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 — 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 — 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

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 HYSTERECTOMY PROCEDURE, AN INSTRUMENT WOULD NOT ADVANCE ON ITS OWN SO THE INSTRUMENT ARM CLUTCH BUTTON WAS PRESSED TO MANUALLY ADVANCE THE INSTRUMENT. WHEN THE BUTTON WAS PRESSED, THE INSTRUMENT ADVANCED INTO THE PATIENT'S PERINEUM AND NICKED A SUPERFICIAL VEIN. THE SURGICAL STAFF REMOVED ALL OF THE INSTRUMENTS AND CONVERTED TO OPEN SURGICAL TECHNIQUES TO ADDRESS THE PATIENT INJURY AND COMPLETE THE PLANNED PROCEDURE. THE HOSPITAL CONFIRMED THAT THE PATIENT WAS NOT ADVERSELY AFFECTED BY THE INCIDENT.

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 HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY 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, THE PATIENT SUSTAINED A BLADDER INJURY. THE DEFECT TO THE PATIENT'S BLADDER WAS REPAIRED BY THE SITE'S UROLOGIST. 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: 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 PARTIAL NEPHRECTOMY PROCEDURE ON (B)(6) 2011. THE DOCUMENTATION PROVIDED STATES THAT THE PATIENT DEVELOPED A HEMATOMA AFTER UNDERGOING THE SURGICAL PROCEDURE. APPROXIMATELY ONE MONTH PRIOR, THIS PATIENT HAD UNDERGONE A CHOLECYSTECTOMY PROCEDURE WITH NO COMPLICATION. NO INTRA-OPERATIVE COMPLICATIONS WERE NOTED IN THE OPERATIVE REPORT OF THE DA VINCI PARTIAL NEPHRECTOMY PROCEDURE PERFORMED ON (B)(6) 2011. AT THE CONCLUSION OF THE SURGICAL PROCEDURE, THE PATIENT'S PERITONEAL CONTENTS WERE INSPECTED AND NO INJURIES OR DEFECTS WERE FOUND. THE PATIENT WAS REPORTEDLY SENT TO THE RECOVERY ROOM IN GOOD CONDITION. DURING THE COURSE OF THE PATIENT'S HOSPITALIZATION, THE PATIENT HAD A REPORTED COMPLAINT OF RETROSTERNAL DISCOMFORT ON (B)(6) 2011. THE PATIENT WAS EVALUATED AND FOUND TO HAVE A NON-Q MYOCARDIAL INFARCTION. ON (B)(6) 2011, THE PATIENT UNDERWENT A LEFT HEART CARDIAC CATHETERIZATION PROCEDURE WITH SELECTIVE RIGHT AND LEFT CORONARY ANGIOGRAPHY AND LEFT VENTRICULOGRAPHY. ACCORDING TO THE PATIENT'S MEDICAL RECORDS

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: 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 MENORRHAGIA 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 FIBROID UTERUS WAS 732 GRAMS AND 14CM, TAKING UP THE ENTIRE PELVIS LEAVING LITTLE ROOM TO WORK ON EITHER SIDE. INSTRUMENTS WERE USED TO CREATE TISSUE TENSION, WHICH ALLOWED THE PERFORMANCE OF THE SURGERY. BLUNT CAUTERY AND SHARP DISSECTION WAS USED TO DISSECT THE BLADDER OFF OF THE ANTERIOR ASPECT OF THE UTERUS AND CERVIX, AND 1CM AROUND THE VAGINA. ENCOUNTERED UTERINE VESSELS WERE VERY THICK AND REQUIRED MULTIPLE CAUTERIZATIONS AND DIVISION. IT WAS NOT POSSIBLE TO ANTEFLEX THE UTERUS DUE TO ITS SIZE. BOTH URETERS WERE VISIBLE AND KEPT IN VIEW WHILE ALL CAUTERY AND DISSECTIONS WERE PERFORMED. EXCELLENT HEMOSTASIS WAS NOTED UPON VAGINAL CUFF CLOSURE. INDIGO CARMINE WAS ADMINISTERED FOR URETER VISUALIZATION AND GOOD FUNCTION WAS OBSERVED. THE EST

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 SUPRACERVICAL HYSTERECTOMY 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 THE PATIENT SUSTAINED A BLADDER LACERATION DURING THE SURGICAL PROCEDURE. THE DAMAGE TO THE PATIENT'S BLADDER WAS REPAIRED BY THE HOSPITAL'S UROLOGIST. 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: 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) 2011, AND ALLEGED A VAGINAL CUFF TEAR 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 PARTIAL HYSTERECTOMY PROCEDURE ON (B)(6) 2011. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: DOCTOR NICKED BLADDER, INTERNAL BLEEDING. SURGICAL CORRECTION

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL, INC. RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI S SUPRACERVICAL HYSTERECTOMY FOR FIBROID UTERUS AND MENORRHAGIA 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. THE UTERUS WAS OF 14-16 WEEKS SIZE AND SIGNIFICANT ADHESIONS OF THE BLADDER TO THE CERVIX AND ANTERIOR PORTION OF THE UTERUS WERE ENCOUNTERED. THE ABDOMINAL FASCIA WAS NOTED TO HAVE A HERNIA DURING TROCAR PLACEMENT. THE URETERS WERE VISUALIZED BILATERALLY SHORTLY AFTER THE ROBOT WAS DOCKED. ADHESIONS WERE LYSED USING BOTH BLUNT AND SHARP DISSECTION. THERE WAS A REPORT OF AN INTRAOPERATIVE COMPLICATION, NAMELY A 2CM CYSTOTOMY IN THE POSTERIOR WALL TOWARDS THE FLOOR OF THE BLADDER, FAR AWAY FROM THE TRIGONE, WHICH WAS REPAIRED BY A UROLOGIST USING A 2 LAYER REPAIR. INDIGO CARMINE WAS ADMINISTERED TO ENSURE BLADDER INTEGRITY. A SEPARATE CONSULTATION REPORT WAS PROVIDED. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS BROUGHT TO THE RECOVERY ROOM IN STABLE CONDITION. THE DISCHARGE DATE WAS NOT PROVIDED. ON (B)(6) 2011, 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: ON (B)(6) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION FROM AN ATTORNEY REPRESENTING A PATIENT WHO UNDERWENT A DA VINCI S HYSTERECTOMY PROCEDURE ON (B)(6) 2011 AND ALLEGED TO HAVE INJURIES INCLUDING URETER INJURY, HYDRONEPHROSIS, AND POSTOPERATIVE HEMORRHAGING. 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: STERILE PROCESSING DEPT INSPECTED DA VINCI CAUTERY SPATULA AFTER IT WAS USED. FOUND ONE OF THE CABLES ON THE ARTICULATING TIP WAS NO LONGER SEATED PROPERLY AND WAS STICKING OUT.

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 CARDIAC ABLATION PROCEDURE ON (B)(6) 2011. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: PERFORATED HIS HEART, NEEDED TO HAVE OPEN HEART 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, INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION INCLUDING MEDICAL RECORDS CONCERNING A PATIENT WHO UNDERWENT A DA VINCI SI SUPRACERVICAL HYSTERECTOMY PROCEDURE ON (B)(6) 2011. BASED ON THE MEDICAL RECORDS PROVIDED, THE PATIENT HAD PREOPERATIVE DIAGNOSIS OF A SYMPTOMATIC FIBROID UTERUS, WITH A LARGE FIBROID ON THE RIGHT SIDE OF THE UTERUS. ACCORDING TO THE OPERATIVE REPORT, THE SURGEON STATED THAT DURING DETACHMENT OF THE FIBROID FROM THE RIGHT SIDE OF THE PATIENT'S PELVIC SIDEWALL, BLEEDING WAS NOTED COMING FROM A FEEDING VESSEL OF THE FIBROID. HEMOSTASIS WAS ACHIEVED WITH CLIP PLACEMENT. FIBRILLAR WAS ALSO PLACED FOR HEMOSTASIS. THE OPERATIVE REPORT DESCRIBES THE USE OF A LAPAROSCOPIC CAMERA, AND AN ENDOSCOPE MORCELLATOR THROUGH A 12 MM PORT. AFTER THE PATIENT'S UTERUS WAS REMOVED AND THE SURGICAL PROCEDURE WAS COMPLETED, THE PATIENT WAS BROUGHT TO THE RECOVERY ROOM IN STABLE CONDITION. ON (B)(6) 2011, THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL WITH URINARY RETENTION. PER OPERATIVE REPORTS, A CT SCAN WAS PERFORMED WHICH SHOWED A PELVIC ABSCESS AND PARTIAL COMPRESSION OF THE RIGHT URETER. ON (B)(6) 2011, THE PATIENT UNDERWENT BILATERAL URETE

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 ADDITIONAL INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI HYSTERECTOMY PROCEDURE ON (B)(6) 2011. THE LEGAL DOCUMENT ALLEGES THE PATIENT SUSTAINED POST OPERATIVE INJURIES, INCLUDING RUPTURE OF THE BLADDER, CREATION OF FISTULA, AND OTHER PHYSICAL AND PSYCHOLOGICAL SEQUELAE AS SET FORTH IN THE MEDICAL RECORD. SPECIFIC DETAILS OF THE DA VINCI SURGERY WERE NOT PROVIDED AND THE LEGAL DOCUMENT DOES NOT ANY SPECIFIC ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY THAT OCCURRED DURING THE REPORTED SURGICAL PROCEDURE.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: 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 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 ROBOTIC LEFT OOPHORECTOMY , RIGHT OVARIAN CYST DRAINAGE, AND EXCISION OF RIGHT PARATUBAL CYST FOR CHRONIC PAIN 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. ON (B)(6) 2011, THE PATIENT PRESENTED WITH DA VINCI ROBOTIC LAPAROSCOPIC REMOVAL OF LEFT OVARY, LYSIS OF ADHESIONS AND RIGHT OVARIAN CYST DRAINAGE WITH ELECTROCAUTERY AND EXCISION OF RIGHT PARATUBAL CYST. ON (B)(6) 2011, READMITTED FOR ABDOMINAL PAIN. CT NOTED FREE AIR IN ABDOMEN BUT NO EVIDENCE OF BOWEL PERFORATION. WITH IV AND ANTIBIOTICS. REPEAT CT SHOWED IMPROVEMENT OF FREE AIR IN ABDOMEN. DISCHARGED HOME ON (B)(6) 2011. THE PATIENT WAS IN AND OUT OF THE HOSPITAL OVER 6 MONTH PERIOD WITH SYMPTOMS OF RECURRENT SMALL BOWEL OBSTRUCTIONS WHICH ALWAYS IMPROVED WITH HOSPITALIZATION, IV FLUIDS AND ANTIBIOTICS. HAS SYMPTOMS OF PAIN, VOMITING, DISTENTION. TAKING ANTI EMETICS. ON (B)(6) 2011 - ADMITTED AGAIN FOR CONTINUED BOWEL

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 HYSTERECTOMY 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 MEDIATION EFFORT ON (B)(4) 2013 INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI SI HYSTERECTOMY PROCEDURE. THE PATIENT HAD A LARGE UTERUS AND IT WAS NOTED DURING THE SURGICAL PROCEDURE THAT THE PATIENT HAD FIBROIDS. DURING THE PROCEDURE, THE SURGEON REPORTEDLY HAD TO ENTER THE PATIENT'S VAGINA IN TWO SPOTS DUE TO THE DISTORTION OF THE ANATOMY CAUSED BY THE FIBROIDS. THESE SPOTS WERE REPAIRED VAGINALLY WITHOUT CONSEQUENCE AT THE SURGERY. THERE WERE NO COMPLICATIONS NOTED AT THE TIME OF THE SURGERY. THE PATIENT WAS DISCHARGED HOME THE NEXT DAY AND ON (B)(6) 2011, THE PATIENT EXPERIENCED PROBLEMS. A CT SCAN PERFORMED ON (B)(6) 2011 NOTED A POSSIBLE BLADDER INJURY. ON (B)(6) 2011, THE PATIENT UNDERWENT A SURGICAL VAGINAL REPAIR OF A VESICOVAGINAL FISTULA WITH LEFT URETERAL CATHETER PLACEMENT, ATTEMPTED RIGHT URETERAL CATHETER PLACEMENT, AND CYSTOSCOPY. IN (B)(6) 2011 THE PATIENT WAS RE-ADMITTED AND THE PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY WITH ABDOMINOVESICAL FISTULA REPAIR ON (B)(6) 2011. THE PATIENT WAS DISCHARGED AFTER TWO 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: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI S RADICAL PARAMETRECTOMY, UPPER VAGINECTOMY, BILATERAL PELVIC LYMPH NODE DISSECTION, BILATERAL COMPLETE URETEROLYSIS, AND LEFT URETERAL STENT PLACEMENT FOR UNEXPECTED DIAGNOSIS OF AN ENDOCERVICAL ADENOCARCINOMA AFTER HYSTERECTOMY AND RETROPERITONEAL FIBROSIS ON (B)(6) 2011. INTUITIVE SURGICAL WAS PROVIDED WITH OPERATIVE REPORTS (2X (B)(6) 2011). ADDITIONAL INFORMATION PROVIDED INCLUDES: HISTORY AND PHYSICAL (H&P) (B)(6) 2011, DISCHARGE SUMMARY (B)(6) 2011, OUTSIDE SLIDE REPORT - (B)(6) 2011, ONCOLOGY CONSULTATION (B)(6) 2011 THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS REPORT OF AN INTRAOPERATIVE CYSTOTOMY DURING URETEROLYSIS OF THE LEFT URETER. THE OPERATION WAS INITIATED WITH BILATERAL PLACEMENT OF URETERAL CATHETERS, THEN AN EEA SIZER WAS PLACED IN THE VAGINA AND A PNEUMOPERITONEUM CREATED THROUGH A SUPRAUMBILICAL INCISION. ON INSPECTION THERE WAS EVIDENCE OF SIGNIFICANT RETROPERITONEAL FIBROSIS ON THE LEFT OF THE PELVIS. DENSE ADHESIONS OF HER RECTOSIGMOID COLON TO THE LEFT PELVIC SIDEWALL

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 AND THE MEDICAL RECORDS OF A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY ON (B)(6) 2011 FOR SEVERE MENORRHAGIA WITH FIBROIDS. THE OPERATIVE REPORT FOR THE DA VINCI SI PROCEDURE WAS NOT PROVIDED; HOWEVER, MEDICAL RECORDS FROM FOLLOW UP VISITS INDICATE THAT THE PATIENT DID NOT SUSTAIN ANY APPARENT INTRAOPERATIVE INJURY. PATIENT WAS DISCHARGED THE NEXT DAY. ON (B)(6) 2011, THE PATIENT REPORTED INCREASING ABDOMINAL PAIN AND PRESENTED TO THE EMERGENCY ROOM. SHE UNDERWENT A DIAGNOSTIC LAPAROSCOPY AND INTRA-ABDOMINAL WASHOUT FOR POST-OPERATIVE PERITONITIS WITH PELVIC HEMATOMA. LATER THE SAME MONTH, THE PATIENT RECEIVED A RIGHT URETERAL STENT FOR RIGHT URETEROVAGINAL FISTULA. IN (B)(6) 2011, A CYSTOSCOPY REVEALED THAT THE URETEROVAGINAL FISTULA HAS HEALED AND THE STENT WAS REMOVED. IN NOVEMBER 2012, THE PATIENT HAD COMPLAINTS OF POST COITAL BLEEDING WITH NO PAIN. IN (B)(6) 2012, THE PATIENT UNDERWENT A REVISION OF VAGINAL CUFF FOR A SMALL VAGINAL CUFF DEFECT. THE PATIENT'S CURRENT CONDITION WAS NOT 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-ASSISTED HYSTERECTOMY ON (B)(6) 2011 FOR PELVIC PAIN, MENORRHAGIA, AND FIBROID UTERUS. ISI WAS PROVIDED WITH THE OPERATIVE REPORT AND THE PATIENT'S MEDICAL RECORDS. PER THE OPERATIVE REPORT, THE UTERUS AND CERVIX REQUIRED MORCELLATION TO REMOVE DUE TO SIZE. THE VAGINAL CUFF WAS ALSO LEFT TO CLOSE ON ITS OWN, AS IT WAS NOTED TO BE VERY DEEP AND HIGH AND PROVED TO BE TECHNICALLY VERY DIFFICULT TO CLOSE. THE VAGINA WAS SUBSEQUENTLY PACKED WITH 1 INCH IODOFORM TAPE. NO OPERATIVE COMPLICATIONS WERE NOTED AND THE ESTIMATED BLOOD LOSS WAS 150 ML. THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2011. A DISCHARGE SUMMARY WAS NOT AVAILABLE FOR REVIEW. THE PATIENT PRESENTED TO HER DOCTOR THE DAY AFTER DISCHARGE FOR A MASS IN HER VAGINA. HER VAGINAL PACKING WAS REMOVED AND SHE WENT HOME. ON (B)(6) 2011, THE PATIENT PRESENTED TO THE ER WITH COMPLAINTS OF SEVERE FLANK PAIN AND WAS ADMITTED WITH PRESUMED PYELONEPHRITIS. SHE WAS TREATED WITH ANTIBIOTICS, AND A CT IVP SHOWED NO INJURY TO THE RIGHT URETER AND INCOMPLETE VISUALIZATION OF THE LEFT URETER. PERSISTENT COPIOUS WATERY VAGI

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 FOR CHRONIC PAIN AND UTERINE LEIOMYOMATA ON (B)(6) 2011. ISI WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES FOLLOW UP MEDICAL NOTES. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI S SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING SURGERY. HOWEVER, THERE WAS AN INADVERTENT CYSTOTOMY PERFORMED AT THE APEX OF THE BLADDER DUE TO EXTENSIVE INTRAABDOMINAL ADHESIONS AND A SMALL BOWEL HERNIA INVOLVING SMALL BOWEL, BLADDER AND THE ANTERIOR ABDOMINAL WALL PERITONEUM. THIS CYSTOTOMY WAS CLOSED PRIMARILY WITH A WATERTIGHT TWO-LAYERED CLOSURE. ON (B)(6) 2011, THE PATIENT PRESENTED WITH VAGINAL BLEEDING AND WAS FELT TO HAVE A DRAINING HEMATOMA. THE SYMPTOMS RESOLVED.

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 PROSTATECTOMY WITH BILATERAL PELVIC LYMPH NODE DISSECTION FOR PROSTATE CANCER ON (B)(6) 2011. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT FOR THE PRIMARY SURGERY AND THE FOLLOW UP OPERATIONS, BUT NO MEDICAL HISTORY OR IMAGING REPORTS. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING SURGERY. THE PROSTATECTOMY WAS STARTED WITH EXPOSURE AND SHARP TRANSECTION OF THE BLADDER NECK, FOLLOWED BY DIVISION OF VAS DEFERENS, DISSECTION OF THE SEMINAL VESICLES, AND PROSTATIC PEDICLES. THE LEFT NEUROVASCULAR BUNDLE WAS CLIPPED SECONDARY TO HIGH VOLUME DISEASE ON THE LEFT. THE APEX WAS DISSECTED, DORSAL VENOUS COMPLEX CAUTERIZED AND DIVIDED AND THE URETHRA SHARPLY DIVIDED. IN ADDITION THERE WAS SIGNIFICANT BLEEDING FROM THE BLADDER NECK AND PROSTATIC PEDICLE ON THE LEFT WHICH WAS CONTROLLED WITH SEVERAL SUTURES. THERE WAS NO EVIDENCE OF RECTAL INJURY AT THE TIME PELVIC LYMPH NODES WERE THEN DISSECTED, CLIPPED AND REMOVED TO THE OBTURATOR NERVE. THE URETHRAL/BLADDER NECK ANASTOMOSIS WAS COMPLETED. AFTER COMPLETION

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: CAUTERY SPATULA USED DURING A LUNG PROCEDURE WAS MISSING PART OF THE PROTECTIVE SHEATH ON THE END OF THE INSTRUMENT.

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 LEGAL COMPLAINT CONCERNING A PATIENT WHO UNDERWENT A DA VINCI SI PROSTATECTOMY PROCEDURE ON (B)(6) 2011. THE LEGAL COMPLAINT CLAIMED THAT THE ROBOTIC DEVICE IS DEFECTIVE AND THAT DURING THE COURSE OF THE SURGERY, THE PATIENT SUSTAINED SIGNIFICANT INJURIES TO THIS INTESTINES AND SMALL BOWELS BY THE USE OF THE DA VINCI SURGICAL ROBOT. IN ADDITION, THE LEGAL COMPLAINT INDICATED THAT THE ROBOTIC SURGERY WAS CONVERTED TO AN OPEN LAPAROTOMY SURGERY WITH REPAIR OF LACERATIONS AND TEARS OF THE INTESTINES AND SMALL BOWELS. THE LEGAL COMPLAINT ALSO CLAIMED THAT DUE TO THE LACERATIONS AND TEARS TO HIS SMALL BOWELS BY THE DA VINCI ROBOTIC SURGERY, THE PATIENT WOULD SPEND THE NEXT FORTY-FOUR DAYS IN THE HOSPITAL. ACCORDING TO THE LEGAL COMPLAINT, THE PATIENT DEVELOPED FEVERS, CONFUSION, ABDOMINAL DISTENSION AND TENDERNESS DUE TO HIS INJURIES, AND ALSO BOUTS OF SEPSIS, SUFFERED ABSCESSES AND GIANT FISTULA. AS A RESULT OF THE INJURIES, THE LEGAL COMPLAINT ALSO INDICATED THAT THE PATIENT HAD TO HAVE MULTIPLE ADDITIONAL OPERATIONS AND HAS SUFFERED PAIN, LOSS OF FUNCTION, EMOTIONAL DISTRESS, AND PERMANENT INJURY.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(4) 2013, INTUITIVE SURGICAL, INC. (ISI) RECEIVED A LEGAL COMPLAINT INDICATING THAT A PATIENT WHO UNDERWENT A DA VINCI SI PROSTATECTOMY PROCEDURE SUSTAINED BLADDER AND PELVIC WALL INJURIES. REPORTEDLY THE INJURIES SUSTAINED BY THE PATIENT CAUSED A SMALL BOWEL OBSTRUCTION WITH 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: ON APRIL 16, 2012 ISI RECEIVED A LEGAL SUMMONS INDICATING ON (B)(6) 2011, THE PATIENT UNDERWENT A DA VINCI S HYSTERECTOMY PROCEDURE AT (B)(6). DURING THE SURGICAL PROCEDURE THE PATIENT SUSTAINED INJURIES TO HER LEFT URETER AND BLADDER. THE PLANNED SURGICAL PROCEDURE WAS CONVERTED TO OPEN LAPAROTOMY SURGERY WITH REPAIR OF THE BLADDER INJURY. THE PATIENT WAS GIVEN TWO UNITS OF PACKED RED BLOOD CELLS DUE TO BLOOD LOSS DURING SURGERY. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2011. ON (B)(6) 2011, THE PATIENT BEGAN HAVING SEVERE PAIN IN HER BACK AND NOTICED THAT SHE WAS PASSING URINE THROUGH HER VAGINA. SECONDARY TO THIS, THE PATIENT WENT BACK TO THE HOSPITAL AND HAD RADIOLOGY TESTS PERFORMED WHICH, CONFIRMED THAT THE PATIENT HAD A URETERAL INJURY REQUIRING AN IMMEDIATE DIVERSIONARY NEPHROSTOMY TUBE TO BE PLACED BY A RADIOLOGIST. A PERCUTANEOUS NEPHROSTOMY TUBE WAS PLACED AND THE STENT WAS ABLE TO PASS FREELY INTO THE BLADDER. THE PATIENT WAS OUTFITTED WITH A NEPHROSTOMY BAG TO COLLECT HER URINE. THE PATIENT WAS THEN TAKEN BACK TO THE OPERATING ROOM AND THE URETERAL STENT IN THE LEFT URETER WAS INTERNALIZED. THIS ALLOWED FOR THE DISCONTINUATION OF THE NEPHROSTOMY BAG. ON (

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 TOTAL HYSTERECTOMY AND BILATERAL SALPINGO-OOPHORECTOMY FOR PERSISTENT POSTMENOPAUSAL VAGINAL BLEEDING 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. PATIENT WAS NOTED TO HAVE NORMAL EXTERNAL ANATOMY. LAPAROSCOPIC VISUALIZATION OF THE ABDOMEN AND PELVIS NOTED PARAOVARIAN ADHESIONS CONSISTENT WITH OLD INFLAMMATORY DISEASE. IT WAS ALSO NOTED THAT THERE WERE A FILMY CULD-DE-SAC ADHESIONS. THE UTERUS WAS NOTED AS UNREMARKABLE. THE FALLOPIAN TUBES WERE NOTED AS DEMONSTRATING PRIOR LIGATION. THE PATIENT WAS PLACED IN STANDARD POSITIONING FOR HYSTERECTOMY. A FOLEY CATHETER AND V-CARE UTERINE MANIPULATOR WERE PLACED. THE VERRES NEEDLE WAS INSERTED INTRAPERITONEALLY THROUGH A 12MM EPIGASTRIC INCISION. ALL PORTS WERE PLACED UNDER DIRECT VISUALIZATION IN 15MMHG OF INSUFFLATION. THE PROCEDURE FLOW WAS AS FOLLOWS: -OPENING OF THE PERITONEUM OVERLYING THE RIGHT PELVIC SIDEWALL -WIDE D

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 AND MEDICAL RECORDS OF A PATIENT WHO UNDERWENT A DA VINCI S HYSTERECTOMY PROCEDURE ON (B)(6) 2011. THE PATIENT HAD A LONG HISTORY OF DYSFUNCTIONAL BLEEDING, MENORRHAGIA, AND PELVIC PAIN. THE PATIENT HAS HAD PREVIOUSLY 9 LAPAROSCOPIES, ONE OF WHICH RESULTED IN A RIGHT SALPINGO OOPHORECTOMY. IN ADDITION, SHE HAS HAD 2 PRIOR CESAREAN SECTIONS. ACCORDING TO THE OPERATIVE REPORTS, THERE WAS A LITTLE BIT OF OOZING COMING FROM THE OMENTUM, WHEN PUTTING IN THE VERESS NEEDLE AND TROCAR. THE SURGEON NOTED SOME BLOOD AROUND THE OMENTUM; HOWEVER, NO OBVIOUS BOWEL OR OTHER INJURY WAS IMMEDIATELY APPARENT. THE SURGEON DECIDED TO CONTINUE WITH THE HYSTERECTOMY PROCEDURE UNTIL MORE OOZING WAS NOTED TO BE COMING FROM THE UPPER ABDOMINAL AREA. THERE WAS AN AREA OF HEMATOMA OVER THE SACRAL REGION OBSERVED FOR SEVERAL MINUTES. SINCE IT WAS NOT EXPANDING, A DECISION WAS MADE TO CONTINUE TO RECHECK IT. THE SURGEON COMPLETED THE HYSTERECTOMY PROCEDURE AND THEN WENT BACK TO RECHECK THE AREA OF HEMATOMA. THE SURGEON DECIDED TO CONSULT WITH A VASCULAR SURGEON. THE VASCULAR SURGEON INSPECTED THE AREA LAPAROSCOPICALLY AND

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED FROM A FACILITY IN EUROPE THAT DURING A DA VINCI SI HYSTERECTOMY PROCEDURE AND WHILE PERFORMING PARA-AORTIC LYMPH NODE DISSECTION, THE SURGEON POSITIONED THE RIGHT MASTER TOOL MANIPULATOR (MTMR) TOWARD THE UPPERMOST BOUNDARY OF HIS AVAILABLE MTM WORKSPACE. THE SURGEON REMOVED HIS FINGERS FROM THE MTMR WHILE HIS HEAD WAS IN THE SURGEON CONSOLE VIEWER (CONTRARY TO A WARNING IN THE LABELING), AND THE INSTRUMENT ASSOCIATED WITH THE MTMR DROPPED DOWN IN AN UNCONTROLLED MANNER, AND CUT THE PATIENT'S ABDOMINAL AORTA. THE PLANNED SURGICAL PROCEDURE WAS CONVERTED TO TRADITIONAL OPEN SURGERY AND THE PATIENT'S AORTA WAS REPAIRED BY PLACEMENT OF A STENT. THE PLANNED HYSTERECTOMY PROCEDURE WAS ALSO COMPLETED. AS OF THE DATE OF THIS REPORT, THE PATIENT IS REPORTED TO BE RECOVERING WITH NO COMPLICATIONS AND WAS DISCHARGED FROM THE HOSPITAL A WEEK AFTER THE OPERATION.

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 PANCREATECTOMY AND SPLENECTOMY PROCEDURE ON (B)(6) 2011. NO INTRA-OPERATIVE COMPLICATIONS WERE DOCUMENTED IN THE OPERATIVE REPORT FOR THE DA VINCI SI SURGICAL PROCEDURE. THE SURGEON NOTED THAT THE PATIENT TOLERATED THE PROCEDURE WELL AND WITHOUT COMPLICATIONS. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2011. THERE WERE NO REPORTS OF A MALFUNCTION OF THE DA VINCI SI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY DURING THE SURGICAL PROCEDURE. ON (B)(6) 2011, THE PATIENT WAS ADMITTED TO A HOSPITAL FOR A REPORTED COMPLAINT OF GRADUALLY WORSENING ABDOMINAL PAIN. A CT SCAN REVEALED THAT THE PATIENT HAD POST-OPERATIVE AND RECURRENT PANCREATITIS. THE CT SCAN ALSO FOUND SMALL CYSTIC MASSES ON THE PANCREAS. ON (B)(6) 2011, THE PATIENT UNDERWENT A PANCREATIC DEBRIDEMENT PROCEDURE AS WELL AS DEBRIDEMENT OF MULTIPLE PERIPANCREATIC ABSCESSES. TWO DRAINS WERE PLACED DURING THE PROCEDURE. THE OPERATIVE REPORT INDICATED THAT THE PATIENT TOLERATED THE PROCEDURE WELL AND WITHOUT COMPLICATIONS. ACCORDING TO THE PATIENT'S MEDICAL RECO

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. RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI SI RIGHT ANTEGRADE PERCUTANEOUS URETEROSCOPY WITH STONE MANIPULATION (NON-ROBOTIC) FOLLOWED BY A ROBOTIC-ASSISTED BILATERAL URETERO NEOCYSTOSTOMIES WITH BILATERAL URETERAL STENT PLACEMENTS AND RIGHT PSOAS HITCH FOR REPAIR OF A PRIOR URETERAL INJURY ON (B)(6) 2011. ISI WAS PROVIDED WITH THE OPERATIVE REPORT. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THE LEFT URETER WAS INADVERTENTLY CUT AND SUBSEQUENTLY REPAIRED BY THE SURGEON. THE PATIENT WAS DISCHARGED TO THE RECOVERY ROOM IN STABLE CONDITION. THERE WAS A REPORT OF A POST-OPERATIVE COMPLICATION, SPECULATED TO BE THE RESULT OF PATIENT ARM POSITION DURING THE 7 1/2 HOUR PROCEDURE. UPON WAKING UP FROM THE SURGERY ON (B)(6) 2011 THE PATIENT PRESENTED WITH BLISTERING AND UPPER EXTREMITY PAIN THAT WAS SIGNIFICANTLY REDUCED IN THE HOURS FOLLOWING THE PROCEDURE. COMPARTMENT SYNDROME, WHILE INITIALLY SUSPECTED, WAS SUBSEQUENTLY RULED OUT. NO ADDITIONAL INFORMATION WAS PROVIDED AFTER THE DATE OF THE 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 CONCERNING A PATIENT WHO UNDERWENT A DA VINCI SI TOTAL LAPAROSCOPIC HYSTERECTOMY WITH LEFT SALPINGO-OOPHORECTOMY AND RIGHT SALPINGECTOMY AND DIAGNOSTIC CYSTOSCOPY PROCEDURE ON (B)(6) 2011. ACCORDING TO THE INFORMATION PROVIDED, THE PATIENT WAS FOUND TO HAVE BOWEL ADHESIONS TO THE ANTERIOR UTERINE SURFACE AND OMENTAL ADHESIONS TO THE ANTERIOR ABDOMINAL WALL DURING THE SURGICAL PROCEDURE PERFORMED ON (B)(6) 2011. THE OPERATIVE REPORT STATES THAT GREAT USE OF CAUTERY WAS USED DURING THE PROCEDURE. A DIAGNOSTIC CYSTOSCOPY WAS PERFORMED AND FOUND TO BE UNREMARKABLE. THE DIAGNOSTIC CYSTOSCOPY ALSO REVEALED GOOD FLOW FROM BOTH URETERAL ORIFICES. THE PATIENT WAS REPORTEDLY DISCHARGED ON AN UNSPECIFIED DATE AFTER AN UNREMARKABLE STAY. ON AN UNSPECIFIED DATE IN LATE (B)(6) 2011, THE INFORMATION INDICATED THAT THE PATIENT BEGAN EXPERIENCING BROWN VAGINAL DISCHARGE AS WELL AS FLATULENCE FROM HER VAGINA. BASED ON VISITS WITH A PHYSICIAN IN LATE (B)(6) 2011, THE PHYSICIAN NOTED THAT THE PATIENT WAS HAVING INTERCOURSE WITH HER SPOUSE. HOWEVER, THE PATIENT ADAMANTLY DENIED THAT THIS WAS THE CASE