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 PROSTATECTOMY AND LYMPHADENECTOMY ON (B)(6) 2012. ISI WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES PATHOLOGY REPORT AND OFFICE NOTES. ACCORDING TO THE PATIENT'S OPERATIVE REPORT, DURING THE PRIMARY SURGICAL PROCEDURE, A SMALL RECTOTOMY DISCOVERED WHICH WAS CLOSED AT THE END OF THE SAME PROCEDURE. THIS WAS DISCOVERED DURING DISSECTION OF LEFT SIDE OF PROSTATE GLAND. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI S SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING SURGERY. THE PATIENT HAD NO APPARENT POST OPERATIVE COMPLICATIONS AND HE WAS DISCHARGED HOME ON (B)(6) 2012. THE PATIENT'S FOLLOW UP CARE WAS NORMAL.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE FOLLOWING PATIENT STORY CONCERNING A DA VINCI SI HYSTERECTOMY PROCEDURE PERFORMED ON (B)(6) 2012, AT (B)(6) WAS FOUND POSTED ON THE (B)(6) BY INTUITIVE SURGICAL ON (B)(6) 2012. AFTER TRYING OTHER MEASURES FAILED TO STOP THE BLEEDING AND PAIN OF FIBROIDS A HYSTERECTOMY WAS NECESSARY. THE PROCEDURE WAS SIMPLE AND SCARING AND BLEEDING WERE MINIMAL. THE FIRST 2 WEEKS WENT BY SMOOTHLY AND THE PAIN WAS GONE WITHIN THE FIRST FEW DAYS. THE BIGGEST INCONVENIENCE WAS NOT BEING ABLE TO DRIVE FOR 2 WEEKS. THEN I HAD A TURN FOR THE WORSE. THE DAY AFTER MY 2 WEEK FOLLOW UP APPOINTMENT I STARTED TO BLEED HEAVILY. I WAS SOAKING A PAD AN HOUR. THE ON-CALL SURGEON DID NOT SEEM TO THINK IT WAS SERIOUS AND ADVISED TO WAIT 4 HOURS AND GO TO THE ER IF IT CONTINUED. THE ER DOCTOR DID AND PHYSICAL EXAM AND DID NOT SEE ANY SIGNS OF A RUPTURE. HE TOO CONSULTED THE ON-CALL SURGEON WHO SUGGESTED I BE RELEASED AND TO CONTACT MY DOCTOR THE FOLLOWING MORNING. ON THE WAY HOME FROM THE ER I BEGAN TO EXPERIENCE INTENSE PAIN IN MY LOWER BACK AND CRAMPS EQUIVALENT TO CONTRACTIONS. I FELT A HUGE GUSH OF BLOOD AND FAINTED. THE AMBULANCE WAS CALLED AND I WAS TAKEN BACK TO THE ER BY THIS TIME I HAD BEEN BLEEDING FOR

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 WITH BILATERAL SALPINGO-OOPHORECTOMY PROCEDURE ON (B)(6), 2012 DUE TO MENORRHAGIA, PELVIC PAIN AND HYDROSALPINX. ISI WAS PROVIDED WITH THE PATIENT'S PRIMARY OPERATIVE REPORT. ADDITIONAL INFORMATION REGARDING THE PATIENT WAS PROVIDED IN 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 SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. ACCORDING TO THE INFORMATION PROVIDED IN THE PATIENT'S CLAIM FORM, ON (B)(6), 2012, THE PATIENT EXPERIENCED HEAVY BLEEDING AND WAS HAVING PAIN. THIS OCCURRED AFTER PICKING UP HER (B)(6) CHILD. THE PATIENT WAS INFORMED TO GO TO ER FOR URTGENT CARE EVALUATION. REPORTEDLY, ON (B)(6), 2012 THE PATIENT PRESENTED TO THE ER, COMPLAINING OF PAIN AFTER ENGAGING IN INTERCOURSE THE PREVIOUS NIGHT. THE PATIENT WAS EVALUATED AND IT WAS DISCOVERED THAT THE PATIENT HAD CUFF SEPARATION. SEROSAGINOUS FLUID IN THE VAULT, CUFF DEHISCED. THE PATIENT UNDERWENT A PROCEDURE TO REPAIR HER CUFF. ON (B)(6) 2012, THE PATIENT CONT

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 MEDIATION EFFORT, INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION INCLUDING MEDICAL RECORDS CONCERNING A PATIENT WHO SUSTAINED AN INJURY TO HER MESENTERIC VEIN PRIOR TO THE START OF A PLANNED DA VINCI SI BILATERAL PELVIC AND PARA-AORTIC LYMPHADENECTOMY PROCEDURE ON (B)(6), 2012. ACCORDING TO THE PROCEDURE NOTE, THE INJURY OCCURRED DURING TROCAR PLACEMENT FOR AN EXPLORATORY LAPAROTOMY FOR STAGING OF UTERINE CANCER. THE PATIENT HAD NOT YET BEEN DOCKED TO THE DA VINCI SI SURGICAL SYSTEM AT THE TIME THE INJURY OCCURRED. THE PATIENT'S MEDICAL HISTORY INCLUDED RECENT TOTAL VAGINAL HYSTERECTOMY ((B)(6) 2012) THAT REVEALED STAGE IB ENDOMETRIAL CARCINOMA THAT REQUIRED SURGICAL STAGING. PRIOR TO THE START OF THE PLANNED SURGICAL PROCEDURE, THE PATIENT WAS INFORMED OF THE RISKS, BENEFITS, PERIOPERATIVE COMPLICATIONS, AND CONVALESCENCE RELATED TO THE PROCEDURE AND SURGICAL CONSENT WAS SIGNED. ACCORDING TO THE OPERATIVE REPORT, AT THE BEGINNING OF THE PLANNED SURGICAL PROCEDURE, A 12 MM TROCAR WAS PLACED SUPRAUMBILICALLY. THE PATIENT WAS NOTED TO HAVE MASSIVE OMENTAL ADHESIONS TO THE PELVIS, SMALL BOWEL, DESCENDING COLON, AND ANTERIOR ABDOMINAL WALL. UPON DIRECT INSERTION

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(4) 2014, INTUITIVE SURGICAL INC.(ISI) RECEIVED AN IMPORTER REPORT (B)(4) WITH THE FOLLOWING EVENT DESCRIPTION: PATIENT HAD ROBOTIC HYSTERECTOMY, THERE WERE TWO LARGE TEARS IN BOTH RIGHT AND LEFT LATERAL WALLS NEAR THE CUFF.

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 DAVINCI ROBOTIC HYSTERECTOMY ON (B)(6) 2012. 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 REPORTED AN INCIDENTAL CYSTOTOMY DURING THE CREATION OF THE BLADDER FLAP AS AN INTRAOPERATIVE COMPLICATION. ON (B)(6) 2012 PATIENT UNDERWENT HYSTERECTOMY WITH BSO AND CYSTOSCOPY WITH REPAIR OF INCIDENTAL CYSTOTOMY. THIS WAS CLOSED BY UROLOGIST DURING PROCEDURE. URETERS WERE IDENTIFIED AND PATENT AT END OF SURGERY, NOTED IN CYSTOSCOPY. DISCHARGED HOME THE NEXT DAY. ON (B)(6) 2012, THE PATIENT RETURN TO HOSPITAL FOR RIGHT URETERAL INJURY, LEAKING URINE FROM VAGINA. CYSTOSCOPY WITH BILATERAL RETROGRADE AND RIGHT URETEROSCOPY WITH STENT PLACEMENT PERFORMED. PATIENT WAS DISCHARGED NEXT DAY. THE PATIENT DID WELL WITH STENT AND RE-IMPLANTATION WAS NOT REQUIRED. NO FURTHER CLINICAL INFORMATION WAS PROVIDED.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI POLYP REMOVAL PROCEDURE ON (B)(6) 2012. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: 'SURGERY TOOK 5 1/2 HOURS INSTEAD OF 2 DUE TO SCAR TISSUE , HAD TO INTUBATE HIM BECAUSE HE COULD NOT BREATHE, A TEAR IN HIS INTESTINE, DEVELOPED A RASH WHOLE BACK TURNED BACK DOCTORS DID NOTHING, PASSED AWAY FOLLOWING MORNING AUTOPSY SHOWS AN INFECTION.'

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 CONCERNING A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY WITH SALPINGO-OOPHORECTOMY ON (B)(6) 2012. THE DOCUMENTATION RECEIVED STATES THAT THE PATIENT SUSTAINED VAGINAL DEHISCENCE AND PARTIAL EVISCERATION. ACCORDING TO THE LEGAL COMPLAINT, THE PATIENT WAS FOUND TO HAVE ADENOMYOSIS AND COLON ADHESIONS DURING THE SURGICAL PROCEDURE. A POST-OPERATIVE CYSTOSCOPY WAS FOUND TO BE NORMAL. THE LEGAL COMPLAINT ALSO INDICATED THAT THE SURGEON LATER NOTED IN AN OFFICE NOTE THAT SHE HAD TAKEN EXTRA CARE TO TAKE WIDE BITES OF TISSUE WITH CUFF CLOSURE DUE TO PATIENT HISTORY OF HEAVY SMOKING. THE PATIENT WAS REPORTEDLY DISCHARGED HOME IN STABLE CONDITION ON THE FIRST POST-OPERATIVE DAY. THE PATIENT WAS FOUND TO HAVE NO COMPLICATIONS DURING A POST-OPERATIVE FOLLOW-UP VISIT ON (B)(6) 2012. ON (B)(6) 2012, THE PATIENT WAS REPORTEDLY ADMITTED TO A HOSPITAL FOR A VAGINAL CUFF DEHISCENCE AND PARTIAL EVISCERATION. THE PATIENT UNDERWENT AN OPEN EXPLORATORY LAPAROTOMY WITH CLOSURE OF THE VAGINAL CUFF. THE INFORMATION RECEIVED STATED THE PATIENT HAS RECOVERED AND APPEARS TO BE DOING WELL. NO ADDITIO

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 FIBROIDS. PROCEDURE DATE IS UNKNOWN. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES MEDICAL RECORDS AND FOLLOW UP OPERATIVE AND PROGRESS REPORTS 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 . LAPAROSCOPIC ROBOTIC HYSTERECTOMY ON (B)(6) 2012. DISCHARGED HOME NEXT DAY IN STABLE CONDITION. ON (B)(6) 2012 VISIT TO UROLOGIST, BEGAN EXPERIENCING RIGHT FLANK AND GROIN PAIN AROUND 2-3 WEEKS POST OP. THEN LEAKAGE IN VAGINA.. ON (B)(6) 2012 CYSTOSCOPY WITH RETROGRADE PYELOGRAM. ATTEMPTED RIGHT URETERAL STENT PLACEMENT. COULD NOT PASS STENT. ON (B)(6) 2012- ROBOTIC RIGHT URETERAL REIMPLANTATION WITH PSOAS HITCH. ON (B)(6) 2012- STENT REMOVAL.

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 PROSTECTOMY WITH BILATERAL PELVIC LYMPH NODE DISSECTION ON (B)(6) 2013 FOR PROSTATE CANCER. ISI WAS PROVIDED WITH THE PATIENT'S OPERATIVE REPORTS FOR THE PRIMARY SURGERY AND THE EXPLORATORY LAPAROTOMY AND THE DISCHARGE SUMMARY. AFTER STANDARD ENTRY, THE ABDOMEN WAS INSPECTED FOR TROCAR OR VERESS NEEDLE INJURY WITH NO PATHOLOGY OBSERVED. ABUNDANT LOOPS OF SMALL BOWEL WERE FOUND SLIDING INTO THE PELVIS WHICH WERE RETRACTED. THE SURGEON PERFORMED A STANDARD PROSTATECTOMY WITH DISSECTION AND TRANSECTION OF SEMINAL VESICLES AND VAS DEFERENS. IT WAS NOTED THAT DURING THE DISSECTION LOOPS OF BOWEL KEPT SLIDING INTO THE PELVIS REQUIRING REPOSITIONING OF THE PROGRASP TO IMPROVE RETRACTION. THE PELVIC LYMPHNODE DISSECTION WAS COMPLETED TO THE LEVEL OF THE OBTURATOR NERVES. DURING THE LYMPHATIC DISSECTION THERE WAS INDICATION OF AN UNINTENTIONAL SUPERFICIAL CAUTERY INJURY TO THE EXTERNAL ILIAC VEIN BECAUSE OF A CRACK IN THE INSULATION SHEATH OF THE RIGHT ROBOTIC INSTRUMENT WHICH IS INTERPRETED TO BE A MONOPOLAR CURVED SHEARS. THE SHEATH COVER WAS REPLACED, AND THERE WE

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 REGARDING A PATIENT THAT UNDERWENT A DA VINCI SI HYSTERECTOMY PROCEDURE ON (B)(6) 2012. THE INFORMATION PROVIDED STATES THAT A FEW WEEKS POST OP, THE PATIENT DEVELOPED SIGNIFICANT URINARY INCONTINENCE. A CT SCAN SHOWED THAT THE PATIENT HAD RIGHT HYDRONEPHROSIS AND HYDROURETER DOWN TO THE PELVIS WITHOUT DISCREET FLUID COLLECTION TO THE VAGINAL WALL. THE FLUID WAS FOUND TO BE CONSISTENT WITH URINE. ON (B)(6) 2012, THE PATIENT UNDERWENT A 2ND DA VINCI SURGICAL PROCEDURE TO REPAIR HER URETER AND A CYSTOSCOPY WITH BILATERAL RETROGRADE PYELOGRAMS. URETERAL STENTS WERE PLACED TO REPAIR THE PATIENT'S URETER. HOWEVER, THE STENT PLACEMENT WAS UNSUCCESSFUL DUE TO URETERAL OBSTRUCTION AND A POSSIBLE URETEROVAGINAL FISTULA. A RIGHT NEPHROSTOMY TUBE WAS THEN PLACED. THE PATIENT TOLERATED THE PROCEDURE WELL AND AFTER COMPLETION OF THE PROCEDURE THE PATIENT WAS EXTUBATED AND TAKEN TO THE POST-ANESTHESIA CARE UNIT FOR ROUTINE POST-SURGICAL CARE. THE PATIENT WAS TRANSFERRED TO THE FLOOR AFTER BEING STABILIZED. THE PATIENT DID WELL POSTOPERATIVELY. THE PATIENT VOIDED SPONTANEOUSLY, HAD ADEQUATE 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 MEDIATION EFFORT ON 08/16/2013 INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION, INCLUDING MEDICAL RECORDS, OF A PATIENT WHO UNDERWENT A DA VINCI S PROCTECTOMY AND OOPHRECTOMY PROCEDURE FOR HER RECTAL CANCER ON (B)(6) 2012. IN THE MEDICAL RECORDS PROVIDED, THERE ARE SEVERAL NOTATIONS BY THE SURGEON THAT THE OPERATIVE RISKS, INCLUDING BLEEDING,ILEOSTOMY, AND INFECTION, WERE DISCUSSED WITH THE PATIENT. PER THE OPERATIVE REPORT, THE SURGERY FIRST COMMENCED LAPAROSCOPICALLY BEFORE THE DA VINCI SI SYSTEM WAS USED. DURING THE INITIAL LAPAROSCOPIC PART OF THE PROCEDURE, THE OPERATIVE REPORT DESCRIBED DISSECTION OF THE STRUCTURES (URETER, OMENTUM, KIDNEY, AND TRANSECTION OF THE INFERIOR MESENTERIC ARTERY AND INFERIOR MESENTERIC VEIN AS WELL AS THE COLON, WHICH WERE CARRIED OUT LAPAROSCOPICALLY WITH THE TAN GIA STAPLER. THE OPERATIVE REPORT DID NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. LATER THE SAME DAY, THE PATIENT DEVELOPED HYPOTENSION AND RETURNED TO THE OPERATING ROOM FOR AN EXPLORATORY LAPAROSCOPY FOLLOWED BY LAPAROTOMY TO CONTROL HER BLEEDING FROM MULTIPLE INTRA-ABDOMINAL BLOOD VESSELS AND CREATION OF ILEOSTOMY.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY WITH PELVIC LYMPHADENECTOMY FOR STAGE A SQUAMOUS CELL CANCER OF THE CERVIX WITH ADENOPATHY OF THE OMENTUM ON (B)(6) 2012. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES FOLLOW UP CARE REPORTS FROM THE HOSPITAL. 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) 2012 PATIENT PRESENTED WITH ABDOMINAL PAIN AND DISTENSION. ON (B)(6) 2012, A CT SCAN WITH CONTRAST OF THE PATIENT'S ABDOMEN AND PELVIS REVEALED MULTIPLE PELVIC FLUID COLLECTIONS CONSISTENT WITH ABSCESSES. THE PATIENT UNDERWENT CT GUIDED DRAINAGE OF A MODERATE-SIZED COLLECTION IN THE RIGHT PARACOLIC SPACE. A CYSTOSCOPY SHOWED A RIGHT URETERAL INJURY WITH LEAKAGE INTO THE PERITONEAL CAVITY. A RIGHT URETER STENT WAS PLACED. ON (B)(6) 2012, THE PATIENT DRAINAGE OF A PELVIC ABSCESS PER THE VAGINA AND REMOVAL OF A PERCUTANEOUS. ON (B)(6) 2013 A RETROGRADE PYELOGRAM REVEALED DAMAGE TO THE DISTAL RIGHT URETER. ON (B)(6) 2013 THE

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL MEDIATION EFFORT ON (B)(6) 2013 INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION, INCLUDING MEDICAL RECORDS, OF A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY PROCEDURE ON (B)(6) 2012 FOR ENDOMETRIAL ADENOCARCINOMA. ACCORDING TO THE OPERATIVE NOTES, THE PATIENT HAD A NORMAL SIZE APPROXIMATELY 6 WEEK UTERUS WITH NORMAL BILATERAL TUBES AND OVARIES, NO GROSS LESIONS SEEN. THERE WAS A MINIMAL AREA OF ADENOCARCINOMA SEEN IN THE ENDOMETRIUM; HOWEVER, NO MYOMETRIAL INVASION WAS PRESENT. ALL LYMPH NODES WERE NORMAL IN APPEARANCE WITH NO EVIDENCE OF METASTATIC DISEASE. NO DAMAGE TO BOWEL, BLADDER, OR BLOOD VESSELS WAS NOTED THROUGHOUT THE PROCEDURE. THE PATIENT DID NOT HAVE ANY COMPLICATIONS DURING THE PROCEDURE AND WAS TAKEN TO THE RECOVERY ROOM IN GOOD CONDITION. THERE WAS NO ALLEGATION OR REPORT OF A MALFUNCTION OF THE DA VINCI SYSTEM, INSTRUMENTS, OR ACCESSORIES IN THE OPERATIVE REPORT. THE POST OPERATIVE HOSPITAL COURSE WAS WITHOUT COMPLICATION AND THE PATIENT WAS DISCHARGED ON (B)(6) 2012 IN STABLE CONDITION. ACCORDING TO THE MEDICAL RECORD, APPROXIMATELY 2 WEEKS AFTER THE DA VINCI SURGICAL PROCEDURE ((B)(6) 2012), THE PAT

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 TO HAVE SUSTAINED A PERFORATED A COLON. 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 MEDIATION EFFORT, ON JULY 25TH, 2013 INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION INCLUDING MEDICAL RECORDS CONCERNING A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY, LEFT SALPINGO-OOPHORECTOMY, ADHESIOLYSIS, AND CYTOSCOPY PROCEDURE ON (B)(6) 2012. THE LEGAL COMPLAINT ALLEGED THAT THE PATIENT SUSTAINED VAGINAL CUFF DEHISCENCE AS A RESULT OF A ROBOTIC-ASSISTED HYSTERECTOMY. ACCORDING TO THE LEGAL COMPLAINT, MULTIPLE ADHESIONS WERE FOUND ON THE LEFT ABDOMINAL WALL, THE CUL-DE-SAC AND LEFT PELVIC GUTTER, AND AROUND THE LEFT ADNEXAL MASS DURING THE SURGERY. IN ADDITION, THE LEGAL COMPLAINT INDICATED THAT THE PROCEDURE WAS TOLERATED WELL AND NO COMPLICATIONS WERE NOTED. BASED ON THE OPERATIVE REPORT, A CYSTOSCOPY WAS PERFORMED AT THE CONCLUSION OF THE SURGICAL PROCEDURE WHICH CONFIRMED GOOD EFFLUX OF INDIGO CARMINE FROM BOTH URETERS. ALSO, IT WAS NOTED IN THE OPERATIVE REPORT THAT THERE WERE NO INJURIES TO THE BLADDER WALL AND THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. ON (B)(6) 2012, THE PATIENT WAS EVALUATED AT A CLINIC FOR COMPLAINTS OF HEAVY BLEEDING AND CLOTS, NOTED TO BE THE SECOND EPISODE OF BLEEDING. THE INFORMATION PROVIDED INDI

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT 1 DAY AFTER A DA VINCI S HYSTERECTOMY PROCEDURE WAS SUCCESSFULLY PERFORMED, THE PATIENT EXPIRED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI HYSTERECTOMY PROCEDURE ON (B)(6) 2012 FOR MENORRHAGIA. ISI WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDED SOME OF THE HOSPITAL RECORDS AND DOCUMENTATION REGARDING THE PATIENT INJURIES. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS AN INTRAOPERATIVE COMPLICATION. THE OPERATIVE REPORT DETAILED A PELVIC SIDEWALL RENT AND A HEMATOMA, WHICH WAS SUTURED AND OBSERVED AND FELT NOT TO BE EXPANDING. THE HYSTERECTOMY PROCEEDED TO COMPLETION. THE PATIENT PROCEEDED TO RECOVERY WHERE SHE HAD AN EPISODE OF HYPOTENSION, WHICH SEEMED RESPONSIVE TO FLUIDS, 2 UNITS OF PACKED RBC'S, AND VOLUME EXPANDERS. THEN FOR 9 HOURS OR SO, SHE WAS ON THE MEDICAL FLOOR, BUT EVENTUALLY BECAME AGITATED, LOST CONSCIOUSNESS AND WAS FOUND TO HAVE A LOWER THAN EXPECTED HEMOGLOBIN. SHE RETURNED TO THE OPERATING ROOM WHERE SHE WAS FOUND TO HAVE AN INJURY TO THE DISTAL RIGHT ILIAC ARTERY. THIS WAS RETROPERITONEAL AND HAD TO BE REPAIRED BY A VASCULAR TEAM. THE PATIENT SUFFERED A VARIETY OF

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: PHYSICIAN WAS PERFORMING A ROBOTIC HYSTERECTOMY. SHE REQUESTED TO PREPARE FOR AN OPEN PROCEDURE. THE STAFF OBSERVED ON THE MONITOR THAT THERE WAS SOME BLEEDING. WE BEGAN GATHERING ITEMS TO OPEN. PHYSICIAN REQUESTED A SUTURE AND THE BLEEDING SUBSIDED. SHE PUT A STITCH WHERE THE HEMATOMA WAS TO SEE IF IT WAS GETTING ANY BIGGER. IT APPEARED NOT TO. WE DID NOT GO OPEN. SHE THEN FINISHED THE PROCEDURE AND CHECKED AGAIN FOR BLEEDING AND CHECKED THE HEMATOMA AREA, IT SEEMED THE SAME AND THEN SHE CLOSED. PATIENT WAS TRANSPORTED TO RECOVERY. HOWEVER IT WAS REPORTED TO US LAST WEEK THAT THIS PATIENT HAD OTHER COMPLICATIONS AND WENT INTO HEMORRHAGIC SHOCK THE MORNING AFTER HER INITIAL SURGERY. AND SHE WAS TAKEN EMERGENTLY FOR AN EXPLORATORY LAPAROTOMY AND WAS FOUND TO HAVE AN INJURY TO HER RIGHT EXTERNAL ILIAC ARTERY.

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 SEPTEMBER 5, 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION FROM AN ATTORNEY REPRESENTING A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY PROCEDURE ON (B)(6) 2012, AND ALLEGED TO HAVE INJURIES INCLUDING INCONTINENCE, ABDOMINAL PAIN, TROUBLE USING RESTROOM, RECTAL BLEEDING, HEADACHES, AND DIZZINESS POST-SURGERY. 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 WHO UNDERWENT A DA VINCI SI HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY (BSO) FOR ADENOMYOSIS AND BILATERAL OVARIAN CYSTS ON (B)(6) 2012. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES HOSPITAL OPERATIVE AND MEDICAL RECORD 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) 2012, PATIENT PRESENTED WITH COMPLAINTS OF ABDOMINAL PAIN AND WAS DIAGNOSED WITH OVARIAN VEIN THROMBOSIS AND WAS PLACED ON COUMADIN. ON (B)(6) 2012, SHE PRESENTED WITH ABDOMINAL PAIN AND A CAT SCAN SHOWED HYDROURETER UP TO THE LEVEL OF THE ILIAC VESSELS. THE PATIENT WAS TAKEN TO THE OR FOR A CYSTOURETHROSCOPY AND PLACEMENT OF A DOUBLE J-STENT WHICH WAS SUCCESSFUL NO FURTHER CLINICAL INFORMATION IS AVAILABLE

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 INCLUDING MEDICAL RECORDS CONCERNING A PATIENT WHO UNDERWENT A DA VINCI S HYSTERECTOMY PROCEDURE ON (B)(6) 2012. ACCORDING TO THE MEDICAL RECORDS, THE PATIENT DEVELOPED POST-OPERATIVE COMPLICATIONS. PRIOR TO THE DA VINCI S SURGICAL PROCEDURE, THE PATIENT WAS INFORMED OF THE RISKS OF THE SURGERY AND CONSENT WAS OBTAINED. THE PATIENT'S PRE-OPERATIVE DIAGNOSIS WAS SYMPTOMATIC UTERINE FIBROIDS. ACCORDING TO THE OPERATIVE REPORT, THE DA VINCI S HYSTERECTOMY PROCEDURE WAS COMPLETED WITHOUT ANY REPORTED COMPLICATIONS. UPON COMPLETION OF THE SURGICAL PROCEDURE, THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN SATISFACTORY CONDITION. SHE WAS DISCHARGED HOME FROM THE HOSPITAL ON POST-OPERATIVE DAY 1 ((B)(6) 2012). THERE WERE NO REPORTED MALFUNCTIONS OF THE DA VINCI S SYSTEM, AN INSTRUMENT, OR AN ACCESSORY IN THE OPERATIVE REPORT. ON (B)(6) 2012, THE PATIENT WAS EVALUATED IN AN EMERGENCY ROOM (ER) FOR A REPORTED COMPLAINT OF ABDOMINAL PAIN AND DIAGNOSED WITH PNEUMOPERITONEUM. THAT SAME DAY, THE PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY AND DRAINAGE OF A PELVIC ABSCESS. THE PATIENT ALSO UNDERWENT AN INCIDENTAL APPENDECTOMY DUE T

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT POST-OP A SUCCESSFUL DA VINCI S MITRAL VALVE REPAIR PROCEDURE, PERFORMED ON (B)(6) 2012, THE PATIENT EXPERIENCED MILD DYSPHAGIA, DYSARTHRIA AND A STRANGE TONGUE. A CT SCAN PERFORMED FOUND THAT THE PATIENT DEVELOPED A RIGHT BRAIN INFARCTION AND WAS TREATED WITH THE DRUG RADICUT. EXAMINATION OF THE PATIENT BY A NEUROLOGICAL PHYSICIAN CONFIRMED THAT THE PATIENT EXPERIENCED A BRAIN INFARCTION, WHICH RESULTED IN THE PATIENT DEVELOPING RIGHT SIDE TONGUE WEAKNESS. THE PATIENT SIDE SURGEON HAS REPORTED THAT THERE WAS NO RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE DA VINCI S SYSTEM, INSTRUMENT AND/OR ACCESSORIES, AS THERE WAS NO MALFUNCTION OF THE DA VINCI S SYSTEM, INSTRUMENT AND/OR ACCESSORIES DURING THE SURGICAL PROCEDURE. THE SITE HAS INDICATED THAT THE BRAIN INFARCTION EXPERIENCED BY THE PATIENT IS A POTENTIAL COMPLICATION OF INTRACARDIAC SURGERY WITH ARRESTED HEART.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: TEXT FROM PATIENT IDENTIFIER = (B)(6), MFR REPORT 2955842-2013-04055: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI PROSTATECTOMY PROCEDURE ON (B)(6) 2012 FOR HIGH RISK ADENOCARCINOMA OF THE PROSTATE AND SUBSEQUENTLY EXPIRED ON (B)(6) 2012. ISI WAS PROVIDED WITH THE DA VINCI OPERATIVE REPORT AND ADDITIONAL INFORMATION INCLUDING READMISSION NOTES AND LAB WORK. 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; HOWEVER, THE SURGEON EXPERIENCED DIFFICULTY CONTROLLING BLEEDING FROM THE DORSAL VENOUS COMPLEX SO THE DA VINCI SURGICAL PROCEDURE WAS CONVERTED TO AN OPEN LAPAROTOMY. TRANSFUSIONS WERE REQUIRED WITH RBC AND PLATELETS. THE PATIENT'S HEMATOCRIT WAS LOW (27%). SUPERFICIAL VENOUS THROMBOSIS WAS NOTED ON THE RIGHT LESSER SAPHENOUS VEIN. THE PATIENT WAS DISCHARGED ON (B)(6) 2012. THE PATIENT RETURNED TO THE EMERGENCY ROOM AND REPORTED URINE LEAKING AFTER MANIPULATION OF THE CATHETER AT HOME. ON (B)(6) 2012, A DRAINAGE CATHETER WAS PLACED IN ABDOMEN. ON (B)(6) 2012, THE PATIENT DEVELOPED

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 PROSTATECTOMY PROCEDURE ON (B)(6) 2012 FOR HIGH RISK ADENOCARCINOMA OF THE PROSTATE AND SUBSEQUENTLY EXPIRED ON (B)(6) 2012. ISI WAS PROVIDED WITH THE DA VINCI OPERATIVE REPORT AND ADDITIONAL INFORMATION INCLUDING READMISSION NOTES AND LAB WORK. 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; HOWEVER, THE SURGEON EXPERIENCED DIFFICULTY CONTROLLING BLEEDING FROM THE DORSAL VENOUS COMPLEX SO THE DA VINCI SURGICAL PROCEDURE WAS CONVERTED TO AN OPEN LAPAROTOMY. TRANSFUSIONS WERE REQUIRED WITH RBC AND PLATELETS. THE PATIENT'S HEMATOCRIT WAS LOW (27%). SUPERFICIAL VENOUS THROMBOSIS WAS NOTED ON THE RIGHT LESSER SAPHENOUS VEIN. THE PATIENT WAS DISCHARGED ON (B)(6) 2012. ON (B)(6) 2012, THE PATIENT RETURNED TO THE EMERGENCY ROOM AND REPORTED URINE LEAKING AFTER MANIPULATION OF THE CATHETER AT HOME. ON (B)(6) 2012, A DRAINAGE CATHETER WAS PLACED IN ABDOMEN. ON (B)(6) 2012, THE PATIENT DEVELOPED PULSELESS ELECTRICAL ACTIVITY AND COULD NOT BE RESUSC

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 CHRONIC PELVIC PAIN AND ENLARGED UTERUS ON (B)(6) 2012. FINDINGS INCLUDED ENDOMETRIOSIS AND FIBROIDS. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDED CERTAIN MEDICAL RECORDS REGARDING POSTOPERATIVE CARE. 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 OTHER THAN THE FINDING OF EXTENSIVE ADHESIONS, HOWEVER AFTER REVIEWING THE FOLLOW UP RECORDS, IT IS CLEAR THAT THE PATIENT'S LEFT URETER WAS TRANSECTED DURING THE INITIAL OPERATION, BUT THIS WENT UNRECOGNIZED UNTIL A FEW DAYS LATER ON (B)(6) 2012 THE PATIENT PRESENTED WITH INCREASING URINARY DIFFICULTY, BLOATING, ABDOMINAL PAIN AND NAUSEA. WORK UP INCLUDED CHEST X-RAY, URINALYSIS, CT SCAN OF THE PELVIS AND ABDOMEN. A 14 CM FLUID COLLECTION WAS FOUND. ON (B)(6) 2012 THE PATIENT RETURNED TO THE OR WHERE SHE UNDERWENT EXPLORATORY LAP, CYSTOSCOPY, RE-IMPLANTATION OF L URETER. THE ABDOMEN COULD NOT BE CLOSED DUE TO SWELLING

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 UNDERWENT LOWER ANTERIOR RESECTION FOR RECTOSIGMOID CANCER ON (B)(6) 2012. THE PATIENT'S OPERATIVE (OP) REPORT FOR THE DA VINCI LOW ANTERIOR RESECTION PROCEDURE INDICATES THAT THE PATIENT WAS FOUND TO HAVE A LARGE FRIABLE BLOODY MASS AND MASS IN THE RECTOSIGMOID. IN ADDITION THERE WERE LESIONS IN THE LIVER CONSISTENT WITH CYSTS. PER THE MEDICAL RECORDS, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT COMPLICATIONS. THE ABDOMEN WAS COPIOUSLY IRRIGATED, CLEAN AND DRIED. THE OP REPORTS DO NOT CONTAIN ANY INDICATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. DURING THE POST-OP RECOVERY PHASE, THE PATIENT DEVELOPED SEPSIS ,INTRABDOMINAL INFECTION. THE PATIENT WAS SENT BACK TO THE OPERATING ROOM FOR AN EMERGENCY EXPLORATORY LAPAROTOMY, DRAINAGE OF PELVIS AND ABDOMINAL ABSCESSES, ABDOMINAL WASHOUT AND PLACEMENT OF A DIVERTING LOOP ILEOSTOMY. PER THE MEDICAL RECORDS, TURBID FLUID WAS ENCOUNTERED CONSISTENT WITH ABSCESS. THE ABDOMEN WAS COPIOUSLY IRRIGATED. PATI

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2012, INTUITIVE SURGICAL WAS PROVIDED A LETTER SENT TO (B)(6) FROM (B)(6), ALLEGING PROLONGED PROCEDURES UP TO 11 HOURS CAN RESULT IN AFFECTS TO THE PATIENT SUCH AS THROMBOSIS, EMBOLISM, COMPARTMENTAL SYNDROME AND HEMATOMAS. ADDITIONALLY, AN ALLEGATION WAS MADE THAT A PATIENT EXPERIENCED AN ABSCESS AFTER A PROCEDURE. THE LETTER ALSO ALLEGED GENERAL PROBLEMS WITH PROPER STERILIZATION OF INSTRUMENTS. NO SITE SPECIFIC INFORMATION WAS PROVIDED WITHIN THE BODY OF THIS LETTER. SEVERAL ATTEMPTS HAVE BEEN MADE TO CONTACT THE AUTHOR OF THE LETTER, (B)(6) AND STAFF, BOTH VIA EMAIL AND PHONE; HOWEVER, AS OF THE DATE OF THIS REPORT NO RETURNED COMMUNICATION HAS BEEN 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 RECEIVED INFORMATION INCLUDING MEDICAL RECORDS OF A PATIENT WHO UNDERWENT A DA VINCI S HYSTERECTOMY PROCEDURE WITH BILATERAL SALPINGO-OOPHORECTOMY, EXTENSIVE LYSIS OF ADHESIONS AND RIGHT URETEROLYSIS ON (B)(6) 2012. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2012. THE PATIENT'S OPERATIVE REPORT (OP) FOR THE SURGICAL PROCEDURE ON (B)(6) 2012 INDICATED THAT THE PATIENT UNDERWENT THE DA VINCI HYSTERECTOMY PROCEDURE WITH BILATERAL SALPINGO-OOPHORECTOMY DUE TO UTERINE FIBROIDS, MENOMETRORRHAGIA AND MILD CERVICAL DYSPLASIA. BASED ON THE INFORMATION IN THE PATIENT'S OP, THERE WAS NO REPORT THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED DURING THE PROCEDURE. THE SURGEON DESCRIBES IN THE OP THAT THERE WERE EXTENSIVE ADHESIONS AND HE DECIDED TO PERFORM EXTENSIVE LYSIS OF ADHESIONS BETWEEN THE BLADDER AND THE ANTERIOR PART OF THE LOWER UTERINE SEGMENT. THE SURGEON STATES IN THE OP THAT THE RIGHT URETER WAS VERY CLOSE TO THE LEVEL OF DISSECTION. THE SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED AND THE PATIENT WAS TAKEN TO THE RECOVERY ROOM WITH STABLE VITAL SIGNS AND IN

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI SI BILATERAL SALPINGO-OOPHORECTOMY PROCEDURE, DURING PLACEMENT OF THE UTERINE MANIPULATOR, THE PATIENT'S BOWEL WAS RUPTURED. THE SURGEON REPAIRED THE PATIENT'S BOWEL, WHICH TOOK APPROXIMATELY 3 HOURS TO REPAIR. TWO DAYS POST OP THE PATIENT EXPERIENCED CARDIOVASCULAR COMPLICATIONS AND COMPLICATIONS AND EXPIRED. THE SURGEON IS ATTRIBUTING THE PATIENT'S DEMISE TO A T-BERG. NO OTHER INFORMATION WAS PROVIDED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI ANTERIOR EXENTERATION, INCLUDING CYSTECTOMY, HYSTERECTOMY AND BILATERAL SALPINGO-OOPHORECTOMY PROCEDURE ON (B)(6) 2012 FOR CHRONIC PYOCYSTIS AND NEUROGENIC BLADDER. 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. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. AN OPEN HASSON TECHNIQUE WAS USED TO ENTER THE PERITONEAL CAVITY. EXTENSIVE ADHESIONS WERE SEEN UPON INSERTION OF THE LAPAROSCOPE. THESE WERE MOSTLY IN THE MIDLINE AND ADJACENT TO THE ILEAL CONDUIT IN THE RIGHT LOWER QUADRANT. THEY WERE TAKEN DOWN USING COLD SHEARS PRIOR TO DOCKING THE DA VINCI SYSTEM. THE BLADDER, UTERUS AND OVARIES WERE COMPLETELY DISSECTED AND DELIVERED THROUGH THE VAGINAL APEX. HEMOSTASIS IN THE PELVIS WAS CONFIRMED. THE ILEAL CONDUIT WAS CAREFULLY INSPECTED AND IRRIGATED TO CONFIRM NO INJURY. CAREFUL INSPECTION OF THE BOWEL UNDERNEATH THE PRIOR ADHESIONS NOTED NO INJURY. AN ON-Q PAIN PUMP WAS PUT INTO PLACE SUBCUTANEOUSLY. ESTIMATED BLOOD LOSS WAS 900 ML. THE PATIEN

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT APPROXIMATELY ONE YEAR AGO, A PATIENT EXPIRED AFTER UNDERGOING A DA VINCI SI GYNECOLOGICAL PROCEDURE.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI S PROSTATECTOMY PROCEDURE, MINOR BLEEDING OCCURRED. THE BLEEDING WAS REGARDED AS NORMAL BLEEDING FROM MINOR VESSELS. THE SURGERY WAS COMPLETED SUCCESSFULLY AND THE PATIENT WENT INTO RECOVERY. THE PATIENT SEEMED FINE DURING RECOVERY; HOWEVER, AT AN UNKNOWN TIME AFTER THE SURGERY, THE PATIENT EXPIRED. NO FURTHER INFORMATION WAS PROVIDED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: 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) 2012 FOR MENOMETRORRHAGIA. ISI WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES A HANDWRITTEN LIMITED HISTORY AND PHYSICAL RECORD FROM (B)(6) 2012 AND SEVERAL RADIOLOGIC REPORTS. ACCORDING TO THE MEDICAL RECORDS, 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. AFTER INTRAVAGINAL PLACEMENT OF THE ROOMY UTERINE MANIPULATOR, A PNEUMOPERITONEUM WAS CREATED USING A VERESS NEEDLE THROUGH THE UMBILICUS AND PORTS WERE PLACED UNDER DIRECT VISUALIZATION. THE UTERO-OVARIAN AND ROUND LIGAMENTS WERE CAUTERIZED WITH THE PK DEVICE AND TRANSECTED WITH MONOPOLAR SCISSORS. THE BLADDER WAS SHARPLY TAKEN OF THE UTERUS AND THE BLADDER FLAP CREATED WHILE THE VESSELS AND TISSUE WAS CAUTERIZED AND TRANSECTED IN A SIMILAR FASHION. SOME BLEEDING WAS NOTED ON THE LEFT SIDE FROM A RESIDUAL VESSEL COMING OF THE UTERINE ARTERY. AFTER COLPOTOMY, THE UTERUS WAS REMOVED THROUGH THE CUFF AND THE COLPOTOMY CLO

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 GALL BLADDER PROCEDURE ON (B)(6) 2012. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: A GALL STONE GOT STUCK IN THE BILE DUCT AND THEY TRIED TO PUSH IT OUT. THEY RUPTURED THE BILE DUCT SHE THEN BLED INTERNALLY. HER SCAR STILL REMAINS.

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 HYSTERECTOMY PROCEDURE, A CYSTOSCOPY AND LYSIS OF ADHESION PROCEDURE ON (B)(6) 2012. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2012 IN STABLE CONDITION. ON (B)(6) 2012, THE PATIENT RETURNED TO THE HOSPITAL'S EMERGENCY ROOM COMPLAINING OF ABDOMINAL PAIN. THE PATIENT'S OPERATIVE (OP) REPORT FOR THE SURGICAL PROCEDURE DATED (B)(6) 2012 INDICATED THAT THE PATIENT'S PREOPERATIVE DIAGNOSIS WAS CHRONIC PAIN AND ABNORMAL VAGINAL BLEEDING. THE OP REPORT DID NOT ALLEGE THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED DURING THE SURGICAL PROCEDURE AND THERE WERE NO ANOMALIES NOTED. PER THE INFORMATION IN THE OP REPORT, THE SURGICAL PROCEDURE WAS COMPLETED AND THE PATIENT TOLERATED THE PROCEDURE WELL. THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. THE PATIENT CALLED THE DOCTOR'S OFFICE ON (B)(6) 2012 COMPLAINING OF NAUSEA AND VOMITING. AN E-SCRIPT FOR ZOFRAN WAS SENT IN FOR HER. ON (B)(6) 2012, THE PATIENT UNDERWENT A CYSTOSCOPY, BILATERAL RETROGRADE URETEROGRAM, B

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL MEDIATION EFFORT, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION OF A PATIENT WHO UNDERWENT A DA VINCI A HYSTERECTOMY PROCEDURE ON (B)(6) 2012 AND ALLEGEDLY SUFFERED AN URETERAL INJURY. NO SPECIFIC ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY WAS REPORTED. NO OTHER INFORMATION WAS PROVIDED.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT APPROXIMATELY 45 MINUTES INTO A DA VINCI SI PROCEDURE WHEN THE ASSISTANT AT THE PATIENT SIDE CART (PSC) PERFORMED A TOOL CHANGE TO SWITCH THE INSTRUMENTS IN THE PATIENT SIDE MANIPULATOR (PSM) ARMS, THE PATIENT'S AORTA WAS PUNCTURED. THE SURGEON MADE THE DECISION TO CONVERT TO TRADITIONAL OPEN SURGICAL TECHNIQUES TO COMPLETE THE PLANNED SURGICAL PROCEDURE. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION RIGHT AFTER THE OPEN SURGICAL PROCEDURE, HOWEVER, THE PATIENT EXPIRED THE FOLLOWING DAY. THE SITE HAS BEEN CONTACTED FOR ADDITIONAL INFORMATION, HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN FORTHCOMING.

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 CORONARY ARTERY BYPASS PROCEDURE FOR STENT STENOSIS ON (B)(6) 2012. ISI WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDED THE PATIENT'S HOSPITAL RECORDS. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. BASED ON THE OPERATIVE REPORT THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR AN ELECTIVE CORONARY ARTERY BYPASS PROCEDURE ON (B)(6) 2012. THE PATIENT WAS INFORMED OF THE RISK, BENEFITS, AND ALTERNATIVES TO THE PROCEDURE. THE PATIENT UNDERSTOOD, AGREED, AND WISHED TO PROCEED WITH THE PROCEDURE. ACCORDING TO THE OPERATIVE REPORT, DURING AN INSTRUMENT CHANGE FOR THE SUPERIOR ROBOTIC PORT AN INADVERTENT AORTIC INJURY WAS CREATED. THIS APPEARED TO SELF TAMPONADE, HOWEVER, PRUDENCE DICTATED CONVERSION TO OPEN AT THIS POINT. THEREFORE, THE ROBOT WAS REMOVED FROM THE FIELD. THE LEFT ANTERIOR THORACOTOMY WAS MADE TO INCLUDE THE THORACOSCOPIC PORT. IN ADDITION IT WAS NOTED THAT, A SMALL LINEAR RENT ON THE OUTER SURFACE OF THE DESCENDING AORTA SUPERIOR TO THE PULMONARY ARTERY WA

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 2 DAYS POST-OP A DA VINCI SI GASTRIC BYPASS PROCEDURE, THE PATIENT DEVELOPED SEPTIC SHOCK AFTER THE JEJUNUM (JJ) AND GASTROJEJUNUM (GJ) STAPLE LINES AND SUTURE CLOSURES OPENED. THERE WAS NO REPORT OF A MALFUNCTION OF THE DA VINCI SYSTEM, INSTRUMENTS AND/OR ACCESSORIES AND IT IS THE SURGEON'S BELIEF THAT OPENING OF THE JJ AND GS STAPLE LINES AND SUTURE CLOSURES WAS RELATED TO THE PATIENT'S ANATOMY. NO OTHER INFORMATION WAS PROVIDED.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI S TOTAL HYSTERECTOMY WITH LYMPHADENECTOMY FOR ADENOCARCINOMA OF THE ENDOMETRIUM (B)(6) 2012. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT . ADDITIONAL INFORMATION PROVIDED INCLUDES OFFICE AND HOSPITAL NOTES REGARDING FOLLOW UP CARE. 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) 2012 THE PATIENT UNDERWENT RADICAL HYSTERECTOMY WITH BSO, RIGHT PELVIC LYMPH NODE BIOPSY AND APPENDECTOMY ON. DISCHARGED ON (B)(6) 2012. RE-ADMISSION ON (B)(6) 2012 FOR EXPLORATORY LAPAROTOMY FOR PELVIC ABSCESS WITH SEPTIC SHOCK. LARGE 8-10 CM POSTERIOR ABSCESS NOTED. NO INTESTINAL PERFORATION OR OTHER INJURY WAS NOTED. UNFORTUNATELY, FOLLOWING SURGERY, SHE EXPIRED DUE TO SEPTIC CONDITION.

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 WITH BSO, UTEROSACRAL LIGAMENT SUSPENSION AND CYSTOSCOPY FOR PELVIC PRESSURE AND THICKENING OF THE ENDOMETRIAL LINING ON (B)(6) 2012. REPORTEDLY, THE PATIENT SUSTAINED A BOWEL INJURY. ISI WAS NOT PROVIDED WITH ANY ORIGINAL MEDICAL RECORDS INCLUDING OPERATIVE REPORT OR DISCHARGE SUMMARIES. ACCORDING TO THE INFORMATION PROVIDED, ON (B)(6) 2012, WHEN IT WAS DISCOVERED THAT THE PATIENT WAS STILL NOT GETTING BETTER GI AND SURGERY WERE CONSULTED. A SECOND CT WAS OBTAINED AND SHE WAS NOTED TO HAVE A POSSIBLE ENTEROTOMY IN THE LOWER COLON. ON (B)(6) 2012, SHE WAS TAKEN BACK TO THE OPERATING ROOM. THE SURGEON DID NOTE A RECTAL INJURY AND THIS WAS REPAIRED AND A PROTECTIVE DIVERTING COLOSTOMY WAS PLACED. POST OPERATIVELY THE PATIENT NEEDED TO BE IN THE ICU FOR SEVERAL DAYS. AN ACUTE MYOCARDIAL INFARCT WAS DIAGNOSED DURING THIS EPISODE. AFTER BEING TREATED WITH IV ANTIBIOTICS HER WHITE COUNT DID DIMINISH. A REHAB FACILITY WAS THEN CONSULTED ON (B)(6) FOR LONG TERM MANAGEMENT. THE PATIENT CONTINUED TO IMPROVE SLOWLY AND WAS ADVANCED IN HER DIET IN A VERY S

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI HIATAL HERNIA REPAIR PROCEDURE ON (B)(6) 2012. ACCORDING TO THE LEGAL DOCUMENT PROVIDED, THE SURGEON SUSPECTED DURING THE DA VINCI SURGERY THAT HE HAD INJURED THE PATIENT'S BOWEL AND DECIDED TO CONVERT TO AN OPEN PROCEDURE. DURING THE OPEN PROCEDURE, THE SURGEON REPORTEDLY DISCOVERED A BOWEL PERFORATION (HOLE IN HER BOWELS). HE ALSO IDENTIFIED MULTIPLE TEARS IN THE MEMBRANE AROUND THE PATIENT'S BOWELS. ACCORDING TO THE LEGAL DOCUMENT, THE SURGEON BELIEVED THIS BOWEL DAMAGE WAS CAUSED BY A GRASPER ON THE DA VINCI ROBOT HE USED. AFTER IDENTIFYING THE BOWEL DAMAGE, THE SURGEON REMOVED PART OF THE PATIENT'S COLON AND THEN REPAIRED THE PATIENT'S HERNIA. THE LEGAL DOCUMENT CLAIMS THAT AFTER THE SURGERY WAS COMPLETED, THE PATIENT REMAINED HOSPITALIZED AND HER MEDICAL CONDITION DECLINED DUE TO COMPLICATIONS FROM THE BOWEL SURGERY. ON (B)(6) 2012 THE SURGEON DECIDED TO PERFORM AN EXPLORATORY SURGERY AFTER A BUILDUP OF GAS WAS OBSERVED IN THE PATIENT'S ABDOMEN. THE EXPLORATORY SURGERY REVEALED THAT THE PATIENT'S SMALL AND LARGE BOWEL WERE FOUND TO BE DEAD. 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: ON (B)(6) 2012, A PATIENT POSTED THE FOLLOWING INFORMATION ON ISI'S SOCIAL NETWORK SITE VIA (B)(6): "I HAD THE DAVINCI SURGERY 8 MONTHS AGO. I STILL HAVE SOME NUMBNESS IN ONE AREA AND I STILL HAVE SOME PAIN. DO YOU KNOW WHY I WOULD STILL HAVE PAIN AFTER THIS LONG? I WILL BE SEEING MY DOCTOR ON (B)(6). I HAVE ASKED HER BEFORE WHY IT STILL HURT; SHE TOLD ME SINCE I HAD PROBLEMS WITH MY LEFT SIDE BEFORE MY SURGERY THAT IS WHY IT STILL HURTS. IT DOES NOT MAKE SENSE AT ALL TO ME. AND ALSO ABOUT A WEEK AGO I STARTED TO SPOT. IT LASTED FOR A DAY AND A HALF."

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 SEPTEMBER 5, 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION FROM AN ATTORNEY REPRESENTING A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY PROCEDURE ON (B)(6) 2012, AND ALLEGED A BOWEL PERFORATION 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 WHO UNDERWENT DA VINCI TOTAL HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY AND CYSTOSCOPY FOR HISTORY OF MENOMETRORRHAGIA, DYSMENORRHEA, AND UTERINE FIBROIDS ON (B)(6) 2012. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING SURGERY. THE OPERATIVE FINDINGS WERE A (B)(6) UTERUS WITH MULTIPLE FIBROIDS. SEQUENTIAL IDENTIFICATION, CAUTERIZATION AND TRANSECTION OF THE INFUNDIBULO PELVIS LIGAMENTS, THE ROUGNON LIGAMENTS, THE BROAD LIGAMENTS. THE ARTERIAL DISSECTION AND CULPOTOMY WERE NOTABLE FOR A DIFFICULT DISSECTION DUE TO THE PRESENCE OF EXTENSIVE ADHESIONS, AND AN ABNORMALLY HIGH ROUTE FOR THE UTERINE ARTERY ON THE RIGHT SIDE. THE ARTERY WAS CAUTERIZED, AND AFTER DISSECTION IT WAS NOTED THAT THE URETER HAD BEEN IN CLOSE PROXIMITY DURING COAGULATION, AND THERE WAS CONCERN FOR THERMAL INJURY. THE REMAINDER OF THE OPERATION WAS COMPLETED, AND A UROLOGIC CONSULT WAS CALLED TO EVALUATE THE STATE OF THE URETER. THE CONSULT SURGEON PERFORMED A URETEROLYSIS FROM THE PELVIC BRIM TO THE INSERT

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 GASTRIC BYPASS PROCEDURE THE SURGEON WAS UNABLE TO MOVE PATIENT SIDE MANIPULATOR (PSM) ARM 2 FROM THE SURGEON CONSOLE. AFTER RESTARTING THE SYSTEM, PSM ARM 2 WORKED FINE. AFTER 15 MINUTES OF OPERATION THE SURGEON LOST CONTROL OF PSM ARM 1, RESULTING IN DAMAGE TO THE PATIENT'S STOMACH. NO FURTHER INJURIES WERE REPORTED.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI SI OVARIAN TRANSPOSITION PROCEDURE, A COMPLICATION OCCURRED AND THE PATIENT STARTED TO BLEED. THE SURGEON ATTEMPTED TO CONTROL BLEEDING BY APPLYING PRESSURE WITH AN INSTRUMENT GRASPER AND APPLYING LAPAROSCOPIC LIGACLIPS. THE LIGACLIPS FAILED TO CONTROL THE BLEEDING AND THE SURGEON ATTEMPTED TO SUTURE THE VESSEL, BUT THIS WAS ALSO UNSUCCESSFUL AT CONTROLLING BLEEDING. THE SURGEON MADE THE DECISION TO CONVERT TO TRADITIONAL OPEN SURGICAL TECHNIQUES. THE SURGICAL STAFF UNDOCKED THE CAMERA ARM AND ONE OF THE INSTRUMENT ARMS FROM THE PATIENT BUT KEPT THE OTHER TWO ARMS WITH THE INSTRUMENTS IN THE PATIENT. THE INSTRUMENTS ARMS WERE APPLYING PRESSURE TO THE SITE OF BLEEDING. THE SURGEON ATTEMPTED TO FIND THE SOURCE OF BLEEDING. IT IS UNCLEAR ON THE SEQUENCE OF EVENTS AFTER THIS. THE PATIENT WAS CONFIRMED TO HAVE EXPIRED. IT IS UNKNOWN WHETHER THE PATIENT EXPIRED DURING OR AFTER THE PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI SI PULMONARY LOBECTOMY PROCEDURE, THE PATIENT'S PULMONARY ARTERY WAS LACERATED, REQUIRING HEMOSTASIS OF THE AFFECTED VESSEL USING A CADIERE FORCEPS INSTRUMENT TO ALLOW FOR COMPLETION OF THE PLANNED SURGICAL PROCEDURE USING OPEN SURGICAL TECHNIQUES. AFTER OBTAINING ADEQUATE EXPOSURE, THE SITE ATTEMPTED TO MANUALLY OPEN THE GRIPS ON THE CADIERE FORCEPS INSTRUMENT USING SEVERAL DIFFERENT ALLEN WRENCHES, HOWEVER, THE INSTRUMENT GRIPS WOULD NOT RELEASE. THE SITE THEN ATTEMPTED TO RELEASE THE INSTRUMENT USING THE MASTER TOOL MANIPULORS (MTM), HOWEVER, THE ERROR MESSAGE UNABLE TO ALIGN MASTERS WAS OBSERVED. UNABLE TO RESOLVE THE ISSUE, THE SITE CONTACTED ISI TECHNICAL SUPPORT ENGINEERING (TSE) FOR TROUBLESHOOTING ASSISTANCE. AFTER PERFORMING AN EMERGENCY STOP/RECOVER OF THE SYSTEM, THE GRIPS ON THE CADIERE FORCEPS INSTRUMENT OPENED. NO OTHER INFORMATION CONCERNING THE REPORTED EVENT WAS PROVIDED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI SI HYSTERECTOMY FOR MENORRHAGIA AND UTERINE FIBROIDS ON (B)(6) 2012. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT ADDITIONAL INFORMATION PROVIDED INCLUDES FOLLOW-UP OPERATIVE AND RADIOLOGY REPORTS THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY]. THERE WAS A REPORT OF AN INTRAOPERATIVE COMPLICATION, NAMELY AN INCIDENTAL CYSTOTOMY WHICH WAS REPAIRED DURING THE INITIAL OPERATION BY A UROLOGIST. THE PATIENT WAS DISCHARGED HOME WITH A FOLEY CATHETER IN THE BLADDER.