CyberKnife — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A PATIENT CONTACTED ACCURAY AND PROVIDED THE FOLLOWING INFORMATION: HAD CYBERKNIFE TREATMENT IN 2014 AT (B)(6) HOSPITAL. SHORTLY AFTER THE TREATMENT THE I HAD URINARY INCONTINENCE FOLLOWED BY LATER FECAL INCONTINENCE. BOTH ARE UNCONTROLLABLE. THERE ARE SURGERIES TO HELP CORRECT THIS PROBLEM HOWEVER I DO NOT WISH TO GO THIS ROUTE AND VERY DISSATISFIED WITH THE OUTCOME.

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 AND BILATERAL SALPINGO-OOPHORECTOMY ON (B)(6) 2012 FOR DYSFUNCTIONAL UTERINE BLEEDING AND ENLARGING UTERINE FIBROIDS. ISI WAS PROVIDED WITH THE PATIENT'S OPERATIVE REPORT (OP) AND THE OP REPORT FOR THE FOLLOWING LAPAROTOMY. NO MEDICAL HISTORY WAS PROVIDED. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING SURGERY. THE HYSTERECTOMY WAS PERFORMED WITH SEQUENTIAL CAUTERY AND TRANSECTION OF THE INFUNDIBULOPELVIC VESSELS, THE ROUND LIGAMENTS, AND THE BROAD LIGAMENTS. IT WAS NOTED DURING THE DISSECTION OF THE BLADDER FLAP THAT THERE WAS MINIMAL SCAR TISSUE FROM HER CESAREAN SECTION. THE CARDINAL LIGAMENTS AND UTERINE VESSELS WERE CAUTERIZED WITH PK CAUTERY AND CUT, AND THE COLPOTOMY MADE TO THE LEVEL OF THE KOH BASKET. THE UTERUS WAS REMOVED VAGINALLY AND THE VAGINAL CUFF CLOSED WITH VLOCK SUTURES. SURGERY WAS COMPLETED WITH NO COMPLICATIONS. ON (B)(6) 2013 PATIENT PRESENTED WITH FEELINGS OF WEAKNESS, PERSISTENT PAIN AND NAUSEA AND LOW GRADE TEMPERATURE AND RLQ MILD TENDERNESS. PATIENT WAS STA

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI HYSTERECTOMY PROCEDURE, THE SURGEON MADE AN INCISION INTO THE PATIENT'S BLADDER WHICH WAS ADHERED. THE INITIAL REPORTER OF THIS COMPLAINT INDICATED THAT THE INCISION WAS CREATED WHILE THE SURGEON WAS PERFORMING A COLPOTOMY. THE BLADDER INJURY WAS RECOGNIZED AND REPAIRED BY A UROLOGIST. THE UROLOGIST NOTED NORMAL FUNCTION OF BOTH URETHRAL SPHINCTERS WITH THE USE OF DYE AND THE BLADDER DEFECT WAS CLOSED WITH SUTURES. THE INITIAL REPORTER INDICATED THAT THE PATIENT WAS DOING OK POST-OPERATIVELY. ON (B)(6) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INITIAL REPORTER. THE INITIAL REPORTER STATED THAT THE BLADDER INJURY WAS DUE TO A SURGICAL ERROR. ACCORDING TO THE INITIAL REPORTER, THE SURGEON DID NOT REALIZE THAT THE BLADDER WAS STILL ADHERED AND INADVERTENTLY CREATED A NICKEL SIZED INCISION IN THE PATIENT'S BLADDER. THE INITIAL REPORTER ALSO STATED THAT NO MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. THE INITIAL REPORTER INDICATED THAT A DRAIN WAS PLACED DURING THE REPAIR AND WAS REMOVED ON POST-OP DAY 1 OR 2. THE PATIENT WAS DISCHARGED AND NO POST-OPERATIVE COMPLICATIONS WERE R

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: I UNDERWENT A ROUTINE BLADDER SLING SURGERY APPROX (B)(6), 2013 AT (B)(6) HOSPITAL IN (B)(6). (B)(6) USED THE DA VINCI ROBOT TO PERFORM THE SURGERY. AS THE ROBOTIC ARM WAS RE-POSITIONING MY SMALL INTESTINE, THE ROBOT SLICED MY SMALL INTESTINE WITHOUT THE SURGEON KNOWING IT. ACCORDING TO THE SURGEON, THE ROBOT STOPPED VIDEO TAPING THE PROCEDURE HALF WAY THROUGH SO HE WAS UNABLE TO DETERMINE WHAT HAD HAPPENED. EMERGENCY LIFE SAVING SURGERY WAS PERFORMED ON (B)(6), 2013 BY THE RESIDENT SURGEON TO REPAIR THE TEAR. IT IS NOW 3 MONTHS POST PROCEDURE AND I STILL HAVE NOT BEEN ABLE TO RETURN TO WORK AS I STILL HAVE AN OPEN ABDOMINAL WOUND. PLEASE, I RESPECTFULLY ASK THAT YOU TAKE THE DA VINCI ROBOT OFF THE MARKET AND NOT LET IT HARM ANY FURTHER PEOPLE. MY HOSPITAL BILLS ARE NEARING (B)(6).

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 A DA VINCI HYSTERECTOMY PROCEDURE A PROBLEM WAS IDENTIFIED AND THE PATIENT WAS TAKEN BACK INTO SURGERY FOR AN EXPLORATORY LAPAROTOMY TO LOOK FOR A BOWEL 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, AN INTUITIVE SURGICAL, INC. (ISI) REPRESENTATIVE REPORTED A TRANSVERSE COLON INJURY THAT WAS OBSERVED AFTER A PATIENT WHO UNDERWENT A DA VINCI CHOLECYSTECTOMY SURGICAL PROCEDURE ON (B)(6) 2013. THE PATIENT UNDERWENT ANOTHER UNSPECIFIED SURGERY ON AN UNKNOWN DATE. NO OTHER DETAILS WERE PROVIDED AT THE TIME. ON (B)(4) 2014, ISI OBTAINED THE FOLLOWING ADDITIONAL INFORMATION FROM THE INITIAL REPORTER: THE PATIENT WAS A MALE WHO WAS (B)(6) (WEIGHT=UNKNOWN). THE INITIAL REPORTER SPOKE WITH THE SITE AND WAS NOT INFORMED OF ANY INTRA-SURGICAL COMPLICATIONS OR MALFUNCTIONS OF THE DA VINCI SYSTEM AND/OR INSTRUMENT/ACCESSORIES. ON AN UNSPECIFIED DATE FOLLOWING THE DA VINCI SURGICAL PROCEDURE, THE PATIENT STARTED TO FEEL SICK. TWO DAYS POST DA VINCI SURGERY ((B)(6) 2013), THE SAME DA VINCI SURGEON PERFORMED AN OPEN EXPLORATORY SURGERY AND FOUND THE PATIENT'S TRANSVERSE COLON WAS CUT. THE INJURY WAS REPAIRED AND THE PATIENT WAS HOSPITALIZED FOR A COUPLE WEEKS. PATIENT WAS DISCHARGED AROUND (B)(6) 2014 TO A REHAB FACILITY FOR AN UNDETERMINED TIME PERIOD. THE SURGEON DOES NOT KNOW WHEN THE INJURY OCCURRED AND HOW IT HAPPENED BUT BELIEVES THE INJURY MAY BE RELATED TO USE ERROR (INS

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 SURGICAL PROCEDURE, A NURSE'S FINGERS WERE INJURED WHILE MANEUVERING THE PATIENT SIDE CART (PSC). ACCORDING TO THE INITIAL REPORTER, THE NURSE WAS HAVING DIFFICULTY CONTROLLING THE ACCELERATION OF PSC AND THE NURSE'S FINGERS WERE INJURED BECAUSE THE PSC DID NOT STOP AS THE CUSTOMER HAD EXPECTED. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) WAS CONTACTED DUE TO THE REPORTED EVENT. THE TSE ADVISED THE SITE NOT TO THROTTLE FULLY WHEN MANEUVERING THE PSC BACKWARDS. THE TSE ALSO ADVISED THE SITE TO STOP THE PSC WHEN THE PSC IS CLOSE TO THE END OF A WALL. ON (B)(6) 2013 AND (B)(6) 2014, ISI CONTACTED THE INITIAL REPORTER. THE INITIAL REPORTER EXPLAINED THAT THE NURSE'S FINGER GOT STUCK BETWEEN A HANDLE ON THE PSC AND A WALL WHILE TRYING TO MOVE THE PSC AGAINST THE WALL. HE ALSO INDICATED THAT THE NURSE UNDERWENT AN X-RAY AND NO FRACTURES WERE FOUND. ACCORDING TO THE INITIAL REPORTER, ONE OF THE NURSE'S FINGERS WAS FOUND TO BE BRUISED AND WRAPPED IN A BANDAGE. THE NURSE WAS ADDITIONALLY TREATED WITH 3 ANTIBIOTIC PILLS.

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 CHOLECYSTECTOMY PROCEDURE, THE SURGEON EXPERIENCED REPEATED INTERMITTENT DELAY AND NON-INTUITIVE MOTION WITH PATIENT SIDE MANIPULATOR ARM 2 (PSM2). THE PSM IS AN INSTRUMENT ARM LOCATED ON THE PATIENT SIDE CART (PSC) THAT PROVIDES STERILE INTERFACE FOR THE ENDOWRIST INSTRUMENT. IT WAS REPORTED THAT THE PATIENT'S COMMON BILE DUCT WAS NICKED. HOWEVER, THE SURGEON STATED THAT THE INJURY TO THE PATIENT'S COMMON BILE DUCT WAS NOT RELATED TO THE PSM2 ISSUES. ON (B)(4) 2013, AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER(FSE) PERFORMED A FIELD EVALUATION AT THE SITE. THE FSE TESTED THE PSM INVOLVED WITH THIS COMPLAINT AND FOUND THE PSM SENSORS WERE FUNCTIONING PROPERLY. THE FSE WAS UNABLE TO REPLICATE THE REPORTED ISSUE. THE FSE REVIEWED THE SYSTEM LOGS AND FOUND MULTIPLE 282 AND 31009 ERROR CODES. AN ERROR CODE 282 INDICATES THAT A TOOL WAS DETERMINED TO BE INVALID BY THE SYSTEM. AN ERROR CODE 31009 INDICATES TOOL WAS FULLY DETECTED, AND THEN ONE OR MORE (BUT NOT ALL) OF THE TOOL SENSORS WERE NOT DETECTED FOR 3 SECONDS. THE FSE EXPLAINED THAT THE REPORTED PSM ISSUES WERE MOST LIKELY RELATED TO AN ISSUE WITH THE STERILE ADAPTER. HOWEVER 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: IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI SIGMOID COLECTOMY PROCEDURE, THE DA VINCI SYSTEM WAS UNDOCKED FROM THE PATIENT WHEN THE SURGEON REALIZED HE DID NOT GET ALL THE DISEASED PORTIONS FROM THE PATIENT. THE SURGEON DECIDED TO PERFORM A TRADITIONAL OPEN SURGICAL PROCEDURE TO REMOVE THE DISEASED ANATOMY. AT THE TIME THE SURGEON MADE THE DECISION TO PERFORM THE OPEN SURGICAL PROCEDURE, THE INITIAL REPORTER WAS NO LONGER IN THE OPERATING ROOM (OR), HOWEVER IT WAS INDICATED THAT THE ENTIRE SURGERY LASTED A COUPLE OF HOURS. ON AN UNSPECIFIED DATE, THE PATIENT WAS RELEASED FROM THE HOSPITAL, HOWEVER, THE PATIENT LATER NOTIFIED THE SURGEON OF COMPLAINTS OF NUMBNESS TO HIS LEFT ARM. ON (B)(4) 2013, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON. THE SURGEON INDICATED THAT THE ARM NUMBNESS WAS IN THE DISTRIBUTION OF THE MEDIAN NERVE AND HAD SINCE BEEN RESOLVED. THERE WERE NO OTHER REPORTED POST-OPERATIVE COMPLICATIONS. THE SURGEON REPORTEDLY ORDERED A CERVICAL SPINE MRI WHICH SHOWED THAT THE PATIENT HAD A CERVICAL DISK BULGING IN C4 THROUGH C7, BUT THERE WAS NO DIRECT NERVE IMPINGEMENT. ACCORDING TO THE SURGEON, THE SURGICAL PROCEDURE LASTED 6-7 HOURS AND THE PATIENT WAS N

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 PROSTATECTOMY PROCEDURE, A PATIENT RETURNED TO THE HOSPITAL 3 DAYS LATER AND WAS FOUND TO HAVE SUSTAINED A COLON INJURY. THE INITIAL REPORTER OF THIS COMPLAINT, THE ROBOTICS COORDINATOR, INDICATED THAT THE PATIENT UNDERWENT A DIVERTING COLOSTOMY PROCEDURE. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ROBOTICS COORDINATOR FROM THE SITE. THE ROBOTICS COORDINATOR STATED THAT THERE WERE NO REPORTS THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE DA VINCI PROSTATECTOMY PROCEDURE. ACCORDING TO THE ROBOTICS COORDINATOR, THE PATIENT RETURNED TO THE HOSPITAL 3 DAYS POST-OPERATIVELY WITH COMPLAINTS OF ABDOMINAL PAIN AND FEVER. THE PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY PROCEDURE AND WAS FOUND TO HAVE SEPSIS AND AN UNSPECIFIED COLON INJURY. THE ROBOTIC COORDINATOR STATED THAT A TEMPORARY COLOSTOMY WAS PLACED AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ACCORDING TO THE ROBOTICS COORDINATOR, THE PATIENT WAS TO RETURN TO THE HOSPITAL AT A LATER DATE FOR FURTHER EVALUATION AND POSSIBLE PLACEMENT OF A BOWEL ANASTOMOSIS.

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 MYOMECTOMY PROCEDURE, THE PATIENT WAS FOUND TO HAVE A SMALL BOWEL INJURY. ACCORDING TO THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR), A SURGEON FOUND THE SMALL BOWEL INJURY DURING A SUBSEQUENT OPEN PROCEDURE TO PERFORM A RESECTION OF THE BOWEL. THE SURGEON INDICATED THAT IT WAS HIS BELIEF THAT THE SMALL BOWEL INJURY WAS CLEARLY A THERMAL INJURY. THE CSR ALSO INDICATED THAT THE PATIENT EXPERIENCED FURTHER UNSPECIFIED POST-OPERATIVE COMPLICATIONS AFTER UNDERGOING THE OPEN BOWEL RESECTION PROCEDURE. ON (B)(4) 2013, ISI CONTACTED THE CSR. THE CSR WAS NOT PRESENT DURING THE SURGICAL PROCEDURE. HOWEVER, THE CSR INDICATED THAT THE DA VINCI MYOMECTOMY PROCEDURE WENT SMOOTHLY AND THERE WERE NO REPORTS THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. THE CSR STATED THAT THE PATIENT HAS SINCE BEEN DISCHARGED FROM THE HOSPITAL AND IS DOING FINE. THE CSR ALSO 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 DEPARTME

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 — 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 — 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.

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.'