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) FROM THE FDA WITH THE FOLLOWING EVENT DESCRIPTION: DA VINCI ROBOT WAS USED TO PERFORM HYSTERECTOMY. DURING PROCEDURE, LEFT URETER CUT, TOXIC FLUID OVERLOAD AND RESULTING CARDIAC INSUFFICIENCY OCCURRED. SIX DAYS LATER, A CARDIAC CATH PERFORMED AND REVEALED DAMAGE DURING HYSTERECTOMY, FOLLOWING DAY, SURGERY TO REPAIR URETER WAS PERFORMED.

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 RADICAL PROSTATECTOMY FOR PROSTATE CANCER ON (B)(6) 2007. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. SUBSEQUENT MEDICAL REPORTS ARE ALSO SUBMITTED. 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) 2007 THE PATIENT PRESENTED WITH SYMPTOMS OF BLADDER SPASMS AND BLOODY URINE. HE WAS FOUND TO HAVE EXTRAPERITONEAL URINE EXTRAVASATION AT THE ANASTOMOSIS. PROLONGED CATHETER DRAINAGE WAS RECOMMENDED. HE DEVELOPED A URINARY TRACT INFECTION AND WAS TREATED WITH LEVAQUIN. SERUM CREATININE WAS FOUND TO BE ELEVATING. ON (B)(6) 2007 THE PATIENT PRESENTED WITH FEVER AND CHILLS AND WAS FOUND TO HAVE ANOTHER URINARY TRACT INFECTION WITH BACTEREMIA. HE ALSO DEVELOPED PALPITATIONS AND SUPRAVENTRICULAR TACHYCARDIA DUE TO MEDICATION WITHDRAWAL. ON (B)(6) 2007 THE PATIENT UNDERWENT CT GUIDED DRAINAGE OF A PELVIC FLUID COLLECTION WITH OLD BLOOD OBTAINED. ON (B)(6) 2007 THE PATIENT UNDERWENT AN OPERATIVE CYSTOGRAM WITH FOLEY CATHETER EXCHANGE. A HOLE W

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-ASSISTED ROBOTIC RADICAL PROSTATECTOMY PROCEDURE FOR PROSTATE CANCER ON (B)(6) 2007. ACCORDING TO THE OPERATIVE REPORT, A ROBOTIC MALFUNCTION OCCURRED DURING THE POSTERIOR BLADDER NECK DISSECTION CAUSING THE SYSTEM TO REQUIRE REBOOTING ABOUT 20 TIMES. THE SURGEON INDICATED, IT WOULD TAKE APPROXIMATELY 30-45 SECONDS TO REBOOT THE ROBOT AFTER EACH ONE OF THE MANUAL FAULT OVERRIDES. THERE WERE ALSO TIMES WHERE THE ROBOT WOULD ACTUALLY TAKE 5 MINUTES TO REBOOT AND WE WOULD HAVE TO GET THE REPRESENTATIVE ON THE TELEPHONE TO DO THIS. DURING BLADDER NECK RECONSTRUCTION, THE SURGEON INDICATED, DUE TO THE ROBOT MALFUNCTION, SOME OF THESE SUTURES TORE THROUGH THE POSTERIOR BLADDER NECK. THE SURGEON ENDED UP PERFORMING ANOTHER FIGURE-OF-EIGHT SUTURE TO RECONSTRUCT THE BLADDER NECK A LITTLE BIT FURTHER. IN THE OPERATIVE REPORT, A RECTO-SIGMOID LACERATION WAS ALSO DISCOVERED AND REPAIRED. THE PATIENT WAS DISCHARGED ON (B)(6) 2007. THERE WERE NO REPORTED SEQUELAE. ON 08/28/2014, ISI CONTACTED THE SITE'S RISK MANAGEMENT DEPARTMENT. THE RISK MANAGER REVIEWED THE INCIDENT RE

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 RADICAL HYSTERECTOMY WITH BILATERAL, SALPINGO-OOPHORECTOMY (WERTHEIM OPERATION), AND BILATERAL PELVIC AND PARAAORTIC LYMPHADENECTOMY WITH ROBOTIC LAPAROSCOPIC APPROACH, PARTIAL VULVECTOMY (POSTERIOR PERINEUM), EXCISION OF POSTERIOR VULVAR LESION FROM THE RIGHT VULVA FOR CERVICAL CANCER, STAGE 1B-1, AND VULVAR CARCINOMA IN SITU AND VULVAR LESION ON (B)(6) 2007. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORTS ((B)(6) 2007, (B)(6) 2008, (B)(6) 2009, (B)(6) 2010, (B)(6) 2013). ADDITIONAL INFORMATION PROVIDED INCLUDES: HISTORY AND PHYSICAL (H &P): (B)(6) 2007; (B)(6) 2013; DISCHARGE SUMMARIES: (B)(6) 2007, (B)(6) 2008, (B)(6) 2013 UROLOGY CONSULTATION/EVALUATION/FOLLOW-UP (F/U): (B)(6) 2008, (B)(6) 2009, (B)(6) 2010, (B)(6) 2012, (B)(6) 2013. 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. INTRAOPERATIVELY, AN EEA SIZER WAS PLACED IN THE VAGINA, A PNEUMOPERITONEUM CREATED THROUGH A LEFT UPPER QUADRANT INCISION AND A PARA-AORTIC AND BILATERAL PE

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 CONCERNING A PATIENT WHO UNDERWENT A DA VINCI SI RADICAL PROSTATECTOMY PROCEDURE ON (B)(6) 2007. THE DOCUMENTATION PROVIDED STATES THAT THE PATIENT DEVELOPED A PSOAS ABSCESS AFTER UNDERGOING THE SURGICAL PROCEDURE. THE OPERATIVE REPORT RELATED TO THE DA VINCI SI RADICAL PROSTATECTOMY PROCEDURE WAS NOT PROVIDED AND NO ADDITIONAL DETAILS ARE AVAILABLE AT THIS TIME. ACCORDING TO THE PATIENT'S MEDICAL RECORDS, TWO WEEKS POSTOP THE PATIENT REPORTED COMPLAINTS OF PAIN IN HIS LEFT HIP WHICH PROGRESSIVELY GOT WORSE. ON (B)(6) 2007, THE PATIENT WAS ADMITTED TO A HOSPITAL FOR REPORTED COMPLAINTS OF LEFT PELVIC PAIN, HIP PAIN, AND FEVER. A CT SCAN REVEALED THAT THE PATIENT HAD AN ILIOPSOAS ABSCESS. THE PATIENT'S MEDICAL RECORDS STATED THAT A FISTULOGRAM WAS PERFORMED AND A FISTULA WAS FOUND BETWEEN THE COLON AND THE ABSCESS. ON (B)(6) 2007, THE PATIENT UNDERWENT A PARTIAL COLON RESECTION WITH ANASTOMOSIS PROCEDURE AND DRAINAGE OF THE ABSCESS. ON (B)(6) 2007, THE PATIENT WAS DISCHARGED HOME WITH ANTIBIOTICS, PAIN PILLS, AND SOME OUTPATIENT THERAPY. THE PATIENT'S DIS

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) 2007. 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 IS IMPOTENT AND INCONTINENT. 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 THAT UNDERWENT A DA VINCI PROSTATECTOMY PROCEDURE ON (B)(6) 2007. 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 THAT UNDERWENT A DA VINCI PROSTATECTOMY PROCEDURE ON (B)(6) 2007. 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, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI HYSTERECTOMY PROCEDURE ON (B)(6) 2007. THE PROVIDED INFORMATION ALLEGES THAT THE PATIENT SUSTAINED A PUNCTURED BLADDER AND INCONTINENCE. THERE WAS NO SPECIFIC ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. NO OTHER INFORMATION WAS PROVIDED. INFORMATION RELATED TO THE DA VINCI SYSTEM WAS NOT PROVIDED; THEREFORE, THE MODEL AND SERIAL ARE NOT KNOWN.

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 TOTAL HYSTERECTOMY, BSO WITH LYSIS OF ADHESIONS AND REPAIR OF A SMALL UMBILICAL HERNIA ON (B)(6) 2007. ISI WAS PROVIDED WITH THE PATIENT'S OPERATIVE REPORT (OP) AND THE SUBSEQUENT IMAGING AND STENT PLACEMENT REPORTS, AND THE OP FOR THE PATIENT'S URETERAL REIMPLANTATION. NO MEDICAL HISTORY REGARDING THE PATIENT WAS PROVIDED TO ISI. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING SURGERY. AFTER EXTENSIVE LYSIS OF OMENTAL ADHESIONS TO AN UMBILICAL HERNIA, THE HYSTERECTOMY WAS PERFORMED WITH SEQUENTIAL CAUTERY AND DIVISION OF THE INFUNDIBULOPELVIC, ROUND, AND BROAD LIGAMENTS. THE UTERINE ARTERIES AND THE CARDINAL LIGAMENTS WERE CAUTERIZED AND DIVIDED. THE COLPOTOMY WAS PERFORMED AGAINST A V-CARE COLPOTOMY CUP, THE UTERINE STRUCTURES REMOVED THROUGH THE VAGINA. THE VAGINAL CUFF WAS SUTURED CLOSED, THE EXISTING FACIAL DEFECT IN THE ANTERIOR ABDOMINAL WALL CLOSED, AND THE SURGERY COMPLETED WITHOUT COMPLICATIONS. IT WAS NOTED THAT THE FOLEY WAS DRAINING BLUE URINE FROM IV INDIGO CARMINIE INDICATING GOOD URI

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 RADICAL RETROPUBIC PROSTATECTOMY FOR LOCALIZED PROSTATE CANCER ON (B)(6) 2007. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORTS ((B)(6) 2007). ADDITIONAL INFORMATION PROVIDED INCLUDES: HISTORY AND PHYSICAL: (B)(6) 2007, INFECTIOUS DISEASE CONSULTATION (B)(6) 2007, GENERAL SURGERY CONSULT (B)(6) 2007, PULMONOLOGY CONSULT (B)(6) 2007, HEMATOLOGY CONSULT (B)(6) 2007, NEUROLOGY CONSULT (B)(6) 2007, NEPHROLOGY CONSULT (B)(6) 2007, DISCHARGE SUMMARY (B)(6) 2007 THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. UPON ENTERING INTO THE ABDOMEN AND CREATING A PNEUMOPERITONEUM NO SIGNIFICANT ADHESIONS WERE NOTED. SUBSEQUENTLY, A ROUTINE RADICAL PROSTATECTOMY WAS PERFORMED WITHOUT INCREASED DIFFICULTY OR NOTED INJURIES TO ADJACENT STRUCTURES. THE WOUND AREA LOOKED TO HAVE NO APPARENT INJURY TO THE BLADDER OR BOWEL. ON (B)(6) 2007 - THE PATIENT UNDERWENT EXPLORATORY LAPAROTOMY WITH EXTENSIVE ADHESIOLYSIS, SMALL BOWEL RESECTION AND REPAIR OF MULTIPLE ENTE

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 JUNE 10, 2008, INTUITIVE SURGICAL WAS NOTIFIED OF A PT DEATH PER LITIGATION DOCUMENTATION WHICH REPORTS THE FOLLOWING: IN 2007, FIVE DAYS AFTER UNDERGOING A DA VINCI RADICAL PROSTATECTOMY PROCEDURE, A PT UNDERWENT EMERGENCY EXPLORATORY LAPAROTOMY AND INTER ALIA. BOWEL NECROSIS WITH SEPTICEMIA WAS OBSERVED AND SAID TO BE THE RESULT OF AN INTEROPERATIVE MESENTERY TEAR. SIX CENTIMETERS OF CONTINUOUS STITCH WAS APPLIED TO REPAIR THE AFFECTED AREA, HOWEVER, THE PT 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) 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: AFTER HAVING DA VINCI ROBOTIC SURGERY FOR PROSTATE REMOVAL, I REMAINED IN THE HOSPITAL FOR 33 DAYS AND WAS GIVEN 18 PINTS OF BLOOD. I ALMOST DIED TWICE BECAUSE OF INTERNAL BLEEDING AND OTHER COMPLICATIONS. THE SURGEON DID NOT EVEN COME TO SEE ME AFTER THE SURGERY. I SPOKE WITH AN INTERN THAT HELPED THE SURGEON WITH THE OPERATION AND HE TOLD ME THAT AT TIMES SOME OF THE ARMS FAILED TO DO WHAT IT SUPPOSED TO DO. ALSO, THE INTERN SAID THAT HE FELT THAT THE SURGEON DID NOT HAVE SUFFICIENT TRAINING TO PERFORM THE OPERATION. I HAD TO HAVE SEVEN MORE OPERATIONS TO CORRECT THE DAMAGE TO MY INTERNAL ORGANS BECAUSE OF THE DEFECTIVE DA VINCI ROBOT. IF A SURGEON DOES NOT HAVE THE TRAINING AND IF THE MFR (INTUITIVE SURGICAL SUPPLY) IS ALLOWED TO MANUFACTURE DEFECTIVE SURGICAL DEVICES SUCH AS THE DA VINCI ROBOT THEN THEY WILL END UP LIKE I DID AND THAT MEANS SLOWLY BLEEDING TO DEATH AND HAVING TO HAVE MORE EXTENSIVE SURGERIES TO REPAIR THE DAMAGES THAT WERE CAUSED TO ME BY THE USE OF THE DA VINCI ROBOT AND THE SURGEON.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: (B)(6). RE: DA VINCI ROBOT IS A VERY DANGEROUS OPERATION DEVICE! DEAR SIR: I AM WRITING A LETTER TO YOU EXPLAINING JUST WHAT HAPPENED TO ME WHEN I WAS OPERATED ON VIA DA VINCI ROBOT. FIRST OF ALL, MY UROLOGIST/SURGEON (MR. (B)(4)) TOLD ME AND MY FAMILY THAT I HAD DEVELOPED PROSTATE CANCER AND THAT I WOULD HAVE TO HAVE MY PROSTATE REMOVED BECAUSE ON THE GLEANSON SCALE READING OF 6. DR. (B)(6) SAID THAT HE RECOMMENDED USING THE DA VINCI ROBOT BECAUSE IT WOULD DO A BETTER JOB AND THAT IT WOULD ALLOW HIM TO SEE EVERYTHING ON A BIG SCREEN SO THAT HE WOULD BE ABLE NOT TO CUT ANY NERVES OR BLOOD VESSELS THAT WOULD AFFECT ME FROM HAVING SEX AND THAT IT WOULD PREVENT ME FROM HAVING INCONTINENCE. DR. (B)(6) CONVINCED ME AND MY FAMILY THAT THE DA VINCI ROBOT WAS THE WAY TO GO AND THAT MY FAMILY COULD PICK ME UP AT THE HOSPITAL THE NEXT MORNING. WHEN MY FAMILY CAME TO GET ME, I WAS IN A BAD WAY. I COULD NOT STAND, EAT, MOVE AND I WAS IN SO MUCH PAIN. THE NURSES HAD PUT ON ME A DRAINAGE BAG AND ABOUT EVERY TWO HOURS THE BAG WOULD FILL UP WITH BRIGHT RED BLOOD JUST LIKE IF I HAD JUST CUT MYSELF. DRAINAGE WOULD NOT BE THE SAME COLOR AS PURE BLOOD. DR. (B)(6) TOLD MY FAMILY THAT I WOULD NOT BE GOI

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: PERFORATED TERMINAL ILEUM WITH INTRA-ABDOMINAL FREE AIR, PERITONITIS FOLLOWING A MYOMECTOMY PERFORMED ROBOTICALLY (LAPAROSCOPICALLY).

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) 2007. 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: IT WAS REPORTED SEVERAL WEEKS AFTER A DA VINCI S PROSTATECTOMY SURGICAL PROCEDURE, THE PT EXPIRED. NO ADDITIONAL INFO WAS PROVIDED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI RADICAL PROSTATECTOMY ON (B)(6) 2006 FOR ADENOCARCINOMA OF THE PROSTATE. ISI WAS PROVIDED WITH THE PATIENT'S OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES PARTIAL RECORDS FROM MULTIPLE SUBSEQUENT HOSPITALIZATIONS. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING THE PRIMARY SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION . ON (B)(6) 2006, THE PATIENT PRESENTED WITH OF URINARY LEAKAGE THROUGH THE RECTUM AND WAS DIAGNOSED WITH A COLOVESICAL FISTULA. MULTIPLE STUDIES AND MANEUVERS WERE USE TO ATTEMPT TO TREAT THIS FISTULA CONDITION. THE PATIENT HAD TO HAVE PERSISTANT DRAINAGE THROUGH A FOLEY CATHETER. THERE WAS STOOL LEAKING INTO HIS FOLEY CATHETER BAG. HE HAD BOUTS OF INFECTION. THE PATIENT DEVELOPED A DVT AS A COMPLICATION OF HIS CONDITION AND REQUIRED COUMADIN. HE HAS PERSISTANT LOWER EXTREMITY EDEMA. ON (B)(6) 2008, THE PATIENT UNDERWENT DIVERSION OF STOOL THROUGH AN ILEOSTOMY, PERINEAL REPAIR OF RECTOURETHRAL FISTULA WITH GRACILIS MUSCLE FLAP TO ALLOW COLO-VESICAL FISTULA

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI SI PROSTATECTOMY FOR PROSTATE ADENOCARCINOMA ON (B)(6) 2006. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES FOLLOW UP MEDICAL AND CONSULTATION REPORTS. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY .THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION . ON (B)(6) 2006 THE PATIENT PRESENTED WITH SYMPTOMS OF PERIANAL SWELLING AND WAS FOUND TO HAVE A PERIRECTAL ABSCESS THAT WAS DRAINED IN THE PHYSICIANS OFFICE. ON (B)(6) 2007 THE PATIENT WAS FOUND TO HAVE A SMALL FISTULA-IN-ANO THAT WAS REMOVED IN OUTPATIENT SURGERY. ON (B)(6) 2007 THE PATIENT HAD A BILATERAL INGUINAL HERNIA REPAIRS.

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 10/01/2015, INTUITIVE SURGICAL, INC. (ISI) RECEIVED FDA VOLUNTARY REPORT MW5056296 WITH THE FOLLOWING EVENT DESCRIPTION: THIS IS A LATE REPORT AS WE WERE UNAWARE WE COULD HAVE REPORTED EARLIER TO FDA. MY MOTHER, (B)(6), AT TIME OF DEATH, WAS UNDERGOING A MITRAL VALUE [SIC] REPAIR WITH THE SURGEON, DR. (B)(6), USING THE DAVINCI ROBOT. THIS OCCURRED AT (B)(6) ON (B)(6) 2006. ACCORDING TO THE PHYSICIAN, THE ROBOT NICKED HER HEART WHICH RESULTED IN BLEEDING OUT AND EMERGENCY OPEN HEART SURGERY. SHE NEVER RECOVERED AND DEVELOPED SEPSIS INFECTION 4 DAYS LATER. WE WERE INFORMED LATER THAT OUR MOM WAS THE ONLY THE 3RD PATIENT FOR HEART VALVE SURGERY ON THIS ROBOT. WE ALSO ARE AWARE THAT ANOTHER WOMAN DIED SUBSEQUENTLY BY THE SAME ROBOT AND PHYSICIAN. THE DOCTOR LEFT TOWN AFTER THIS. (WE NEVER FILED A LAWSUIT DUE TO (B)(6) LAWS ON DAMAGES.) I AM WRITING THIS TO INFORM THE FDA AND TO NOTIFY YOU OF AN ADVERSE EVENT FOR YOUR STATS OF THIS DAVINCI ROBOT. MY HOPE IS THAT NO ONE WILL HAVE TO DIE FROM THIS ROBOT IN THE FUTURE IN THE CARDIAC REALM OF USE FOR DAVINCI. THANK YOU. (B)(6). ON 10/02/2015, ISI CONTACTED THE INITIAL REPORTER (THE PATIENT'S DAUGHTER) AND OBTAINED THE FOLLOWING INFORMATI

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 PROSTATECTOMY PROCEDURE ON (B)(6)2006, AND ALLEGED TO HAVE SUSTAINED A PERFORATED BOWEL INJURY. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI PROSTATECTOMY PROCEDURE ON (B)(6) 2006. 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. THE PATIENT WAS MADE AWARE THAT HIS INJURIES MAY BE THE RESULT OF THE DA VINCI ON (B)(6) 2013.

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 DIAGNOSTIC LAPAROSCOPY AND CHOLECYSTECTOMY PROCEDURE FOLLOWED BY A PLANNED OPEN PANCREATICODUODENECTOMY SURGICAL PROCEDURE ON (B)(6) 2006. THE PATIENT REPORTEDLY EXPIRED ON AN UNSPECIFIED DATE. ISI WAS PROVIDED WITH THE (B)(6) 2006 OPERATIVE REPORT AS WELL AS HER SUBSEQUENT OPERATIVE SUMMARIES AND HER HOSPITAL DISCHARGE SUMMARY. ACCORDING TO THE MEDICAL RECORDS, THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY FOR FURTHER CARE ON (B)(6) 2006 AND THEN WAS DISCHARGED ON (B)(6) 2006. NO FURTHER MEDICAL RECORDS WERE PROVIDED AFTER THIS DISCHARGE DATE. THE OPERATIVE REPORT DATED (B)(6) 2006 INDICATED THAT THE PATIENT UNDERWENT A ROBOTIC ASSISTED LAPAROSCOPY AND CHOLECYSTECTOMY, OPEN PANCREATICODUODENECTOMY, PORTAL VEIN RESECTION AND RECONSTRUCTION. THE PREOPERATIVE DIAGNOSIS WAS NOTED AS PANCREATIC HEAD MASS AND CYSTIC NEOPLASM AND THE POSTOPERATIVE DIAGNOSIS WAS PANCREATIC CARCINOMA. THE SURGICAL PROCEDURE BEGAN WITH A ROBOTIC ASSISTED DIAGNOSTIC LAPAROSCOPY TO IDENTIFY THE BODY AND NECK OF THE PANCREAS. THE PROCEDURE THEN PROCEEDED WITH A CHOLECYSTECTOMY. ONCE 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: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI S PROSTATECTOMY PROCEDURE ON (B)(6) 2005. 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. NO OTHER INFORMATION WAS PROVIDED.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI PROSTATECTOMY PROCEDURE ON (B)(6) 2005. 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. REPORTEDLY, THE PATIENT EXPIRED IN (B)(6) 2010. 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: DURING A PROCEDURE TO REPAIR THE MITRAL VALVE REGURGITATION INVOLVING USE OF THE DA VINCI ROBOTIC SURGICAL SYSTEM, THE AORTIC VALVE LEAFLET WAS PERFORATED DURING PLACEMENT OF THE CARDIOPLEGIA CATHETER. THIS NECESSITATED INITIATION OF CARDIOPULMONARY BYPASS TO REPAIR THE LEAFLET AND COMPLETE THE PROCEDURE. UPON REMOVAL FROM BYPASS, THE PATIENT ENTERED CARDIOGENIC SHOCK DUE TO BIVENTRICULAR FAILURE. ADDITIONALLY THE PATIENT WENT INTO RENAL FAILURE. THE PATIENT REMAINS HOSPITALIZED WITH PARTIAL RECOVERY OF LEFT VENTRICULAR FUNCTION.

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 10/30/2015, ISI RECEIVED FDA VOLUNTARY REPORT MW5044826 WITH THE FOLLOWING EVENT DESCRIPTION: HAD A DA VINCI ASSISTED PROSTATECTOMY IN (B)(6) 2005 (CAN'T RECALL EXACT DATE) AT (B)(6) HOSPITAL; (B)(6). ONE OF MY URETERS WAS KINKED HAD TO WHERE [SIC] A STENT FOR SIX WEEKS. WAS CHARACTERIZED AS A SLIGHT COMPLICATION. WAS IT REPORTED? (B)(6); SSA (B)(4). ON 11/05/2015, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE PATIENT DIRECTLY. ALTHOUGH THE EVENT DATE NOTED ON THE FDA VOLUNTARY REPORT IS (B)(6) 2005, THE PATIENT COULD NOT VERIFY THE ACTUAL DATE AS TO WHEN HE UNDERWENT THE DA VINCI-ASSISTED PROSTATECTOMY PROCEDURE IN 2005. THE PATIENT STATED, IT WAS AROUND THAT TIME. ACCORDING TO THE PATIENT, THE SITE DID NOT PROVIDE HIM WITH A POSSIBLE CAUSE OF THE OPERATIVE COMPLICATION. PER THE PATIENT, THERE WAS NO ALLEGATION FROM THE SITE THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. ON 11/20/2015, ISI CONTACTED THE SITE'S LEGAL AFFAIRS DEPARTMENT. HOWEVER, THE SITE'S LEGAL AFFAIRS DEPARTMENT WAS UNWILLING TO PROVIDE ANY INFORMATION REGARDING THE REPORTED EVENT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING A PROCEDURE EMPLOYING THE USE OF THE DA VINCI ROBOTIC SURGICAL SYSTEM TO TREAT ATRIAL FIBRILLATION VIA RF ABLATION OF ECTOPIC FOCI, INTRAOPERATIVE BLEEDING WAS EXPERIENCED, THAT REQUIRED INITIATION OF CARDIOPULMONARY BYPASS. THE BLEEDING OF THE ATRIAL WALL WAS CAUSED BY THE ATRICURE ABLATION ELECTRODE (ISOLATOR TRANSPOLAR PEN), WHICH HAD BEEN UNHOOKED FROM THE ROBOTIC ARM AND WAS BEING MANIPULATED MANUALLY. CARDIOPULMONARY BYPASS WAS INITIATED TO RECTIFY AND COMPLETE THE PROCEDURE. SECONDARY COMPLICATIONS INCLUDED A STROKE AND AORTIC DISSECTION. THE PATIENT HAS BEEN DISCHARGED.

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 PROSTATECTOMY PROCEDURE ON (B)(6) 2004 AND DURING THE PROCEDURE IT WAS NOTED THAT THERE WAS BLEEDING DUE TO POOR FUNCTION OF THE STAPLER.(NON ISI DEVICE) . IT WAS ALSO NOTED THAT THE PATIENT HAD A BLADDER LACERATION WHICH APPEARED TO BE DUE TO THE DA VINCI ROBOT FAILURE. ACCORDING TO THE OPERATIVE REPORT THE FOLLOWING WAS NOTED:THERE WAS EXTENSIVE SCARRING ON THE RIGHT SIDE BETWEEN THE NEUROVASCULAR BUNDLE AND THE RIGHT PROSTATE. ON THE LEFT SIDE, THERE WAS LESS SCARRING; HOWEVER, THERE WAS STILL ADHESION BETWEEN THE PERIPROSTATIC TISSUES AND THE PROSTATE. DURING THE PROCEDURE, THE DAVINCI ROBOT FAILED AND THE PROCEDURE HAD TO BE COMPLETED WITH CONVENTIONAL LAPAROSCOPY. THE VESICOURETHRAL ANASTOMOSIS WAS PERFORMED; HOWEVER, THERE WAS SOME LEAKING FROM THE POSTERIOR ASPECT AT THE END OF THE OPERATION. THE ENDOSCOPIC STAPLING DEVICE WAS BROUGHT IN AND THIS WAS USED TO DIVIDE THE DORSAL VENOUS COMPLEX. THERE WAS SEEN TO BE SOME BLEEDING, HOWEVER, WITH WHAT APPEARED TO BE POOR FUNCTION OF THE STAPLER. THE DORSAL VENOUS COMPLEX WAS THEN OVERSEWN CONTROLLING THE BLE

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING A MINIMALLY INVASIVE SURGICAL PROCEDURE, A SMALL TEAR OCCURRED IN THE ANTERIOR PORTION OF THE SUPERIOR VENA CAVA (SVC) WHEN DISSECTING THE SVC PERICARDIAL REFLECTION. IT APPEARED THAT A PORTION OF THE SVC WAS PINCHED BETWEEN THE INSTRUMENT JAWS WHEN THE SURGEON WAS ATTEMPTING TO BLUNT DISSECT THROUGH THE PERICARDIAL REFLECTION. A SMALL RIGHT THORACOTOMY WAS MADE TO CONTROL THE BLEEDING FROM THE SVC. NO SYSTEM OR INSTRUMENT MALFUNCTION WERE REPORTED. IT WAS REPORTED THAT THE PT RECOVERED AND WAS RELEASED FROM THE HOSP.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: SYSTEM FAILURE DURING A DA VINCI SURGICAL PROCEDURE. SURGEON WAS UNABLE TO RESTART THE SYSTEM. SYSTEM ERROR MESSAGE FUNCTIONED APPROPRIATELY. THE CASE WAS CONVERTED AND COMPLETED. NO OTHER PATIENT INJURY 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 HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY (BSO) FOR FIBROID UTERUS ON (B)(6) 2013. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES: HISTORY AND PHYSICAL ON (B)(6) 2013. 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 (INCIDENTAL CYSTOTOMY). AFTER INSERTION OF THE V-CARE UTERINE MANIPULATOR AND CREATION OF A PNEUMOPERITONEUM WITH THE VERESS NEEDLE , 4 ADDITIONAL PORTS WERE INSERTED AND THE ROBOT DOCKED. INSPECTION OF THE PELVIS REVEALED SEVERE OMENTAL AND SMALL BOWEL ADHESIONS. EXTENSIVE ADHESIOLYSIS WAS PERFORMED ANTERIORLY BY THE BLADDER AS WELL AS SEPARATING THE SMALL BOWEL FROM THE POSTERIOR FUNDUS UTERI. LATERAL LIGAMENTS WERE CAUTERIZED AND CUT BILATERALLY DOWNWARDS. THE BLADDER FLAP WAS CREATED USING SHARP AND BLUNT DISSECTION. THEN A POSTERIOR COLPOTOMY WAS PERFORMED FOLLOWED BY A CIRCUMFERENTIAL INCISION AFTER CAUTERIZATION. THE SPECIMEN WAS THEN REMOVED THROUGH THE VAGINA. AT THIS TI

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 A PUBLISHED CITRON RESEARCH ARTICLE TITLED INTUITIVE SURGICAL: ANGEL WITH BROKEN WINGS, OR THE DEVIL IN DISGUISE? ON JANUARY 17, 2013, IT WAS STATED IN AN EMBEDDED LINK ON PAGE 22 THAT IN DECEMBER 2003 THE WIDOW OF A (B)(6) TEACHER FILED A LAWSUIT AFTER A DOCTOR AT [HOSPITAL] ACCIDENTLY CUT HIS AORTA AND THE VENA CAVA WHILE USING THE DA VINCI SURGICAL ROBOT TO REMOVE A CANCEROUS KIDNEY. THE LAWSUIT ALLEGED THAT THE HOSPITAL ALLOWED DOCTORS INEXPERIENCED WITH THE ROBOT TO PERFORM THE SURGERY. THE CLAIM FURTHER CHARGED THAT THE HOSPITAL WAS MORE INTERESTED IN USING ITS NEW DEVICE THAN IN ENSURING HER HUSBAND'S SAFETY. ACCORDING TO THE LEGAL FINDINGS IN THIS CASE, THE COMPLAINT WAS FILED ON (B)(6) 2003 AND THE ONLY NAMED DEFENDANT WAS THE HOSPITAL. THE ALLEGATIONS STEM FROM THE CLAIM THAT THE DECEDENT UNDERWENT A TOTAL NEPHRECTOMY PROCEDURE. THE COMPLAINT ALSO ALLEGED THAT ISI HAD ESTIMATED 18 ROBOTIC SURGERIES WERE NECESSARY TO BE PROFICIENT WITH THE SYSTEM AND THAT ISI CERTIFIED THE DOCTOR AFTER ONLY THREE TRAINING SESSIONS. THE COMPLAINT STATED THAT THE DECEDENT SUFFERED FROM A SEVERED AORTA AND VENA CAVA. IN ADDITION, IT WAS ALLEGED THAT A LAP PAD WAS LEFT INSIDE OF THE DECEDEN

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE DA VINCI SURGICAL SYSTEM IS CURRENTLY BEING USED FOR MOBILIZATION OF THE INTERNAL MAMMARY ARTERY (IMA) DURING CORONARY ARTERY BYPASS PROCEDURES UNDER FDA CLEARANCE K002489 (ISSUED 2001), AND FOR TOTALLY ENDOSCOPIC CORONARY ARTERY BYPASS PROCEDURES UNDER THE AUSPICES OF IDE # G010011. BASED ON THE INFO PROVIDED, THE EVENT DOES NOT MATCH ANY COMPLAINT RECORDED FOR THE DA VINCI SURGICAL SYSTEM OR ITS INSTRUMENTS, NOR DOES IT MATCH ANY PROCEDURE PERFORMED UNDER THE IDE. THE MEDWATCH REPORT INDICATES THAT THE USER FACILITY WAS NOTIFIED AND INTUITIVE SURGICAL HAS NOT BEEN CONTACTED BY THE FACILITY, LEADING TOTHE CONCLUSION THAT A RELATIONSHIP BETWEEN THE PT CONDITION AND THE DA VINCI SYSTEM USED DURING THE PROCEDURE COULD NOT BE ESTABLISHED BY THE HOSPITAL. COMPANY'S CONCLUSION IS THAT THIS IS NOT AN MDR REPORTABLE EVENT BASED ON THE FOLLOWING: NO DEATH OR SERIOUS INJURY ATTRIBUTED TO THE DEVICE OCCURRED. NO MALFUNCTION OF THE DEVICE WAS REPORTED TO HAVE OCCURRED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2012, INTUITIVE SURGICAL RECEIVED A PATIENT STORY POSTED ON THE INTERNET CONCERNING THEIR DA VINCI HYSTERECTOMY SURGICAL PROCEDURE: THE PATIENT INDICATED THAT ON (B)(6) 2000 SHE UNDERWENT A DA VINCI HYSTERECTOMY PROCEDURE AT (B)(6) HOSPITAL (LOCATION UNKNOWN) AND DURING THE SURGICAL PROCEDURE HER BLADDER WAS NICKED. THE PATIENT INDICATED THAT PRIOR TO THE SURGICAL PROCEDURE; SHE WAS ADVISED TO UNDERGO A HYSTERECTOMY WITH CYSTOCELE AND RECTOCELE REPAIR. THE PATIENT INDICATED THAT HER DOCTOR ADVISED HER THAT HER BLADDER DURING THE SURGICAL PROCEDURE WAS NOT ADDRESSED BECAUSE IT HAD DESCENDED TO A LEVEL 3, HER CERVIX WAS NOT REMOVED AND THE RECTOCELE WAS REPAIRED. THE PATIENT INDICATED THAT 2 DAYS POST OP SHE WAS RELEASED FROM THE HOSPITAL AND THAT SHE DID NOT RECOVER FROM THE SURGICAL PROCEDURE. THE PATIENT INDICATED FOR 7 DAYS AFTER THE DA VINCI SURGICAL PROCEDURE, HER BLADDER WOULD HARDEN AND SHE FELT AS THOUGH SHE WAS EXPERIENCING END STAGE LABOR AND HAD TO SEEK A SPECIALIST FOR HER BLADDER. THE PATIENT INDICATED THAT EXAMINATION BY THE SPECIALIST FOUND THAT HER BLADDER EXHIBITED EXTENSIVE SCARRING, MUSCLE DAMAGE AND THERE WAS NO EVIDENCE OF RECTOCELE REPAIR. THE PATIENT