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 WENT TO THE CLINIC OVER THE WEEKEND WITH FOOT DROP THAT WAS POTENTIALLY DUE TO A MISPLACED SCREW. FOUR SCREWS WERE PLACED DURING A SINGLE POSITION OLIF PROCEDURE USING THE GUIDANCE SYSTEM ON (B)(6) 2020. AN INTERBODY WAS PLACED PRIOR TO PLACING THE SCREWS. DURING THE PROCEDURE, THE INSTRUMENT ON THE SURGEON SCREEN DID NOT MATCH THE INSTRUMENT IN RELATION TO THE PATIENT. A SECOND SNAPSHOT WAS COMPLETED TO RESOLVE THE ISSUE. THE PATIENT DID NOT HAVE TO BE RE-REGISTER. NO OTHER ISSUES OCCURRED DURING THE PROCEDURE. THE SCREWS LOOKED TO BE MATCHED UP WITH THE PLANNED TRAJECTORIES ACCORDING TO CONFIRMATION IMAGES TAKEN DURING THE PROCEDURE; HOWEVER, AFTER FURTHER EXAMINATION, THE LEFT L5 SCREW WAS MEDIAL BY 3.5-10 MM. THE INITIAL PROCEDURE WAS DELAYED LESS THAN AN HOUR. A REVISION PROCEDURE WAS PLANNED TO REPOSITION THE SCREW, BUT HAD NOT BEEN SCHEDULED.

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 AFTER A MONARCH-ASSISTED BRONCHOSCOPY PROCEDURE ON (B)(6) 2020, THE PATIENT WAS OBSERVED TO HAVE A PNEUMOTHORAX DURING POST-OP CHECK-UP. A CHEST TUBE WAS PLACED TO TREAT THE PNEUMOTHORAX. THE PNEUMOTHORAX WAS RESOLVED, AND THE PATIENT WAS RELEASED ON (B)(6) 2020.

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: THE PATIENT HAD A PLANNED SINGLE POSITION LATERAL DECUBITUS SURGERY FOR PEDICLE SCREW FIXATION AND INTERBODY FUSION FROM L4-S1. ROBOTIC GUIDANCE WAS PLANNED FOR PLACEMENT OF PEDICLE SCREWS FROM L4-S1 (6 SCREWS) USING THE GLOBUS EXCELSIUS GPS SYSTEM. TWO SURGEONS TRAINED TO USE THE GLOBUS EXCELSIUS GPS SYSTEM, TWO GLOBUS REPS AND A VASCULAR SURGEON WERE PRESENT DURING THE PROCEDURE. THE ICT (INTRA-OPERATIVE REGISTRATION DEVICE (REFERENCE FRAME)) IS PLACED IN THE ILIAC CREST TO ASSIST WITH IMAGE MERGE. A DYNAMIC REFERENCE BASE (DRB (MOTION CHECKER)) IS ALSO PLACED IN THE ILIAC CREST AND ACTS AS SURVEILLANCE MARKER FOR REAL-TIME INTRAOPERATIVE ACCURACY. THE ROBOTIC SOFTWARE USES AN ALGORITHM TO REGISTER INTRAOPERATIVE FLUOROSCOPY SCAN IMAGES LEVEL BY LEVEL (AP & LATERAL) AND PERFORMS A 2D-3D MERGE WITH A PRE-OPERATIVE CT SCAN. THIS REGISTRATION IS INTENDED TO ENSURE THAT THE RADIOGRAPHIC IMAGES INDICATING THE INTENDED LOCATION OF SURGERY AND THE ACTUAL PATIENT POSITION IN THE O.R. MATCHES, THUS ENABLING THE ROBOT TO GUIDE SCREW PLACEMENT. IN THIS CASE, THE SOFTWARE WAS HAVING DIFFICULTY PERFORMING THE INITIAL IMAGE MERGE AND REGISTRATION. A SOFTWARE RESET WAS ADVISED BY THE REP. FOLLO

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 THE PATIENT EXPERIENCED FOOT DROP POST-OPERATIVELY DUE TO SCREWS THAT WERE NOT PLACED TO PLAN. THE MISPLACED SCREWS WERE 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: ABSTRACT: PEDICLE SCREW FIXATION IN PEDIATRIC SPINE SURGERY HAS BECOME COMMON PRACTICE GIVEN THE FIXATION STABILITY AND IMPROVED CURVE CORRECTION. HOWEVER, DUE TO PROXIMITY TO VITAL STRUCTURES, ACCURACY IS PARAMOUNT. LITERATURE HAS REPORTED ACCURACY RATES FROM 87.5 TO 90% USING TRADITIONAL FREEHAND TECHNIQUES. THIS STUDY PRESENTS OUR INITIAL EXPERIENCE WITH PEDICLE SCREW PLACEMENT USING THE NEWEST GENERATION OF SPINAL ROBOTICS FOR TREATMENT OF PEDIATRIC SPINAL DEFORMITY. A COHORT OF PATIENTS, AGED 8¿21 YEARS, UNDERGOING SPINAL FUSION SURGERY USING ROBOTIC-ASSISTED TECHNOLOGY WAS REVIEWED. DIAGNOSES, COBB ANGLES, SURGICAL TIME, ROBOT TIME, NUMBER OF SCREWS PLACED, AND COMPLICATIONS WERE RECORDED. ACCURACY OF SCREW PLACEMENT WAS ASSESSED BASED ON ANALYSIS OF SUCCESSFUL SCREW EXECUTION, EVALUATION SCREW POSITION USING INTRAOPERATIVE FLUOROSCOPY AND POST-OPERATIVE RADIOGRAPHS, AND CLINICAL EVALUATION. THE AVERAGE AGE WAS 14.5 YEARS. PREVALENT DIAGNOSES INCLUDED IDIOPATHIC (65%) AND NEUROMUSCULAR SCOLIOSIS (13%). MEAN PREOPERATIVE CURVE MEASURED 66.8°. THE MEDIAN TIME FOR OPERATION WAS 235 MINUTES WITH MEDIANS OF 8 LEVELS FUSED AND 5 SCREWS PLACED PER PATIENT. OF THE 314 SCREWS PLACED,

Senhance — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE COMPLAINANT, (B)(6), REPORTED THAT ON DAY 6, THERE WAS AN ANASTOMOTIC LEAKAGE DETECTED, THEN CLINICALLY AND DIGITALLY CONFIRMED. PATIENT WAS ADMINISTERED ANTIBIOTIC THERAPY (METRONIDAZOLE-500 MG 3X DAILY; CEFUROXIME-1 G 3X DAILY) AND HAD A PROLONGED HOSPITAL STAY BUT RECOVERED FOR A (B)(6) 2020 DATE OF RESOLUTION. IT WAS REPORTED THAT CAUSALITY TO THE SENHANCE SURGICAL SYSTEM WAS POSSIBLE. THIS EVENT DID NOT OCCUR WITHIN THE U.S. THIS EVENT OCCURRED IN (B)(6) HOSPITAL IN LITHUANIA. ADDITIONALLY, THIS EVENT OCCURRED ON (B)(6) 2020, AND ASENSUS SURGICAL WAS INTERNALLY MADE AWARE ON 10-AUGUST-2023.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: EXISTING PATIENT FOLDER INCLUDED MR, PATIENT WAS POSITIONED, FIDUCIALS PLACED, O-ARM SCAN TAKEN WITH PATIENT ON BED, NOT ATTACHED TO ROSA. O-ARM CT SCAN WAS TAKEN AND IMPORTED VIA DIRECT TRANSFER, SCAN WAS MERGED WITH MR AND RESULTED IN INACCURATE MERGE, WITH CT SCAN SUPERIOR TO MR. MANUAL ADJUSTMENT WAS ATTEMPTED, AND RE-CALCULATION WAS DONE, BUT SAME RESULT OCCURRED. PATIENT WAS SENT DOWN TO RADIOLOGY FOR IN-HOUSE CT, SCAN UPLOADED TO PACS, MERGE WAS SUCCESSFUL AND ACCURATE. PRIOR TO ACQUISITION OF SCAN, IDEAL PARAMETERS WERE DISCUSSED WITH O-ARM REPRESENTATIVE, SEEG, 12 ELECTRODES, DELAY OF 40 MINUTES+.THE PATIENT WAS UNDER ANESTHESIA.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE FOLLOWING EVENT OCCURRED DURING AN RNS CASE ON (B)(6) 2020: AT THE BEGINNING OF THE CASE, THE SURGEON PLACED THE LEKSELL FRAME ON THE PATIENT, AND THEN PROCEEDED TO PLACE 5 BONE FIDUCIALS FOR REGISTRATION. THE OR TEAM THEN TOOK THE PATIENT DOWN TO CT TO BE SCANNED AND THEN RETURNED TO THE OR. BECAUSE THE ROBOT IS NOT CONNECTED TO PACS (AS THEY USUALLY USE THE O-ARM) THE 0.625 BONE CT WAS LOADED ONTO THE PLANNING STATION AND MERGED TO THE PLAN THAT WAS CREATED PRE-OPERATIVELY. THE PLAN WAS THEN EXPORTED VIA USB TO THE ROBOT BY THE CLINICAL REPRESENTATIVE (CR). THE PATIENT WAS ATTACHED TO THE ROBOT VIA THE LEKSELL HEAD HOLDER (THE PATIENT WAS SLIGHTLY TILTED, BUT NOT IN A FULL BEACH CHAIR POSITION). REGISTRATION BEGAN AND THE 5 FIDUCIALS WERE REGISTERED. AT THIS POINT, THE RMS GENERATED AN ERROR THAT WAS >1.0. THE SURGEON THEN REGISTERED THE PATIENT AGAIN, REMOVING A FIDUCIAL SHE FELT WAS LOOSE GENERATING AN RMS OF GREATER THAN 3.0. BELIEVING THAT THERE WAS ANOTHER LOOSE FIDUCIAL, REGISTRATION WITH 3 FIDUCIALS WERE TRIED GIVING AN RMS OF GREATER THAN 8.0. AT THIS POINT, IN ORDER TO AVOID GOING TO CT AGAIN (AS THE O-ARM WAS ALSO BROKEN) THE SURGEON TRIED UTILIZING POINTS ON THE LE

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION USAGE SHEET THAT THE PATIENT'S RIGHT KNEE WAS REVISED. REP STATED: "PATIENT CAME THROUGH ER WITH WOUND ISSUES. WAS BROUGHT INTO SURGERY FOR I&D AND SWAP OF LINER. REMOVAL IMPLANT/X-RAYS NOT AVAILABLE.".

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

Senhance — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE COMPLAINANT, DR. (B)(6), REPORTED A PATIENT BLADDER RUPTURE FOR WHICH SURGICAL INTERVENTION WAS NEEDED. IT WAS REPORTED THAT CAUSALITY TO THE SENHANCE SURGICAL SYSTEM WAS PROBABLE, BUT WITHOUT ANY FURTHER DETAILS PERTAINING TO PATIENT TREATMENT OR RESOLUTION. THIS EVENT DID NOT OCCUR WITHIN THE UNITED STATES. THE EVENT OCCURRED IN FELDKIRCH REGIONAL HOSPITAL IN AUSTRIA. ADDITIONALLY, THIS EVENT OCCURRED ON 16-OCTOBER-2020, AND ASENSUS SURGICAL WAS INTERNALLY MADE AWARE ON 07-SEPTEMBER-2022.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING BRAIN BIOPSY CASE WITH THE SURGEON, SIGNIFICANT INACCURACY WAS EXPERIENCED. PRIOR TO THE START OF THE CASE, THERE WERE ISSUES MERGING THE PRE-OP O-ARM CT SCAN TO EXISTING MRI SCAN (THIS MERGE ISSUE HAS BEEN ADDRESSED IN ANOTHER COMPLAINT). IMPROVED SUCCESS WAS SEEN WHEN MERGING WITH EXISTING CT SCAN. INTRAOPERATIVELY, THE BIOPSY NEEDLE WAS PLACED ALONG THE TRAJECTORY AND UPON ATTEMPT TO ASPIRATE THE ABSCESS, NO FLUID WAS DRAWN, WHICH WAS NOT EXPECTED. AT THIS TIME, THE SAMPLE WAS BROUGHT TO THE LAB AND DETERMINED NOT TO BE DESIRED TISSUE. AT THIS TIME, IT WAS NECESSARY TO OBTAIN AN ADDITIONAL INTRA-OPERATIVE O-ARM CT SCAN TO ENSURE THE LOCATION OF THE NEEDLE. THERE WERE ISSUES WITH THIS O-ARM SCAN AS WELL, HOWEVER EXTENSIVE EFFORT WAS MADE TO MANUALLY MERGE THIS SCAN. IT WAS DETERMINED THAT THE NEEDLE WAS OFF THE TARGET BY APPROXIMATELY 6MM. A NEW TRAJECTORY WAS PLANNED USING THIS INFORMATION TO CORRECT FOR THE ERROR. UPON ASPIRATION OF THE BIOPSY NEEDLE AT THE NEW TRAJECTORY, FLUID WAS DRAWN AS INITIALLY EXPECTED AND THE DESIRED TISSUE WAS OBTAINED. THE DELAY DUE TO THIS ISSUE TOOK APPROXIMATELY 45 MINUTES ADDITIONAL ANESTHESIA TO THE PATIENT WAS NEEDED DUE TO THIS DELAY.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING BIOPSY CASE WITH DR. (B)(6), A DELAY OF 35 MINUTES TOOK PLACE PRIOR TO BONE FIDUCIAL REGISTRATION. THE PLANNING FOR THIS PROCEDURE WAS DONE USING AN MRI IMAGE AND MEDTRONIC O-ARM SPIN WAS REQUIRED FOR BONE FIDUCIAL REGISTRATION. UPON FIRST ATTEMPT, THE AUTOMATIC MERGE OF THE O-ARM CT IMAGE TO THE MRI WAS NOT ACCURATE. MACRO-ADJUSTMENTS WERE MADE AND THE "RECALCULATE MERGE" FUNCTION WAS ATTEMPTED WHICH CAUSED THE IMAGE TO REVERT TO THE INITIAL AUTOMATIC MERGE ATTEMPT. AT THIS TIME, DR. (B)(6) ELECTED TO GET ANOTHER O-ARM SCAN TO INCLUDE MORE OF THE SKULL WITH THE IDEA THAT THERE WOULD BE MORE DATA TO MERGE MORE ACCURATELY. UPON ATTEMPTING TO MERGE THE SECOND O-ARM SPIN, THE SAME ISSUE OCCURRED. AT THIS TIME, DR. (B)(6) REQUESTED THE PATIENT BE BROUGHT TO GET A PROPER CT SCAN. THE FIELD SERVICE ENGINEER (FSE) SUGGESTED TO MERGE TO A RECENT CT SCAN IF AVAILABLE. THE FSE WAS ABLE TO RETRIEVE A RECENT HEAD CT SCAN AND SUCCESSFULLY MERGE TO PROPER CT SCAN. ADDITIONALLY, AN INTRO-OPERATIVE O-ARM WAS REQUIRED TO ENSURE POSITION OF BIOPSY NEEDLE WHERE A 3RD O-ARM SCAN WAS MERGED TO THE PROPER CT SCAN WITH SIGNIFICANT ERROR. THE MAYFIELD HEAD CLAMP CREATED MAJOR ARTIFACT IN THE IMAGE

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.

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 TO TREAT DEGENERATIVE DISC WITH FIXATION. IT WAS REPORTED THAT THE LEFT L4 SCREW WAS DEVIATED DURING AN OPEN L4-L5 TLIF. THE SURGEON OPERATED ON THE RIGHT L4 AND L5 WITHOUT ISSUE SO THEY PROCEEDED TO THE LEFT SIDE. L4 WAS FIRST, FOLLOWED BY L5. WHEN EXECUTING L5, THE SURGEON FOUND THAT THE INCISION WAS NOT LARGE ENOUGH. THIS CAUSED EXCESSIVE LATERAL PRESSURE ON THE SURGICAL ARM FROM THE SOFT TISSUE AND LED TO THE SHOULDER UNLOCKING. THE SURGEON DECIDED TO ABORT THE USE OF THE GUIDANCE SYSTEM FOR LEFT L5. DURING THE PROCEDURE, THERE WAS AN ISSUE WITH AIR PRESSURE IN THE GUIDANCE SYSTEM. THE PNEUMATIC MOTOR WOULD NOT BOOT ON BY ITSELF. ONCE DURING THE OPERATION STEP AND ONCE AFTER THE PROCEDURE, A LOW PRESSURE ERROR MESSAGE WAS DISPLAYED AND THE SYSTEM HAD TO BE REBOOTED TO GET THE PRESSURE TO BE RESTORED. AFTER THE PROCEDURE, THE CONFIRMATION IMAGES SHOWED THAT L4 LEFT WAS MEDIAL BY 3 MM. THE SURGEON BELIEVED THIS WAS DUE TO THE EXCESSIVE PRESSURE PLACED ON THE SURGICAL ARM. L5 LEFT WAS ACCURATE. THE PATIENT WAS EXPERIENCING NERVE DAMAGE. THE PROCEDURE WAS DELAYED LESS THAN AN HOUR.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE COMPANY CLINICAL REPRESENTATIVE INFORMED ABOUT A CASE INACCURACY. THIS CASE ALSO HAD A SUBDURAL HEMATOMA THAT VERY WELL COULD HAVE BEEN THE RESULT OF THIS INACCURACY. THE SUBDURAL HEMATOMA REQUIRED A CRANIOTOMY AND ENDING THE SUBDURAL BLEEDING THAT WAS OCCURRING. THIS PROCESS OF THE CRANIOTOMY ADDED ROUGHLY AN HOUR TO 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: AUTOMATIC MERGE PERFORMED WITH CT TO MRI. MERGE WAS INACCURATE, ADJUSTMENTS AND RE-CALCULATION DID NOT EASILY FIX PROBLEM. DELAY OF 30 MINUTES. SEEG AND CRANIOTOMY, PATIENT UNDER ANESTHESIA, NO INCISION MADE, NO REGISTRATION PERFORMED.

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING A PRIMARY RIGHT MAKO PKA 3.0 CASE THE ROBOTIC ARM LOCKED MID CASE. THE TIBIA AND POSTERIOR FEMORAL CUT WERE ALREADY PERFORMED. WHEN THE ERROR APPEARED ON SCREEN, THE ARM LOCKED JUST AS THE SURGEON WAS ABOUT TO BEGIN BURRING. I RELEASED THE ARM AND ADVISED THE SURGEON, TO RETURN THE ARM TO THE HOLSTER POSITION. I THEN MOVED THE ROBOT AWAY FROM THE OPERATING BED. I PERFORMED AN ¿ARM STATUS CHECK¿ WHICH SHOWED NO ERRORS. ON ATTEMPTING TO PROGRESS WITH THE CASE THE SAME ISSUE OCCURRED AGAIN. AT THIS POINT I CALLED FIELD SERVICE ENGINEER. SHE ADVISED THAT THE ERROR WAS MOST LIKELY RELATED TO A MOTOR OR ENCODER PROBLEM WHICH I WOULD NOT BE ABLE TO TROUBLESHOOT AND WHICH WOULD NEED TO BE SERVICED BY THE ENGINEERS. I INFORMED SURGEON OF THIS AND PUT FSE ON SPEAKER PHONE TO ALSO EXPLAIN THAT TO HIM. AS WE DO NOT HAVE CONVENTIONAL INSTRUMENTATION FOR PKAS, SURGEON MADE THE DECISION TO CONVERT TO A NAVIGATED TKA. I ASKED IF THE PATIENT WAS CONSENTED FOR THIS. HE UNSCRUBBED AND CALLED THE PATIENTS NOK TO OBTAIN CONSENT FOR THE TKA WHICH WAS GRANTED. STRYKER COLLEAGUE ATTENDED THE HOSPITAL TO ASSIST WITH THE CONVERTED TKA. WE PERFORMED A NAVIGATED TKA WHICH SURGEON WAS HAPPY WITH THE FIN

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE COMPANY CLINICAL REPRESENTATIVE (CR) ASSISTED THE SURGEON FOR AN ABLATION CASE ON (B)(6) 2020 USING BS17937. AROUND 8:22AM EST, THE CR ATTEMPTED TO RETRIEVE IMAGING THROUGH PACS, BUT THIS FAILED AND THE SOFTWARE NEEDED TO BE RESTARTED. THE CR WAS ABLE TO QUERY IMAGING, BUT NOT RETRIEVE. THE IQ-VIEW SOFTWARE APPEARED TO ALLOW THE RETRIEVAL RANDOMLY BUT THERE WAS NO REASON OR PATTERN FOR WHEN IT WOULD AND WOULD NOT WORK CORRECTLY. THE SURGEON DECIDED TO GIVE UP ON PACS RETRIEVAL AND OBTAINED A CD WITH PATIENT IMAGING. AROUND 9:40AM EST, THE CD WAS LOADED INTO THE SOFTWARE TO LOAD THE PATIENT IMAGING. THE SURGEON WOULD LIKE TO ESCALATE THIS ISSUE SINCE THE PACS RETRIEVAL APPEARS TO WORK BUT WILL RANDOMLY NOT WORK. THE CR CONFIRMED WITH PACS/IT THAT ALL INFO IS CORRECT FOR PACS NETWORK. SINCE QUERY/RETRIEVE DOES WORK SOMETIMES, THAT MEANS THE INFO IS CORRECT ON BOTH THE ROBOT SIDE AND PACS SIDE. MOST LIKELY THERE IS AN ISSUE WITH THE IQ-VIEW SOFTWARE AND THE BRAIN SOFTWARE. THE PATIENT WAS UNDER ANESTHESIA AND NO INCISION MADE. THE DELAY WAS AROUND AN HOUR SINCE PACS WAS BEING RELIED ON FOR PATIENT IMAGING.

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DOCTOR COMPLAINED OF SMALL NOTCH ON ANTERIOR FEMUR. WENT TO RECUT ANTERIOR TO MAKE SURE BLADE WAS RUN OUT COMPLETELY. NOTCH INCREASED FURTHER. NO SURGICAL DELAY. CASE TYPE / APPLICATION: TKA.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: COMPANY CLINICAL REPRESENTIVE (CR) WAS PRESENT FOR A MONTERIS ABLATION CASE. THE SURGEON PLANNED ONE TRAJECTORY FOR A FAIRLY SUPERFICIAL LESION IN THE PARIETAL LOBE. FIDUCIAL REGISTRATION WAS PERFORMED BY GETTING AN O-ARM SCAN AND MERGING IT TO THE PREOPERATIVE MRI. BOTH SURGEON AND CR LOOKED AT THE MERGE AND CONFIRMED ACCURACY. AFTER PLACING THE TRAJECTORY, THE PATIENT WAS DETACHED FROM ROSA AND THE MRI MACHINE WAS BROUGHT IN TO BEGIN THE ABLATION. WHEN THE FIRST INTRAOPERATIVE MRI WAS TAKEN, HOWEVER, IT SHOWED THAT THE TRAJECTORY WAS SEVERAL MILLIMETERS INFERIOR THAN THE PLANNING TARGET POINT. AS A RESULT, SURGEON WAS NOT ABLE TO ABLATE AS MUCH AS THE LESION AS HE WANTED. SURGEON AND CR AGAIN LOOKED AT THE MERGE BETWEEN THE O-ARM SCAN AND THE PREOPERATIVE MRI AND DID NOT BELIEVE THAT THE MERGE COULD HAVE CAUSED THE INACCURACY. SURGEON DID NOT NOTICE ANY HEAD SHIFT, THE TRAJECTORY DID NOT SEEM TO SKIVE DURING DRILLING OR BOLT PLACEMENT, AND THE FIDUCIAL REGISTRATION GAVE A GOOD RMS VALUE THAT BOTH THE CR AND SURGEON FOUND ACCEPTABLE. THE INTRAOPERATIVE MRI SCAN SHOWING THE PLACEMENT OF THE FIBER WOULD NOT MERGE CORRECTLY TO THE PREOPERATIVE MRI, BUT THE CR RETRIEVED IT FOR THE CHT

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION USAGE SHEET THAT THE PATIENT'S RIGHT KNEE WAS REVISED. A 2X11 TS INSERT WAS IMPLANTED. UPDATE (B)(6)2020 WG: SALES BRANCH PROVIDED THE PRIMARY USAGE SHEET. A 2X9 TS INSERT WAS REVISED TO A 2X11 TS INSERT. UPDATE: "PATIENT WAS TREATED WITH I&D DUE TO ACUTE INFECTION. X-RAYS/REMOVED POLYETHYLENE ARE NOT AVAILABLE."

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: WHEN REGISTERING, THE ROBOT STARTED TO MOVE ON ITS OWN IN DIFFERENT DIRECTIONS. THE CLINICAL REPRESENTATIVE (CR) SHUT DOWN THE ROBOT AND RECALIBRATED THE POINTER PROBE TO REGISTER. THE ARM STOPPED DRIFTING ON ITS OWN, BUT WAS STILL DIFFICULT TO WORK WITH. THE CR AND THE SURGEON DECIDED TO CONTINUE ON WITH THE SURGERY SINCE THEY GOT A 0.7 RMS AND THE VERIFICATION LOOKED GOOD. WHEN THEY MERGED THE INTER-OPERATIVE SCAN, THE BIOPSY NEEDLE WAS ABOUT 9MM LATERAL FROM THE PLANNED TRAJECTORY. A CONVERTED SURGERY HAD TO BE DONE: THE SURGEON HAD TO USE THE STEALTH TO COMPLETE THE PROCEDURE. THERE WAS NO INJURY TO THE PATIENT BUT A DELAY > 30 MINUTES WAS OBSERVED.

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 DONE TO REMOVE AND REPLACE 4 SCREWS FROM T12 AND L2 THAT WERE NOT PLACED TO PLAN.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IN AN ATTEMPT TO REGISTER THE PATIENT, CONTACT-LESS REGISTRATION FAILED MULTIPLE TIMES IN MANY ATTEMPTS TO TROUBLESHOOT ANY ISSUES OCCURRING IN THE OPERATING ROOM. THE FIRST ATTEMPT OF CONTACT-LESS REGISTRATION GAVE AN "INSUFFICIENT ACCURACY" ERROR. AT THIS TIME, THE SCANNING OF THE PATIENT WAS ATTEMPTED AGAIN AND THE ERROR WAS NOT SHOWN HOWEVER, THERE WAS SIGNIFICANT ERROR SEEN UPON VERIFICATION. IT WAS DECIDED TO ATTEMPT REGISTRATION FROM THE BEGINNING AGAIN. THIS TIME, THE ERROR ON THE MARKING OF THE POINTS WAS BELOW 1.5 AND MADE SURE THAT NO OR LIGHTS WERE IN THE WAY, NO HAIR ETC. ONCE AGAIN UPON THE COMPLETION OF REGISTRATION, THE "INSUFFICIENT ACCURACY" ERROR WAS SEEN. AT THIS TIME, IT WAS DECIDED TO USE A DIFFERENT CT SCAN FOR THE REGISTRATION OF THE PATIENT. THIS DID NOT WORK EITHER AS "INSUFFICIENT ACCURACY" ERROR WAS SEEN ONCE MORE. AT THIS TIME, ANOTHER LASER WAS USED AS BS18978 IS IN THE SAME BUILDING. AFTER A FULL RE-BOOT AND USING THE OTHER LASER, THE "INSUFFICIENT ACCURACY" ERROR WAS STILL SEEN. AT THIS TIME, THE SURGEONS DECIDED TO EDIT THE PLAN TO ACCOUNT FOR THE ERROR IN THE REGISTRATION AS THIS CAUSED OVER A 2 HOUR DELAY WHILE THE PATIENT WAS UNDER ANESTHESIA. TH

Mazor Renaissance — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ABSTRACT: THE ACCURACY OF ROBOT-ASSISTED PEDICLE SCREW IMPLANTATION IS A SAFE AND EFFECTIVE METHOD IN LUMBAR SURGERY, BUT IT STILL REMAINS CONTROVERSIAL IN LUMBAR REVISION SURGERY. THIS STUDY EVALUATED THE CLINICAL SAFETY AND ACCURACY OF ROBOT-ASSISTED VERSUS FREEHAND PEDICLE SCREW IMPLANTATION IN LUMBAR REVISION SURGERY. THIS WAS A RETROSPECTIVE STUDY. FROM JANUARY 2018 TO DECEMBER 2019, 81 PATIENTS UNDERWENT POSTERIOR LUMBAR REVISION SURGERY IN OUR HOSPITAL. AMONG THEM, 39 PATIENTS UNDERWENT REVISION SURGERY PERFORMED WITH ROBOT-ASSISTED PEDICLE SCREW IMPLANTATION (RENAISSANCE ROBOTIC SYSTEM), WHEREAS THE REMAINING 42 PATIENTS UNDERWENT TRADITIONAL FREEHAND PEDICLE SCREW IMPLANTATION. ALL PATIENTS UNDERWENT MAGNETIC RESONANCE IMAGING (MRI), COMPUTED TOMOGRAPHY (CT), AND X-RAY BEFORE REVISION SURGERY. THE SEX, AGE, BODY MASS INDEX, BONE MINERAL DENSITY, OPERATIVE TIME, BLOOD LOSS, OPERATIVE SEGMENTS, INTRA-OPERATIVE FLUOROSCOPY TIME, AND COMPLICATIONS WERE COMPARED BETWEEN THE TWO GROUPS. THE ACCURACY OF PEDICLE SCREW IMPLANTATION WAS MEASURED ON CT SCANS BASED ON GERTZBEIN ROBBINS GRADING, AND THE INVASION OF SUPERIOR LEVEL FACET JOINT WAS EVALUATED BY BABU¿S METHOD. THERE WAS NO

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE 25-SEP-2020, THE NEUROSURGEON ASKED TO HAVE A COMPANY CLINICAL REPRESENTATIVE PRESENT TO SUPPORT A CASE AND CHECK IF THERE ARE NO PROBLEM WITH THE SCREEN. THE CASE WAS SUPPORTED BY PHONE: THE NEUROSURGEON CALLED BECAUSE ROBOT BOOTING FOR 2 SECONDS AND THEN SHUTDOWN (START BUTTON IS BECOMING RED AFTER 2 SECONDS). NO SOLUTION FOUND, SURGERY WAS ABORTED.

Senhance — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE COMPLAINANT, (B)(6) REPORTED THAT ON DAY 7, AFTER TME FOR RECTAL CANCER PATIENT COMPLAINED OF SUDDEN PURULENT DISCHARGE FROM THE ANUS AND ELEVATED BLOOD TEMPERATURE, SOME WEAKNESS. THIS ADVERSE EVENT WAS AN ANASTOMOTIC LEAKAGE. A DIGITAL EXAMINATION REVEALED A DEFECT OF (1 CM) IN THE POSTERIOR WALL OF COLO-ANAL ANASTOMOSIS. ANTIBIOTICS WERE ADMINISTERED (METRONIDAZOLE-500 MG 3X DAILY AND CEFUROXIME-1 G 3X DAILY) AND SYMPTOMS DISSAPEARED FOR A RESOLUTION DATE OF (B)(6) 2020. THIS EVENT DID NOT OCCUR WITHIN THE UNITED STATES. THE EVENT OCCURRED IN (B)(6). IT WAS REPORTED THAT THE CAUSALITY TO THE SENHANCE SURGICAL SYSTEM WAS POSSIBLE. THE EVENT OCCURRED ON (B)(6) 2020, AND ASENSUS SURGICAL WAS INTERNALLY MADE AWARE ON 09-AUGUST-2023..

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 ABDOMINOPERINEAL EXCISION SURGICAL PROCEDURE, A SYNCHROSEAL INSTRUMENT PIVOT PIN WASHER DETACHED FROM THE INSTRUMENT AND FELL INSIDE THE PATIENT. IT WAS REPORTED THAT THE WASHER WAS RETAINED WITHIN THE PATIENT. IT WAS ALSO NOTED THAT THE SYNCHROSEAL INSTRUMENT¿S JAW COVER HAD A SPLIT/TEAR. 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 PIVOT PIN WASHER WAS PRESENT DURING INSTRUMENT INSPECTION AND AT THE BEGINNING OF THE PROCEDURE. THE REPORTED ISSUE OCCURRED DURING USE, BUT IT IS UNKNOWN WHAT EXACT SURGICAL TASK WAS BEING PERFORMED AT THE TIME OF THE REPORTED EVENT. THE SURGEON BELIEVED THAT THE CAUSE OF THE REPORTED ISSUE COULD HAVE BEEN A POTENTIAL CLASH WITH ANOTHER INSTRUMENT, HOWEVER THIS WAS NOT CONFIRMED TO BE THE CAUSE OF THE REPORTED EVENT. IT WAS ALSO INDICATED THAT IT IS UNKNOWN IF THE INSTRUMENT COLLIDED WITH ANOTHER INSTRUMENT OR OTHER HARD MATERIAL AT THE TIME OF THE REPORTED EVENT. THE SYNCHROSEAL INSTRUMENT WAS IN USE FOR OVER FOUR HOURS WHEN THE REPORTED USE OCCURRED. THE PIVOT PIN WASHER D

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 AFTER A MONARCH-ASSISTED BRONCHOSCOPY PROCEDURE, THE PATIENT WAS OBSERVED TO HAVE A PNEUMOTHORAX DURING POST-OP CHECK-UP. THE LOCATION OF THE TARGET WAS LEFT LOWER LOBE. DURING THE CASE, THE INSTRUMENTS USED WERE SUPERD ASPIRATION NEEDLE, TRIPLE NEEDLE BRUSH AND SUPERTRAX FORCEPS. ENDOBRONCHIAL ULTRASOUND AND AN X-RAY WERE PERFORMED ON THE PATIENT. A CHEST TUBE WAS PLACED TO TREAT THE PNEUMOTHORAX, AND THE PATIENT WAS HELD OVERNIGHT. THE PATIENT HAS SINCE RECOVERED AND WAS RELEASED FROM HOSPITAL.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DA VINCI CAIDRE GRASPER ARM FELL OFF INSIDE OF PATIENT WHEN JAWS WERE OPENED. A SLOTTED GRASPER WAS INSERTED THROUGH A PORT TO RETRIEVE BROKEN ARM PIECE. SLOTTED GRASPER BROKE AT THE HINGE WHEN JAWS WERE CLOSED ON ARM PIECE. ALL PIECES OBTAINED AND GIVEN TO ASSOCIATE MANAGER. (B)(4), US. 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: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

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 FEMORAL NOTCHING OCCURRED DURING A ROBOTIC ASSISTED TOTAL KNEE ARTHROPLASTY. NO ADDITIONAL PATIENT INJURY WAS REPORTED.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: COMPANY CLINICAL REPRESENTATIVE (CR) WAS ASSISTING FOR TWO ABLATION CASES. ONCE THE SECOND CASE BEGAN, ONCE AGAIN THE MERGE OF THE NEWLY ACQUIRED CT EXAM TO THE MR LOOKED GOOD AND ACCEPTABLE. HOWEVER, ONCE THE FIDUCIAL REGISTRATION PROCESS BEGAN, IT WAS VERY APPARENT THAT THE CT AND MR WERE NOT MATCHED UP. ALTHOUGH A POINT LOOKED GOOD ON THE CT, THE MR WAS SHOWING THAT THE POINT WAS AT LEAST 5MM DEEPER, INDICATING ONCE AGAIN THAT THE MERGE WAS NOT LINED UP. DUE TO CONCERN WITH THE SURGEON, THE CASE WAS ABORTED AS TO AVOID ANY INACCURACY FOR THE PATIENT. THEY HAVE HAD 3 CASES IN THE PAST MONTH WHERE THE MERGE WAS GOOD AND ACCURACY WAS SPOT-ON. THIS ISSUE SEEMS TO BE CORRELATED WITH THE NEW MERGE PROCESS. THE ROBOT WILL NOT BE USED AT THE HOSPITAL UNTIL THIS IS RESOLVED.

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.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE COMPANY CLINICAL REPRESENTATIVE WAS INFORMED BY EMAIL THAT THE ROSA PUSHED ON THE PATIENT SKIN. THIS HAPPENED DURING THE REGISTRATION VALIDATION. ACCORDING TO THE DESCRIPTION OF THE SURGEON IT WAS DURING A COOPERATIVE MOVE TO CHECK THE ACCURACY OF THE FOREHEAD. THE SURGEON PLACED THE POINTER ON THE FOREHEAD AND THE ARM MOVED DOWN AND IT WAS ONLY WITH A LOT OF FORCE POSSIBLE TO GET THE ARM MOVED AWAY FROM THE PATIENT HEAD. THE REGISTRATION WAS ABORTED AND REDONE. DURING THE SECOND TIME, THE SYSTEM WAS WORKING NORMAL. THE SURGERY WAS CONTINUED. THERE WAS APPROXIMATELY 45 MINUTES DELAY, AND THE PATIENT EXHIBITED A RED PRESSURE MARK 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: DURING REVIEW OF A LITERATURE ARTICLE INVOLVING DA VINCI ASSISTED ROBOTIC PROCEDURES TITLED ¿FIRST REPORT COMPARING THE TWO TYPES OF SINGLE-INCISION ROBOTIC SACROCOLPOPEXY: SINGLE SITE USING THE DA VINCI XI OR SI SYSTEM AND SINGLE PORT USING THE DA VINCI SP SYSTEM¿ , THE FOLLOWING EVENTS WERE REPORTED. THE ARTICLE INCLUDED 48 PATIENTS WHO UNDERWENT SINGLE-SITE ROBOTIC SACROCOLPOPEXY (SS-RSC) USING DA VINCI SI OR XI SYSTEM FOR SYMPTOMATIC APICAL PELVIC ORGAN PROLAPSE QUANTIFICATION (POP-Q) STAGE III-IV BETWEEN NOVEMBER 2015 AND SEPTEMBER 2019 AND 8 PATIENTS WHO UNDERWENT SINGLE-PORT ROBOTIC SACROCOLPOPEXY (SP-RSC) USING DA VINCI SP SYSTEM DURING JANUARY 2019. THE OPERATIVE TIME WAS COMPARABLE BETWEEN SS-RSC AND SP-RSC GROUPS. SIGNIFICANT DIFFERENCES WERE NOTED IN THE DOCKING AND CERVIX SUTURING TIMES BETWEEN THE TWO GROUPS (P < 0.05). THESE WERE LONGER IN THE SS-RSC GROUP THAN IN THE SP-RSC GROUP (5.0 ± 2.6 MIN VS 2.3 ± 1.3 MIN, P < 0.001; 4.5 ± 1.8 MIN VS 2.1 ± 1.9 MIN, P < 0.01, RESPECTIVELY). THE MEAN ESTIMATED BLOOD LOSS (EBL) WAS COMPARABLE AND BELOW 75.0 ML IN THE SS-RSC AND SP- RSC GROUPS (51.9 ± 33.7 ML VS 71.3 ± 41.2 ML). INTRAOPERATIVELY, THERE WAS NO TRANSFUSION OR CONVER

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 WAS HAVING A REVISION SURGERY DUE TO A SCREW BEING PLACED INFERIORLY DURING A PROCEDURE ON (B)(6) 2020. THE S1 SCREW WAS DEVIATED. THE MANUFACTURER REPRESENTATIVE NOTED THAT IT WAS UNKNOWN HOW THE PLACEMENT BECAME INFERIOR AS ALL OTHER SCREW PLACEMENTS WERE NOTED TO BE FINE AND THERE WERE NO ISSUES WITH SKIVING OF THE SCREW. THE PROCEDURE WAS NOT DELAYED.

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 ¿FIRST REPORT COMPARING THE TWO TYPES OF SINGLE-INCISION ROBOTIC SACROCOLPOPEXY: SINGLE SITE USING THE DA VINCI XI OR SI SYSTEM AND SINGLE PORT USING THE DA VINCI SP SYSTEM,¿ THE FOLLOWING EVENTS WERE REPORTED: THE ARTICLE STUDY INCLUDED 48 PATIENTS WHO UNDERWENT SINGLE-SITE ROBOTIC SACROCOLPOPEXY (SS-RSC) USING DA VINCI SI OR XI SYSTEM FOR SYMPTOMATIC APICAL PELVIC ORGAN PROLAPSE QUANTIFICATION (POP-Q) STAGE III-IV BETWEEN NOVEMBER 2015 AND SEPTEMBER 2019 AND 8 PATIENTS WHO UNDERWENT SINGLE-PORT ROBOTIC SACROCOLPOPEXY (SP-RSC) USING THE DA VINCI SP SYSTEM DURING JANUARY 2019. THE OPERATIVE TIME WAS COMPARABLE BETWEEN SS-RSC AND SP-RSC GROUPS. PER THE ARTICLE, THERE WERE "SIGNIFICANT DIFFERENCES WERE NOTED IN THE DOCKING AND CERVIX SUTURING TIMES BETWEEN THE TWO GROUPS (P < 0.05). THESE WERE LONGER IN THE SS-RSC GROUP THAN IN THE SP-RSC GROUP (5.0 ± 2.6 MIN VS 2.3 ± 1.3 MIN, P < 0.001; 4.5 ± 1.8 MIN VS 2.1 ± 1.9 MIN, P < 0.01, RESPECTIVELY). FURTHERMORE, "THE MEAN ESTIMATED BLOOD LOSS (EBL) WAS COMPARABLE AND BELOW 75.0 ML IN THE SS-RSC AND SP- RSC GROUPS (51.9 ± 33.7 ML VS 71.3 ± 41.2 ML)."

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.

At 6:00 a.m. on September 2, 2020, an employee was adjusting a robot used to make molds. The robot activated and struck the employee. The employee was hospitalized to treat fractures to the ribs and back area and a punctured lung.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE FIELD SERVICE ENGINEER (FSE) ATTEMPTED TO BOOT UP ROBOT PRIOR TO SURGERY. ROBOT PC WOULD NOT TURN ON, BUT CONTROLLER STARTED AS EXPECTED. THE FSE OPENED ROBOT AND CONFIRMED THAT ALL CONNECTIONS WERE CONNECTED PROPERLY, AND THAT ALL FUSES APPEARED TO BE INTACT. THE FSE ATTEMPTED TO RE-SEAT MEMORY, MOTHERBOARD, AND CONNECTIONS, BUT WITHOUT CORRECTING THE ISSUE.

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 ON AN UNKNOWN DATE, THE TIP COVER ACCESSORY OF THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT FELL INTO THE PATIENT'S ANATOMY AND WAS NOT RETRIEVED. THERE WAS NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER ON 10-AUG-AND 19-AUG-2020 AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE EVENT DATE IS UNKNOWN. THE MCS INSTRUMENT WAS INSPECTED PRIOR TO USE. THE MCS TIP COVER ACCESSORY WAS INSTALLED PROPERLY WITH THE INSTALLATION TOOL. THERE WAS NO RESISTANCE FELT UPON REMOVAL OF THE MCS INSTRUMENT THROUGH THE CANNULA. THERE WERE NO ISSUES WITH FUNCTIONALITY OF THE MCS INSTRUMENT AND NO INSTRUMENT COLLISIONS. THE MCS INSTRUMENT WAS IN USE DURING THE WHOLE PROCEDURE. THE MCS TIP COVER ACCESSORY FELL INSIDE OF THE PATIENT AT THE END OF THE PROCEDURE AND IT COULD NOT BE FOUND. IT WAS NOT RETRIEVED. THERE WERE NO POST-OPERATIVE COMPLICATIONS. IT WAS UNKNOWN IF THERE WAS A DELAY IN PROCEDURE. THE PATIENT¿S STATUS WAS "NORMAL." THE PROCEDURE WAS NOT RECORDED ON VIDEO.

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 ON AN UNKNOWN DATE, THE TIP COVER ACCESSORY OF THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT FELL INTO THE PATIENT'S ANATOMY AND WAS NOT RETRIEVED. THERE WAS NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER ON 10-AUG-2020 AND 19-AUG-2020 AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE EVENT DATE IS UNKNOWN. THE MCS INSTRUMENT WAS INSPECTED PRIOR TO USE. THE MCS TIP COVER ACCESSORY WAS INSTALLED PROPERLY WITH THE INSTALLATION TOOL. THERE WAS NO RESISTANCE FELT UPON REMOVAL OF THE MCS INSTRUMENT THROUGH THE CANNULA. THERE WERE NO ISSUES WITH FUNCTIONALITY OF THE MCS INSTRUMENT AND NO INSTRUMENT COLLISIONS. THE MCS INSTRUMENT WAS IN USE DURING THE WHOLE PROCEDURE. THE MCS TIP COVER ACCESSORY FELL INSIDE OF THE PATIENT AT THE END OF THE PROCEDURE AND IT COULD NOT BE FOUND OR RETRIEVED. THERE WERE NO POST-OPERATIVE COMPLICATIONS. IT WAS UNKNOWN IF THERE WAS A DELAY IN PROCEDURE. THE PATIENT¿S STATUS WAS "NORMAL." THE PROCEDURE WAS NOT RECORDED ON VIDEO.

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.

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 BLADE OF A HARMONIC ACE INSTRUMENT BROKE WHEN IN A PATIENT; IT¿S THE 3RD TIME IT HAPPENED WITHIN THE MONTH. THERE WAS NO REPORT OF PATIENT INJURY. ON (B)(6) 2020, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT FROM THE CONSOLE SURGEON: DURING A DA VINCI-ASSISTED TOTAL HYSTERECTOMY PROCEDURE, THE TIP OF A HARMONIC ACE INSTRUMENT FELL OFF INTO THE PATIENT WHILE THE SURGEON WAS OPENING A VAGINAL CUFF. THE BROKEN SINGLE PIECE WAS FOUND AND VISUALLY REMOVED WITH A LAPAROSCOPIC GRASPER INSTRUMENT; NO X-RAY WAS NEEDED AS THE FRAGMENT WAS SEEN AND RETRIEVED VISUALLY. THERE WERE NO INTRA-OPERATIVE COMPLICATIONS AND NO MEDICAL INTERVENTION, OTHER THAN FRAGMENT RETRIEVAL, WAS REQUIRED. THE INSTRUMENT DID TOUCH THE PLASTIC OF THE V-CARE MANIPULATOR. THE INSTRUMENT WAS NEVER REMOVED AND IT WAS IN USE INTERMITTENTLY FOR APPROXIMATELY 15 MINUTES PRIOR TO THE ISSUE. THE INSTRUMENT WAS NOT REMOVED AT ANY TIME PRIOR TO THE EVENT. THERE WERE NO POST-OPERATIVE COMPLICATIONS AND THE PATIENT IS RECOVERING APPROPRIATELY. THE PROCEDURE COMPLETED ROBOTICALLY WITH NO REPORTED IN

At 11:00 a.m. on August 28, 2020, an employee was shredding cabbage with a food processing machine (Robot Coupe CL 50). The employee was hand-feeding cabbage into the food processing machine. The employee reached too far into the machine, and the tips of her right index and middle fingers contacted the rotating blade (point of operation) of the machine, causing amputation injuries. The employee was hospitalized.

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 19-MAY-2022, INTUITIVE SURGICAL, INC (ISI) RECEIVED FDA VOLUNTARY REPORT #MW5109945 WITH THE FOLLOWING EVENT DESCRIPTION: "BOWEL AND URETER PERFORATION; DA VINCI ASSIST HYSTERECTOMY PERFORMED AND NO PROBLEMS UNTIL 5 DAYS POST-OP. CT SCAN REVEALED PERITONITIS AND OPEN LAPAROTOMY BOWEL RESECTION WAS PERFORMED 7 DAYS POST-OP (REVEALED INJURY TO SMALL BOWEL) AND ADDITIONAL CT REVEALED THAT R URETER WAS ALSO SEVERED (STENT PLACED 9 DAYS POST-OP). URETERAL-VAGINAL FISTULA AND SEVERE UROSEPSIS IN (B)(6) 2020. I UNDERWENT 7 MORE SURGICAL PROCEDURES AND HAVE HAD 14 CT SCANS OF THE ABDOMEN IN 18 MONTHS FOLLOWING THE INJURY. STAGED URETERAL REIMPLANTATION WAS PERFORMED 6 MONTHS POST-OP AND ADDITIONAL TREATMENTS FOR SEVERE ABDOMINAL PAIN AND RIGHT AND LEFT KIDNEY HYDRONEPHROSIS, ADHESIONS, HERNIA AND INCONTINENCE REMAIN. SURGEONS SUSPECT THERMAL INJURY AS URETERS WERE SCOPED IN THE INITIAL PROCEDURE. NOT SURE ABOUT MODEL (SI, SP, X) BUT MONOPOLAR SCISSORS WERE USED AS WELL AS PK APPARATUS. REPEATED ATTEMPTS TO GET INFO FROM THE HOSPITAL AND INTUITIVE (MANUFACTURER) HAVE FAILED. OTHER THAN MY SURGEON'S OP REPORT, I HAVE NOT BEEN GIVEN THE INFORMATION I NEED TO RESEARCH THIS EQUIPMENT IN DETA

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: BOWEL AND URETER PERFORATION; DA VINCI ASSIST HYSTERECTOMY PERFORMED AND NO PROBLEMS UNTIL 5 DAYS POST-OP. CT SCAN REVEALED PERITONITIS AND OPEN LAPAROTOMY BOWEL RESECTION WAS PERFORMED 7 DAYS POST-OP (REVEALED INJURY TO SMALL BOWEL) AND ADDITIONAL CT REVEALED THAT R URETER WAS ALSO SEVERED (STENT PLACED 9 DAYS POST-OP). URETERAL-VAGINAL FISTULA AND SEVERE UROSEPSIS IN (B)(6) 2020. I UNDERWENT 7 MORE SURGICAL PROCEDURES AND HAVE HAD 14 CT SCANS OF THE ABDOMEN IN 18 MONTHS FOLLOWING THE INJURY. STAGED URETERAL REIMPLANTATION WAS PERFORMED 6 MONTHS POST-OP AND ADDITIONAL TREATMENTS FOR SEVERE ABDOMINAL PAIN AND RIGHT AND LEFT KIDNEY HYDRONEPHROSIS, ADHESIONS, HERNIA AND INCONTINENCE REMAIN. SURGEONS SUSPECT THERMAL INJURY AS URETERS WERE SCOPED IN THE INITIAL PROCEDURE. NOT SURE ABOUT MODEL (SI, SP, X) BUT MONOPOLAR SCISSORS WERE USED AS WELL AS PK APPARATUS. REPEATED ATTEMPTS TO GET INFO FROM THE HOSPITAL AND INTUITIVE (MANUFACTURER) HAVE FAILED. OTHER THAN MY SURGEON'S OP REPORT, I HAVE NOT BEEN GIVEN THE INFORMATION I NEED TO RESEARCH THIS EQUIPMENT IN DETAIL. ADHESIONS WERE EXTENSIVE, AND FOLEY CATHETER AS WELL AS URETERAL STENT WAS PLACED FOR POST-OP PERIOD. FDA SAFETY REPORT ID