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 SCREENS ON THE SYSTEM WENT BLACK TWICE BEFORE THE 3 DEFINE SCAN WAS COMPLETED. THE SCREEN WENT BLACK FOR ABOUT 90 SECONDS, AND ALL INSTRUMENTS WOULD HAVE TO BE REVERIFIED AFTER EACH INSTANCE. THE CODES REMAINED. THE SYSTEM WAS DELAYED BY TEN MINUTES. THE SURGEON PLANNED ON INSERTING FOUR SCREWS, BUT THE ANESTHESIOLOGIST ABORTED THE SURGERY DUE TO THE PATIENT'S HIGH BLOOD PRESSURE AFTER TWO SCREWS WERE INSERTED. THE THIRD SCREW WAS IN THE PROCESS OF BEING INSERTED WHEN THE SURGERY WAS ABORTED. THE MANUFACTURE REPRESENTATIVE BELIEVED THE ENTIRE SURGERY WOULD HAVE BEEN COMPLETED HAD THE SITE NOT FACED DELAYS. THERE WAS NO FURTHER PATIENT HARM REPORTED.

Monarch Platform — 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 WAS UNDERGOING A MONARCH BRONCHOSCOPY DEVELOPED A PNEUMOTHORAX AND WAS VERIFIED VIA CHEST X-RAY. THE TARGET WAS A RML LESION ON THE FISSURE. A CHEST TUBE PLACED, THE PATIENT WAS ADMITTED OVERNIGHT, AND DISCHARGED ON (B)(6) 2022. A MEDTRONIC ARCPOINT NEEDLE AND MONARCH FORCEPS (WHICH WERE DISCARDED) WERE USED DURING THIS CASE. THE PHYSICIAN REPORTED THAT THEY DON'T BELIEVE THE PNEUMOTHORAX WAS CAUSED BY THE MONARCH SYSTEM, BUT RATHER BY THE LOCATION OF THE NODULE IN RELATION TO THE FISSURE. THE CASE WAS COMPLETED SUCCESSFULLY.

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 POSTERIOR INSTRUMENTATION WITH INTERBODY SPACERS AND FUSION OF L4-S1. IT WAS REPORTED THAT THIS SYSTEM COULD NOT PASS REGISTRATION DURING THE CASE. THE STAFF HOWEVER FELT LIKE THE ISSUE DID NOT LIE WITH THE GUIDANCE SYSTEM, BUT INSTEAD WITH THE SCANS. THE SURGERY WAS ABORTED AND WILL BE RESCHEDULED AFTER THE PATIENT LOSING SOME WEIGHT PER SURGEON REQUEST. THE SUSPECTED OR MOST LIKELY CAUSE OF THE REGISTRATION ISSUE WAS THE PATIENT'S BMI OR BMI GAIN SINCE THE CT SCAN. THERE WAS NO PATIENT HARM AND THE PROCEDURE WAS DELAYED LESS THAN ONE HOUR.

Senhance — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE COMPLAINANT, PROF. (B)(6), REPORTED A TRANSABDOMINAL PREPERITONEAL REPAIR (RTAPP) WAS PERFORMED ON (B)(6) 2022, AND NEXT DAY THE PATIENT WAS DISCHARGED WITHOUT PROBLEMS. ON (B)(6) 2022 THE PATIENT HAD ABDOMINAL PAIN AND INFLAMMATION FOR WHICH AN ORGAN LESION WAS SUSPECTED AND THE PATIENT WAS RE-OPERATED. THE RE-SURGERY FOUND A THERMIC LESION OF THE SMALL BOWEL (3CM) WITH ABSCESS FOR WHICH AN OPEN RESECTION AND ILEOASCENDOSTOMY WERE PERFORMED. THE PATIENT FOLLOW-UP WAS UNEVENTFUL NOTING A (B)(6) 2022 DATE OF RESOLUTION. IT WAS REPORTED THAT CAUSALITY TO THE SENHANCE SURGICAL SYSTEM WAS POSSIBLE. THIS EVENT DID NOT OCCUR WITHIN THE UNITED STATES. THE EVENT OCCURRED IN (B)(6) IN GERMANY. ADDITIONALLY, THIS EVENT OCCURRED ON (B)(6) 2022, AND ASENSUS SURGICAL WAS INTERNALLY MADE AWARE ON 25-SEPTEMBER-2022.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING REVIEW OF A LITERATURE ARTICLE INVOLVING DA VINCI ASSISTED ROBOTIC PROCEDURES TITLED, ¿ROBOTIC SINGLE-PORT SURGERY: PRELIMINARY EXPERIENCE IN GENERAL SURGERY", THE FOLLOWING EVENTS WERE REPORTED. A REVIEW OF THE DATABASE WAS PERFORMED ON THE PATIENTS WHO UNDERWENT SINGLE INCISION SURGERY WITH THE DA VINCI SP SURGICAL SYSTEM FROM JULY 2019 TO SEPTEMBER 2021 WAS PERFORMED ACCORDING TO THE ARTICLE. PROCEDURES PERFORMED INCLUDED 141 SINGLE PORT CHOLECYSTECTOMY (SP-C) AND 77 SINGLE PORT TRANSABDOMINAL PREPERITONEAL INGUINAL HERNIA REPAIR (SP-TAPP). MOST OF THE PATIENTS WERE DISCHARGED THE SAME DAY. THERE WERE TWO PATIENTS REQUIRED ADMISSION IN THE SP-TAPP COHORT AND WERE THE COMBINED CASES WITH THE UROLOGY TEAM (PARTIAL NEPHRECTOMY AND PROSTATECTOMY). IN THE SP-C GROUP, 2 PATIENTS WERE ADMITTED POSTOPERATIVELY DUE TO PERSISTENT NAUSEA AND VOMITING. ALL THE POST-OPERATIVE COMPLICATIONS WERE CLAVIEN-DINDO GRADE II OR LESS AND INCLUDED 3 SEROMAS (RESOLVED SPONTANEOUSLY), 2 PROLONGED POSTOPERATIVE ILEUS (MANAGED CONSERVATIVELY), 1 URINARY RETENTION (REQUIRED FOLEY CATHETER), AND 1 URINARY TRACT INFECTION (ANTIBIOTIC TREATMENT). THERE WERE NO MAJOR COMPLICATIONS, URGENT REOPERATIONS,

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, A SMALL RETAINING SCREW IN THE RUBBERIZED SECTION PROXIMAL TO THE SYNCHROSEAL INSTRUMENT JAW APPEARED TO BECOME DETACHED AND WAS LOST WITHIN THE PATIENT. THE CUSTOMER HAS USED X-RAY ON THE PATIENT BUT WAS UNABLE TO IDENTIFY A FOREIGN OBJECT. THE CUSTOMER HAVE ASKED INTUITIVE SURGICAL (IS) TO CONFIRM THE MATERIAL TYPE OF THE SCREW TO ADD IN ITS LOCATION AND POTENTIAL RETRIEVAL. THE PROCEDURE WAS COMPLETED WITH NO REPORT OF PATIENT INJURY. ON 17-AUG-2022, ADDITIONAL INFORMATION WAS PROVIDED BY THE SPECIALTY SALES MANAGER: DURING THE SURGERY, THEY NOTICED A CIRCULAR WASHER LYING INSIDE THE PATIENT, WHICH WAS REMOVED. UPON INSPECTION OF THE SYNCHROSEAL INSTRUMENT THEY NOTICED THAT THERE IS A SMALL PIN SIZED HOLE ON THE INSTRUMENT WHICH COULD HAVE HAD A PIN INSIDE. THEY WERE NOT SURE AT THIS POINT AS TO WHETHER IT HAD A PIN INSIDE EARLIER. THEY NOTICED THAT THE OTHER SIDE HAD A PIN AND WASHER. THEY THEN TOOK OUT ANOTHER INSTRUMENT AND INSPECTED IT TO UNDERSTAND THE STRUCTURE. ONCE THEY UNDERSTOOD THAT THERE IS A MISSING PIN, THEY NEEDED TO KNOW HOW BIG IT WAS AND WHAT SHAPE THEY SHOULD SEARCH FOR WITHIN THE PATIENT. IT

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 DURING A CASE, THE STAR MARKER COULD NOT BE FOUND. THE SITE DID AN HD SCAN AND DROPPED IT DOWN 3 AND STILL COULDN'T BE FOUND. THE SURGERY WAS ABORTED. THERE WAS NO IMPACT ON THE PATIENT OUTCOME. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THIS ISSUE OCCURRED DURING SCAN PLAN. THE SURGERY WAS ABORTED POST-INCISION.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2022 THE PATIENT HAD SPINAL SURGERY WITH USE OF MAZOR ROBOTIC ASSISTANCE. PER THE SURGEON, DURING THE PROCEDURE THE EXPANDING TECHNOLOGY FAILED. ALSO POST OP, IT WAS SUSPECTED THAT THE SCREWS PLACED BY THE MAZOR WERE MALPOSITIONED FROM THE PLANNED TRAJECTORY. ANOTHER PROCEDURE WAS REQUIRED FOR SCREW REVISION AND COMPRESSION OF THE EXPANDABLE CAGE. FDA SAFETY REPORT ID # (B)(4).

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 MALIGNANT HYSTERECTOMY SURGICAL PROCEDURE, A CUSTOMER REPORTED THAT SYNCHROSEAL INSTRUMENT WAS BROKEN. A FRAGMENT FELL INTO THE PATIENT¿S ANATOMY AND WAS RETRIEVED IN THE SAME PROCEDURE. THE PROCEDURE CONTINUED AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE FRAGMENT WAS REMOVED WITH A FORCEPS INSTRUMENT. IT WAS CONFIRMED VIA ENDOSCOPE THAT ALL FRAGMENTS WERE RETRIEVED. NO ADDITIONAL SURGICAL PROCEDURE WAS PERFORMED. AN X-RAY WAS PERFORMED AFTER THE PROCEDURE AS USUAL. THE SURGEON BELIEVED THAT THE SYNCHROSEAL INSTRUMENT COLLIDING WITH ANOTHER INSTRUMENT WAS THE CAUSE OF THE FRAGMENT FALLING INTO PATIENT. THE SYNCHROSEAL WAS INSPECTED PRIOR TO USE WITH NO ISSUE. A VESSEL SEALING TASK WAS BEING PERFORMED WHEN THE FRAGMENT FELL INSIDE THE PATIENT. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE SURGICAL PROCEDURE. THE CUSTOMER DID NOT REMOVE THE INSTRUMENT PRIOR TO THE INSTRUMENT BREAKAGE. UPON FINAL REMOVAL OF THE INSTRUMENT, THE WRIST OF THE INSTRUMENT WAS STRAIGHTENED. THE SURGICAL S

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 RUBBER WASHER FROM THE 8 MM SYNCHROSEAL FELL OFF INSIDE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

Monarch Platform — 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 MONARCH BRONCHOSCOPY PROCEDURE PATIENT EXPERIENCED PNEUMOTHORAX. LESION IN THE LINGULA 1.7 X 9 CM. LESION WAS PERIPHERAL. CHEST TUBE WAS PLACED, THE PATIENT WAS HOSPITALIZED, AND RELEASED ON (B)(6) 2022. THE CASE WAS COMPLETED AND THE PHYSICIAN DID NOT ATTRIBUTE THE EVENT TO THE MONARCH SPECIFICALLY. OTHER INSTRUMENTS USED IN THIS CASE WERE THE ARCPOINT NEEDLE, OLYMPUS CYTOLOGY BRUSH, OLYMPUS MICRO BRUSH, AND OLYMPUS ENDOJAW DISPOSABLE BIOPSY FORCEPS.

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 SIGMOID COLECTOMY SURGICAL PROCEDURE, A SMALL METAL RING FROM THE SYNCHROSEAL INSTRUMENT FELL INTO THE PATIENT. THE FRAGMENT WAS REPORTEDLY RETRIEVED DURING A DIFFERENT PROCEDURE. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

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 UNILATERAL INGUINAL HERNIA PROCEDURE, THE SURGEON NOTICED CAUTERIZED TISSUE WHERE ENERGY WAS NOT INTENTIONALLY APPLIED. IT WAS NOTED THAT NOTHING WAS VISIBLY WRONG WITH THE INSTRUMENT. IT IS UNKNOWN WHAT SPECIFIC TISSUE WAS UNINTENTIONALLY CAUTERIZED AND IF ANY MEDICAL INTERVENTION WAS RENDERED DUE TO THE COMPLICATION. ADDITIONALLY, THE SEVERITY OF THE BURN INJURY IS UNKNOWN. FURTHERMORE, IT IS UNKNOWN WHAT SPECIFIC INSTRUMENT WAS INVOLVED WITH THE COMPLICATION. THE SURGICAL PROCEDURE WAS REPORTEDLY COMPLETED WITH NO PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ABSTRACT: ROBOTIC ASSISTED SURGERY IS CONTINUOUSLY GETTING MORE COMMON IN SPINAL SURGERY. MANY STUDIES HAVE ALREADY SHOWN AN IMPROVEMENT IN THE ACCURACY OF PEDICLE SCREW PLACEMENT AND A DECREASE OF SURGICAL REVISIONS. UP TO NOW ONLY A FEW STUDIES EXIST REGARDING THE LEARNING CURVE AND THE TIME NEEDED FOR ROBOTIC ASSISTED SPINAL FUSIONS. FOR GERMANY NO RELEVANT DATA ARE AVAILABLE SO FAR. THIS PROSPECTIVE AND COMPARATIVE STUDY FOCUSSED ON THE LEARNING CURVE COMPARED TO THE STANDARD SURGICAL PROCEDURE. MATERIAL AND METHODS: SINGLE-CENTER PROSPECTIVE DATA COLLECTION OF ALL PERFORMED SPINAL FUSIONS, WHETHER STANDARD OPEN (SO) OR ROBOTIC ASSISTED (RAS), OVER A PERIOD OF 5 MONTHS. EVALUATION OF TIME NEEDED FOR ROBOTIC REGISTRATION AND PEDICLE SCREW PLACEMENT, AMOUNT OF BLOOD LOSS, X-RAY DOSE, AND COMPLICATIONS. LEARNING CURVE WAS CALCULATED USING CURVE FITTING REGRESSION MODELS IN SPSS. RESULTS: 71 NON-RANDOMIZED PATIENTS WERE INCLUDED OF WHOM 42 (MEAN AGE 64 ± 15 YEARS) UNDERWENT ROBOTIC ASSISTED SURGERY (RAS) (MAZOR X STEALTH STATION, MEDTRONIC), 29 (MEAN AGE 63 ± 19 YEARS, P = 0.761) UNDERWENT STANDARD OPEN SURGERY (SO). THE AVERAGE NUMBER OF IMPLANTED SCREWS FOR SO WAS 6 ± 3, AND FOR

Monarch Platform — 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 MONARCH BRONCHOSCOPY A PATIENT WAS BLEEDING IN THE RIGHT MIDDLE LOBE FOLLOWING THE USE OF A MEDTRONIC ARCPOINT NEEDLE AND THE MONARCH FORCEPS. THE BLEEDING OBSTRUCTED THE PHYSICIAN¿S VIEW AND WAS NOTED IN THE ENDOTRACHEAL TUBE. THE MONARCH PORTION OF THE CASE WAS ABORTED, AND THE PHYSICIAN PERFORMED AN EMERGENT CONVERSION TO REMOVE THE ROBOT AND ATTEMPTED TO CONTROL THE BLEEDING. THE PATIENT WAS GIVEN A BLOOD TRANSFUSION AND TRANSPORTED TO THE OPERATING ROOM (OR). WHEN IN THE OR, THE PHYSICIAN, WHILE UNDER BRONCHOSCOPIC GUIDANCE, WAS ABLE TO CONTROL THE BLEEDING VIA BRONCHOSCOPE VISUALIZATION AND EPINEPHRINE. PATIENT WAS DISCHARGED TWO DAYS LATER AND IS DOING WELL. NO FAULTS OR MALFUNCTIONS WERE REPORTED FROM SYSTEM. THE MONARCH FORCEPS WERE DISCARDED DURING THE EVENT AND WILL NOT BE RETURNED FOR FAILURE ANALYSIS.

Monarch Platform — 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 THE FIRST, AND ONLY CASE OF THE DAY (1:45PM), THE RIGHT LOWER LOBE (RLL) LESION 1.5CM EXPECTED INFECTION, PHYSICIAN DID 4 BRUSHES AND PATIENT SUSTAINED A SMALL PNEUMOTHORAX. A CHEST TUBE WAS PLACED TAKING A WEEK TO RESOLVE. AURIS FORCEPS, A MICRO BRUSH (BRAND WAS NOT RECORDED), AND AN OLYMPUS PERIVIEW FLEX TBNA NEEDLE WERE ALL USED IN THIS CASE. PATIENT WAS ADMITTED AND A CHEST TUBE WAS PLACED. THE CHEST TUBE WAS REMOVED ON (B)(6) 2022 AND THE PATIENT WAS DISCHARGED THE SAME DAY. THE PATIENT IS CURRENTLY DOING WELL. THE PHYSICIAN DOES NOT ATTRIBUTE THE PNEUMOTHORAX TO THE MONARCH SYSTEM.

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 DURING AN RNS THE PATIENT RECEIVED A BLOOD TRANSFUSION DUE TO A BLEED. THE TRANSFUSION OCCURRED AFTER THE STEREOTACTIC PORTION AND DURING THE CRANIOTOMY. OTHER THAN THE BLOOD TRANSFUSION THERE WAS NO ADDITIONAL IMPACT REPORTED. NO FURTHER INFORMATION AVAILABLE REGARDING THIS EVENT.

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 THERE WAS A DEVIATION DURING A SINGLE POSITIONER LATERAL CASE FROM L2-L5. THE SURGICAL SYSTEM WAS MOUNTED TO THE PATIENT USING A SCHANZ PIN, SCHANZ BRIDGE AND MIS CONNECTOR. THE PATIENT WAS NOTED TO BE SMALL AND WAS POSITIONED WITH THEIR LEFT SIDE UP. THE SURGEON STARTED AT RIGHT L2 AND PLACED THE PEDICLE SCREWS UP BEFORE MOVING TO THE TOP SIDE LEFT AND GOING DOWN. DURING THE CASE, THE SURGEON FELT ACCURATE AND AN INTRA-OP X-RAY WAS TAKEN TO CONFIRM ACCURACY. WHEN THE SURGEON DRILLED LEFT L2, THE PATIENT HAD A BODILY RESPONSE AND BUCKED, WHICH DID NOT SEEM TO CAUSE ANY ISSUES AND THE CASE CONTINUED. THE SURGEON FINISHED THE LEFT SIDE, TOOK AN X-RAY AND PROCEEDED WITH THE OLIF PORTION. A DAY AFTER THE PROCEDURE, THE PATIENT HAD SERIOUS LEG WEAKNESS AND DISCOMFORT ON THEIR LEFT SIDE. A CT SCAN WAS DONE AND L2-L3 ON THE LEFT SIDE WERE FOUND TO BE DEVIATED 3-5 MM MEDIALLY AND L2-L3 ON THE RIGHT SIDE WERE 3-5 MM OFF LATERALLY. THE SURGEON BELIEVED THAT THE DRILL HIT THE NERVE ROOT WHEN THE PATIENT BUCKED. THE MANUFACTURER REPRESENTATIVE NOTED THAT THE EVIDENCE POINTED TO

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 THE SURGEON QUESTIONED THE ALIGNMENT ON POST OP X-RAY GIVEN THE PLANNED AND VALIDATED CUTS MEASURED DO NOT CORRELATE. PLANNED FOR NEUTRAL TO SLIGHT VALGUS KNEE OVERALL, STARTED AT 18 DEG VALGUS. VALIDATED CUTS SUGGEST WE SHOULD HAVE ENDED UP AT NEUTRAL OR CLOSE TO HOWEVER ON POST OP X-RAYS HAVE ENDED AT 10 DEG VARUS. THE PATIENT HAS ALSO REPORTED SIGNS OF PAIN AND INSTABILITY. THE PATIENT IS BEING CONSIDERED FOR A REVISION. NO ADDITIONAL 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: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY PROCEDURE, THE SURGEON WAS UNABLE TO FOCUS THE ENDOSCOPE. AT THE TIME THE ISSUE OCCURRED, THE PATIENT WAS ANESTHETIZED AND PORTS WERE PLACED. THE CUSTOMER HAD POWER CYCLED THE SYSTEM, TRIED TO FOCUS BOTH FROM THE SURGEON SIDE CONSOLE (SSC) AND CAMERA HEAD BUTTONS, AND PERFORMED 3D CALIBRATION BUT THE FOCUSING ISSUE WAS STILL NOT IMPROVED. THE CUSTOMER CONTACTED AN ISI TECHNICAL SUPPORT ENGINEER (TSE) FOR TROUBLESHOOTING ASSISTANCE AND WAS ADVISED TO TIGHTEN THE CAMERA CABLE AND TRY TO REFOCUS AGAIN. THE CUSTOMER REPORTED THAT THE CAMERA CABLE WAS NOT LOOSE AND MECHANICAL SOUND WAS HEARD WHEN HE PRESSED ON THE FOCUS BUTTON OF THE CAMERA HEAD. THE IMAGE STILL COULD NOT BE FOCUSED. THE CUSTOMER WAS ADVISED THAT THE ISSUE MAY BE FROM THE CAMERA HEAD. THE PATIENT REMAINED ANESTHETIZED FOR APPROXIMATELY THREE HOURS BEFORE THE BACKUP CAMERA HEAD ARRIVED. AFTER THE CAMERA HEAD WAS REPLACED BY AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE), THE PROCEDURE WAS RESUMED AND COMPLETED WITHOUT FURTHER ISSUES. THERE WAS NO INTRAOPERATIVE PATIENT HEALTH DAMAGE OBSERVED; HOWEVER, THE PATIENT ORIGINALLY HAD INTERSTI

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 RIGHT L2 SCREW.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE CASE WAS SCHEDULED AS PREOP CT WORKFLOW FOR POSTERIOR PERCUTANEOUS SCREW PLACEMENT WITH THE ROBOT AT L4 AND L5 FOLLOWING AN L4/5 LLIF. THE SCAN UPLOADED WITH NO ISSUES AND WAS CONFIRMED TO BE TO PROTOCOL. THE SURGEON PLANNED SCREWS AT L4 AND L5 WHILE THE PATIENT WAS REPOSITIONED PRONE. DRB AND SM WERE PLACED IN PSIS IN STANDARD ORIENTATION WITH CAMERA AT THE FOOT. THE SM WAS REGISTERED PRIOR TO X-RAY COMING INTO THE FIELD. IMAGES WERE INITIALLY OBTAINED FOR L4 AND L5, BUT THE MERGE WAS UNSUCCESSFUL - WAGGING UP AND DOWN IN THE LATERAL IMAGES AND SLIGHT ROCKING IN THE AP. L3 AND S1 WERE ADDED IN THE WORKFLOW PAGE AND "DUMMY" SCREWS WERE QUICKLY PLANNED AT L3 AND S1. IMAGES WERE OBTAINED FOR L3 AND S1 WITH THE SAME RESULT - UNSUCCESSFUL MERGE WITH WHAT SEEMED LIKE EQUAL MOVEMENT WHEN VERIFYING. NEW SHOTS WERE THEN OBTAINED FOR L4 AND L5 AND ONCE AGAIN WE COULD NOT GET A MERGE, WE WERE CONFIDENT IN ACCEPTING. THE SURGEON BAILED TO TRADITIONAL JAMSHID PLACEMENT, ALREADY FRUSTRATED WITH HIS EXPERIENCES OF THE DAY, ALTHOUGH FLUORO WORKFLOW WAS OFFERED TO HIM.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: HAD A VERY DIFFICULT TIME GETTING A MERGE. THE DRR WAS LESS THAN SUFFICIENT AS FAR AS QUALITY/BEING ABLE TO MERGE WITH OUR FLUORO SHOTS. OUR FLUORO SHOTS I THOUGHT WERE GREAT, BUT ULTIMATELY HAD NO EXPLANATION FOR NOT BEING ABLE TO GET A MERGE. WE WENT BACK ADJUSTED THE WINDOWING ON THE CT. THAT DIDN'T HELP. "DEEP SEARCH" AND "AUTO MERGE" WERE ATTEMPTED SEVERAL TIMES AFTER MOVING THE DRR INTO WHAT I FELT/COULD MAKE OUT TO BE THE MATCHING ANATOMY OF THE FLUORO SHOTS. THERE WAS SOME WEIRD BOX IN THE DRR THAT I COULD NOT EXPLAIN EITHER.

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 TONGUE BASE RESECTION-BENIGN SURGICAL PROCEDURE, THE RIGHT MASTER TOOL MANIPULATORS (MTM) WERE NOT MOVING. THE OPERATING ROOM STAFF, CALLED TECHNICAL SUPPORT TO REPORT THAT THE RIGHT-HAND CONTROL ON THE SP WAS FROZEN. PRIOR TO CALLING IN, THE SITE CONVERTED TO OPEN SURGICAL PROCEDURE. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) WAS UNABLE TO VIEW LIVE LOGS FROM THE SYSTEM. THE ISI TSE ASKED IF THE CALLER COULD VERIFY INSTRUMENT ASSIGNMENTS, BUT THE CALLER STATED THAT THE SYSTEM HAD BEEN TAKEN AWAY. THE CALLER STATED THAT THEY PERFORMED A REBOOT ON THE SYSTEM WITH NO CHANGE. THE CALLER WAS REQUESTING THE FIELD SERVICE ENGINEER (FSE) TO FOLLOW UP. ISI MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

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 THERE WAS AN ALLEGED INACCURACY ON (B)(6). IT WAS REPORTED THAT MULTIPLE SCREWS WERE DETERMINED TO BE MEDIALLY OFF VIA POST-OP SCAN. THE SITE REGISTERED VIA A CT TO FLUORO MERGE WITH A PERCUTANEOUS PIN IN THE PSIS. THE SCREWS WERE PLACED ACCURATELY BILATERALLY AT ALL LEVELS PER THE ROBOTIC PLAN. T8-L1 WERE THEN REGISTERED VIA CT TO FLUORO MERGE WITH THE BONE MOUNT CLAMP AT APPROXIMATELY T10-T11. THE SCREWS WERE PLACED ACCURATELY. THE FINAL THREE LEVELS T5-T7 WERE REGISTERED THE SAME WAY WITH THE BONE MOUNT CLAMP ON T7. WHEN BEGINNING TO PLACE THE FIRST SCREW AT T7, THERE WAS A SHOULDER SHIFT ERROR. THE ROBOT WAS REGISTERED AGAIN WITHOUT MOVING THE CLAMP AND, AGAIN, WHEN THE SITE STARTED PLACING THE T7 SCREW, THEY RECEIVED A SHOULDER SHIFT ERROR. THE CLAMP WAS REMOVED, AND IT WAS NOTICED THAT THE SPINOUS PROCESS HAD CRACKED. THE CLAMP WAS MOVED UP ONE LEVEL TO T6, AND THE ROBOT REGISTERED ONE LAST TIME TO PLACE THE SCREW BILATERALLY UP TO T5. NO INTRA-OPERATIVE IMAGING WAS TAKEN TO CONFIRM THE SCREW PLACEMENT. THE PATIENT WAS IN SOME PAIN POST OPERATIVELY. WHEN IT WA

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SIMPLE PROSTATECTOMY SURGICAL PROCEDURE THAT THE SYNCHROSEAL INSTRUMENT ARCED WHILE USING THE SEAL FUNCTION. THE PROCEDURE WAS COMPLETED WITH NO REPORTS OF PATIENT INJURY. INTUITIVE SURGICAL INC. (ISI) FOLLOWED UP WITH THE CUSTOMER TO CONFIRM THAT THE INSTRUMENT WAS INSPECTED BEFORE THE PROCEDURE WITH NO ISSUES NOTICED. THE SURGEON WAS SEALING PROSTATE TISSUE WITH NO SPECIFIC VESSEL. THERE WAS A WARNING MESSAGE REGARDING INCOMPLETE SEALING FOLLOWED BY VISIBLE ARCHING. IT WAS WORKING FOR ABOUT 60 MINUTES PRIOR TO THIS ISSUE. THERE WAS MILD RETENTION / RETRACTION DURING SEALING. THE VESSELS WERE SMALL, ABOUT LESS THAN 5MM. SOME CHAR HAD BUILT UP ON THE INSTRUMENT. THERE WAS SOME UNEXPECTED BLEEDING, APPROXIMATELY 50CC ESTIMATED BLOOD LOSS (EBL), AFTER SWITCHING TO THE MARYLAND BIPOLAR FORCEPS INSTRUMENT. THERE WAS NO TRANSFUSION PERFORMED. THE BLEEDING WAS RESOLVED WITH BIPOLAR AND MONOPOLAR CAUTERY. THE INITIAL REPORTER ALSO STATED THE FOLLOWING; ¿ MAY HAVE FOUND THE CULPRIT FOR THE BROKEN SYNCHROSEALS HERE AT CENTRAL MAINE MEDICAL CENTER (CMMC). FOOTE DOES A LOT OF INSTRUMENT TO INSTRUMENT INTRA-OPERATIVE CLEANING WHICH I IMAGINE IS W

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 DAVINCI 30MM ENDOWRIST STAPLER WAS PLACED ON THE PULMONARY ARTERY AND FIRED. WHEN THE STAPLER WAS PROMPTED TO UNCLAMP, AN ERROR SHOWED THAT THE ACTION THAT UNCLAMPS THE STAPLER WAS UNABLE TO FUNCTION. THE ROBOT WAS MANUALLY PUT INTO FAULT MODE TO ALLOW THE BEDSIDE ASSIST TO USE THE WRENCH, WHICH IS THE FALLBACK/SAFETY MEASURE WHEN THIS HAPPENS. WHEN GOING IN THE PROPER ORDER, THE WRENCH WAS UNABLE TO FULLY SPIN, WHICH PREVENTED THE STAPLER FROM UNCLAMPING THE PA. THE DAVINCI REPS WERE ON THE PHONE WITH THEIR TECHNICAL TEAM WORKING THE PROBLEM, AND COMMUNICATING WITH THE SURGEON AND BEDSIDE ASSIST ON HOW TO GET THE STAPLER TO UNCLAMP. FDA SAFETY REPORT ID# (B)(4).

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 PROSTATECTOMY WITHOUT LYMPHADENECTOMY PROCEDURE, A SPARK OCCURRED BETWEEN THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT AND SYNCHROSEAL INSTRUMENT. THE SYNCHROSEAL INSTRUMENT STOPPED WORKING COMPLETELY. THE CUSTOMER REMOVED THE INSTRUMENTS AND OBSERVED CRACKS IN THE BLADE PORTION OF THE SYNCHROSEAL INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYNCHROSEAL INSTRUMENT REPORTEDLY ARCED DURING THE CASE. THERE WERE CRACKS AND CHAR OBSERVED ON THE INSTRUMENT'S BLADES. THE INSTRUMENTS WERE REPORTEDLY CLOSE TO EACH OTHER DURING THE CASE. IT WAS HARD TO TELL WHERE THE ELECTRICAL ENERGY ARCED TO. THE CUSTOMER REPORTED UNEXPECTED MINOR BLEEDING DURING THE EVENT BUT WAS NOT REALLY SURE WHAT WAS THE CAUSE OF THE BLEEDING. THE CUSTOMER SUSPECTED THAT BLEEDING WAS CAUSED DUE TO THE TIME IT TOOK TO USE THE MARYLAND BIPOLAR FORCEPS INSTRUMENT INSTEAD OF THE SYNCHROSEAL INSTRUMENT AS THE SYNCHROSEAL INSTRUMENT SEALS FASTER. THE PATIENT LOST MINIMAL AMOUNT OF BLOOD, AROUND 50CC¿S. NO BLOOD TRANSFUSION WA

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY WITH OUT LYMPHADENECTOMY PROCEDURE, A SPARK OCCURRED BETWEEN THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT AND SYNCHROSEAL INSTRUMENT. THE SYNCHROSEAL INSTRUMENT STOPPED WORKING COMPLETELY. THE CUSTOMER REMOVED THE INSTRUMENTS AND OBSERVED CRACKS IN THE BLADE PORTION OF THE SYNCHROSEAL INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYNCHROSEAL INSTRUMENT ARCED DURING THE CASE. THERE WERE CRACKS AND CHAR OBSERVED ON THE INSTRUMENT'S BLADES. THE INSTRUMENTS WERE REPORTEDLY CLOSE TO EACH OTHER DURING THE CASE. IT WAS HARD TO TELL WHERE THE ELECTRICAL ENERGY ARCED TO. THE CUSTOMER REPORTED UNEXPECTED MINOR BLEEDING DURING THE EVENT BUT WAS NOT REALLY SURE WHAT WAS THE CAUSE OF THE BLEEDING. THE CUSTOMER SUSPECTED THAT BLEEDING WAS CAUSED DUE TO THE TIME IT TOOK TO USE THE MARYLAND BIPOLAR FORCEPS INSTRUMENT INSTEAD OF THE SYNCHROSEAL INSTRUMENT AS THE SYNCHROSEAL INSTRUMENT SEALS FASTER. THE PATIENT LOST MINIMAL AMOUNT OF BLOOD, AROUND 50CC¿S. NO BLOOD TRANSFUSION WAS NEEDED.

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 CUSTOMER CALLED AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) AND REPORTED THAT TWO DIFFERENT UNSPECIFIED STAPLER INSTRUMENTS WERE INSTALLED AND FELL APART WHILE INSIDE THE PATIENT. THE TSE REVIEWED LOGS AND NOTED STERILE ADAPTER ENGAGEMENT CODES IN THE LOGS. THE TSE ASKED IF ALL PIECES WERE COLLECTED AND ACCOUNTED FOR AND THE CUSTOMER STATED THAT ACCORDING TO THE OPERATING ROOM NIGHT STAFF THAT THEY WERE. THE TSE THEN ASKED IF THE STAPLERS WERE AVAILABLE TO BE SENT BACK FOR ANALYSIS AND THE CUSTOMER DOES NOT BELIEVE STAPLERS WERE KEPT. THE TSE ALSO ASKED IF THERE WAS ANY PATIENT INJURY AND THE CUSTOMER REPORTED THAT THERE WAS NO PATIENT INJURY. THE SITE WAS REQUESTING FOR ISI FIELD SERVICE ENGINEER (FSE) TO FOLLOW UP AS SITE WAS WARY OF USING SYSTEM AFTER THE ISSUE OCCURRED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY AND WITH A LESS THAN A 15-MINUTE DELAY.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED DURING A BRONCHOSCOPY PROCEDURE THE PATIENT EXPERIENCED A PNEUMOTHORAX DURING THE REMOVAL BRONCHOSCOPE. THE PATIENT WAS HOSPITALIZED, AND A CHEST TUBE WAS PLACED. THE CHEST TUBE WAS REMOVED, AND THE PATIENT WAS DISCHARGED TWO DAYS LATER. THE TARGET LOCATION WAS LEFT UPPER LOBE (LUL). IT WAS REPORTED THAT A HUGE SNAPPING AND STRAIGHTENING OF THE BRONCHOSCOPE OCCURRED DURING THE REMOVAL.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED ESOPHAGECTOMY SURGICAL PROCEDURE, BLEEDING OCCURRED FROM ONE OF THE TWO BRANCHES OF THE AORTIC ARCH LEADING TO THE ESOPHAGUS. THE ISSUE OCCURRED 15 MINUTES AFTER SEALING AND TRANSECTING THE SIDE BRANCH WITH A SYNCHROSEAL INSTRUMENT. THE SIDE BRANCH WAS PROPERLY FREED FORM SURROUNDING TISSUE AND THEN SEALED WHILE DEEP IN THE JAWS OF THE SYNCHROSEAL. THE SURGEON PERFORMED A FULL CYCLE OF SEALING, OBSERVED TISSUE EFFECT DURING THE SEALING PROCESS, AND THEN TRANSECTED. THE SURGEON BELIEVES THE SEAL COULD NOT HANDLE THE PRESSURE FROM THE AORTIC BRANCH AND BEGAN BLEEDING 15 MINUTES LATER. THE SURGEON WAS ABLE TO TAMPONADE THE BLEEDING WITH AN UNSPECIFIED INSTRUMENT INSTALLED ON UNIVERSAL SURGICAL MANIPULATOR 1 (USM1) BY USING COMPRESSION. USM2, 3, AND 4 WERE THEN REMOVED. THE SURGEON MADE THE CLINICAL DECISION TO CONVERT TO A THORACOTOMY TO CONTROL THE HEMORRHAGE. THE SURGEON PERFORMED SUTURE LIGATION OF THE BLEEDING SITE ON THE AORTA AND THE PATIENT WAS TRANSFUSED 2 UNITS OF PACKED CELLS. BLOOD LOSS WAS ESTIMATED TO BE BETWEEN 500 AND 600ML. THE SURGEON INDICATED THAT THE PATIENT WAS DOING FINE AND RECOVERING POST-OPERATIVELY. 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-ASSISTED LOW ANTERIOR RESECTION (LAR) PROCEDURE, THE PATIENT'S URINE OUTPUT WAS BORDERLINE LOW, SO BASIC LABS WERE ASSESSED. ON POSTOPERATIVE DAY (POD) #1 (B)(6) 2022), THE PATIENT HAD LOW URINE OUTPUT AND WAS ENCOURAGED TO TRY CLEAR FLUIDS. THE PATIENT'S CREATININE LEVELS WERE NOTED TO HAVE RISEN TO 2.32 (FROM 1.02), SODIUM WAS 127 AND THE HEMOGLOBIN WAS NOTED TO BE LOW AT 8.8. THE PATIENT WAS STARTED ON IV FLUIDS AND CANDESARTAN, CHLORTHALIDONE AND SPIRONOLACTONE WERE HELD AT THIS TIME. THE PATIENT WAS DIAGNOSED WITH ACUTE KIDNEY INJURY DUE TO HYPOVOLEMIA, AND HYPONATREMIA. ON POD #2 (B)(6) 2022), SHE WAS AGAIN ENCOURAGED TO INCREASE ORAL INTAKE. THE CREATININE WAS TRENDING DOWNWARD AT 1.81, SODIUM WAS 129 AND HEMOGLOBIN WAS STABLE AT 8.3. DIARRHEA WAS ALSO NOTED (STARTED ON POD #2). ON POD #3 (B)(6) 2022), THE PATIENT'S URINE OUTPUT WAS NOTED TO BE ADEQUATE. THE PATIENT WAS DISCHARGED THAT SAME DAY WITH A RECOMMENDATION TO FOLLOW UP WITH HER PRIMARY CARE PHYSICIAN IN 1-2 WEEKS ON AN OUT-PATIENT BASIS WITH BMP FOLLOW UP. A PATHOLOGY REPORT ON (B)(6) 2022 DEMONSTRATED INVASIVE MODERATELY DIFFERENTIATED ADENOCARCINOMA ARISING IN A

Monarch Platform — 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 POST-PROCEDURE CXR (CHEST X-RAY) REVEALED A PNEUMOTHORAX, IN THE LEFT UPPER LOBE, IN A PATIENT HAD COME IN FOR A BRONCHOSCOPY PROCEDURE. THE PATIENT WAS HOSPITALIZED, AND A CHEST TUBE WAS PLACED. THE CHEST TUBE WAS REMOVED, AND THE PATIENT WAS DISCHARGED ON (B)(6) 2022. THERE WERE NO FAULTS OR DEVICE MALFUNCTIONS REPORTED DURING THE PROCEDURE.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE CT SCAN TAKEN AFTER AN SEEG PROCEDURE SHOWED THAT THE PATIENT HAD A HEMORRHAGE. SURGEON PROCEEDED WITH A CRANIOTOMY AND WAS ABLE TO STOP THE BLEEDING. FIELD SERVICE ENGINEER MERGED THE CT TO THE PATIENT¿S PLAN AND NOTED THAT SEVERAL TRAJECTORIES WERE DEVIATED AND CURVED.

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.

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 SINGLE PORT (SP) SIMPLE PROSTATECTOMY SURGICAL PROCEDURE, AN ERROR 25741 WAS DISPLAYED WHEN DOCKING. THE SITE TRIED TO RECOVER THE FAULT BY PERFORMING AN EMERGENCY POWER OFF (EPO), AND CYCLING THE CANNULA MOUNT LEVER, HOWEVER, THE ERROR PERSISTED. THE PROCEDURE WAS CONVERTED TO A DA VINCI MULTIPORT SYSTEM. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

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 HYSTERECTOMY PROCEDURE, THE E-100 GENERATOR TURNED OFF UNEXPECTEDLY AND WHEN THE SURGEON WAS ATTEMPTING TO USE THE SYNCHROSEAL INSTRUMENT, THE SURGEON REPORTED HAVING TROUBLE MOVING THE INSTRUMENT. THE SURGEON INDICATED THAT THE INSTRUMENT WAS NOT WORKING OR RESPONDING CORRECTLY AND WOULD NOT OPEN. BY THE TIME THE SURGICAL STAFF TURNED THE GENERATOR BACK ON, THE SURGEON HAD REPORTEDLY OBSERVED BLEEDING AND ELECTED TO CONVERT THE PROCEDURE TO OPEN SURGERY. ON (B)(6) 2022, INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SURGEON AND RECEIVED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: AFTER THE ISSUE OCCURRED WITH THE SYNCHROSEAL INSTRUMENT, THE SURGICAL STAFF OPENED A SECOND SYNCHROSEAL INSTRUMENT. THE SURGEON WAS ABLE TO USE THE BACKUP SYNCHROSEAL INSTRUMENT WITHOUT ANY ISSUES. HOWEVER, THE SURGEON ELECTED TO CONVERT THE CASE TO OPEN SURGERY DUE TO BLOOD LOSS AND TO CONTROL BLEEDING. THE CAUSE OF THE BLEEDING WAS NOT PROVIDED. HOWEVER, THE SURGEON MENTIONED THAT THE DA VINCI SYSTEM WAS A CONTRIBUTING FACTOR TO THE INTRA-OPERATIVE COMPLICATION SINCE HE COULD NOT CONTROL BLEEDING AND WAS UNABLE TO CAUTERIZE. TH

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 EXCELSUS GPS SYSTEM, THE CASE WAS ABORTED DUE TO ROBOTIC ERROR, AND SCREWS WERE THEN PLACED WITHOUT ROBOT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF A VIDEOSURGERY AND OTHER MINIMALLY INVASIVE TECHNIQUES ARTICLE TITLED, ¿SINGLE PLUS ONE-PORT ROBOTIC SURGERY USING THE DA VINCI SINGLE-SITE PLATFORM VERSUS CONVENTIONAL MULTI-PORT LAPAROSCOPIC SURGERY FOR LEFT-SIDED COLON CANCER¿ (BAE, S. U., JEGON, W. K. AND BAEK, S. K., 2022). THE STUDY COMPARES THE CLINICAL AND COSMETIC OUTCOMES OF SINGLE PLUS ONE-PORT ROBOTIC SURGERY (SPORS) WITH THOSE OF MULTI-PORT LAPAROSCOPIC SURGERY (MPLS),WHICH IS PRESENTLY THE STANDARD SURGICAL TREATMENT FOR COLON CANCER. THE STUDY INCLUDED 36 PATIENTS WHO UNDERWENT SPORS AND 61 PATIENTS WHO UNDERWENT MPLS FOR LEFT-SIDED COLON CANCER BETWEEN AUGUST 2014 AND JANUARY 2016. WITHIN THE JOURNAL ARTICLE, OPERATIVE COMPLICATIONS INVOLVING DA VINCI-ASSISTED SURGICAL PROCEDURES WERE NOTED: TWO PATIENTS IN THE SPORS GROUP DEVELOPED A SUPERFICIAL SURGICAL SITE INFECTION AT THE SPECIMEN EXTRACTION SITE. ONE INSTANCE OF POSTOPERATIVE ANASTOMOTIC SITE BLEEDING OCCURRED IN THE SPORS GROUP, BUT REOPERATION OR ANOTHER INTERVENTION WAS NOT REQUIRED. ADDITIONALLY, IN THE SPORS GROUP, THERE WAS ONE CASE OF POST-OPERATIVE ILEUS AND TWO CASES OF POST-OPERATIVE PSEUDOMEMBRANOUS COL

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF A VIDEOSURGERY AND OTHER MINIMALLY INVASIVE TECHNIQUES ARTICLE TITLED, ¿SINGLE PLUS ONE-PORT ROBOTIC SURGERY USING THE DA VINCI SINGLE-SITE PLATFORM VERSUS CONVENTIONAL MULTI-PORT LAPAROSCOPIC SURGERY FOR LEFT-SIDED COLON CANCER¿ (BAE, S. U., JEGON, W. K. AND BAEK, S. K., 2022). THE STUDY COMPARES THE CLINICAL AND COSMETIC OUTCOMES OF SINGLE PLUS ONE-PORT ROBOTIC SURGERY (SPORS) WITH THOSE OF MULTI-PORT LAPAROSCOPIC SURGERY (MPLS),WHICH IS PRESENTLY THE STANDARD SURGICAL TREATMENT FOR COLON CANCER. THE STUDY INCLUDED 36 PATIENTS WHO UNDERWENT SPORS AND 61 PATIENTS WHO UNDERWENT MPS FOR LEFT-SIDED COLON CANCER BETWEEN AUGUST 2014 AND JANUARY 2016. WITHIN THE JOURNAL ARTICLE, OPERATIVE COMPLICATION INVOLVING DA VINCI SURGICAL PROCEDURES WERE NOTED: ONE PATIENT REQUIRED CONVERSION FROM SINGLE PORT TO REDUCED PORT LAPAROSCOPIC SURGERY DUE TO AIR LEAK AND COLLISIONS OF ROBOTIC ARMS. IT WAS FURTHER NOTED, "REGARDING SINGLE PORTS, THE SINGLE-SITE PORT USED IN THE FIRST 3 CASES WAS NOT FLEXIBLE AND HAD POOR DURABILITY. IN ANOTHER CASE, A THIRD PATIENT CHANGED FROM A SINGLE PORT OF A GLOVE PORT TO SECURE DISTANCE BETWEEN INSTRUMENT TIPS AND THE

Monarch Platform — 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 PHYSICIAN NAVIGATED TO THE LESION, AND WHEN THE RADIAL ENDOBRONCHIAL ULTRASOUND (REBUS) PROBE WAS INTRODUCED, IT PUSHED A SMALL WHITE FOREIGN BODY (FB) OUT OF THE MONARCH SCOPE INTO THE PATIENT'S LUNGS. THE PHYSICIAN WAS ABLE TO REMOVE THE FB USING FORCEPS AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

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 A PATIENT HAD RETURNED TO HAVE A SCREW DEVIATION CORRECTION COMPLETED FOR A SCREW THAT WAS PLACED USING THIS SYSTEM ON (B)(6). THE CASE WAS L4 TO S1 AND THE INACCURACY WAS BELIEVED TO BE CAUSED BY PATIENT SHIFT AND LOCATED ON THE L4 SCREW PLACEMENTS. THE SHIFT WAS BELIEVED TO BE ~4-5MM MEDIAL. THERE WAS NO KNOWN IMPACT TO THE PATIENT OUTCOME. ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT THE PATIENT EXPERIENCED FOOT DROP SYMPTOMS FROM THE MEDIAL PLACED SCREW.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: SCREW PLACED MEDIAL AT L3.

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 14-MAY-2020, INTUITIVE SURGICAL, INC (ISI) BECAME AWARE OF A HEAD & NECK ARTICLE TITLED, ¿ONE-YEAR OUTCOMES FOR DA VINCI SINGLE PORT ROBOT FOR TRANSORAL ROBOTIC SURGERY¿ (VAN ABEL, K. M., YIN, L. X., ET AL., 2020). WITHIN THE JOURNAL ARTICLE, AN OPERATIVE COMPLICATION INVOLVING A DA VINCI SURGICAL PROCEDURE WAS NOTED. WITHIN THE ARTICLE, THE FOLLOWING IS NOTED: ¿THERE WERE 4 POSTOPERATIVE HEMORRHAGES FOR AN OVERALL BLEED RATE OF 5.1 %. THE DETAILS ON THESE POSTOPERATIVE HEMORRHAGE EVENTS ARE REPORTED IN TABLE 3. THERE WERE TWO MORTALITIES IN THIS COHORT OF 78, ONE SECONDARY TO A POST-TONSILLECTOMY HEMORRHAGE AND ANOTHER SECONDARY TO A POSTOPERATIVE PULMONARY EMBOLUS, FOR AN OVERALL MORTALITY RATE OF 2.6%¿ PROCEDURE INFORMATION PROCEDURE CATEGORY PROCEDURE NAME TRANSORAL ROBOTIC SURGERY. ISI FOLLOWED-UP WITH THE AUTHOR, WHO STATED THE FOLLOWING REGARDING THE REPORTED COMPLICATIONS: "NO, THERE WAS NO ALLEGATION OR CLAIM THAT A MALFUNCTION OF THE SYSTEM OR INSTRUMENT WAS INVOLVED IN THESE COMPLICATIONS. THESE ARE KNOWN RISKS WITH THIS SURGICAL PROCEDURE, DOCUMENTED WITH THE SI AND TRANSORAL LASER MICROSURGERY AS WELL. WE DID NOT IDENTIFY A RATE HIGHER THAN THE PUBLISHED AVERAGES."

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 SURGEON HAD TO CONVERT TO OPEN SURGERY. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER REPORTED THAT THE SURGEON DECIDED TO CONVERT TO OPEN SURGERY BASED ON COMFORT LEVEL. THE SURGEON HAD PLANNED TO CONVERT TO OPEN AND THE ROOM WAS ALREADY SETUP. THERE WERE NO DA VINCI CONTRIBUTING FACTORS TO CONVERTING THE PROCEDURE; THIS WAS A DECISION MADE COMPLETELY BY THE SURGEON. THE CUSTOMER FOLLOWED UP WITH THE PATIENT THE NEXT DAY AND THE PATIENT WAS DOING WELL.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: INTUITIVE SURGICAL INC. (ISI) BECAME AWARE OF A SURGERY ARTICLE TITLED, ¿PERIOPERATIVE OUTCOMES OF MINIMALLY INVASIVE ILEOCOLIC RESECTION FOR COMPLICATED CROHN DISEASE: RESULTS FROM A REFERRAL CENTER RETROSPECTIVE COHORT¿ (ABDALLA, S., ET AL., 2022). A STUDY WAS CONDUCTED TO COMPARE THE INTRAOPERATIVE AND POSTOPERATIVE OUTCOMES OF MINIMALLY INVASIVE ILEOCOLIC RESECTION (MISICR) FOR COMPLICATED VERSUS UNCOMPLICATED CROHN DISEASE (CD). A RETROSPECTIVE ANALYSIS OF ALL CONSECUTIVE ADULT PATIENTS WITH CD UNDERGOING MISICR FROM 01-SEP-2014 AND 31-MAR-2021 WAS CONDUCTED. PATIENTS WERE DIVIDED INTO 2 GROUPS, COMPLICATED AND UNCOMPLICATED, BASED ON THE PREOPERATIVE AND INTRAOPERATIVE FINDINGS. PERIOPERATIVE OUTCOMES WERE COMPARED BETWEEN PATIENTS WITH COMPLICATED CD (COMPLICATED GROUP) AND PATIENTS WITHOUT THESE LESIONS (UNCOMPLICATED GROUP). THE FOCUSED WAS ON ROBOTIC AND LAPAROSCOPIC ILEOCOLIC RESECTIONS (ICR) FOR CD. WITHIN THE JOURNAL ARTICLE, OPERATIVE COMPLICATIONS INVOLVING A DA VINCI SURGICAL PROCEDURE WERE NOTED: INTRAOPERATIVE COMPLICATIONS OCCURRED IN 4 PATIENTS WITHOUT DIFFERENCES BETWEEN GROUPS. IN THE UNCOMPLICATED GROUP, 2 PATIENTS HAD AN UNINTENDED FULL-THICKNESS BOWEL INJUR

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED DURING A MONARCH BRONCHOSCOPY THE PATIENT SUSTAINED A SMALL PNEUMOTHORAX. THERE WAS VERY LIMITED INITIAL INFORMATION PROVIDED, AND NO RESPONSE AFTER REACHING OUT TO THE CUSTOMER ON MULTIPLE OCCASIONS.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF AN UROLOGY ARTICLE TITLED, ¿INTRAOPERATIVE DECISION-MAKING: THERMAL INJURY DURING ROBOTIC PYELOPLASTY¿ (HIGGINS, M., AND SALTZMAN, A., 2020). WITHIN THE CLINICAL JOURNAL ARTICLE, IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PYELOPLASTY PROCEDURE, AN INADVERTENT THERMAL INJURY TO A URETER OCCURRED DUE TO ARCING FROM A MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT TO A FENESTRATED BIPOLAR FORCEPS (FBF) INSTRUMENT. THE INJURY OCCURRED WHILE THE SURGEON WAS PERFORMING INITIAL PROXIMAL URETERAL DISSECTION AND WHILE ACTIVATING ENERGY WITH THE MCS INSTRUMENT WHICH WAS TOUCHING THE FBF INSTRUMENT. AT THE TIME THE INJURY OCCURRED, THE FBF INSTRUMENT WAS BEING USED TO PROVIDE UPWARD URETERAL RETRACTION. ON 22-JUN-2020, ISI OBTAINED THE FOLLOWING ADDITIONAL INFORMATION FROM THE AUTHOR OF THE ARTICLE REGARDING THE REPORTED EVENT: THERE IS NO ALLEGATION OR CLAIM THAT A MALFUNCTION OF A DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE INVOLVING THE OPERATIVE COMPLICATION. THERE IS ALSO NO ALLEGATION OR CLAIM THAT A MALFUNCTION OF A DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY CAUSED OR CONTRIBUTED TO THE OPER

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: C3-T4 OPEN POSTERIOR CERVICO-THORACIC FUSION. 1.1R4 SOFTWARE. PRE-OP CT WORKFLOW. 12" FLUOROSCOPY. CT-SCAN LOADED AND SCREWS PREPLANNED. HE ONLY PLANNED TO USE EGPS TO PUT IN SCREWS AT T2-T4. PRIOR TO THE SURGERY, THE PATIENT HAD A FRACTURE AT C7-T1 CAUSING THE PREVIOUS POSTERIOR SCREWS TO PULL OUT AT T1-T2. DR. (B)(6) PUT THE ANGLED SPINOUS PROCESS CLAMP ON T5 AND DUE TO THE AMOUNT OF SKIN THE ANGLED SPINOUS PROCESS CLAMP WAS POINTING STRAIGHT UP. THUS NOT ALLOWING THE C-ARM INTO TO POSITION FOR REGISTRATION IMAGED. FOLLOWING THAT MISTAKE HE PUT A SHORTER SPINOUS PROCESS CLAMP ON THE SP. SM WAS ON THE SAME CLAMP. THIS ALLOWED THE C-ARM TO MOVE UNDER THE BED WITHOUT HITTING THE MAYFIELD ATTACHMENT HOWEVER, THE LATERAL SHOT WAS DIFFICULT TO VISUALIZE ON THE C-ARM. DR. (B)(6) HAD A DIFFICULT TIME IDENTIFYING EACH LEVEL DUE TO THE MINIMAL CONTRAST OF THE C-ARM. THE SETTING WERE ADJUSTED TO BETTER THE IMAGE ON THE C-ARM BUT THE MERGE WAS UNSUCCESSFUL. THE MERGE LOOKED LIKE IT HAD FOUND THE AN IMAGE ON THE CT THAT WAS IN AN OBLIQUE AP VIEW. FOR THE LATERAL, IT COULD NOT IDENTIFY THE CORRECT LEVEL. WE RESET THE SOFTWARE, FOLLOWED BY COMPLETE REBOOT BUT IT CONTINUED TO FAIL THE MERGE. SCO