da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A LITERATURE ARTICLE THAT DESCRIBED A RETROSPECTIVE COHORT STUDY, INCLUDING CONSECUTIVE PATIENTS THAT UNDERWENT THORACIC SURGERY IN A SINGLE CENTER FROM FEBRUARY 2014 TO JANUARY 2023. ROBOTIC THORACIC SURGERY WAS USED IN ANATOMICAL LUNG RESECTION IN 85% OF THE CASES. OVER THE STUDY PERIOD, 1,067 PATIENTS UNDERWENT ROBOTIC SURGERY: 509 HAD LOBECTOMIES AND 391 HAD SEGMENTECTOMIES. THERE WERE 30 CONVERSIONS TO THORACOTOMY (2.8%) OF WHICH 7 WERE EMERGENCIES. SIX CONVERSIONS WERE DUE TO BLEEDING AND 1 CASE WAS CONVERTED DUE TO AN UNSPECIFIED ANESTHESIA ISSUE. THE MENTIONED POSTOPERATIVE COMPLICATIONS WERE REFRACTORY LUNG INFECTION, STROKE AND ONE FISTULA. THERE WERE NO SPECIFIC DA VINCI DEVICE MALFUNCTIONS REPORTED. THE AUTHOR ALSO DID NOT ALLEGE THAT ANY INTUITIVE SURGICAL INC (ISI) PRODUCTS CAUSED OR CONTRIBUTED TO THE COMPLICATIONS. MULTIPLE REQUESTS FOR ADDITIONAL INFORMATION FROM THE DESIGNATED AUTHOR WERE MADE, BUT NO RESPONSE 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: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED THYROIDECTOMY SURGICAL PROCEDURE, THE USER NOTICED THAT THE HARMONIC ACE INSTRUMENT HAD A BROKEN BLADE. THE BLADE FELL INTO THE PATIENT'S ANATOMY AND WAS RETRIEVED DURING THE SAME PROCEDURE. THE INSTRUMENT WAS REMOVED AND REPLACED WITH A BACKUP. FOLLOWING THIS, THE USER CONTINUED AND COMPLETED THE PROCEDURE WITH NO FURTHER ISSUES. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION: THE REPORTER CONFIRMED THAT ALL FRAGMENTS WERE RETRIEVED USING FORCEPS INSTRUMENTS AND CONFIRMED VIA VISUAL INSPECTION. NO ADDITIONAL SURGICAL PROCEDURES OR POST-OPERATIVE TESTS WERE PERFORMED. THERE WAS NO REPORT OF POST-SURGICAL COMPLICATIONS, AND THE PATIENT HAS NOT RETURNED TO THE HOSPITAL. THE SURGEON WAS DISSECTING TISSUE WHEN THE FRAGMENTS FELL INTO THE PATIENT. THE INSTRUMENT WAS USED LESS THAN AN HOUR BEFORE THE EVENT. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIALS DURING THE SURGICAL PROCEDURE. THE STAFF DID NOT FEEL ANY RESISTANCE TO THE REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA. UPON FINAL REMOVAL OF THE INSTRUMENT, THE WRIST WAS STRAIGHTENED, AND THE SU

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 THE CUSTOMER HAD SOME CONCERNS WITH THE DA VINCI SYSTEM "NOT BEING INTUITIVE WITH THE MOTIONS BUT LIKE SOMETHING ELSE". THE CUSTOMER WAS UNABLE TO PROVIDE ADDITIONAL DETAILS AT THE TIME. THE FIELD SERVICE ENGINEER (FSE) NOTED THAT THE CASE WAS CONVERTED FROM A SINGLE PORT TO MULTI-PORT AND EXTENDED. THERE WAS NO REPORTED INJURY.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND POST OP CT SCAN SHOWS A MEDIAL BREACH OF THE L1R SCREW.

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-ASSISTED BARIATRIC SURGICAL PROCEDURE, A FRAGMENT FROM AN UNKNOWN INSTRUMENT FELL INSIDE THE PATIENT'S ANATOMY AND WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED AS PLANNED.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A CERVICAL SPINE PROCEDURE. IT WAS REPORTED THAT THE DOCTOR WAS 1-2 MM OFF ON THE CERVICAL. IT WAS THE RIGHT C4 THAT THE DOCTOR FELT INACCURATE. THE PATIENT LOST BLOOD (500CC'S). BLEEDING WAS ABLE TO BE CONTROLLED. THE PROCEDURE WAS DELAYED 10 MINUTES.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE, A T10 TO T4 EXTENSION TO A PREVIOUS CONSTRUCT. IT WAS REPORTED THAT THE SURGEON STARTED INSERTING ALL SCREWS ON THE RIGHT SIDE FIRST, STARTING FROM T10 AND GOING DOWN TO T4. WHEN THE SURGEON TAPPED T4, THE NON-MEDTRONIC NEUROMONITORING SYSTEM INDICATED THAT ALL MOTOR FUNCTIONS WERE LOST IN THE PATIENT'S LOWER EXTREMITIES. THE SURGEON USED A BALL-TIP SEALER TO FEEL THAT THERE WAS NO WALL ON THE MEDIAL SIDE OF THE T4 PEDICLE. THEY WERE UNSURE WHY TAPPING WAS INACCURATE BUT SUSPECTED EITHER SKIVING OR PATIENT MOVEMENT. THEY DID NOT OBSERVE ANY SOFT TISSUE PRESSURE ON THE CANNULA NOR DEFLECTION OF THE CANNULA FROM THE GELPEE. THE SURGEON ALSO DID NOT OBSERVE ANY CEREBROSPINAL FLUID (CSF) LEAKAGE. THE SURGEON MOVED THE ROBOT OUT OF THE WAY AND USED FREEHAND NAVIGATION TO INSERT THE SCREW AT T4. THE SURGEON FELT THAT THE T4 SCREW ON THE RIGHT SIDE WAS SCREWED APPROPRIATELY. THE SURGEON THEN ABORTED NAVIGATION ENTIRELY AND PROCEEDED TO COMPLETE THE CASE BY INSERTING THE T10 THROUGH T4 SCREWS ON THE LEFT SIDE BY FREEHAND. THE SURGEON WAS FRUSTRATED BECAUSE OF THE PATIENT HARM, BUT WILL CONTINUE

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO H11 FOR FOLLOW-UP INFORMATION.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO H11 FOR FOLLOW-UP INFORMATION.

ExcelsiusGPS — 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 PROCEDURE USING THE EXCELSIUS CRANIAL APPLICATION, A BIOPSY SAMPLE WAS TAKEN AND CAUSED EXCESSIVE 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: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL WITH LYMPHADENECTOMY PROSTATECTOMY SURGICAL PROCEDURE, THE CUSTOMER CALLED IN TO REPORT THAT THEY TRIED TO CONNECT A SCISSOR ON THE UNIVERSAL SURGICAL MANIPULATOR (USM) 4 AND THE ERROR 32098 APPEARED. THE CUSTOMER TRIED DISCONNECTING THE INSTRUMENT AND CONNECTING IT BACK AGAIN BUT THERE WAS NO IMPROVEMENT. THEY REBOOTED AND HARD POWER CYCLED THE SYSTEM SEVERAL TIMES WITH NO SUCCESS. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) TRIED CHECKING ERROR LOGS, BUT THE SYSTEM WAS NOT CONNECTED TO ONSITE. THE TSE ASKED THEM IF THEY COULD DISABLE THE USM AND USE THE OTHER THREE ARMS, WHICH WAS THE CASE. THE TSE EXPLAINED THAT USM 4 WOULD NOT BE USABLE AND ASKED THEM IF THEY COULD CONTINUE SURGERY WITH ONLY THREE ARMS. THE CUSTOMER EXPLAINED THAT THEY WOULD TRY TO FINISH THE PROCEDURE WITH THREE ARMS BUT WOULD LIKE IT TO BE FIXED BEFORE THE SURGERY TOMORROW MORNING. THE OPERATING ROOM (OR) SUPERVISOR CALLED BACK TO REPORT THAT THE SURGEON DECIDED TO CONVERT TO LAPAROSCOPIC SURGERY. SHE ALSO STATED THAT THE INTERNET CONNECTION WAS RESTORED. THE TSE CONFIRMED ERROR 32098 POINTING TO USM 4. THE PROCEDURE WAS CONVERTED

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A LITERATURE ARTICLE DESCRIBED A STUDY THAT AIMED TO ASSESS THE SAFETY AND QUALITY EVENT OF THE DA VINCI SINGLE-PORT (SP) ROBOTIC SYSTEM IN RIGHT SEGMENTAL COLECTOMIES AMONG ADULT PATIENTS VERSUS THE PROCEDURES PERFORMED WITH MULTIPORT DA VINCI SYSTEMS. FIVE RIGHT COLECTOMIES WERE PERFORMED IN ADULT PATIENTS USING THIS DA VINCI-SP SYSTEM BETWEEN MAY 2022 AND NOVEMBER 2022, AND WERE COMPARED TO 25 PATIENTS THAT UNDERWENT RIGHT COLECTOMIES USING THE MULTIPORT DA VINCI SYSTEM BETWEEN JANUARY 2019 AND DECEMBER 2022. ALL PROCEDURES WERE COMPLETED WITHOUT REQUIRING CONVERSION TO OPEN SURGERY. IN THE MULTI-PORT GROUP, TWO PATIENTS REQUIRED INTRAOPERATIVE BLOOD TRANSFUSIONS. ONE PATIENT REQUIRED TIME IN THE INTENSIVE CARE UNIT (ICU) AND THEREFORE HAD A PROLONGED LENGTH OF STAY. ANOTHER PATIENT HAD A POSTOPERATIVE BLOOD TRANSFUSION BECAUSE OF ANASTOMOTIC SITE BLEEDING. THERE WERE NO SPECIFIC DA VINCI DEVICE MALFUNCTIONS REPORTED OR ALLEGED. MULTIPLE REQUESTS FOR ADDITIONAL INFORMATION FROM THE DESIGNATED AUTHOR WERE MADE, BUT NO RESPONSE 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: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, A SMALL CIRCULAR PART ON THE JAWS OF THE SYNCHROSEAL INSTRUMENT FELL OUT. A FRAGMENT FELL INTO THE PATIENT AND WAS RETRIEVED DURING THE SAME SURGICAL PROCEDURE. THE PROCEDURE WAS COMPLETED AS PLANNED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION: DISSECTING WAS BEING PERFORMED WHEN THE DEVICE FRAGMENT FELL INTO THE PATIENT. THE SURGEON BELIEVES THE INSTRUMENT BREAK WAS CAUSED BY A DEFECTIVE INSTRUMENT. THE INSTRUMENT WAS IN USE 30 SECONDS PRIOR TO THE ISSUE. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE SURGICAL PROCEDURE. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIAL DURING THE SURGICAL PROCEDURE. THE INSTRUMENT DID NOT FALL INTO THE PATIENT DURING AN INSTRUMENT TIP / ACCESSORY COLLISION. THE INSTRUMENT WAS NOT REMOVED DURING THE PROCEDURE (PRIOR TO THE BREAKAGE). THE SURGICAL STAFF DID NOT FEEL ANY RESISTANCE UPON REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA. UPON FINAL REMOVAL OF THE INSTRUMENT, THE WRIST WAS STRAIGHTENED. THE SURGICAL STAFF DID NOT NOTICE AN

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO H11 FOR FOLLOW-UP INFORMATION.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT WHILE USING THE EXCELSIUS GPS SYSTEM, THE CASE WAS ABORTED AND SCREWS WERE THEN PLACED BY HAND USING FLURO.

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-ASSISTED SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT SHEARS HEAD WAS BROKEN. THE BROKEN PIECES WERE REMOVED AND DISCARDED. THE SURGEON WAS DISSECTING THE INSTRUMENT FOR ABOUT 30 MINUTES WHEN THE ISSUE WAS IDENTIFIED. THE CUSTOMER DID NOT IDENTIFY ANY ISSUES WITH THE INSTRUMENT'S FUNCTIONALITY DURING THE SURGICAL PROCEDURE. THE CUSTOMER RETRIEVED THE BROKEN PIECE(S), AND NO X-RAY OR ULTRASOUND WAS PERFORMED. THE PROCEDURE WAS COMPLETED ROBOTICALLY. THE PATIENT DID NOT RETURN TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT.

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-ASSISTED LIVER RESECTION SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT WAS NOT ABLE TO DELIVER ENERGY WHEN ACTIVATED BY THE SURGEON AT THE SURGEON SIDE CONSOLE (SSC). THE CUSTOMER RESEATED THE ENERGY CABLE THREE TIMES, BUT THE ISSUE REMAINED. THE PROCEDURE WAS CONVERTED TO OPEN. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PATIENT WAS CONVERTED TO OPEN DUE TO THE HARMONIC ACE NOT FUNCTIONING. IT WAS A LIVER TRANSPLANT SURGERY. THERE WAS NO INJURY REPORTED.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT WHILE USING THE EXCELSIUS GPS SYSTEM, THE CASE WAS ABORTED DUE TO ISSUES WITH MERGING.

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-ASSISTED DISTAL GASTRECTOMY SURGICAL PROCEDURE THE TISSUE PAD OF THE HARMONIC ACE INSTRUMENT BECAME DISLODGED DURING THE PROCEDURE. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A BACKUP INSTRUMENT. INTUITIVE RECEIVED THE FOLLOWING ADDITIONAL INFORMATION VIA FOLLOW-UP: THE FRAGMENT FELL WHEN THE SURGEON WAS TREATING THE GREATER CURVATURE SIDE OF THE STOMACH, DURING THE FIRST FIRE. IT REPORTEDLY FELT LIKE POWDER WAS FLYING AROUND. THE SURGEON PICKED UP THE FRAGMENT, WRAPPED IT IN GAUZE, AND REMOVED IT. THE HARMONIC ACE INSTRUMENT WAS IMMEDIATELY REPLACED WITH A NEW ONE, AND THE SURGERY WAS COMPLETED WITHOUT ANY PROBLEMS. THE INSTRUMENT DID NOT HAVE ANY COLLISIONS AND DID NOT APPEAR TO HAVE ANY OPERATIONAL PROBLEMS BEFORE THE REPORTED ISSUE OCCURRED. THE INSTRUMENT HAD NOT BEEN REMOVED PRIOR TO THE BREAKAGE. UPON FINAL REMOVAL OF THE INSTRUMENT, THE WRIST WAS STRAIGHTENED. NO RESISTANCE WAS FELT THROUGH THE CANNULA. NO DAMAGE WAS NOTICED TO THE CANNULA. NO ADDITIONAL INSTRUMENT DAMAGE WAS FOUND. THERE WERE NO ADDITIONAL PROCEDURES PERFORMED, NOR TESTING, DUE TO THE ISSUE. THE PATIENT HAS NOT RETURNED TO 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 DURING A DA VINCI-ASSISTED RADICAL SALVAGE PROSTATECTOMY SURGICAL PROCEDURE, A SURGEON CALLED IN AFTER PORT PLACEMENT AND BEFORE INSTALLING ANY INSTRUMENT TO REPORT THAT THE RIGHT EYE ON THE SURGEON CONSOLE (SSC) WAS BLACK. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) ASKED IF ICONS WERE DISPLAYED, WHICH WAS NOT THE CASE. THE SURGEON WAS VERY NERVOUS AND WANTED TO HAVE AN IMMEDIATE SOLUTION. THE TSE GUIDED THE SURGEON TO CHECK BOTH VIDEO CHANNELS ON THE TSC (TOUCHSCREEN): BOTH EYES WERE DISPLAYING PROPERLY. THE TSE GUIDED THE SURGEON TO PERFORM A HARD POWER CYCLE OF THE SSC, UNPLUGGING THE SSC POWER CORD FROM THE WALL FOR 1 MINUTE, AND, JUST IN CASE, RESEATING THE SSC BFC (BLUE FIBER CABLE). THIS DID NOT BRING ANY IMPROVEMENT. THE TSE GUIDED THE SURGEON TO CHANGE THE HIGH-RESOLUTION STEREO VIEWER (HRSV) POSITION, EXTREME UP, AND EXTREME DOWN: THIS DID NOT HAVE ANY IMPACT EITHER. LIVE LOGS WERE CLEAN. THE SURGERY WAS POSTPONED. THE PROCEDURE WAS ABORTED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYSTEM'S FUNCTIONALITY WAS INSPECTED WHEN IT WAS POWERED ON. NO ERR

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A LITERATURE ARTICLE THAT DESCRIBED A STUDY THAT PROSPECTIVELY COLLECTED MEDICAL RECORDS OF 429 PATIENTS WHO UNDERWENT ROBOT-ASSISTED RADICAL PROSTATECTOMY (RARP) BETWEEN JANUARY 2015 AND OCTOBER 2023 USING THE SINGLE-PORT (SP) OR MULTI-PORT DA VINCI SYSTEM BY A SINGLE EXPERIENCED ROBOTIC SURGEON. THERE WERE NO CONVERSIONS TO OPEN SURGERY MENTIONED IN THE ARTICLE. THERE WAS ONE INTRAOPERATIVE COMPLICATION IN THE SP-RARP COHORT. THE INTRAOPERATIVE COMPLICATION OCCURRED DURING THE TRANSVESICAL (TV) RARP IN A PATIENT WITH A HISTORY OF A HOSTILE ABDOMEN. THERE WAS A SMALL ENTEROTOMY DURING THE INITIAL BLADDER ENTRY, WHICH WAS PROMPTLY IDENTIFIED AND REPAIRED PRIMARILY USING INTERRUPTED LEMBERT PERMANENT SUTURES BY GENERAL SURGERY. 23 PATIENTS REQUIRED RE-ADMISSION AFTER THE PROCEDURE, AND THE MAJORITY OF THE READMISSIONS IN THE SP COHORT WERE DUE TO POSTOPERATIVE FLUID COLLECTIONS THAT REQUIRED PERCUTANEOUS DRAINAGE. THE DRAINAGES WERE IDENTIFIED TO BE POSTOPERATIVE SEROUS COLLECTION AND NOT LYMPHOCELES. THERE WERE NO SPECIFIC DA VINCI DEVICE MALFUNCTIONS REPORTED, NOR DID THE AUTHOR ALLEGE THAT INTUITIVE SURGICAL INC. (ISI) PRODUCTS CAUSED OR CONTRIBUTED TO THE EVENT. MULTIPLE REQUEST

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-ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, A PIECE FROM THE INSIDE OF THE UNIVERSAL SEAL HAD BROKEN OFF AND FALLEN INSIDE THE PATIENT'S ANATOMY. THE PROCEDURE WAS COMPLETED AS PLANNED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE REPORTED EVENT OCCURRED AT THE BEGINNING OF THE SURGICAL PROCEDURE. THE UNIVERSAL SEAL DID NOT COLLIDE WITH ANY OTHER INSTRUMENT OR HARD MATERIAL DURING THE SURGICAL PROCEDURE. FRAGMENTS DID NOT FALL INSIDE THE PATIENT DURING AN INSTRUMENT TIP OR ACCESSORY COLLISION. THE UNIVERSAL SEAL WAS NOT REMOVED DURING THE SURGICAL PROCEDURE PRIOR TO THE BREAKAGE. THERE WAS NO SURGICAL RESISTANCE, DAMAGE TO THE CANNULA, AND NO ADDITIONAL DAMAGE UPON REMOVAL OF THE UNIVERSAL THROUGH THE CANNULA. THE SURGICAL STAFF CONFIRMED THAT ALL FRAGMENTS HAD BEEN RETRIEVED BY VISUAL INSPECTION AND MANUALLY PLACING THE FRAGMENTS TOGETHER. THERE WAS NO ADDITIONAL SURGICAL PROCEDURE THAT WAS REQUIRED TO BE PERFORMED TO REMOVE THE FRAGMENT. THERE WERE NO POST OPERATIVE TESTS THAT WERE PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING A

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED.

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 ASSISTED PROSTATECTOMY, THE NURSE CALLED THE TECHNICAL SUPPORT ENGINEER (TSE) AND STATED THE IMAGE FROM THE ENDOSCOPE WAS FLICKERING ON THE VISION SIDE CART (VSC) AND THE SURGEON SIDE CONSOLE (SSC) AND THAT THIS IS THE THIRD ENDOSCOPE WITH THIS ISSUE. THE TSE ADVISED TO CLEAN THE ENDOSCOPE CONTROLLER (EC) AND CAMERA CONNECTOR WITH ETHANOL AFTER PROCEDURE, BUT THE NURSE INSISTED ON CLEAN THE EQUIPMENT WHILE PROCEDURE WAS ONGOING. AFTER THE CLEANING THE IMAGE WAS BETTER BUT STARTED TO FLICKER AGAIN AFTER A FEW SECONDS. UNRELATED TO THE IMAGE ISSUE, THERE WAS UNCONTROLLABLE BLEEDING AND THE SURGEON DECIDED TO CONVERT TO OPEN SURGERY TO ACHIEVE HEMOSTASIS. NO ADDITIONAL CLEANING OF EC AND CAMERA WAS PERFORMED. IT WAS LATER CLARIFIED IN FOLLOW UP WITH THE CLINICAL SALES REPRESENTATIVE (CSR), THAT THE PROCEDURE WAS CONVERTED BECAUSE THERE WAS NO RELIABLE ENDOSCOPE AVAILABLE, AND THE ISSUE COULDN¿T BE RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INTRAOPERATIVE COMPLICATION OR UNCONTROLLABLE BLEEDING AND THAT THIS WAS PURELY A TECHNICAL PROBLEM.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THE PATIENT CODED DURING THE PROCEDURE. A TEN POINT ACCURACY CHECK WAS PERFORMED WITH NO ISSUE DETECTED. A THREE POINT ACCURACY CHECK/BIST TEST WAS PERFORMED WITH NO ISSUES DETECTED. THE SYSTEM WAS THEN BROUGHT INTO THE OPERATING ROOM(OR) FOR THE PROCEDURE. THE SCREWS WERE SET VIA K-WIRE. THE PROCEDURE WAS PERFORMED IN TWO SEGMENTS, T9-L1 AND L2 - S1. THE SURGEON EXPOSED THE TOP HALF FIRST, AND DROPPED SCREWS BILATERALLY VIA NAVIGATION. THE SCREW PLACEMENT WAS CONFIRMED VIA FLUOROSCOPY, AND THE SURGEON WAS HAPPY WITH THE SCREW PLACEMENT. THE SYSTEM WAS REMOVED FROM THE PATIENT, TO START THE SECOND SEGMENT, L2-S1. THE PATIENT HAD PREVIOUSLY INSTALLED HARDWARE IN L2-S1, SO THE SURGEON EXPOSED THE BOTTOM HALF OF THE CONSTRUCT, AND REMOVED THE OLD RODS AND SCREWS. THE SYSTEM WAS THEN RECONNECTED TO THE PATIENT, AND S2 REGISTERED WITHOUT ISSUE. K-WIRES WERE INSERTED FOR THE S2 SCREWS, AND THE SCREW WERE PLACED BILATERALLY. ALL NEW SCREWS WERE STIMULATED VIA NEUROMODULATION GREATER THAN 20. BEGINNING L2 AND MOVING TO S1, THE OLD SCREWS WERE REMOVED AND REPLACED FREEHAND.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT WHILE USING THE EXCELSIUS GPS SYSTEM, THE CASE WAS ABORTED AND SCREWS WERE THEN PLACED BY HAND USING FLURO.

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-ASSISTED SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT BROKE. A FRAGMENT FROM THE INSTRUMENT FELL INSIDE THE PATIENT BUT WAS IMMEDIATELY RETRIEVED DURING THE SAME SURGICAL PROCEDURE. HEAD BROKE. THE USER COMPLETED THE PROCEDURE ROBOTICALLY USING A BACKUP HARMONIC ACE INSTRUMENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND THERE WAS NO INSTRUMENT COLLISION.

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-ASSISTED SURGICAL PROCEDURE, THE HARMONIC ACE HEAD BROKE. IT IS UNCLEAR IF A FRAGMENT FELL INSIDE THE PATIENT. HOWEVER, THE CUSTOMER REPORTED THAT THE FRACTURED PART WAS COMPLETELY REMOVED AND NO FRAGMENT REMAINED IN PATIENT. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH A BACKUP HARMONIC ACE INSTRUMENT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HARTMANN'S PROCEDURE THAT THE ENDOSCOPE HAD A FOGGY IMAGE. THE PROCEDURE WAS REPORTEDLY CONVERTED TO AN OPEN PROCEDURE.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT THE PATIENT HAD A BRAIN BLEED FOLLOWING SEEG CASE. ALL TRAJECTORIES WERE OFF BY 2-3MM. DURING THE CASE, LASER REGISTRATION WAS PREFORMED AND VERIFICATION LOOKED GOOD. SICK BOX HAS BEEN CHECKED FOR CORRECT PARAMETERS BEFORE EVERY CASE. NO FURTHER INFORMATION KNOWN.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO H11 FOR FOLLOW-UP INFORMATION.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT WHILE USING THE EXCELSIUS GPS SYSTEM, THE CASE WAS ABORTED AND SCREWS WERE THEN PLACED BY FLURO DURING SURGERY.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT APPROXIMATELY A MONTH AGO A PATIENT WAS PUT UNDER ANESTHESIA AND HAD BONE FIDUCIALS PUT IN WHEN THE CASE HAD TO BE ABORTED DUE TO A DRIFTING ARM AND BEING UNABLE TO CALIBRATE THE TOOLS. THE SURGERY WAS COMPLETED TWO DAYS LATER.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ROBOT WOULD NOT TURN ON AT (B)(6). WE ASSUME A FUSE HAS BLOWN.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT SCREWS USING THE EXCELSUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT THE MISPLACED SCREWS CAUSE A LACK OF MOTION AND SENSATION FOR THE LEFT LEG SINCE THE SPINAL CORD WAS INJURED BY THE MISPLACED SCREWS. THE REPRESENTATIVE SPOKE WITH THE SURGEON ON AUGUST 14TH, AND ACCORDING TO THE SURGEON, THE CONDITION OF THE PATIENT GOT SLIGHTLY BETTER TILL THAT DAY AS HE GOT BACK SOME SENSATION AND MOTION BUT IS STILL FAR AWAY FROM BEING ABLE TO WALK 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: IT WAS REPORTED AFTER A DA VINCI-ASSISTED NIPPLE SPARING MASTECTOMY PROCEDURE, THE PATIENT EXPERIENCED AN EXPANDING RIGHT BREAST HEMATOMA AND REQUIRED RE-OPERATION THE SAME DAY. THE RE-OPERATION INCLUDED A RIGHT BREAST RE-EXPLORATION, WASHOUT, AND TISSUE EXPANDER IMPLANT PLACEMENT AND UPSIZE. THE PATIENT WAS DISCHARGED ON POST-OPERATIVE DAY ONE WITHOUT COMPLICATIONS.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT WHILE USING THE EXCELSIUS GPS SYSTEM, THE CASE WAS ABORTED AND SCREWS WERE THEN PLACED BY HAND DURING 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: IT WAS REPORTED THAT A PATIENT WHO WAS ENROLLED IN A STUDY UNDERWENT A DA VINCI-ASSISTED NIPPLE SPARING MASTECTOMY, RECEIVED AN INTRA-OPERATIVE "INDIRECT" THERMAL INJURY FROM USING THE BIPOLAR CAUTERY IN THE BREAST ENVELOPE TRANSMITTING HEAT ACROSS THE DERMIS TO THE EPIDERMIS. TWO AREAS IN LATERAL LEFT BREAST WITH DESQUAMATION SECONDARY TO BIPOLAR CAUTERY WERE USED DURING SKIN FLAP DISSECTION. THE BEDSIDE ASSIST NOTED WARMTH ON THE FLAP AND BIPOLAR STOPPED FOR 1 OF 2 LESIONS. ONE 0.8 CM DIAMETER AND ONE 0.2 CM DIAMETER. ANTIBIOTIC OINTMENT WAS USED ON THE DAY OF SURGERY. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY AND CAME BACK FOR A 14-DAY VISIT WITH NO OTHER REPORTABLE ISSUES. THERE WAS NO DEVICE MALFUNCTION.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT WHILE USING THE EXCELSIUS GPS SYSTEM, THE CASE WAS ABORTED AND SCREWS WERE THEN PLACED BY HAND DURING 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: A PATIENT WHO WAS ENROLLED IN A CLINICAL STUDY UNDERWENT A DA VINCI-ASSISTED NIPPLE SPARING MASTECTOMY PROCEDURE WITH IMMEDIATE NON-ROBOTIC RECONSTRUCTION. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS AND THE PATIENT WAS DISCHARGED THE SAME DAY. THERE WAS NO DEVICE MALFUNCTIONS REPORTED DURING THE PROCEDURE. THREE WEEKS LATER, THE PATIENT SHOWED SIGNS OF CELLULITIS AND ANTIBIOTICS WERE GIVEN. THE PATIENT PRESENTED TO THE EMERGENCY ROOM (ER) FIVE DAYS LATER WITH WORSENING OF SYMPTOMS, WAS GIVEN IV ANTIBIOTICS, AND WAS DISCHARGED THE SAME WITH ORAL ANTIBIOTICS (ZYVOX). THE NEXT DAY, THE CELLULITIS PROGRESSED TO AN ABSCESS AND THE PATIENT WAS HOSPITALIZED FOR IMPLANT REMOVAL AND WASHOUT ABSCESS.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A PATIENT IN A STUDY UNDERWENT A DA VINCI-ASSISTED BILATERAL NIPPLE SPARING MASTECTOMY (NSM) SURGICAL PROCEDURE. BILATERAL INCISIONS WERE EXTENDED TO REMOVE THE SPECIMEN. BILATERAL SKIN FLAPS WERE VIABLE AT THE END OF THE NSM AND RECONSTRUCTION PROCEDURES. A ONE STAGE RECONSTRUCTION WAS PERFORMED AND BILATERAL DRAINS WERE PLACED (REMOVED 12 DAYS LATER). THE PATIENT WAS DISCHARGED THE SAME DAY. THERE WERE NO INTRA-OPERATIVE ADVERSE EVENTS AND NO DA VINCI DEVICE MALFUNCTIONS DURING THE PROCEDURE. A RETURN TO THE OPERATING ROOM FOR REMOVAL OF ANTIBIOTIC BEADS AND REPLACEMENT OF IMPLANT OCCURRED SEVEN MONTHS LATER. DURING A FOLLOW-UP VISIT THE NEXT MONTH, A RIGHT BREAST SEROMA WAS REPORTED; A PALPABLE FLUID COLLECTION ON THE RIGHT RECONSTRUCTED BREAST WAS NOTED. A RADIOLOGY VISIT WAS ORDERED FOR EVALUATION AND ASPIRATION; 142 CC OF SEROMA WERE ASPIRATED FROM THE RIGHT BREAST POCKET. NO SEQUELAE WERE NOTED. THE STUDY INVESTIGATOR REPORTED THE EVENT AS NOT A SERIOUS ADVERSE EVENT (SAE), A CLAVIEN-DINDO GRADE III, NOT RELATED TO THE DA VINCI STUDY DEVICE, NOT RELATED TO THE NSM PROCEDURE, NOT RELATED TO THE RECONSTRUCTION PROCEDURE.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT WHILE USING THE EXCELSIUS GPS SYSTEM, SCREW WAS MISPLACED DURING A PROCEDURE WITH EGPS. THE SURGEON FOUND OUT VIA INTRA-OPERATIVE CT WHEN SWITCHING SYSTEMS TO STEALTH NAVIGATION. HAVING STRUGGLED TO OBTAIN GREEN BOARDER TRAJECTORIES FOR THE FIRST TWO SCREWS USING EGPS, A LANDMARK CHECK WAS CARRIED OUT AND IT WAS DISCOVERED THAT THE REGISTRATION WAS NOT ACCURATE. IT WAS AT THIS POINT THAT THE SURGEON REQUESTED TO CEASE USING EGPS AND TO OBTAIN ANOTHER O-ARM SPIN AND PROCEED WITH STEALTH NAVIGATION. CASE WAS AN MIS TUMOR STABILIZATION FOR L3 TUMOR. THE PLAN WAS TO INSTRUMENT L1,L2, L4 AND L5.

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-ASSISTED RADICAL SALVAGE PROSTATECTOMY PROCEDURE, THE IMAGE OF THE SURGICAL FIELD FROZE TWICE WHILE THE SURGEON WAS DISSECTING THE ILIAC ARTERY, CAUSING AN INJURY AND BLEEDING. THE 0 DEGREE ENDOSCOPE PLUS WAS INSPECTED PRIOR TO USE AND THERE WAS NO DAMAGE OR ANYTHING OUT OF THE ORDINARY IDENTIFIED. WHEN THE IMAGE FROZE FOR APPROXIMATELY 1 MINUTE, THE SYSTEM WAS STILL DISPLAYING THE SURGICAL FIELD, BUT THE IMAGE DID NOT REACT TO THE MOVEMENT INITIATED BY THE SURGEON. THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WAS BEING USED TO DISSECT THE ILIAC ARTERY WHEN THE LOSS OF THE IMAGE OCCURRED; CAUSING THE MCS INSTRUMENT TO INJURE THE ARTERY AND BLEEDING OCCURRED. THE BLEEDING WAS UNEXPECTED, AND THE BLOOD LOSS WAS ESTIMATED TO BE APPROXIMATELY 400ML. TO RESOLVE THE BLEEDING, THE HOLE ON THE ARTERY WAS SUTURED CLOSED; THE PATIENT DID NOT REQUIRE A TRANSFUSION OF BLOOD PRODUCTS. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) WAS CALLED TO HELP TROUBLESHOOT THE ISSUE, AND UPON REVIEWING THE LOGS, A RECURRENT ERROR INDICATING AN ISSUE WITH THE 0 DEGREE ENDOSCOPE PLUS WAS OBSERVED. THE CUSTOMER INFORMED THE TSE THAT A SPARE 0 DEGRE

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MED/POST HAPTICS WERE SO LARGE THAT IT ALLOWED SAW BLADE TO CUT SUPERFICIAL FIBERS OF THE MCL. PRODUCT MANAGEMENT HAVE BEEN MADE AWARE AND ARE SUBMITTING THIS CASE TO ENGINEERS IN US FOR AN EXPLANATION. ALL CASE DETAILS HAVE BEEN FORWARDED TO FSE TEAM REQUIRED LIGAMENT REPAIR AND TS POLY.

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-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT TIP COVER ACCESSORY WAS POSSIBLY LEFT IN THE PATIENT. THE CUSTOMER BELIEVED THE MCS TIP COVER ACCESSORY FELL OFF INTO THE PATIENT. THE CUSTOMER WAS NOT ABLE TO LOCATE IT INSIDE OR OUTSIDE THE PATIENT. THE CUSTOMER DID AN X-RAYS TO SEE IF THEY COULD FIND IT IN THE PATIENT. THE PROCEDURE WAS COMPLETED.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT A REVISION SURGERY WAS NEEDED TO REMOVE AND REPLACE MISPLACED SCREWS THAT WERE PLACED USING THE EXCELSIUS GPS SYSTEM.