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 AT AN UNSPECIFIED TIME, EITHER DURING OR AFTER A DA VINCI GASTRIC BYPASS PROCEDURE, THE PATIENT EXPIRED. THE SURGEON INDICATED THAT THIS CASE WAS REVIEWED BY A COMMITTEE OF PEERS, ADMINISTRATORS, THE MEDICAL AND LEGAL DEPARTMENT AND IT WAS CONFIRMED THAT THE PATIENT'S DEATH WAS NOT RELATED TO A ROBOTIC COMPLICATION NOR WAS IT SURGICAL MISADVENTURE. 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 AFTER COMPLETION OF A DA VINCI HYSTERECTOMY PROCEDURE, THE PATIENT WAS FOUND TO HAVE ISCHEMIC COLITIS ON POST-OPERATIVE DAY 2. AS A RESULT OF THE ISCHEMIC COLITIS, THE PATIENT UNDERWENT AN OPEN COLON RESECTION PROCEDURE. THE SITE WAS UNSURE IF THE ISCHEMIC COLITIS WAS RELATED TO THE PATIENT'S HISTORY OF DIVERTICULITIS. ON (B)(4) 2013, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE CLINICAL SALES REPRESENTATIVE (CSR). THE CSR WAS NOT PRESENT DURING THE SURGICAL PROCEDURE. HOWEVER, THE CSR STATED THAT THERE WAS NO REPORT FROM THE SITE THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. ACCORDING TO THE CSR, THE PATIENT CAME BACK TO THE HOSPITAL ON POST-OP DAY 2 WITH COMPLAINTS OF ABDOMINAL PAIN AFTER BEING DISCHARGED FROM THE HOSPITAL. THE CSR ALSO STATED THAT A COLOSTOMY WAS CREATED DURING THE OPEN RESECTION PROCEDURE. THE CSR DID NOT KNOW THE CURRENT STATUS OF THE PATIENT. THE CSR STATED THAT AFTER THE EVENT OCCURRED, AN ISI FIELD SERVICE ENGINEER (FSE) PERFORMED A FIELD EVALUATION AT THE SITE ON AN UNSPECIFIED DATE. ACCORDING TO THE CSR, THE FSE AND THE SITE'S BIOMED DEPARTMENT EVALUATED THE DA VINCI

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 AFTER COMPLETION OF A DA VINCI CHOLECYSTECTOMY PROCEDURE PERFORMED ON (B)(6) 2013, THE PATIENT WAS FOUND TO HAVE A BILE LEAK ON POST-OPERATIVE DAY 1 OR 2. THE PATIENT UNDERWENT SURGERY ON (B)(6) 2013 TO REPAIR THE BILE LEAK. ON (B)(6) 2013, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE CLINICAL SALES REPRESENTATIVE (CSR) WHO WAS PRESENT DURING THE SURGICAL PROCEDURE. ACCORDING TO THE CSR, THERE WAS NO MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM DURING THE PROCEDURE AND THERE WERE NO INTRA-OPERATIVE COMPLICATIONS. HOWEVER, THE CSR INDICATED THAT THE SURGICAL PROCEDURE WAS VERY DIFFICULT SINCE THE PATIENT HAD NUMEROUS ADHESIONS AND INFLAMMATION. THE CSR STATED THAT THE SURGEON, WHO PERFORMED THE DA VINCI CHOLECYSTECTOMY PROCEDURE ON (B)(6) 2013, ALSO PERFORMED THE SURGICAL PROCEDURE USING THE DA VINCI SURGICAL SYSTEM TO REPAIR THE BILE LEAK ON (B)(6) 2013. ON (B)(6) 2013, ISI CONTACTED THE RISK MANAGER FROM THE SITE. THE RISK MANAGER INDICATED THAT NO MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM OCCURRED DURING THE SURGICAL PROCEDURE. SHE STATED THAT BILE LEAKS ARE COMMON POST-OPERATIVE COMPLICATIONS AND THAT THE DA VINCI SURGICAL SYSTEM DID NOT CAUSE THE BILE LEAK

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-ASSISTED RADICAL HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY AND COMPLETE PELVIC LYMPHADENECTOMY PROCEDURE ON (B)(6) 2013 FOR STAGE 1B1 SQUAMOUS CELL CARCINOMA OF THE CERVIX. THE PLAINTIFF'S ATTORNEY ALLEGES THAT THE DA VINCI SURGICAL SYSTEM INJURED THE PATIENT AND SPREAD UNDIAGNOSED UTERINE CANCER THROUGHOUT THE PATIENT'S BODY. ISI WAS PROVIDED WITH THE DA VINCI SURGERY OPERATIVE REPORT AND ADDITIONAL MEDICAL RECORDS. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT AND/OR ACCESSORY DURING THE DA VINCI SURGERY. NO INTRA-OPERATIVE COMPLICATIONS WERE NOTED AND THE ESTIMATED BLOOD LOSS FROM THE SURGICAL PROCEDURE WAS 100 CC. THE SURGICAL PROCEDURE WAS COMPLETED AND THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN GOOD CONDITION. ON (B)(6) 2013, AND (B)(6) 2014, THE PATIENT UNDERWENT A CT-SCAN OF HER ABDOMEN AND PELVIS. THE IMPRESSION FROM (B)(6) 2013 CT-SCAN SHOWED NO DEFINITIVE EVIDENCE OF METASTATIC DISEASE. THE IMPRESSION FROM THE (B)(6) 2014 INCLUDED NEW CARCINOMATOSIS AND OMENTAL CAKING CONSISTENT WITH NEW METASTATIC

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 SURGICAL PROCEDURE, THE FIRST ASSISTANT INTRODUCED AN ENDOSCOPIC STAPLER INSTRUMENT THROUGH AN ASSISTANT PORT. REPORTEDLY, THE INSTRUMENT DID NOT GO ALL THE WAY ACROSS THE DORSAL VEIN COMPLEX, CAUSING THE PATIENT TO BLEED PROFUSELY. THE SURGEON MADE THE DECISION TO CONVERT THE PROCEDURE TO OPEN SURGICAL TECHNIQUES; HOWEVER, THE PATIENT EXPIRED. NO OTHER INFORMATION WAS PROVIDED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI SI CHOLECYSTECTOMY PROCEDURE, THE PATIENT SUSTAINED A BILE DUCT INJURY. THE SURGEON MADE THE DECISION TO CONVERT THE PLANNED SURGICAL TO OPEN TECHNIQUES TO REPAIR AND COMPLETE THE 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: IT WAS REPORTED THAT DURING A DA VINCI SI HYSTERECTOMY PROCEDURE, THE SURGEON UNINTENTIONALLY NICKED THE PATIENT'S ARTERY AND CONVERTED TO TRADITIONAL OPEN SURGERY TO REPAIR THE 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 (B)(6) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED A (B)(4) DATED (B)(4) 2013 AND TITLED, TROUBLE STILL WITH INCISION AREA AFTER BOTCHED DAVINCI SURGERY. FINALLY MY SURGEON ORDERED A CT SCAN AND SURE ENOUGH ... I HAVE A HERNIA! THE INTERNET POSTING CONTAINED THE FOLLOWING EVENT DESCRIPTION: TROUBLE STILL WITH INCISION AREA AFTER BOTCHED DAVINCI SURGERY. FINALLY MY SURGEON ORDERED A CT SCAN AND SURE ENOUGH ... I HAVE A HERNIA! I HAVE TO HAVE SURGERY AGAIN!!!! ANYONE ELSE GET HERNIA AFTER HYSTERECTOMY? WEB LINK: HTTPS://WWW.WHATNEXT.COM/QUESTIONS/TROUBLE-STILL-WITH-INCISION-AREA-AFTE R-BOTCHED-DAVINCI-SURGERY-FINALLY-MY-SURGEON-ORDERED-A-C T-SCAN-AND-SURE-ENOUGH-I-HAVE-A-HERNIA

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 MESH REVISION PROCEDURE USING THE DA VINCI SURGICAL SYSTEM, THE PATIENT EXPERIENCED BLEEDING FROM A VESSEL. THE AFFECTED VESSEL WAS REPAIRED INTRA-OPERATIVELY WITH THE DA VINCI SURGICAL SYSTEM. REPORTEDLY, THE SYSTEM WAS FUNCTIONING NORMALLY WHEN THE DAMAGE TO THE PATIENT'S VESSEL OCCURRED. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO ADVERSE OUTCOME WAS REPORTED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE PT WAS UNDERGOING ROBOTIC MYOMECTOMY AND RIGHT PARATUBAL CYSTECTOMIES USING THE DA-VINCI ROBOT. DURING ENUCLEATION OF ONE OF THE FIBROIDS, WHILE USING THE MONOPOLAR SPATULA, THE PULLEY SYSTEM FOR THE SPATULA BROKE. THE INSTRUMENT WAS REMOVED AND INSPECTED. IT WAS NOTED THAT 2 PIECES WERE MISSING: ONE PIECE WAS THE CIRCULAR GUARD WHICH COVERED THE WIRE PULLEY ON THE SIDE OF THE INSTRUMENT AND THE SECOND WAS THE OVERLYING FLANK WHICH COVERED THE CIRCULAR GUARD. THE SURGEON RETURNED TO THE SURGICAL SITE AND THE CIRCULAR GUARD WAS RECOVERED FROM THE PT. HOWEVER, THE FLANK PIECE COULD NOT BE LOCATED. AFTER EXHAUSTIVE EFFORTS TO LOCATE THE RETAINED PIECE AND DISCUSSION WITH THE PT'S FAMILY, IT WAS AGREED TO ALLOW THE PIECE TO REMAIN IN PLACE WITHOUT PROGRESSING TO MORE INVASIVE EFFORTS TO LOCATE THE PIECE.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI NISSEN FUNDOPLICATION AND CHOLECYSTECTOMY PROCEDURE PERFORMED ON (B)(6) 2013, THE PATIENT WAS FOUND TO HAVE SUSTAINED AN ESOPHAGEAL PERFORATION ON POST-OP DAY 1. ON (B)(6) 2013, ISI CONTACTED THE CLINICAL SALES REPRESENTATIVE (CSR) WHO WAS PRESENT DURING THE FIRST HALF OF THE SURGICAL PROCEDURE. DURING THE TIME THE CSR WAS PRESENT DURING THE CASE, SHE DID NOT WITNESS ANY INTRA-OPERATIVE COMPLICATIONS OR ISSUES WITH THE DA VINCI SURGICAL SYSTEM. ON (B)(6) 2013, THE CSR STATED THAT SHE SPOKE TO THE SURGEON AND WAS TOLD THAT THE PATIENT HAD PASSED AWAY. THE DATE AND CAUSE OF THE PATIENT'S DEMISE WAS NOT PROVIDED BY THE SURGEON. THE CSR INDICATED THAT THE SURGEON INFORMED HER THAT SHE FELT AS THOUGH THE DA VINCI SURGICAL PROCEDURES WENT WELL. THERE WERE NO REPORTS OF ANY INTRA-OPERATIVE COMPLICATIONS OR A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY DURING THE SURGICAL PROCEDURES. NO ADDITIONAL INFORMATION WAS PROVIDED BY THE CSR.

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 LOWER ANTERIOR RESECTION PROCEDURE PERFORMED ON (B)(6) 2013, THE SURGEON INDICATED THAT THE PATIENT EXPERIENCED A STROKE AND SUBSEQUENTLY PASSED AWAY ON AN UNSPECIFIED DATE. ACCORDING TO THE INITIAL REPORTER, THE SURGEON INFORMED HIM THAT THE PATIENT HAD MANY CO-MORBID CONDITIONS, WOKE UP BLIND, AND LATER PASSED AWAY. ON (B)(6) 2013, ISI CONTACTED THE RISK MANAGER (RM) AT THE SITE. THE RM REVIEWED THE PATIENT'S MEDICAL HISTORY AND NOTED THAT THE PATIENT HAD EXPERIENCED MULTIPLE STROKES IN THE PAST PRIOR TO UNDERGOING THE DA VINCI SURGICAL PROCEDURE ON (B)(6) 2013. THE PATIENT'S MEDICAL HISTORY INCLUDED PROSTATE CANCER, ABDOMINAL ANEURYSMS, AORTIC ANEURYSM, CORONARY ATHEROSCLEROSIS, HEART DISEASE, COLON CANCER, HYPERTENSION, DIASTOLIC DYSFUNCTION, AND CHRONIC TOBACCO USE. THE RM ALSO REVIEWED THE OPERATIVE REPORT AND DID NOT FIND ANY NOTATION THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. ACCORDING TO THE OPERATIVE REPORT, THERE WERE NO COMPLICATIONS AND THE PATIENT TOLERATED THE PROCEDURE WELL. BASED ON THE PATIENT'S MEDICAL RECORDS, THE PATIENT WOKE UP POST-OPERATIVELY WITH CO

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, THE USER FACILITY CONTACTED AN INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) DURING A DA VINCI MYOMECTOMY PROCEDURE AND REQUESTED HER TO COME IN BECAUSE MULTIPLE INSTRUMENTS KEPT BREAKING. WHEN THE CSR ARRIVED, SHE NOTED THAT THE PORT PLACEMENT WAS INCORRECT FOR THE TYPE OF SURGICAL PROCEDURE AND THE VISION WAS OBSCURED, NOT ALLOWING THE INSTRUMENT TIPS TO BE VIEWED. THE CSR STATED THAT THE SURGEON WAS RESISTANT TO HER RECOMMENDATIONS BUT FINALLY AGREED TO MOVE THE CAMERA PORT FOR A BETTER VIEW OF THE INSTRUMENTS. ACCORDING TO THE CSR, THE SURGEON REPEATEDLY OVER ROTATED THE MASTER TOOL MANIPULATOR (MTM) AND KEPT LOSING VIEW OF THE INSTRUMENT'S TIPS. THE MASTER TOOL MANIPULATOR REFERS TO THE MASTER CONTROLLERS WHICH PROVIDE THE MEANS FOR THE SURGEON TO CONTROL THE INSTRUMENTS AND ENDOSCOPE INSIDE THE PATIENT FROM THE SURGEON SIDE CONSOLE. THE INSTRUMENTS WERE BEING PUSHED AGAINST THE MYOMA WITH ENOUGH FORCE THAT IT WAS CAUSING THE INSTRUMENTS TO BREAK. THE CSR STATED SHE WITNESSED THE INSTRUMENT CABLES BREAKING ON A MARYLAND BIPOLAR INSTRUMENT. THE CSR OBSERVED THAT THE VIEW OF THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT TIPS WAS LOST AND 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 DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI RADICAL PROSTATECTOMY PROCEDURE IN OR ABOUT (B)(6) 2011. THE LEGAL DOCUMENT ALLEGES THAT THE 64 YEAR OLD MAN SUSTAINED SEVERE INTERNAL INJURIES, DAMAGE TO OTHER ORGANS, CONTINUING PAIN AND UNDERWENT ADDITIONAL SURGERIES TO ADDRESS THE SEVERE INTERNAL DAMAGES. NO OTHER DETAILS WERE PROVIDED REGARDING THE PATIENT'S INJURIES. THE LEGAL DOCUMENT NOTED THAT MONOPOLAR CURRENT WAS USED DURING THE DA VINCI PROSTATECTOMY PROCEDURE; HOWEVER, THERE WAS NO SPECIFIC ALLEGATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS, AND/OR ACCESSORIES. THE PATIENT DID NOT BELIEVE THE CAUSE OF HIS INJURIES WERE RELATED TO THE DA VINCI SYSTEM UNTIL (B)(6) 2013. THE PROVIDED INFORMATION DID NOT INCLUDE THE HOSPITAL NAME AND THE DETAILS OF THE DA VINCI SYSTEM INVOLVED WITH THE REPORTED EVENT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE REPORTER IS A SURGEON WHO CALLED TO REPORT THAT SHE WAS PERFORMING A MYOMECTOMY (SURGICAL REMOVAL OF FIBROID FROM THE UTERUS) WITH A DA VINCI ROBOT. THE PROCEDURE WAS CONVERTED TO OPEN LAPAROTOMY BECAUSE THE FIBROID WAS TOO BIG. AFTER THE SURGERY X-RAY WAS TAKEN WHICH SHOWS A 1 CM METALIC PIECE OF THE TIP OF THE ROBOT, DETACHED AND IN THE OMENTUM, SHE TRIED LOOKING FOR THE TIP BEFORE CLOSING THE PT BUT COULD NOT FIND IT.

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 MYOMECTOMY PROCEDURE, THE SURGEON MADE THE DECISION TO CONVERT THE PLANNED SURGICAL PROCEDURE TO A LAPARATOMY TO COMPLETE THE DISSECTION OF A MASSIVE FIBROID FOR REMOVAL. A RADIOGRAPH WAS PERFORMED POST THE SURGICAL PROCEDURE DUE TO THE PATIENT'S BLOOD LOSS APPROXIMATELY 1000ML) AT WHICH TIME IT WAS DISCOVERED THAT THE PATIENT HAD RETAINED A 1CM LINEAR AND FRAYED METALLIC FOREIGN BODY. THE FOREIGN BODY WAS IN THE PATIENT'S RIGHT UPPER ABDOMEN QUADRANT, IN FRONT OF THE ASCENDING COLON AND DEEP INTO THE ABDOMEN WALL. A DIAGNOSTIC LAPAROSCOPY WITH FLUOROSCOPIC GUIDANCE CONFIRMED THAT THE FOREIGN OBJECT WAS WITHIN THE PATIENT'S OMENTUM. THE SURGEON STATED THAT THE FOREIGN OBJECT WAS A PIECE OF PULLEY TYPE WIRE ON THE WRISTED ARM OF THE INSTRUMENT. 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 HOURS AFTER A DA VINCI PARAESOPHAGEAL HERNIA PROCEDURE THE PATIENT HAD EXPIRED. IT WAS NOTED THAT THE PROCEDURE WAS CONVERTED TO TRADITIONAL OPEN SURGICAL TECHNIQUES FOR AN UNKNOWN REASON AND THAT THE PATIENT HAD CHRONIC PRE-EXISTING MEDICAL CONDITIONS THAT CONTRIBUTED TO THEIR DEATH. NO FURTHER 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: ON (B)(6) 2013, A PATIENT UNDERWENT A DA VINCI MITRAL VALVE REPAIR PROCEDURE. THE SITE EXPERIENCED SEVERAL FAULTS WITH THE PATIENT SIDE MANIPULATOR ARM (PSM) 2 WITH THE DA VINCI SYSTEM AND CONTACTED INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT. THE FAULTS WERE RECOVERED AND THE SITE COMPLETED THE DA VINCI PROCEDURE. THE SITE WAS INFORMED THAT AN ISI FIELD SERVICE ENGINEER (FSE) WOULD COME OUT TO INSPECT THE DA VINCI SYSTEM. AT AN UNSPECIFIED TIME AFTER THE DA VINCI SYSTEM WAS UNDOCKED FROM THE PATIENT, THE PATIENT SUBSEQUENTLY EXPIRED. ISI DID NOT BECOME AWARE OF THE PATIENT'S DEATH UNTIL THE FOLLOWING DAY WHEN AN ISI FSE VISITED THE SITE TO INSPECT THE DA VINCI SYSTEM. A NURSE AT THE SITE HAD INFORMED THE FSE THAT THE PATIENT DIED AFTER THE DA VINCI SURGICAL PROCEDURE. THE DA VINCI SYSTEM WAS REPAIRED AND VERIFIED TO BE READY FOR USE. ON (B)(6) 2013, THE SURGEON INFORMED AN ISI REPRESENTATIVE THAT THE PATIENT'S DEATH HAD NOTHING TO DO WITH THE DA VINCI SYSTEM BUT THE SURGEON DID NOT PROVIDE ANY FURTHER DETAILS. ON (B)(6) 2013, ISI CLINICAL CONSULTANT SPOKE WITH THE SURGEON INVOLVED WITH THE REPORTED EVENT. THE SURGEON VERIFIED THAT THE PATIENT DIED FOLLOWING A DA VINCI MITRAL

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2013, THE CUSTOMER USED THE ROSA DEVICE TO GUIDE THE IMPLANTATION OF 8 DEPTH ELECTRODES FOR A CRANIAL SEEG. DURING THE PROCEDURE, AN INTRACRANIAL HEMORRHAGE OCCURRED; IT WAS DETECTED LATER ON WITH THE POST-OPERATIVE CT-SCAN OF THE PT AND TREATED BY ADDITIONAL 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 DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI PROSTATECTOMY PROCEDURE ON (B)(6) 2009. EXACT PROCEDURE DATE WAS NOT PROVIDED. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY:SEVERAL TENDONS WERE SEVERED, CAUSED ERECTILE DYSFUNCTIONS.

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 PROSTATE CANCER PROCEDURE ON EITHER MAY 2005 OR 2006. PROCEDURE DATE IS UNKNOWN. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: BLED PROFUSELY DURING SURGERY, ROBOTIC SURGERY ABORTED AND A RADICAL PROCEDURE WAS DONE TO REMOVE PROSTATE, CANCER CAME BACK.

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 PROSTATE CANCER PROCEDURE ON 2005. PROCEDURE DATE IS UNKNOWN. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: CUT URINARY MUSCLE, INABILITY TO OBTAIN ERECTION, PENAL IMPLANT, INCONTINENCE

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI HYSTERECTOMY PROCEDURE IN (B)(6) 2012. PROCEDURE DATE IS UNKNOWN. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: NERVE WAS CUT.

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 COLONOSCOPY PROCEDURE ON (B)(6) 2012. PROCEDURE DATE IS UNKNOWN. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: SEVERE PAIN AFTER SURGERY, THOUGHT IT WAS A HERNIA BUT IT TURNED OUT TO BE A LARGE INFECTION, TOOK OUT MORE OF COLON. HAD TO WEAR COLOSTOMY BAG FOR A FEW MONTHS ENDED UP GETTING A LARGE HERNIA (SIZE OF A FOOTBALL), HAD 2 PICC LINES 3 FINGERS 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 DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI PROSTATECTOMY PROCEDURE IN (B)(6) 2009. PROCEDURE DATE IS UNKNOWN. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: CUT COLON WHICH CREATED A FISTULA, 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 RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI HYSTERECTOMY PROCEDURE IN (B)(6) 2009. PROCEDURE DATE IS UNKNOWN. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: SEVERE PAIN TO THE TOUCH, NERVE INJURY CAUSING DEEP PAIN, HEMATOMA, GRANULOMAS ON THE CERVICAL CUFF AFTER 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 DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI SPINE SURGERY SOMETIME ON 2000. PROCEDURE DATE IS UNKNOWN. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: SUFFERED TWO MINOR STROKES DURING THE SURGERY, UNABLE TO WALK FOR LONG PERIODS OF TIME, NUMBNESS IN LEFT FOOT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI HYSTERECTOMY WITH BSO PROCEDURE SOMETIME ON 2011. PROCEDURE DATE IS UNKNOWN. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: BLEEDING, BLOOD CLOT, INCONTINENCE.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI HYSTERECTOMY PROCEDURE SOMETIME ON 2012. PROCEDURE DATE IS UNKNOWN. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: PERFORATED BOWEL, HEMORRHAGE INTO VAGINAL AREA.

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 SOMETIME ON 2008. PROCEDURE DATE IS UNKNOWN. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: BLADDER BURNED.

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 SOMETIME ON 2008. PROCEDURE DATE IS UNKNOWN. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: DEVELOPED 2 BLOOD CLOTS IN HIS LEGS HAD TO SURGICALLY IMPLANT A VENA CAVA; SURGEON TOLD HIM THAT HE HAD CUT A NERVE DURING SURGERY AND THAT COULD BE WHAT WAS CAUSING THE PROBLEMS. HAS PERMANENT INCONTINENCE, WEAR PADS, HAD AN ARTIFICIAL URINARY SPHINCTER.

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 RADICAL CYSTECTOMY PROCEDURE ON (B)(6) 2009. PROCEDURE DATE IS UNKNOWN. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: IMPOTENCE, KIDNEY MALFUNCTIONED BECAUSE OF SCAR TISSUE CAUSED BY DA VINCI.

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 REMOVAL PROCEDURE ON (B)(6) 2011. PROCEDURE DATE IS UNKNOWN. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: 2 DAYS AFTER SURGERY WAS IN IMMENSE PAIN, ADMITTED TO HOSPITAL 2 DAYS LATER. SHE WAS SEPTIC DUE TO A LEAK, WENT IN AND REPAIRED LEAK. WAS DIAGNOSED WITH A HERNIA A FEW DAYS AFTER BEING RELEASED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI HYSTERECTOMY PROCEDURE SOMETIME ON 2009. PROCEDURE DATE IS UNKNOWN. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: LARGE HEMATOMA ON BLADDER, BLADDER SPASMS.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI BLADDER AND GALL BLADDER PROCEDURE ON (B)(6) 2013 & (B)(6)2013. EXACT DATE OF PROCEDURES HAS NOT BEEN PROVIDED AT THIS TIME. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED BLADDER. PATIENT WAS SENT HOME WITH A CATHETER FOR 7 DAYS FOR IT TO HEAL, HAD TO HAVE GALL BLADDER OUT BECAUSE IT WAS FULL OF SLUDGE.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI HYSTERECTOMY PROCEDURE SOMETIME ON 2010. PROCEDURE DATE IS UNKNOWN. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: EXTRA FLUID, BLOOD CLOTS, SEVERE ABDOMINAL PAIN, INFECTION, HERNIA, 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 RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI HYSTERECTOMY PROCEDURE SOMETIME ON 2009.. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: CUT BLADDER, 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 RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI CHOLECYSTECTOMY PROCEDURE ON 2009. PROCEDURE DATE IS UNKNOWN. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: PAIN DUE TO HERNIA, LARGE HERNIA AT INCISION SITE.

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 RADICAL CYSTECTOMY & URINARY DIVERSION/ PROSTATE & LYMPH NODES PROCEDURE IN 2007. PROCEDURE DATE IS UNKNOWN. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: HERNIA, ERECTILE DYSFUNCTION, PENILE IMPLANT AFTER TWO YEARS

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 SOMETIME ON 2007. PROCEDURE DATE IS UNKNOWN. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: BLOOD VESSELS WERE CUT WHICH CAUSED INTERNAL BLEEDING

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 IN (B)(6) 2009. PROCEDURE DATE IS UNKNOWN. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: BOWEL WAS DAMAGE.

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 INTESTINE REMOVAL PROCEDURE ON (B)(6) 2012. PROCEDURE DATE IS UNKNOWN. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: LARGE HERNIA AT THE SITE OF THE INCISION, PAIN, DISCOMFORT, NAUSEA. HERNIA REMOVAL 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 DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI PROSTATECTOMY PROCEDURE IN (B)(6) 2011. PROCEDURE DATE IS UNKNOWN. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: INCONTINENCE, PAIN, BOWEL PROBLEMS, HAD TO HAVE BLADDER 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 DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI PROSTATECTOMY PROCEDURE SOMETIME ON 2009. PROCEDURE DATE IS UNKNOWN. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: PATIENT REPORTED INCONTINENCE.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI GALL BLADDER PROCEDURE SOMETIME ON 2009 OR 2010. PROCEDURE DATE IS UNKNOWN. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: LACERATED LIVER.

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 NEPHRECTOMY PROCEDURE IN (B)(6) 2007 AND HYSTERECTOMY WITH BSO IN (B)(6) 2008. PROCEDURE DATES ARE UNKNOWN. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: CHRONIC PAIN, NERVE DAMAGE, PAIN IN SPINE.'

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI HYSTERECTOMY PROCEDURE SOMETIME ON 2008. PROCEDURE DATE IS UNKNOWN. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: URETHRA WAS CUT. CONSTANTS UTE'S, BLADDER INFECTIONS, KIDNEY INFECTIONS AND STOMACH 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 DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI PARTIAL HYSTERECTOMY PROCEDURE ON 2007. PROCEDURE DATE IS UNKNOWN. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: SEVERE PAIN IN RIGHT THIGH, MAJOR SCARRING DUE TO DAVINCI, ONGOING PAIN SINCE 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 DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI PROCTECTOMY PROCEDURE ON (B)(6) 2008. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: IMPOTENT, INCONTINENCE OF BOWEL AND BLADDER.

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 STENTS HEART PROCEDURE ON 2006. PROCEDURE DATE IS UNKNOWN. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: RUPTURED ARTERY