23. WITH THE ASSISTANCE OF AN ISI (B)(4), THE SITE POWERED DOWN THE SYSTEM TO CLEAR THE FAULT. THE SITE CONTINUED WITH THE PROCEDURE, HOWEVER, THE SYSTEM ERROR REOCCURRED. THE SITE DISABLED THE ENDOSCOPIC CAMERA MANIPULATOR (ECM) TO CONTINUE THE CASE. THE SITE THEN ELECTED TO MANUALLY MANIPULATE THE CAMERA AND ENDOSCOPE FOR APPROXIMATELY 5 TO 6 HOURS WHEN A LOSS OF CARBON DIOXIDE INSUFFLATION OCCURRED RESULTING IN THE HEART PUSHING UP INTO THE ENDOSCOPE TWO TIMES CAUSING LACERATIONS TO THE PATIENT'S RIGHT VENTRICLE. THE PROCEDURE WAS CONVERTED TO A THORACOTOMY TO PERFORMED A NON ROBOTIC REPAIR OF THE DAMAGED VENTRICLE WITH SEVERAL STITCHES AND TO COMPLETE THE PLANNED PROCEDURE. AFTER THE 14 HOUR PROCEDURE, THE PATIENT COULD NOT BE EXTUBATED NECESSITATING A TRACHEOSTOMY. AS OF (B)(6), THE PATIENT REMAINED UNDER CARE AT (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: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY FOR SEVERE DYSPLASIA PROCEDURE ON (B)(6) 2008. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT FOR THE PRIMARY SURGERY AND THE SUBSEQUENT FISTULA REPAIR PROCEDURES. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING SURGERY. THE HYSTERECTOMY PROCEEDED IN THE STANDARD MANNER WITH THE TUBO-OVARIAN LIGAMENTS AND ROUND LIGAMENTS COAGULATED AND CUT THEN THE BLADDER FLAP CREATED. THE UTERINE ARTERIES WERE SKELETONIZED AND CUT. THE COLPOTOMY WAS MADE WITH THE AID OF KOH RING, AND THE LATERAL CERVICAL VAGINAL ATTACHMENTS WERE COAGULATED AND CUT STAYING CLOSE TO THE UTERUS. THE VAGINAL CUFF WAS CLOSED WITH RUNNING SUTURE AND LIGATURES. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATION. ON (B)(6) 2008 THE PATIENT PRESENTED WITH A HISTORY OF RECURRENT LEAKAGE OF URINE THROUGH HER VAGINA, AND UNDERWENT CYSTOSCOPY, BILATERAL RETROGRADE PYELOGRAMS AND VAGINOSCOPY. PYELOGRAMS SHOWED NO FILLING DEFECTS, BUT A 2-3 CM OPENING ON THE POSTERIOR BLADDER WALL WAS CONNECTED TO 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: IT WAS REPORTED THAT DURING A DA VINCI S BEATING HEART DOUBLE VESSEL CORONARY ARTERY BYPASS GRAFT PROCEDURE AT THE HOSPITAL, THERE WAS AN UNEXPLAINED MOVEMENT ON THE SYSTEM ARM WHICH HAD THE ENDOWRIST STABILIZER INSTRUMENT ATTACHED TO IT. THE UNEXPECTED MOVEMENT CAUSED THE FEET AT THE DISTAL END OF THE ENDOWRIST STABILIZER INSTRUMENT TO TIP DOWNWARD RESULTING IN DAMAGE TO THE MYOCARDIUM OF THE PATIENT'S LEFT VENTRICLE. THE SURGICAL TEAM IMMEDIATELY CONVERTED TO AN OPEN STERNOTOMY TO SUCCESSFULLY REPAIR THE DAMAGED VENTRICLE WITH A SINGLE MEDTRONIC U-CLIP S50. THE PATIENT WAS REPORTED AS RECOVERING WELL WITH NO POST-OPERATIVE COMPLICATIONS.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL MEDIATION EFFORT, ON JULY 25TH, 2013 INTUITIVE SURGICAL RECEIVED INFORMATION INCLUDING MEDICAL RECORDS, OF A PATIENT WHO HAD A DA VINCI ASSISTED LAPAROSCOPIC TOTAL HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY PROCEDURE ON (B)(6) 2008. THE OPERATIVE REPORT DOES NOT CONTAIN ANY ALLEGATIONS OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY. THE PATIENT HAD A CT SCAN OF HER ABDOMEN/PELVIS ON (B)(6) 2008 WHICH REVEALED FLUID COLLECTION IN THE PELVIS AND RECTUM, MOST LIKELY CONSISTENT WITH SEROMA OR HEMATOMA. THE PATIENT WAS SEEN FOR SIMILAR SYMPTOMS AND RECEIVED COURSE OF AUGMENTIN ON (B)(6) 2008. THE PATIENT EXPERIENCED A REACTION TO AUGMENTIN (JOINT PAINS) AND DISCONTINUED ANTIBIOTICS ON (B)(6) 2008. ON (B)(6) 2008 THE PATIENT EXPERIENCED ORANGE/BLOOD-TINGED WATERY VAGINAL BLEEDING AND FELT ACHY. SHE SOAKED THROUGH SEVERAL PADS OVER THE COURSE OF 2-3 HOURS, BUT BLEEDING THEN SUBSIDED. ON THE MORNING OF (B)(6) 2008, THE PATIENT CONTINUED TO HAVE WATERY VAGINAL BLEEDING AND NEW ONSET FEVER TO 104.8 WITH CHILLS. THE PATIENT TOOK MOTRIN AND THEN CAME TO THE HOSPITAL PER HER PHYSICIAN'S RECOMMENDATION. THE PATIENT WAS ADMITTED AND WAS STARTED ON ANTIBIOTICS

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI HYSTERECTOMY PROCEDURE ON (B)(6) 2008. THE LEGAL COMPLAINT ALLEGED THAT THE PATIENT SUFFERED FROM SEVERE AND CONTINUING PAIN, WITH FREQUENT VISITS TO THE EMERGENCY ROOMS OF NEARBY HOSPITALS. IN ADDITION, ACCORDING TO THE LEGAL COMPLAINT, THE PATIENT'S SEVERE PAIN BECAME INCREASINGLY UNBEARABLE AND SHE UNDERWENT AN ADDITIONAL SURGERY IN (B)(6) 2009. DURING THE ADDITIONAL SURGERY, THE LEGAL COMPLAINT CLAIMED THAT THE PATIENT WAS FOUND TO HAVE DENSE ADHESIONS BETWEEN THE RIGHT ADNEXA AND THE BOWEL. THE LEGAL COMPLAINT ALSO INDICATED THAT AFTER THE ADNEXA WAS REMOVED, THE APPENDIX WAS REMOVED TO DO A COMPLETE PAIN CLEAN UP OF THE RIGHT SIDE OF THE PELVIS.

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 PROSTATECTOMY FOR PROSTATE CANCER PROCEDURE ON (B)(6) 2008. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES FOLLOW UP OPERATIVE REPORTS AND NOTES 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) 2013, IT WAS NOTED THAT THE PATIENT'S FOLEY CATHETER WAS NOT DRAINING WELL. THE PATIENT RETURNED TO SURGERY FOR EXPLORATION OF BLADDER AND PELVIS WITH RECONSTRUCTION OF BLADDER NECK AND RE-ANASTAMOSIS OF BLADDER NECK. PATIENT WAS DISCHARGED HOME ON (B)(6) 2008. 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 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 URINARY INCONTIENCE 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: IT WAS REPORTED THAT TOWARDS THE END OF A DA VINCI S GYNECOLOGIC DIAGNOSTIC LAPAROSCOPY PROCEDURE, THE ASSISTANT SURGEON PLACED THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT INSIDE OF THE PT'S BODY AND WAS MOVING THE INSTRUMENT OUTSIDE OF THE FIELD OF VIEW. THE CONSOLE SURGEON TOOK CONTROL OF THE INSTRUMENT WITHOUT HAVING A VISUAL OF WHERE THE INSTRUMENT WAS LOCATED AND ACTIVATED THE INSTRUMENT TIP, WHICH CREATED A TRANSECTION CUT TO THE PT'S RIGHT INTERNAL ILIAC ARTERY AND RIGHT URETER. THE PROCEDURE WAS CONVERTED TO OPEN SURGICAL TECHNIQUES AND A VASCULAR SURGEON AND UROLOGIST WERE CALLED IN TO REPAIR THE PT'S RIGHT INTERNAL ILIAC ARTERY AND STENT THE URETER. A BLOOD TRANSFUSION WAS REQUIRED DURING THE REPAIR SURGERY. IT WAS REPORTED THAT THE PT IS RECOVERING AS PLANNED POST-OPERATIVE DAY 27.

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 NISSEN FUNDOPLICATION AND CHOLECYSTECTOMY PROCEDURE ON (B)(6) 2008. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: GALL BLADDER HAD LEAKED, HAD TO HAVE EMERGENCY 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: AS PART OF A LEGAL MEDIATION EFFORT ON (B)(4) , 2013, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION INCLUDING MEDICAL RECORDS OF A PATIENT WHO UNDERWENT A DA VINCI SI SUPRACERVICAL HYSTERECTOMY PROCEDURE ON (B)(6) 2008 WITH A PRE-OPERATIVE DIAGNOSIS OF MARKEDLY LARGE UTERINE FIBROIDS WITH A 19CM UTERUS. ACCORDING TO THE PATIENT'S OPERATIVE (OP) REPORT DATED (B)(6) 2008, THERE WAS NO INDICATION THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED DURING THE SURGICAL PROCEDURE AND THERE WAS NO INDICATION THAT THE PATIENT EXPERIENCED ANY INTRAOPERATIVE COMPLICATIONS. DUE TO THE LARGE SIZE OF THE PATIENT'S UTERUS, IT WAS MORCELLATED AND WAS REMOVED IN SMALL PIECES. THE OPERATIVE REPORT DOES NOT HAVE ANY INDICATION OF BOWEL OR BLADDER INJURY. THE SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED AND THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. ON (B)(6) 2008, THE PATIENT UNDERWENT A CT UROGRAM. THE FINDINGS SHOWED THAT THE PATIENT HAD A VESICOVAGINAL FISTULA WITH THE DEFECT IN THE BLADDER BASE APPROXIMATELY 13MM IN SIZE. THERE WAS NO EVIDENCE OF RENAL OR PROXIMAL URETERAL STONES AND THE PATIENT'S LUNG BASES WERE CLEAR. 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 7/11/08, ISI RECEIVED MEDWATCH REPORT, WHICH INDICATES THAT AN ADVERSE EVENT OCCURRED IN '08, DURING THE USE OF THE DA VINCI S SURGICAL SYSTEM AND A GYNECARE X-TRACT TISSUE MORCELLATOR IN A SURGICAL PROCEDURE. THE REPORT WAS SUBMITTED TO THE FDA BY THE PT, HOWEVER, A DESCRIPTION OF THE EVENT WAS NOT PROVIDED.

Kyodo America has received one report of a consumer lifting the mower from the ground and suffered minor lacerations from the moving blade.

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 S HYSTERECTOMY PROCEDURE ON (B)(6) 2008. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI S SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING THE SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. ON (B)(6) 2008, THE PATIENT PRESENTED WITH SYMPTOMS OF STOOL PER VAGINA. SHE WAS RE-ADMITTED FOR A RECTOVAGINAL FISTULA. CT DRAINAGE WAS PERFORMED ON (B)(6) 2008. ON (B)(6) 2008, THE PATIENT UNDERWENT A LAPAROTOMY WITH A COLOSTOMY FOR DEFECT OF SIGMOID COLON PERFORMED. THE PATIENT'S VAGINAL CUFF WAS ALSO NOTED AS OPEN. A PELVIC ABSCESS PRESENT WAS DRAINED. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2008 WITH WOUND VAC THERAPY. ON (B)(6) 2008 THE PATIENT UNDERWENT A SUBSEQUENT COLOSTOMY CLOSURE ON (B)(6) 2008. THE PATIENT WAS DISCHARGED ON (B)(6) 2008.

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 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 INCONTIENCE 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: IN 2008, IT WAS REPORTED THAT THE SITE EXPERIENCED A SYSTEM FAULT WHILE SETTING UP FOR A DA VINCI S PROSTATECTOMY SURGICAL PROCEDURE. NO PT ISSUES WERE REPORTED AT THAT TIME. ON 7/3/08, ADDITIONAL INFO WAS RECEIVED FROM THE ATTENDING SURGEON WHO INDICATED THAT CONTINUOUS SYSTEM FAULTS OCCURRED AFTER THE PT PORTS WERE PLACED, RESULTING IN A 1 HOUR DELAY. DURING THE DELAY, THE PT'S ABDOMEN BECAME DEFLATED AND THE PT BUCKED VERTICALLY. WITH THE ASSISTANCE OF AN ISI TECHNICAL SUPPORT ENGINEER VIA TELEPHONE, THE SYSTEM FAULTS WERE RESOLVED BY CLEANING THE FIBEROPTIC CABLE AND THE PLANNED SURGICAL PROCEDURE WAS COMPLETED. THE PT RETURNED TO THE OPERATING ROOM THREE DAYS AFTER THE PROCEDURE WAS PERFORMED WITH THE SYSTEM AND A SMALL BOWEL LACERATION WAS DISCOVERED AND REPAIRED. IT IS BELIEVED THAT THE SMALL BOWEL LACERATION WAS CAUSED AT SOME POINT IN THE PROCEDURE ON 4/1/08, WHEN THE INJURED AREA OF THE BOWEL WAS NOT IN VIEW. THIS COULD HAVE OCCURRED DURING INITIAL PLACEMENT OF THE SURGICAL PORTS, WHEN THE PT BUCKED ON THE TABLE AND THE TROCARS WERE STILL INSTALLED DURING THE SYSTEM DELAY, DURING MANIPULATION OF THE BOWEL, OR DURING AN UNOBSERVED INSERTION OF A DA VINCI S OR ASSISTANT 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: 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 INJURIES AND DAMAGES.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: NO CONCLUSION CAN BE DRAWN TO THE PRODUCT, AS IT HAS NOT BEEN RETURNED FOR EVALUATION.