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 CONCERNING A PATIENT WHO UNDERWENT A DA VINCI SI TOTAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY, RIGHT OOPHORECTOMY, AND HIGH UTEROSACRAL SUSPENSION PROCEDURE ON (B)(6) 2011. THE MEDICAL RECORDS INDICATE THAT THE PATIENT SUSTAINED A POST-OPERATIVE COMPLICATION. BASED ON THE MEDICAL RECORDS PROVIDED, THE PATIENT HAD A PREOPERATIVE DIAGNOSIS OF PELVIC ENDOMETRIOSIS, DYSPAREUNIA, AND ABDOMINAL PAIN. THE MEDICAL RECORDS ALSO REVEALED THAT THE PATIENT WAS TREATED ON MULTIPLE OCCASIONS FOR INTERSTITIAL CYSTITIS AND DYSURIA BETWEEN (B)(6) 2011 THROUGH (B)(6) 2012. THE PATIENT WAS TREATED WITH SILVER NITRATE INSTILLATIONS AND/OR UNDERWENT BLADDER CATHETERIZATIONS. ACCORDING TO THE OPERATIVE REPORT, AFTER UNDERSTANDING THE NATURE AND RISKS OF THE PROCEDURE, THIS PATIENT SIGNED INFORMED CONSENT. THE SURGEON STATED THAT THE DA VINCI SI SURGICAL PROCEDURE WAS COMPLETED WITH NO COMPLICATIONS. THE SURGEON CLOSED THE VAGINAL CUFF WITH SUTURES AND STATED IN THE OPERATIVE REPORT THAT EXCELLENT VAGINAL CUFF SUPPORT WAS NOTED. THE PATIENT TOLERATED THE PROCEDURE WELL AND AT THE COMPLETIO

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 DEMAND LETTER AND MEDICAL RECORDS INVOLVING A PATIENT WHO REPORTEDLY SUFFERED FROM POST-OPERATIVE COMPLICATIONS AFTER UNDERGOING A DA VINCI S HYSTERECTOMY PROCEDURE ON (B)(6) 2011. ACCORDING TO THE OPERATIVE REPORT, THE PATIENT'S PRE-OPERATIVE DIAGNOSIS WAS PELVIC PAIN, ABNORMAL UTERINE BLEEDING, AND DYSPAREUNIA. THE PATIENT'S CERVIX AND UTERUS WERE REMOVED WITHOUT COMPLICATIONS AND THE PATIENT TOLERATED THE PROCEDURE WELL. THE OPERATIVE REPORTS DO NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. ACCORDING TO THE DEMAND LETTER, THE PATIENT STARTED TO HAVE PROBLEMS WITH PELVIC PAIN AND VAGINAL DRAINAGE AND SHE STATED SHE FELT AS IF SOMETHING CAME LOOSE FROM MY BODY ON AN UNSPECIFIED DATE. ON (B)(6) 2012, APPROXIMATELY 4 MONTHS AFTER THE DA VINCI SURGICAL PROCEDURE, THE PATIENT WAS DIAGNOSED WITH A VAGINAL CUFF PERFORATION, CUFF DEHISCENCE, AND MILD PERITONITIS. THE PATIENT UNDERWENT DIAGNOSTIC LAPAROSCOPY AND LAPAROSCOPIC REPAIR OF THE CUFF PERFORATION AND CUFF DEHISCENCE. PER THE (B)(6) 2012 OPERATIVE REPORT, THERE WAS A PIECE OF OMENTUM THAT WAS PROTRUDING THROUGH THE VAGINAL PERFO

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 TOTAL HYSTERECTOMY FOR SYMPTOMATIC UTERINE FIBROIDS AND MENOMETRORRHAGIA ON (B)(6) 2011. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES HOSPITAL OPERATIVE , RADIOLOGY, AND OPERATIVE 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) 2011 THE PATIENT PRESENTED WITH INCONTINENCE. IVP PERFORMED SHOWING LEFT URETERAL INJURY WITH URETEROVAGINAL FISTULA ON (B)(6) 2011 CYSTOSCOPY AND STENT PLACEMENT ON (B)(6) 2011 NEPHROSTOMY FOR PERSISTENT FISTULA ON (B)(6) 2012 VESICOVAGINAL FISTULA REPAIR WITH REIMPLANTATION OF LEFT URETER.

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 9 DAYS POST A SUCCESSFUL DA VINCI S HYSTERECTOMY PROCEDURE, THE PATIENT RETURNED TO THE HOSPITAL WITH COMPLICATIONS AND WAS FOUND TO HAVE A DAMAGED URETER.

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. RECEIVED A VOLUNTARY REPORT MW5031642 WITH THE FOLLOWING DESCRIPTION: I HAD A DA VINCI ROBOTIC HYSTERECTOMY ON (B)(6) 2011. I HAD PAIN AFTER THE SURGERY THAT DID NOT GO AWAY. EIGHT DAYS AFTER SURGERY, I BEGAN LEAKING URINE. ULTIMATELY IT WAS DISCOVERED THAT MY BLADDER HAD BEEN CUT DURING THE SURGERY. BLADDER WAS LEAKING AND INFECTED.

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 S TOTAL HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY FOR UTERINE FIBROIDS AND ENDOMETRIOSIS ON (B)(6) 2011. 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. THE OPERATIVE NOTE STATES THAT THERE WERE EXTENSIVE ADHESIONS POSTERIORLY AND THAT THERE WAS POOR VISUALIZATION POSTERIORLY. SHE UNDERWENT A DIFFICULT HYSTERECTOMY DUE TO ENDOMETRIOSIS. SHE BECAME ANURIC POSTOPERATIVELY. THE CT SCAN DEMONSTRATED BILATERAL URETERAL OBSTRUCTION. IN THE OR THE URETERS WERE FOUND TO BE OBSTRUCTED AT THE VAGINAL CUFF AND POSTERIOR BLADDER. A BILATERAL URETERAL REIMPLANTATION WAS PERFORMED SUCCESSFULLY. THE STENTS WERE REMOVED ON (B)(6) 2012.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY, BILATERAL URETEROLYSIS, BILATERAL PELVIC LYMPH NODE DISSECTION ON (B)(6) 2011 FOR ENDOMETRIAL ADENOCARCINOMA OF THE UTERUS. ISI WAS PROVIDED WITH THE PATIENT'S OPERATIVE REPORT FOR THE PRIMARY SURGERY AND THE URETERAL REIMPLANTATION. NO MEDICAL HISTORY WAS PROVIDED. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING THE SURGERY. THE SURGERY WAS NOTABLE FOR EXTENSIVE SIGMOID ADHESIONS TO THE LEFT PELVIC SIDEWALL AND LEFT ADNEXA. THE HYSTERECTOMY PROCEEDED WITH SEQUENTIAL LIGATION AND DIVISION OF THE ROUND LIGAMENTS, INFUNDBULO PELVIC LIGAMENTS WITH CARE TO IDENTIFY AND LOCALIZE THE URETER. URETEROLYSIS WAS PERFORMED DUE TO INVOLVEMENT AND INDURATION OF THE PERIRECTAL AND PERIVESICAL SPACES. THE BLADDER WAS SHARPLY DISSECTED AND THE UTERINE VESSELS AND THE CARDINAL LIGAMENTS LIGATED AND CUT. THE CULPOTOMY WAS MADE, AND THE UTERUS DELIVERED THROUGH THE VAGINA. THE VAGINAL CUFF WAS CLOSED WITH RUNNING SUTURES, AND THE PELVIC LYMPH NODE DISSECTION COMPLETED

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 25, 2013 INTUITIVE SURGICAL, INC. RECEIVED INFORMATION INCLUDING MEDICAL RECORDS OF A PATIENT WHO UNDERWENT A DA VINCI SI SACROCOLPOPEXY PROCEDURE ON (B)(6) 2011 DUE TO PELVIC PROLAPSE. THERE WAS NO REPORT IN THE PATIENT'S OPERATIVE (OP) REPORT THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORIES OCCURRED AND THERE WAS NO INDICATION THAT THE PATIENT EXPERIENCED ANY INTRA-OPERATIVE COMPLICATIONS. IT WAS STATED IN THE OP REPORT THAT AFTER THE SURGICAL TASK OF SECURING THE PATIENT'S VAGINAL MESH WAS PERFORMED, EXCELLENT HEMOSTASIS WAS NOTED. THE SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED AND THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2011. ON (B)(6) 2011 THE PATIENT RETURNED TO THE HOSPITAL'S EMERGENCY ROOM COMPLAINING OF LOWER ABDOMINAL PAIN AND SHOULDER PAIN. THE PATIENT UNDERWENT A DIAGNOSTIC TEST AND IT WAS DISCOVERED THAT SHE HAD A SMALL AMOUNT OF FREE AIR. A CHEST X-RAY WAS PERFORMED AND THE PATIENT BECAME PROGRESSIVELY WORSE IN HER SYMPTOMS. ON EXAMINATION, THE PATIENT WAS IN FAIRLY ACUTE DISTRESS. A CBC TEST SHOWED THAT THE PATIENT

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI SI DIAGNOSTIC LAPAROSCOPY, EXTENSIVE PELVIC ADHESIOLYSIS, BILATERAL URETEROLYSIS, STRIPPING OF THE PELVIC SIDEWALL PERITONEUM, RESECTION OF A RIGHT OVARIAN REMNANT, AND PARTIAL UPPER VAGINECTOMY ON (B)(6) 2011. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES, HISTORY AND PHYSICAL EXAM, THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. THE PATIENT DEVELOPED A PULMONARY EMBOLISM FOLLOWING SURGERY AND REQUIRED ANTICOAGULATION WITH COUMADIN. ON (B)(6) 2011 THE PATIENT HAD A CONSULTATION WITH A UROLOGIST FOR AN APPARENT URETEROVAGINAL FISTULA WITH DISTAL RIGHT URETER INJURY. A CT UROGRAM WAS PERFORMED AT HER HOME AFTER SHE BEGAN HAVING LEAKING FLUID PER VAGINA. ON (B)(6) 2011 THE PATIENT WAS ADMITTED TO A MEDICAL CENTER AND DIAGNOSED WITH A URETEROVAGINAL AND URETEROENTERIC FISTULA. SHE UNDERWENT A CYSTOSCOPY WITH ATTEMPTED URETERAL STENT BUT INSTEAD REQUIRED A PERCUTANEOUS NEPHROSTOMY. ON (B)(6) 2012 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: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI PROSTATECTOMY PROCEDURE ON (B)(6) 2011. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: SWELLING ON RIGHT SIDE, HERNIA WHICH WAS VERY PAINFUL, ERECTIONS TOUGH, LEAKS URINE, PAINFUL TO TOUCH, AND EXPERIENCED BLADDER PROBLEMS.

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 THE BEGINNING OF A DA VINCI SI PROSTATECTOMY AND LYMPHADENECTOMY PROCEDURE, THE SURGEON GRASPED THE PATIENT'S COLON WITH THE MARYLAND BIPOLAR FORCEPS INSTRUMENT AND ENERGY BEGAN TO EMIT WITHOUT THE FOOT PEDAL HAVING BEEN ACTIVATED. THE SURGEON IMMEDIATELY REMOVED THE MARYLAND BIPOLAR FORCEPS INSTRUMENT AND FOUND THE ELECTRICAL SURGICAL UNIT (ESU) SETTING WAS PLACED ON AUTO. THE ESU SETTING WAS CHANGED AND THE PLANNED SURGICAL PROCEDURE WAS COMPLETED. THE PATIENT'S COLON WAS REPAIRED AND NO FURTHER ADVERSE EVENT 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, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI HYSTERECTOMY PROCEDURE ON (B)(6) 2011 FOR UTERINE PLACENTAL SITE TROPHOBLASTIC TUMOR. ISI WAS PROVIDED WITH THE OPERATIVE REPORT. THE INFUNDIBULOPELVIC LIGAMENT WAS ISOLATED AND THE UTERO-OVARIAN LIGAMENT WAS CAUTERIZED, AS WAS THE PROXIMAL FALLOPIAN TUBE. THE OVARIES WERE TUCKED AWAY. THE BLADDER FLAP WAS CREATED AND TAKEN DOWN WITHOUT DIFFICULTY. THE VCARE CONE BULGE WAS EASILY SEEN. AFTER REMOVAL OF THE UTERUS, THE CUFF WAS CLOSED TIGHTLY WITH SUTURE. THE PATIENT WAS BEING REVERSED AT THE TIME OF THE OPERATIVE NOTE, AND TOLERATED THE PROCEDURE WELL. SHE WAS DISCHARGED ON (B)(6) 2011 FOR A TOTAL HOSPITAL STAY OF THREE DAYS. ON (B)(6) 2011, THE PATIENT WAS ADMITTED FOR PELVIC PAIN AND A FLUID COLLECTION SUSPICIOUS FOR VAGINAL CUFF ABSCESS ON A CT SCAN. INTERVENTIONAL RADIOLOGY DRAINED SAID ABSCESS. THE VAGINAL CUFF LOOKED FINE UPON PHYSICAL EXAMINATION. SHE WAS DISCHARGED HOME ON (B)(6) 2011. NO ADDITIONAL INFORMATION IS AVAILABLE AFTER HER 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: IT WAS REPORTED THAT DURING A DA VINCI HYSTERECTOMY PROCEDURE THE SURGEON EXPERIENCED INSUFFLATION LOSS AT THE CAMERA TROCAR. THE SITE REPLACED THE CAMERA TROCAR; HOWEVER, THE INSUFFLATION LOSS PERSISTED. AT THIS TIME THE SURGEON MADE THE DECISION TO CONVERT TO TRADITIONAL OPEN SURGICAL TECHNIQUES TO COMPLETE THE PLANNED PROCEDURE. NO SYSTEM MALFUNCTION 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: AS PART OF A LEGAL MEDIATION EFFORT ON (B)(4) 2013, INTUITIVE SURGICAL RECEIVED INFORMATION, INCLUDING MEDICAL RECORDS, OF A PATIENT WHO UNDERWENT A DA VINCI SI VAGINAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY AND CYSTOSCOPY IN ADDITION TO A RIGHT INGUINAL HERNIA REPAIR WITH MESH PLACEMENT ON (B)(6) 2011. THE OPERATIVE REPORT DOES NOT CONTAIN ANY REPORT OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY. POST-OPERATIVELY, THE PATIENT COMPLAINED OF PELVIC PAIN. ON (B)(6) 2011 THE PATIENT HAD A CT SCAN OF THE ABDOMEN AND PELVIS WHICH SHOWED OVARIAN VEIN THROMBOSIS. THE PATIENT WAS STARTED ON LOVENOX AND ANTIBIOTICS AND TRANSITIONED TO COUMADIN (ANTI-COAGULANT). ON (B)(6) 2011 THE PATIENT UNDERWENT A DIAGNOSTIC LAPAROSCOPY; THE POST- OPERATIVE DIAGNOSIS WAS VAGINAL CUFF BLEEDING. A SMALL ADHESION WAS TAKEN DOWN THAT WAS ATTACHED TO THE INGUINAL HERNIA REPAIR SITE. THE PATIENT ALSO RECEIVED 3 BLOOD TRANSFUSIONS DURING THAT ADMISSION, ACCORDING TO THE MEDICAL RECORDS. AT THE PATIENT'S 6 WEEK POSTOPERATIVE HYSTERECTOMY CHECKUP ON (B)(6) 2011, THE PATIENT COMPLAINED OF OCCASIONAL RANDOM PAIN FROM HER HERNIA REPAIR BUT WAS DOING WELL OTHERWISE. IN (B)(6) 2012, SHE REPORTED HAV

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 07/25/2013, INTUITIVE SURGICAL RECEIVED INFORMATION OF A PATIENT WHO UNDERWENT A DA VINCI S HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY PROCEDURE ON (B)(6) 2011 FOR SEVERE CERVICAL DYSPLASIA. THIS PATIENT HAD A FAMILY HISTORY OF OVARIAN CANCER. PRIOR TO THE PROCEDURE, THE PATIENT WAS INFORMED OF THE SURGERY RISKS, INCLUDING CUFF DEHISCENCE, PORT CUFF HEALING. THE PATIENT AGREED AND SIGNED THE CONSENT TO PROCEDURE AND RISKS THEREOF. THE MONOPOLAR SCISSORS INSTRUMENT WAS USED TO TRANSECT THE VAGINAL CUFF FROM THE CERVIX AND WAS DONE IN A CIRCUMFERENTIAL MANNER. THE PATIENT'S ENTIRE CERVIX, UTERUS, TUBES, AND OVARIES WERE REMOVED. THE SURGEON NOTED ACHIEVING EXCELLENT VAGINAL CUFF CLOSURE AFTER SUTURING AS WELL AS APPLYING AN INTERCEED ADHESION BARRIER TO THE CUFF. THE DA VINCI SYSTEM WAS UNDOCKED AND THE PROCEDURE SWITCHED TO TRADITIONAL LAPAROSCOPE FOR THE REMAINDER OF THE PROCEDURE. THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. THE PATIENT HAD 3 POST-OPERATIVE CHECK-UPS WITH HER DOCTOR FROM (B)(6) 2011. DURING THESE VISITS, HER VAGINAL CUFF WAS NOTED TO BE INTACT AND HEALING WELL. APPROXIMATELY 2 MONTHS AFTER THE DA VIN

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI SI PROSTATECTOMY PROCEDURE ON (B)(6) 2011 DUE TO PROSTATIC CANCER, STAGE T1C. ISI WAS PROVIDED WITH THE PATIENT'S OPERATIVE REPORT. ADDITIONAL INFORMATION WAS PROVIDED INCLUDED THE PATIENT'S ATTORNEY CLAIM FORM. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING THE SURGICAL PROCEDURE. THERE WAS NO REPORT OF AN INTRA-OPERATIVE COMPLICATION. REPORTEDLY, THE PATIENT TOLERATED THE SURGICAL PROCEDURE WELL AND WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE AND SATISFACTORY CONDITION. NO OTHER PATIENT MEDICAL RECORDS WERE PROVIDED. THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED IN THE PATIENT'S CLAIM FORM: ON (B)(6) 2011, AN EXPLORATORY LAPAROTOMY WITH SMALL BOWEL RESECTION, ABDOMINAL WASHOUT AND WOUND VAC PLACEMENT WAS PERFORMED. OPERATIVE FINDINGS INCLUDE: GROSS ENTERIC SPILLAGE WITH PARTICULATE MATTER, NO PUS, SMALL BOWEL INJURY APPROX 1 CM IN SIZE IN THE MID ILEUM, REMAINING SMALL BOWEL AND LARGE BOWEL APPEARED INTACT, STOMACH WAS NORMAL. ON (B)(6) 2011 - ABDOMINAL WASHOUT WITH ABDOMINAL VAC DRESSING

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

da Vinci Surgical System — 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 HYSTERECTOMY PROCEDURE ON (B)(6) 2011. THE DOCUMENTATION RECEIVED STATES THAT THE PATIENT DEVELOPED A PELVIC ABSCESS AFTER UNDERGOING THE SURGICAL PROCEDURE. THE PATIENT'S OPERATIVE REPORT STATED THAT EXTREME SCAR TISSUE AND AN EXTREMELY LARGE FUNDAL FIBROID WERE OBSERVED. DUE TO THE SIZE OF THE UTERUS, THE UTERUS WAS CUT IN HALF AND REMOVED VAGINALLY. ACCORDING TO THE OPERATIVE REPORT, THE PATIENT TOLERATED THE PROCEDURE WELL AND SHE WAS TAKEN TO RECOVERY WITHOUT SEQUELAE. ON (B)(6) 2011, THE PATIENT WAS EVALUATED IN AN EMERGENCY ROOM (ER) FOR REPORTED COMPLAINTS OF ABDOMINAL PAIN, NAUSEA, VOMITING, AND FEVER. A CT SCAN PERFORMED ON THE PATIENT'S ABDOMEN AND PELVIS REVEALED A PELVIC ABSCESS WITH STOOL-LIKE MATERIAL WITHIN. ON (B)(6) 2011, THE PATIENT UNDERWENT PERCUTANEOUS DRAINAGE OF THE PELVIC ABSCESS. A TOTAL OF 15 ML OF PURULENT FLUID WAS REMOVED. IN ADDITION, PLACEMENT OF A DRAINAGE CATHETER WAS PERFORMED. ACCORDING TO THE PATIENT'S MEDICAL RECORDS, THE PATIENT TOLERATED THE PROCEDURE WELL AND NO IMM

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI HYSTERECTOMY PROCEDURE THE SURGEON ACCIDENTALLY CUT THE PATIENT'S HYPOGASTRIC NERVE. THE PROCEDURE WAS CONVERTED TO TRADITIONAL OPEN SURGICAL TECHNIQUES TO COMPLETE THE PLANNED PROCEDURE AND REPAIR THE PATIENT'S HYPOGASTRIC NERVE. NO SYSTEM MALFUNCTION 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: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI OVARY REMOVAL ON (B)(6) 2011. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: PERFORATED HER INTESTINE IN ERROR, PAIN, URINARY AND BOWEL PROBLEMS AND CAN FEEL INCISION.

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. RECEIVED INFORMATION INCLUDING MEDICAL RECORDS OF A PATIENT WHO EXPERIENCED POST-SURGICAL COMPLICATIONS AFTER UNDERGOING A DA VINCI SI OVARIAN CYSTECTOMY PROCEDURE (B)(6) 2011. ON (B)(6) 2011 THE PATIENT RETURNED TO THE HOSPITAL EMERGENCY ROOM COMPLAINING OF SEVERE ABDOMINAL PAIN IN THE PERIUMBILICAL AREA. DURING A CT SCAN IT WAS DISCOVERED THAT THE PATIENT HAD AN INCARCERATED HERNIA. ON (B)(6) 2011, THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO REPAIR THE HERNIA. THE PATIENT'S OPERATIVE (OP) REPORT FOR THE SURGICAL PROCEDURE OF (B)(6) 2011 ALLEGED THAT DURING THE DA VINCI SI OVARIAN CYSTECTOMY PROCEDURE, IT WAS NOTED THAT THE PATIENT SIDE MANIPULATOR ARMS ON THE PATIENT SIDE CART COLLIDED A LOT WHILE DOCKED TO A SINGLE PORT SITE. TO RESOLVE THE ISSUE, THE SURGEON MADE THE DECISION TO CREATE ADDITIONAL PORT SITES TO PERFORM THE PROCEDURE USING MULTIPLE PORTS. THERE WERE NO OTHER SYSTEM ISSUES DOCUMENTED IN THE OP REPORT. THE SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. A CT SCAN OF THE PATIENT'S ABDOMEN

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 AN OPERATIVE REPORT AND A LEGAL DOCUMENT FROM AN ATTORNEY REPRESENTING A PATIENT WHO UNDERWENT A DA VINCI HYSTERECTOMY PROCEDURE ON (B)(6) 2011. DURING THE DA VINCI HYSTERECTOMY PROCEDURE A NEEDLE FELL IN PATIENT. PER THE OPERATIVE REPORT THE SURGEON STATED THAT THE NEEDLE WAS LOST UPON TRYING TO REMOVE IT FROM THE PORT. ATTEMPTS WERE MADE TO FIND THE NEEDLE AND AN X-RAY AND FLUOROSCOPY WERE PERFORMED AND THE NEEDLE WAS LOCATED IN THE RIGHT UPPER QUADRANT AND WAS REMOVED THROUGH THE TROCAR SLEEVE INTACT. NO FURTHER COMPLICATIONS WERE NOTED, AND THE PATIENT WAS TAKEN TO THE RECOVERY ROOM POST- PROCEDURE. THIS LEGAL DOCUMENT ALLEGES THAT THE PATIENT'S BOWL MAY HAVE BEEN INJURED BY UNINTENDED AND UNKNOWN RELEASE OF MONOPOLAR ENERGY FROM THE CAUTERY DEVICE OF THE ROBOT. ACCORDING TO THE LEGAL DOCUMENT, APPROXIMATELY AFTER 8 DAYS OF WORSENING SYMPTOMS, THE PATIENT BECAME SEPTIC. ON (B)(6) 2011, A LAPAROTOMY WITH WASHOUT OF ABDOMEN AND SMALL BOWEL RESECTION WAS PERFORMED. IT WAS ALLEGED IN THE LEGAL DOCUMENT THAT DURING THIS PROCEDURE, THE PATIENT WAS FOUND TO HAVE PERITONITIS, AND PERFORATION OF THE SMALL INTESTINE. ON (B)(6) 2011,

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI SI PYELOPLASTY PROCEDURE, THE SURGEON OBSERVED ENERGY COMING FROM BOTH THE MONOPOLAR AND BIPOLAR INSTRUMENTS WHEN THE MONOPOLAR CAUTERY WAS INTENDED TO BE ACTIVATED. THE PATIENT EXPERIENCED A SMALL BOWEL INJURY WHICH WAS SUCCESSFULLY RESECTED. THE PATIENT WAS HOSPITALIZED FOR 2.5 WEEKS BEFORE BEING DISCHARGED HOME. NO FURTHER INFORMATION HAS BEEN 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 THAT UNDERWENT A DA VINCI SI PROSTATECTOMY PROCEDURE ON (B)(6) 2011. ACCORDING TO THE LEGAL DOCUMENT, THE PATIENT WAS REPORTED TO HAVE SUSTAINED A PUNCTURED COLON INJURY.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2011, I HAD A TOTAL HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY USING THE DA VINCI INTERFACE. I SUFFERED A COMPLETE TRANSECTION OF THE RIGHT DISTAL URETER. POST OP I DEVELOPED A FISTULA WITH URETERAL STRICTURE. I HAD A SURGICAL REPAIR ON (B)(6) 2011, WHICH DID NOT CHANGE THE TOTAL URINARY INCONTINENCE I SUFFERED AS A RESULT OF THE INITIAL SURGERY WITH THE DA VINCI. THE SECOND SURGERY DID NOT HELP AND (B)(6) 2014, I HAD ANOTHER REPAIR. I AM STILL SUFFERING FROM SEVERE INCONTINENCE.

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 SACROCOLPOPEXY PROCEDURE ON (B)(6) 2011 FOR VAGINAL PROLAPSE. THE OPERATIVE NOTES INDICATE THAT THE PATIENT'S UTERUS AND RIGHT ADNEXA WERE ABSENT AND THE LEFT ADNEXA AND LEFT SIGMOID COLON WERE SCARRED TOGETHER. THE USE OF MONOPOLAR SCISSORS AND PK INSTRUMENTS WERE MENTIONED IN THE PROCEDURE NOTES, BUT THERE WAS NO REPORT OF A DA VINCI SI SYSTEM OR INSTRUMENT MALFUNCTION. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TAKEN TO THE RECOVERY ROOM IN GOOD CONDITION. ACCORDING TO THE MEDICAL RECORD, THE PATIENT DID NOT HAVE ANY COMPLICATIONS WITH THE DA VINCI SI SURGICAL PROCEDURE. THE PATIENT HAD SOME LOW BACK PAIN THAT WAS FELT TO BE RELATED TO POSITIONING THAT KEPT HER FROM AMBULATING QUICKLY. SHE WAS DISCHARGED TO RETURN HOME ON HOSPITAL DAY NUMBER THREE. IN (B)(6) 2011, THE PATIENT WAS DIAGNOSED WITH A PELVIC ABSCESS, DIVERTICULITIS OF THE COLON WITH PERFORATION, AND HAD A SIGMOID COLECTOMY. THE PATIENT NOTED AS BEING HOSPITALIZED SEVERAL TIMES THROUGHOUT (B)(6) 2011 THROUGH (B)(6) 2012, FOR BACK AND LEG ISSU

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 02/03/2015, INTUITIVE SURGICAL, INC. (ISI) RECEIVED VOLUNTARY REPORT MW5038369 WITH THE FOLLOWING EVENT DESCRIPTION: ON (B)(6) 2011, I HAD A TOTAL HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY USING THE DA VINCI INTERFACE. I SUFFERED A COMPLETE TRANSECTION OF THE RIGHT DISTAL URETER. POST OP I DEVELOPED A FISTULA WITH URETERAL STRICTURE. I HAD A SURGICAL REPAIR ON (B)(6) 2011, WHICH DID NOT CHANGE THE TOTAL URINARY INCONTINENCE I SUFFERED AS A RESULT OF THE INITIAL SURGERY WITH THE DA VINCI. THE SECOND SURGERY DID NOT HELP AND (B)(6) 2014, I HAD ANOTHER REPAIR. I AM STILL SUFFERING FROM SEVERE INCONTINENCE. ON 02/25/2015, ISI CONTACTED THE PATIENT DIRECTLY AND OBTAINED THE FOLLOWING INFORMATION: THERE WERE NO REPORTS MADE TO HER FROM THE SITE THAT A MALFUNCTION OF THE DV SURGICAL SYSTEM OCCURRED DURING THE PROCEDURE. TO HER KNOWLEDGE, THE PATIENT EXPLAINED THAT DURING THE DV SURGICAL PROCEDURE, HER URETER WAS COMPLETELY CUT AND ANOTHER SURGEON WAS CALLED IN TO TRY AND REPAIR THE URETER. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY ON (B)(6) 2011 WITH A FEVER. ON (B)(6) 2011, THE PATIENT WAS SEEN BY ANOTHER PHYSICIAN DUE TO THE FEVER. NO ADDITIONAL INFORMATION WAS PROVIDED 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 THAT UNDERWENT A DA VINCI BLADDER LIFT ON (B)(6) 2011. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURY DUE TO THE DA VINCI SURGERY:BOWEL INJURY.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI COLON RESECTION PROCEDURE ON (B)(6) 2011 AND SUBSEQUENTLY EXPIRED ON AN UNSPECIFIED DATE. ISI WAS PROVIDED WITH THE DA VINCI OPERATIVE REPORT AND ADDITIONAL HOSPITAL REPORTS. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT, OR ACCESSORY DURING SURGERY. THERE WAS NO REPORT OF AN INTRA-OPERATIVE COMPLICATION ALTHOUGH THE OPERATION HAD TO BE CONVERTED TO AN OPEN PROCEDURE DUE TO THE SIZE OF THE TUMOR. THE PATIENT WAS ADMITTED TO THE HOSPITAL FROM (B)(6) 2011. NO FURTHER MEDICAL RECORDS WERE PROVIDED. A LETTER FROM AN ATTORNEY INDICATES THAT THE PATIENT SUSTAINED A BOWEL PERFORATION, UNDERWENT ADDITIONAL SURGERIES, AND THEN PASSED AWAY. THE PATIENT'S DATE AND CAUSE OF DEATH WERE NOT PROVIDED. ISI HAS MADE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE ATTORNEY AND THE SITE'S RISK MANAGEMENT GROUP; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT. A FOLLOW-UP MDR WILL BE IF ADDITIONAL INFORMATION IS RECEIVED.

da Vinci Surgical System — 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 THAT UNDERWENT A DA VINCI SI RIGHT SALPINGO-OOPHORECTOMY PROCEDURE ON (B)(6) 2011. PER THE RECORDS RECEIVED THE SURGERY WAS UNREMARKABLE. IMMEDIATELY FOLLOWING THE INITIAL SURGERY, THE PATIENT WAS BROUGHT BACK TO THE OPERATING ROOM FOR HYPOTENSION AND WAS NOTED TO HAVE A LARGE AMOUNT OF BLOOD IN THE UPPER ABDOMEN AND PELVIS. THE PATIENT UNDERWENT A DIAGNOSTIC LAPAROSCOPY WHICH WAS CONVERTED TO AN EXPLORATORY LAPAROTOMY WITH NO CLEAR FINDING IN REGARD TO THE ABSOLUTE SOURCE OF THE BLEEDING. THE PATIENT WENT TO THE RECOVERY ROOM IN A STABLE CONDITION. THE PATIENT RECOVERED WELL AND WAS DISCHARGED ON DAY 5 ((B)(6) 2011) THE PATIENT WAS THEN SEEN AND READMITTED ON (B)(6) 2011, WITH A PERI-HEPATIC ABSCESS. THE PATIENT REQUIRED ANTIBIOTICS AND A FOUR DAY HOSPITALIZATION, AND UNDERWENT A CT GUIDED INTERVENTIONAL RADIOLOGY DRAINAGE OF THE ABSCESS. PER THE INITIAL OPERATIVE REPORT FOR THE (B)(6) 2011 PROCEDURE, THE PATIENT TOLERATED THE OOPHORECTOMY PROCEDURE WELL. THE PATIENT WAS TAKEN TO THE RECOVERY ROOM REPORTEDLY IN STABLE CONDITION. PER THE DI

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 CONCERNING A PATIENT WHO UNDERWENT A DA VINCI SURGICAL PROCEDURE TO REPAIR THE PATIENT'S RECURRENT VESICO-VAGINAL FISTULA ON (B)(6) 2011. THE MEDICAL RECORDS INDICATE THAT THE PATIENT UNDERWENT A HYSTERECTOMY PROCEDURE IN (B)(6) 2011. NO INFORMATION WAS PROVIDED AS TO WHERE THIS WAS PERFORMED OR WHAT SURGICAL APPROACH WAS USED. ACCORDING TO THE PATIENT'S MEDICAL RECORDS, THE PATIENT DEVELOPED A VESICOVAGINAL FISTULA AT AN UNSPECIFIED TIME AFTER THE HYSTERECTOMY PROCEDURE WAS PERFORMED. IN (B)(6) 2011, A SURGEON ATTEMPTED A ROBOTIC REPAIR OF THE VESICOVAGINAL FISTULA. NO MEDICAL INFORMATION WAS PROVIDED ON THIS PROCEDURE. THE PATIENT CONTINUED TO HAVE A VESICOVAGINAL FISTULA, AND ON (B)(6) 2011, THE PATIENT UNDERWENT ROBOTIC-ASSISTED REPAIR OF A RECURRENT VESICOVAGINAL FISTULA, LYSIS OF ADHESIONS, ENTEROLYSIS, CYSTOSCOPY, AND PLACEMENT OF BILATERAL OPEN-ENDED URETERAL CATHETERS. THE OPERATIVE REPORT FOR THIS PROCEDURE DESCRIBES LYSIS OF BOWEL ADHESIONS AND RETRACTION OF THE BOWEL TO KEEP IT OUT OF THE SURGICAL FIELD. TWO DAYS POST-OP, MEDICAL RECORDS INDICATE THE PATIENT

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISCOVERY ACTIVITY, ON (B)(4) 2015, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI TRACHELECTOMY PROCEDURE. ISI WAS PROVIDED WITH A COPY OF THE HOSPITAL'S RISK OCCURRENCE REPORT FROM THE HOSPITAL'S RISK MANAGEMENT DEPARTMENT. THE RISK OCCURRENCE REPORT INDICATED THAT DURING THE SURGICAL PROCEDURE, A BLADDER LACERATION OCCURRED. THE DEFECT TO THE PATIENT'S BLADDER WAS REPAIRED BY THE SITE'S UROLOGIST AFTER COMPLETION OF THE PLANNED SURGICAL PROCEDURE. NO ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT WAS PROVIDED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI PROSTATECTOMY PROCEDURE, THE TOTAL AMOUNT OF BLEEDING SUSTAINED BY THE PATIENT WAS 300 CC. THE PATIENT REPORTEDLY RECEIVED A TRANSFUSION WITH A TOTAL OF 800 CC. DURING THE SURGICAL PROCEDURE, NO MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY WAS REPORTED OR OBSERVED. ACCORDING TO THE INITIAL REPORTER OF THIS COMPLAINT, THE NEXT MORNING, THE PATIENT BECAME BROOD-PRESSURE [SIC] REDUCTIONS AND INDUCED TACHYSYSTOLE. AN X-RAY REVEALED THAT THE LEFT LOWER LOBE OF THE PATIENT'S LUNG HAD BECOME THROMBOSED. THE PATIENT UNDERWENT THROMBOLYTIC THERAPY AND WAS REPORTEDLY GETTING WELL. THE INITIAL REPORTER INDICATED THAT THE SURGEON BELIEVED THAT A POSSIBLE CAUSE OF THE THROMBOSIS WAS DUE TO THE PROLONGED SURGERY TOTALING APPROXIMATELY 7.5 HOURS. HOWEVER, THE SURGEON DID NOT KNOW THE ACTUAL CAUSE OF THE THROMBOSIS.

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 9/3/2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED A LEGAL COMPLAINT CONCERNING A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY PROCEDURE ON (B)(6) 2011. ACCORDING TO THE LEGAL COMPLAINT, THE PATIENT SUSTAINED URETER DAMAGE, INCLUDING SIGNIFICANT POST-OPERATIVE INTRA-ABDOMINAL BLEEDING, THERMAL BURNING, SEVERE INFECTION WITH INTRA-ABDOMINAL ABSCESSES, A URETER-VAGINAL FISTULA AND OTHER MEDICAL COMPLICATIONS AND CONSEQUENCES REQUIRING FURTHER SURGERIES, PROCEDURES AND STENT PLACEMENT ON (B)(6) 2011, AND AGAIN ON (B)(6) 2011.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI SI RIGHT AND LEFT HEMICOLECTOMY PROCEDURE ON (B)(6) 2011. THE PATIENT ALSO UNDERWENT A TRU-CUT LIVER BIOPSY. THE LEGAL COMPLAINT ALLEGES THAT THE PATIENT'S COLON TISSUE WAS POTENTIALLY DAMAGED BY A ROBOTIC ARM ATTACHMENT THAT LED TO POST-OPERATIVE COMPLICATIONS. ACCORDING TO THE PATIENT'S MEDICAL RECORDS, A COLONOSCOPY PERFORMED ON THE PATIENT REVEALED AN ADENOMATOUS NEOPLASM OF THE RIGHT COLON. AFTER A FULL DISCUSSION OF ALTERNATIVE, INDICATIONS, RISKS, AND COMPLICATIONS, THE PATIENT WISHED TO UNDERGO AN ONCOLOGIC RESECTION BECAUSE OF THE RISK AND/OR FUTURE RISK OF INVASIVE COLON CANCER, AND INFORMED CONSENT WAS OBTAINED. ACCORDING TO THE PATIENT'S MEDICAL RECORDS, THE DA VINCI SI SURGICAL PROCEDURE WENT WELL. ON POST-OP DAY 1, THE PATIENT'S TEMPERATURE SPIKED TO 103 ALTHOUGH HER HEART RATE AND BLOOD PRESSURE WERE NORMAL, AND HER URINE OUTPUT WAS 1500 CC OVER THE PREVIOUS 12 HOURS. THE PATIENT HAD NO COMPLAINTS OF ABDOMINAL PAIN, ALTHOUGH THE ABDOMEN WAS NOTED TO BE A LITTLE DISTENDED. ON POST-OP DAY 3, THE PATIENT'S TEMPERATURE SPIKED AGAIN TO 101.7. SHE WAS NOT TACHYC

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 S TOTAL HYSTERECTOMY, LEFT OVARIAN CYSTECTOMY, LYSIS OF ADHESIONS FOR HISTORY OF WORSENING MENORRHAGIA AND LARGE FIBROID UTERUS ON (B)(6) 2011. ISI WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES: THE DISCHARGE SUMMARY FROM HER READMISSION ON (B)(6) 2011, AND DISCHARGE SUMMARY AND THE OPERATIVE REPORT FROM THE FOLLOW ON SURGERY ON (B)(6) 2011 AND THE DISCHARGE SUMMARY HER DRAINAGE ON (B)(6) 2011. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING THE SURGERY. AFTER A BRIEF DELAY BECAUSE OF CONCERNS ABOUT DIFFICULTY WITH TIDAL VOLUME, THE PROCEDURE PROCEEDED AS PLANNED. USING PROGRASP, PK DISSECTOR AND ENDOSHEARS, THE BROAD LIGAMENTS, UTERINE ARTERIES WERE COAGULATED AND CUT, AND THE UTERUS REMOVED WITH A COLPOTOMY RING AS A BACKSTOP. IT TOOK 20 MINUTES TO FILET THE UTERUS WITH MONOPOLAR SCISSORS TO ALLOW REMOVAL THROUGH THE VAGINA, AND FILMY ADHESIONS TAKEN DOWN IN THE COLIC GUTTERS WITH SHARP AND BLUNT DISSECTION. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. 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 MEDIATION EFFORT ON (B)(6) 2013 INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION INCLUDING MEDICAL RECORDS OF A PATIENT WHO UNDERWENT A DA VINCI SI RADICAL PROSTATECTOMY AND BILATERAL PELVIC LYMPHNODE DISSECTION PROCEDURE ON (B)(6) 2011, DUE TO A PRE-OPERATIVE DIAGNOSIS OF PROSTATE CARCINOMA. APPROXIMATELY 24 HOURS FOLLOWING THE SURGICAL PROCEDURE THE PATIENT DEVELOPED ABDOMINAL DISTENSION AND EXPERIENCED ABDOMINAL PAIN. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED ACUTE RENAL FAILURE, HYPOXIA, URINARY RETENTION AND HYPOTHERMIA. THERE WAS NO INDICATION IN THE PATIENT'S OPERATIVE (OP) REPORT THAT A MALFUNCTION OF THE DA VINCI SI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED AND THERE WAS NO INDICATION THAT THE PATIENT EXPERIENCED ANY INTRA-OPERATIVE COMPLICATIONS. THE SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED. REPORTEDLY, THE PATIENT TOLERATED THE PROCEDURE AND WAS SENT TO THE RECOVERY ROOM IN STABLE CONDITION. DURING THE PATIENT'S POST-OPERATIVE HOSPITALIZATION, THE PATIENT COMPLAINED OF ABDOMINAL PAIN, EXPERIENCED SHORTNESS OF BREATH, NAUSEA AND VOMITING AND DEVELOPED POST-OPERATIVE ILEUS AND LEUKOCYTOSIS. ON (B)(6) 2011 THE PATIENT UNDERWENT AN ABD

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 S PROSTATECTOMY PROCEDURE ON A (B)(6) 2011, AND ALLEGED TO HAVE SUSTAINED A PUNCTURED BOWEL. 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 SI PROSTATECTOMY PROCEDURE ON (B)(6) 2011. 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 HIATAL HERNIA REPAIR PROCEDURE ON (B)(6) 2011. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY:PROBLEMS WITH NERVES IN LOWER BACK, BACK AND TAIL BONE. UNABLE TO SIT FOR LONG PERIODS OF TIME BECAUSE LEGS GO NUMB.

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 RECEIVED INFORMATION INCLUDING LIMITED MEDICAL RECORDS, OF A PATIENT WHO DEVELOPED POST- SURGICAL COMPLICATIONS AFTER HAVING A DA VINCI S HYSTERECTOMY PROCEDURE ON (B)(6) 2011 FOR MENORRHAGIA AND FIBROID UTERUS. THE PATIENT'S POST OPERATIVE RECOVERY WAS UNEVENTFUL AND SHE WAS DISCHARGED THE NEXT DAY AFTER HAVING THE DA VINCI PROCEDURE. NO ADDITIONAL OPERATIVE INFORMATION WAS PROVIDED. PATIENT RETURNED TO THE HOSPITAL (B)(6) 2011 AFTER BILATERAL LOWER ABDOMINAL PAIN AND WAS FOUND TO HAVE PELVIC ABSCESS WITH AN ABDOMINAL CT. SHE HAD A WASH OUT ON (B)(6) 2011. SHE REMAINED AFEBRILE, HOWEVER CONTINUED WITH LEUKOCYTOSIS. THERE WAS NO CHANGE IN ABSCESSES ON REPEAT CT SCAN ON (B)(6) 2011. ON (B)(6) 2011, PATIENT HAD DIAGNOSTIC LAPAROSCOPY CONVERTED TO AN EXPLORATORY LAPAROTOMY AND REPEAT WASHOUT. A WOUND VAC AND JP DRAIN WAS PLACED AFTER THIS, WHICH WAS REMOVED 3 DAYS LATER, AND 5 DAYS LATER, AND THE PATIENT'S ABDOMINAL WOUND CLOSED. THE PATIENT'S SYMPTOMS CONTINUED TO IMPROVE. THE PATIENT WAS DISCHARGED (B)(6) 2011 WITHOUT ADDITIONAL ANTIBIOTICS. DURING HER POST OPERATIVE SCHEDULED FOLLOW UP, THE PATIENT WAS NOTED TO

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 S TOTAL HYSTERECTOMY FOR MENORRHAGIA AND DYSMENORRHEA ON (B)(6) 2011. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES FOLLOW UP HOSPITAL AND RADIOLOGY 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. ROBOTIC HYSTERECTOMY (B)(6) 2011. DISCHARGE HOME NEXT DAY. ON (B)(6) 2011 RE-ADMITTED FOR FEVER AND PAIN. CT NOTED NO ABSCESS. SUBSEQUENT IVP NOTED RIGHT URETERAL INJURY. ON (B)(6) 2011 - CYSTOSCOPY, URETEROSCOPY WITH ATTEMPTED URETERAL STENT PLACEMENT - RIGHT URETER. UNABLE TO PASS STENT. NEPHROSTOMY TUBE PLACED IN SEPARATE PROCEDURE. ON (B)(6) 2011 ATTEMPT TO INTERNALIZE A DOUBLE J STENT. NEPHROSTOMY TUBE REMOVED THEN. ON (B)(6) 2011 RETURN TO CYSTOSCOPY LAB WITH MANIPULATION OF STENT AND UNABLE TO REPLACE. ON (B)(6) 2011 ANOTHER NEPHROSTOMY TUBE PLACED. DISCHARGED (B)(6) 2011. ON (B)(6) 2011 READMITTED FOR DVT OF RIGHT LOWER LEG FOLLOWING MULTIPLE PROCEDURES AND DECREASED ACTIVITY. D

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO ALLEGEDLY SUSTAINED AN INJURY DURING A DA VINCI SURGICAL PROCEDURE ON (B)(6), 2008 AT AN UNSPECIFIED HOSPITAL AND SUBSEQUENTLY EXPIRED ON AN (B)(6) 2008. NO OTHER INFORMATION REGARDING THE REPORTED ALLEGATION WAS PROVIDED.

da Vinci Surgical System — 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 INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI S SACROCOLPOPEXY AND TRANSOBTURATOR SLING PROCEDURE ON (B)(6) 2011. ACCORDING TO THE PATIENT'S MEDICAL RECORDS, THE PATIENT HAD A PRE-OPERATIVE DIAGNOSIS OF VAGINAL VAULT PROLAPSE AND STRESS URINARY INCONTINENCE. BASED ON THE OPERATIVE REPORT, UPON INSPECTION OF THE ABDOMINAL CAVITY, SOME ADHESIONS WERE NOTED FROM THE SMALL BOWEL TO THE RIGHT PELVIC SIDE WALL. THE DA VINCI SYSTEM WAS DOCKED IN A NORMAL MANNER. THE SURGEON STATED THAT DURING DISSECTION FOR THE UTEROSACRAL SPACE FOR THE PLACEMENT OF THE SUSPENSORY PORTION OF THE Y-MESH, THE SACRAL VEIN WAS INTERRUPTED. THE SURGEON ALSO INDICATED THAT A LARGE AMOUNT OF BLEEDING WAS NOTED AND COULD NOT BE CONTROLLED ROBOTICALLY. DUE TO THE UNCONTROLLED BLEEDING, THE SURGEON ELECTED TO PERFORM EXPLORATORY LAPAROTOMY. THE LAPAROTOMY WAS PERFORMED BY A TRANSVERSE PFANNENSTEIL INCISION THROUGH A PREVIOUS SCAR THAT THE PATIENT HAD. THE INCISION WAS CARRIED THROUGH THE SUBCUTANEOUS TISSUE AND ABDOMINAL FASCIA. DURING THE EXPLORATORY LAPAROTOMY, THE SURGEON FOUND BLEEDING OF THE MIDDLE SACRAL VEIN. THE SURGEON WAS ABLE TO RAPIDLY

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 S TOTAL HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY, BILATERAL URETEROLYSIS, BILATERAL LYMPHADENECTOMY , EXTENSIVE ENTEROLYSIS (LASTING OVER 4 HOURS) FOR ENDOMETRIAL CARCINOMA. PROCEDURE DATE IS UNKNOWN. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES FOLLOW UP OPERATIVE AND MEDICAL REPORTS FOR POST OPERATIVE CARE. THERE WAS NOT AN 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) 2011 THE PATIENT PRESENTED WITH ABDOMINAL PAIN AND PURULENT DRAINAGE PER VAGINA. ON (B)(6) 2011 AN ATTEMPT WAS MADE TO DRAIN ABDOMINAL FLUID BY OPENING VAGINAL CUFF. ON (B)(6) 2011, THE PATIENT DEVELOPED FEVER THOUGHT TO BE ENTERIC-CUTANEOUS FISTULA ON (B)(6) 2011 THE PATIENT UNDERWENT REVISION OF ILEOSTOMY ON (B)(6) 2011 THE PATIENT UNDERWENT OPEN CHOLECYSTECTOMY ON (B)(6) 2011 THE PATIENT UNDERWENT EVALUATION FOR CHRONIC WOUND INFECTION. ON (B)(6) 2011 WOUND DEBRIDEMENT ON (B)(6) 2011 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, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI S HYSTERECTOMY ON (B)(6) 2011 FOR ENDOMETRIOSIS. ISI WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI S SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING THE SURGERY. THERE WAS A REPORT OF AN INTRAOPERATIVE COMPLICATION, NAMELY A TROCAR INJURY TO THE SMALL INTESTINE. IT WAS REPAIRED BY A GENERAL SURGEON AT THE TIME OF THE PRIMARY OPERATION; HOWEVER THE PATIENT'S CONDITION WORSENED. ON (B)(6) 2011 THE PATIENT RETURNED TO SURGERY FOR A LAPAROTOMY WHERE A SECOND AREA OF PERFORATION WAS FOUND. HER RECOVERY WAS COMPLICATED BY RECURRENT BOUTS OF BACTERIAL AND FUNGAL INFECTION. SHE HAD TO RETURN FOR A SECOND LAPAROTOMY ON (B)(6) 2011 FOR LYSIS OF ADHESIONS. AT ONE POINT A TRACHEOSTOMY WAS REQUIRED AFTER PROLONGED INTUBATION. HER LAST HOSPITAL DISCHARGE WAS ON (B)(6) 2011 AFTER 65 DAYS IN THE HOSPITAL.

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 TOTAL HYSTERECTOMY FOR MENOMETRORRHAGIA AND DYSFUNCTIONAL UTERINE BLEEDING ON (B)(6) 2011. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES HOSPITAL OPERATIVE REPORTS, RADIOLOGY REPORTS AND FOLLOW-UP PHYSICIAN COMMENTS. 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) 2011 PATIENT WAS READMITTED FOR RIGHT SIDED PAIN AND HYDRONEPHROSIS. EXPLORATORY LAPAROSCOPY AND CYSTOSCOPY WITH RIGHT RETROGRADE PYELOGRAM AND RIGHT URETERAL STENT PLACEMENT FOR URETERAL INJURY. ON (B)(6) 2011 CYSTOSCOPY AND RIGHT PYELOGRAM AND RIGHT URETEROSCOPY. CONTINUED INCONTINENCE. ON (B)(6) 2012 THE PATIENT WAS SEEN FOR CONTINUED INCONTINENCE. UTEROVAGINAL FISTULA SUSPECTED. ON (B)(6) 2012 CYSTOSCOPY RIGHT URETERAL REIMPLANTATION, RESECTION OF FISTULA AND RIGHT OOPHORECTOMY

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 SUPRACERVICAL HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY, AND SACROCOLPOPEXY ON (B)(6) 2011. BASED ON THE MEDICAL RECORDS PROVIDED, THE PATIENT ELECTED TO HAVE AN ABDOMINAL HYSTERECTOMY AFTER DEVELOPING UTEROVAGINAL PROLAPSE DURING (B)(6) 2009. THE OPERATIVE REPORT FOR THE DA VINCI S SURGICAL PROCEDURE WAS NOT PROVIDED FOR REVIEW. THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2011. SHE WAS DISCHARGED ON AN UNSPECIFIED ANTIBIOTIC TO BE TAKEN TWICE A DAY. ON (B)(6) 2011, THE PATIENT WAS EVALUATED IN AN EMERGENCY ROOM (ER) FOR REPORTED COMPLAINTS OF FEVER, CONSTIPATION, AND PELVIC PAIN, PRESSURE, AND DISCHARGE. CT SCANS OF THE PATIENT'S ABDOMEN PERFORMED ON (B)(6) 2011 REVEALED A PELVIC ABSCESS NEXT TO THE VAGINAL CUFF. THE PATIENT WAS TREATED CONSERVATIVELY WITH ANTIBIOTICS AND PERCUTANEOUS DRAINAGE. ON (B)(6) 2011, THE PATIENT UNDERWENT A LAPAROSCOPY PROCEDURE IN ADDITION TO EXPLORATORY LAPAROTOMY WITH REMOVAL OF THE SACROCOLPOPEXY MESH. ACCORDING TO THE OPERATIVE REPORT, THE SURGEON DID NOT FIND ANY EVIDENCE OF AN INJURY TO THE BOWEL OR VASCULAR STRUCTURES. THE SACROCOLP

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

da Vinci Surgical System — 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, LEFT SALPINGO-OOPHORECTOMY, AND EXTENSIVE LYSIS OF ADHESIONS FOR CHRONIC PELVIC PAIN AND ENDOMETRIOSIS ON (B)(6) 2011. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT AND LIMITED SUBSEQUENT MEDICAL RECORDS. ADDITIONAL INFORMATION PROVIDED INCLUDES MULTIPLE CT SCANS OF THE ABDOMEN AND PELVIS. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. THE PELVIC ANATOMY WAS ABNORMAL HOWEVER AND THERE WERE MULTIPLE ADHESIONS AND SIGNS OF ENDOMETRIOSIS. THIS INVOLVED THE OVARIES AND COMPLETELY OBLITERATED THE CUL-DE-SAC AND MADE VISUALIZATION OF THE POSITION OF THE URETERS QUITE DIFFICULT THE PATIENT PRESENTED 9 DAYS AFTER SURGERY WITH SYMPTOMS OF BLEEDING AND WAS DIAGNOSED WITH A CUFF CELLULITIS AND CT SCANS SHOWED POSSIBLE ABSCESSES. SHE RETURNED TO THE OR FOR A DIAGNOSTIC LAPAROSCOPY AND RE-SUTURING OF THE VAGINAL CUFF. HYSTERECTOMY, LEFT SALPINGO-OOPHORECTOMY, AND EXTENSIVE LYSIS OF ADHESIONS PERFORMED ON (B)(6) 2011. POSTOP COURSE UNCO