ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DOCTOR WAS PERFORMING A SINGLE POSITION LATERAL FUSION AND WE HAD ISSUES WITH THE MERGE. THE LEVELS IN QUESTION WERE L3 AND L4. THERE WAS SIGNIFICANT SHIFT IN THE A/P AND LATERAL IMAGES WHEN COMPARED TO THE CT SCAN. THIS WAS ATTEMPTED TO BE FIXED BY SEGMENTING THE LEVELS SO THAT EACH LEVEL WAS ON A SEPARATE X-RAY. ALSO, WE ADDED L2 AND L5 TO HELP CORRECT THE SHIFT BUT IT DID NOT WORK. CSR WAS AT THE CASE AND HAS THE LOGS. WE FOLLOWED HIS RECOMMENDATIONS FOR TRYING TO FIX THE SHIFT. WE WERE UNABLE TO FIX THE SHIFT AND THE ROBOT PORTION OF THE CASE WAS ABORTED.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: HAD TO SHUT OFF 7 TIMES THROUGH OUT CASE TO EITHER GET IT TO SHOW US INSTRUMENTS THAT HAD ALREADY BEEN CHECKED IN BUT WAS SAYING THEY HAD NOT.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REHOMING ARM WOULDN'T WORK.

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 SUBTOTAL GASTRECTOMY PROCEDURE, THE POSTERIOR GASTRIC ARTERY WAS DISSECTED WITH A HARMONIC ACE INSTRUMENT. THE ISSUE OCCURRED WHEN THE SURGEON WAS ABOUT TO ANASTOMOSE THE STOMACH AND SUDDENLY EXPERIENCED BLEEDING FROM THE POSTERIOR GASTRIC ARTERY. THE SURGEON WAS UNABLE TO STITCH THE BLEEDING SECTION USING THE ROBOT. THE BLEEDING WAS SUPPRESSED WITH AN UNSPECIFIED INSTRUMENT INSTALLED ON UNIVERSAL SURGICAL MANIPULATOR (USM) 4. THE SURGEON MADE THE CLINICAL DECISION TO CONVERT TO OPEN SURGERY DUE TO BLEEDING. THE AMOUNT OF BLOOD LOSS AT THE TIME OF THE DECISION WAS ABOUT 100ML. THE TOTAL AMOUNT OF BLOOD LOSS WAS ABOUT 500ML. THE OPEN PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT THE PATIENT REQUIRING A BLOOD TRANSFUSION.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ROBOT NEVER CONFIRMED WE WERE IN TARGET OR WOULDN'T SEND TO ANY TRAJECTORIES.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE SYSTEM WAS INITIALLY TURNED ON, ALL CHECKS PERFORMED, INSTRUMENTS VERIFIED ETC. THE SYSTEM WAS THEN SHUT DOWN FOR STAGE 1 OF THE PROCEDURE (AS INFORMED PREVIOUSLY BY INR TEAM TO NOT LEAVE ROBOT SWITCHED ON FOR A LONG TIME BEFORE THE CASE STARTS). WHEN TURNING THE SYSTEM BACK ON FOR COMMENCEMENT OF STAGE 2 THE SCREEN DISPLAYED "REBOOT AND SELECT PROPER BOOT DEVICE OR INSERT BOOT MEDIA IN SELECTED BOOT DEVICE AND PRESS A KEY". LOCAL INR SUPPORT INFORMED US TO SWITCH OFF BATTERY AND RESTART SYSTEM USING AC POWER ONLY OR TO RESTART SYSTEM WHILE HOLD "ESC". NEITHER OF THESE RESOLVED THIS ISSUE AND THE CASE WAS ABANDONED. AFTER THE CASE WE TROUBLESHOOTED WITH INTERNATIONAL INR SUPPORT AND WERE ABLE TO "DISABLE LEGACY BOOT MODE".

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 PIECE OF THE CANNULA SEAL FELL INTO THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING LAST SCREW PLACEMENT (L5R) THE HIGH SPEED DRILL, PILOT DRILL AND THE TAP WERE NAVIGATED ACCURATELY, BUT SCREW WAS NOT. THE SCREW WAS PUT SLIGHTLY IN FORAMEN, IT WAS FOUND IN THE X-RAY VERIFICATION SHOT. SCREW WAS IMMEDIATELY REMOVED AND RE-PLANNED AND AGAIN - HIGH SPEED DRILL, PILOT DRILL AND TAP WERE NAVIGATED ACCURATELY, BUT DURING SCREW PLACEMENT THE DOCTOR SAW AND FELT THAT THE SCREW JUMPED INTO OLD CANAL. ONCE MORE SCREW WAS IMMEDIATELY REMOVED AND RE-PLANNED AND AGAIN HIGH SPEED DRILL, PILOT DRILL AND TAP WERE NAVIGATED ACCURATELY, BUT SCREW WAS PUT WITHOUT ROBOT/NAVIGATION WITH STANDARD SCREWDRIVER AND UNDER X-RAY CONTROL. AFTER DISCUSSION WITH THE REP HE COULDN'T CONFIRM THAT THE OFFSET TURNED TO RED WHEN SCREWDRIVER WAS IN EE.

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 VENTRAL HERNIA SURGICAL PROCEDURE, THE CUSTOMER STATED THAT THE CAUTERY WAS NOT WORKING, AND A QUESTION MARK WAS DISPLAYED ON THE INTEGRATED ELECTROSURGICAL UNIT (IESU/ERBE) FRONT PANEL, INDICATING THAT THE ERBE COULD NOT DETERMINE WHICH UNIVERSAL SURGICAL MANIPULATOR (USM) THE INSTRUMENT WAS ENGAGED ON. THE CUSTOMER HAD REPLACED THE CORDS AND EXHAUSTED THEIR SUPPLY. THE CUSTOMER TRIED DIFFERENT CAUTERY INSTRUMENTS, STILL THE ISSUE PERSISTED. THE CUSTOMER POWER CYCLED THE SYSTEM AND REMOVED AC POWER FROM THE ERBE AND THE ISSUE PERSISTED. THE SYMPTOMS INDICATED BAD ENERGY CORD(S) OR BAD ENERGY CONNECTORS ON THE ERBE. THE PROCEDURE WAS CONVERTED TO OPEN SURGERY WITH NO REPORTS OF PATIENT INJURY. AN 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.

CyberKnife — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: SIDE EFFECT - ANESTHESIA DELAROSA (AD).

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE ROBOT SEEMED TO BE MORE SENSITIVE THEN USUAL AND A SCREW ACTUALLY SEEMED TO MISS LATERALLY. TO HELP WITH EXAMINING WHAT WENT WRONG, THE DIFFICULTIES WE HAD PERSISTED ON THE PATIENTS RIGHT SIDE. THE PA SEEMED TO THINK THE TRAJECTORY LOOKED PERFECT UNTIL IT CAME TIME FOR THE DRIVER ARRAY TO PASS DOWN THE END EFFECTOR, THEN SHOWING A SUDDEN CHANGE IN TRAJECTORY. I AM UNSURE IF AN ISSUE COULD BE RELATED TO TECHNIQUE OR NOT. WE HAVE SINCE USED THE ROBOT THIS WEEK AND DID NOT SEEM TO HAVE ISSUES.

Senhance — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE EVENT OCCURRED OUTSIDE THE UNITED STATES. THE EVENT OCCURRED ON (B)(6) 2022, INTERNALLY MADE AWARE ON (B)(6) 2023. THE PATIENT EXPERIENCED SUTURE FAILURE WHICH REQUIRED INTERVENTION FOR TREATMENT (RESOLVED ON (B)(6) 2022). INTERVENTION INCLUDED, RELAPAROSCOPY, COLONOSCOPY, AND ENDOVAC THERAPY. IT WAS REPORTED THAT THE CAUSALITY TO THE SENHANCE SURGICAL SYSTEM WAS POSSIBLE.

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 LYMPHADENECTOMY PROCEDURE, THE MONOPOLAR CURVED SCISSOR (MCS) TIP COVER ACCESSORY CAME LOOSE WHEN REMOVING THE MCS INSTRUMENT AND FELL INSIDE THE PATIENT'S ABDOMEN. AT THE TIME THE EVENT OCCURRED, THE SURGICAL STAFF WAS IN THE PROCESS OF EXCHANGING THE MCS INSTRUMENT WITH A LARGE NEEDLE DRIVER INSTRUMENT. THERE WAS NO DIFFICULTY FELT WHILE REMOVING THE MCS INSTRUMENT. AFTER THE EVENT OCCURRED, THE MCS INSTRUMENT REMAINED OUTSIDE THE PATIENT FOR THE REMAINDER OF THE PROCEDURE AND WAS NO LONGER USED DURING THE PROCEDURE. PER THE SURGEON, THE MCS TIP COVER ACCESSORY LIKELY CAME LOOSE DURING THE INSTRUMENT CHANGE. THE MSC TIP COVER ACCESSORY APPEARED TO HAVE BEEN PROPERLY INSTALLED DURING THE SURGICAL PROCEDURE WITH NO PART OF THE ORANGE SURFACE VISIBLE AFTER INSTALLATION NOR WAS IT INSTALLED BEYOND THE ORANGE SURFACE. THE INSTALLATION TOOL HAD BEEN USED; ELECTROLUBE OR ANY OTHER LUBRICANT HAD NOT BEEN APPLIED PRIOR TO INSTALLATION OF THE MCS TIP COVER ACCESSORY. THE MCS INSTRUMENT AND MCS TIP COVER ACCESSORY HAD BEEN INSPECTED PRIOR TO USE. THE SURGEON DID NOT NOTICE ISSUES WITH THE FUNCTIONALITY OF THE MCS INS

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THIS EVENT OCCURRED IN AN INTRA-OP T10-PELVIS REVISION CASE. EXISTING HARDWARE WAS PRESENT FROM L3-S1. AFTER ALL STEPS OF THE INTRA-OP WORKFLOW HAD BEEN COMPLETED, A THOROUGH AND DETAILED ANATOMY CHECK WAS DONE. THE SURGEON AND HIS FELLOW ADJUSTED ALL SCREWS THAT HAD BEEN PRELIMINARILY PLANED. AFTER THE SURGEONS MODIFIED, REVIEWED, AND APPROVED ALL SCREWS; THE ROBOT WAS PUSHED INTO THE CORRECT POSITION. SCREWS WERE PLACED T10-L2 ON THE LEFT PRIOR TO PLACING SCREWS T10-L2 ON THE RIGHT (SURGEON PREFERENCE). S2AI SCREWS WERE PLACED LAST. ACCURACY CHECKS WERE CONDUCTED THROUGHOUT THE SCREW PLACEMENT PROCESS A SPIN WAS CONDUCTED AFTER ALL SCREWS WERE PLACED. THE LEFT T10 SCREW APPEARED TO BREACH THE MEDIAL WALL OF THE PEDICLE AND THE SCREW APPEARED SLIGHTLY MEDIAL TO THE PLAN. THE EXTENT OF THE BREACH COULD NOT BE DETERMINED DUE TO THE SCAN QUALITY (VERY POOR DUE TO THE PATIENT SIZE AND METAL SCATTER). THE SURGEON CAREFULLY REVIEWED THE SCREW AND NEURO MONITORING DATA BEFORE DECIDING TO LEAVE IT IN PLACE. THE LEFT T10 PEDICLE WAS SMALL, AND THE SURGEON SELECTED A SCREW DIAMETER THAT WAS CLINICALLY APPROPRIATE AND HIM EFFECTIVE FIXATION. THE SURGEON FELT IT WAS POSSIBLE THAT THE 4.5 HIGH

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 THE PATIENT SUSTAINED A PNEUMOTHORAX. RIGHT UPPER-LOBE, GROUND-GLASS OPACIFICATION WITH SOME SOLID AREA. AN ARCPOINT NEEDLE AND AN AURIS CYTOLOGY BRUSH WERE USED DURING THIS PROCEDURE BUT WERE DISPOSED OF AFTERWARDS, THE LOT NUMBER WAS NOT RECORDED. PATIENT RECEIVED A SMALL-BORE TUBE, A POST-PLACEMENT X-RAY, WITH NO PLEURAL VACUUM NEEDED. THE PATIENT WAS DISCHARGED THE NEXT DAY.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING L3-L4 SPL CASE, C-ARM IMAGES WERE MIRRORED AFTER THE MERGE. BEFORE THE MERGE, EVERYTHING WENT NORMALLY: IMAGES WERE TRANSFERRED NORMALLY, CENTROIDS WERE PLACED BUT AFTER MERGING C-ARM SHOTS WERE REVERSED. RE-IMAGING THE PATIENT, RESETTING SOFTWARE, RESTARTING C-ARM, RESTARTING EGPS, CREATING NEW CASE DID NOT SOLVE THE PROBLEM. ALSO DURING PANNING PHASE, THE ANTERIOR PART OF THE CAGE NEEDED TO BE PLANNED POSTERIORLY TO GET LEFT SIDE ACCESS. PROCEDURE WAS PERFORMED THE OLD FASHION WAY.

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 GPS SYSTEM, A PEDICLE PROBE WAS PLACED AND A MEDIAL BREACH WITH CEREBROSPINAL FLUID LEAK WAS OBSERVED AND FIXED INTRAOPERATIVELY.

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 BRONCHOSCOPY PROCEDURE ON (B)(6) 2022, THE PATIENT RETURNED TO THE EMERGENCY ROOM (ER) ON (B)(6) 2022, EXPERIENCING SHORTNESS OF BREATH. A CHEST TUBE WAS PLACED AND THE PATIENT WAS ADMITTED TO THE HOSPITAL. THE PHYSICIAN WHO PERFORMED THE BRONCHOSCOPY DOES NOT ATTRIBUTE THIS EVENT TO THE MONARCH SYSTEM, STATING IT WAS A RESULT OF THE NEEDLE BEING DEPLOYED INTO THE EDGE OF THE PLEURA. THE PATIENT DID NOT EXPERIENCE ANY OTHER ISSUES OTHER THAN SHORTNESS OF BREATH. THE CHEST TUBE WAS REMOVED ON (B)(6) 2022, A X-RAY WAS PERFORMED, AND THE PATIENT WAS DISCHARGED. THERE WAS NO EVIDENCE THAT THE MONARCH SYSTEM DID NOT PERFORM AS INTENDED.

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 PATIENT EXPERIENCED ADVERSE EFFECTS FOLLOWING SURGERY WHERE A SCREW USING THE EXCELSIUS GPS SYSTEM WAS MISPLACED INTRA-OPERATIVELY CAUSING A LEFT MEDIAL BREACH.

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 ANTERIOR RESECTION SURGICAL PROCEDURE, THE CUSTOMER REPORTED THAT THE VISION WAS LOST. THEY ATTEMPTED TO RECONNECT THE CAMERA TO THE ENDOSCOPE CONTROLLER (EC), BUT THE CAMERA HAD A SELF-TEST FAILURE, AND THE COLOR BAR WAS DISPLAYED. THEY REPLACED THE CAMERA WITH A BACKUP ONE, BUT ALL THE AVAILABLE CAMERAS HAD THE SAME SYMPTOM. LASTLY, THEY REBOOTED THE SYSTEM AND CLEANED THE CAMERA CONNECTOR; HOWEVER, THE ISSUE PERSISTED. THE CUSTOMER ELECTED TO CONVERT TO LAPAROSCOPIC PROCEDURE. NO KNOWN IMPACT OR PATIENT CONSEQUENCE REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP ON 19-OCT-2022 AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CAMERAS WERE INSPECTED PRIOR TO USE WITH NO ABNORMALITY. DURING THE PROCEDURE, THE VISION LOSS OCCURRED ON BOTH OF THE SURGEON SIDE CONSOLE (SSC) AND VISION SIDE CART (VSC). INFORMATION REGARDING PATIENT DEMOGRAPHICS, RELEVANT TESTING, AND MEDICAL HISTORY WERE REQUESTED; HOWEVER, THE REPORTER WAS NOT ABLE TO PROVIDE THAT 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 DURING A DA VINCI-ASSISTED PROCEDURE THAT ARM 3 OF THE SINGLE PORT (SP) SYSTEM ENCOUNTERED INSTRUMENT ENGAGEMENT ISSUES. THE OR STAFF STATED THEY UNDOCKED THE ARM AND RE-DRAPED BEFORE CALLING. THEY HAD ALSO POWER CYCLED AND TRIED MORE THAN ONE INSTRUMENT ON ARM 3, BUT ISSUES PERSISTED. THE PATIENT WAS ON THE TABLE, UNDER ANESTHESIA, AND PORTS HAD BEEN PLACED AT THE TIME. THE TSE REVIEWED THE LIVE LOGS AND FOUND ERRORS 23300 AND 31009. THE TSE INFORMED THE OR STAFF THAT ALL TROUBLESHOOTING STEPS HAD BEEN PERFORMED AND ARM 3 NEEDS SERVICE. IT WAS CONFIRMED FOLLOWING A FOLLOW-UP CALL THAT THE SURGEON CONVERTED TO AN XI MULTIPORT SYSTEM. THERE WAS NO REPORT OF PATIENT INJURY. AN ATTEMPT HAS BEEN MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER CONCERNING THE REPORTED EVENT WITH NO SUCCESS.

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 SCRUB COUNT WAS OFF, AND THE CUSTOMER WAS MISSING A MONOPOLAR CURVED SCISSORS (MCS) TIP COVER. THE CUSTOMER LOCATED THE MCS TIP COVER INSIDE OF THE PATIENT AND REMOVED IT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SITE ON (B)(6) 2022 AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER STATED THAT THE ISSUE WAS IDENTIFIED WHILE CLOSING THE PATIENT. THE MCS INSTRUMENT AND TIP COVER WERE INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. THE MCS TIP COVER WAS RETRIEVED BY GOING BACK IN THE ABDOMEN. ALL FRAGMENTS WERE RETRIEVED, AND THIS WAS CONFIRMED THROUGH INSPECTION OF THE MCS TIP COVER. THE CASE WAS EXTENDED FOR A FEW MINUTES DUE TO THE ISSUE. IT WAS UNKNOWN WHAT TASK WAS PERFORMED WHEN THE MCS TIP COVER FELL INTO THE PATIENT. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE MCS INSTRUMENT DURING THE PROCEDURE. THE MCS INSTRUMENT DID NOT COLLIDE WITH ANOTHER INSTRUMENT. A REDUCER WAS NOT USED. THERE WAS NO DIFFICULTY REMOVING THE MCS INSTRUMENT. THE MCS INSTRUMENT WRIST WAS STRAIGHTENED UPON REMOVAL. NO D

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING NAVIGATION, WHILE MOVING TO TRAJECTORY FOR OUR L5 R AND S1 R SCREWS THE AXIAL SLICE WAS UNRECOGNIZABLE (COULD NOT MAKE OUT ANY PEDICLE, VERTEBRAL BODY, S.P). WE CHECK OUR LEFT SIDED SCREWS TRAJECTORY, AND EVERYTHING LOOKED PERFECT. I WENT BACK TO THE PLANNING PAGE TO CHECK OUR RIGHT SIDED SCREWS AXIAL IMAGES AND AGAIN, EVERYTHING LOOKED PERFECT. THOUGH, WHILE BRINGING INSTRUMENTS IN THE EE ALL INSTRUMENT TRACKED CORRECTLY DOWN PLANNED SCREW TRAJECTORY EVEN THOUGH IT DID NOT VISIBLY LOOK LIKE A CORRECT AXIAL SLICE (ANATOMY UNRECOGNIZABLE). AFTER A FEW SOFTWARE RESETS AND A HARD SHUT DOWN, AND SWITCHING EES I INFORMED DR. GENTRY IT WAS JUST THE SLICE OF THE SCAN WE WERE IN, AND I BELIEVED EVERYTHING WAS SAFE. WHEN ADDING LAYERS TO OUR AXIAL CUT THE IMAGE WAS IMPROVING (COULD MAKE OUT DISTINCT ANATOMY) BUT DOC STILL DID NOT TRUST IT. ADJUSTING THE PLAN HAD LITTLE TO NO EFFECT AS WELL. HE WOULD NOT MAKE AN INCISION TO CHECK TRAJECTORY OF INSTRUMENTS UNDER FLOURO AND BAILED ON THE ROBOT.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: CHECKED THE SYSTEM AFTER REPLACING THE FUSES AND FOUND THAT THE POWER IS BACK ON THE SYSTEM WITH POWER AND BATTERY LED INDICATOR ON THE CONTROL PANEL. SYSTEM'S FANS WERE ALSO RUNNING BUT THERE WAS NO DISPLAY ON THE MONITOR. LED ON THE MONITOR IS RED. I.E. NO VIDEO SIGNALS FROM COMPUTER. 2. CONNECTED AN EXTERNAL HDMI CABLE FROM PC TO MONITOR DIRECTLY BUT STILL NO VIDEO SIGNAL ON MONITOR. 3. CONNECTED EXTERNAL MONITOR ON THE PC DIRECTLY AND NO DISPLAY ON THE EXTERNAL MONITOR TOO. 4. CHECKED THE VOLTAGE ON PC POWER SUPPLY AND IT WAS 54 VOLT DC. 5. PC FAN WAS ALSO RUNNING. 6. IT HAS BEEN OBSERVED THAT THE PC IS NOT BOOTING UP SO THERE IS NO DISPLAY ON THE MONITOR. KINDLY SUGGEST FURTHER.

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 BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE CLINICAL SALES REPRESENTATIVE (CSR) CALLED AN INTUITIVE SURGICAL INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) TO REPORT THAT THE CANNULA KEPT SLIPPING OUT AND THE SURGEON HAD TO CONVERT TO OPEN SURGERY. THE PATIENT STAYED IN THE HOSPITAL AN EXTRA COUPLE OF DAYS BECAUSE OF THE OPEN SURGERY. 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.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: FAILED MERGE OF L4 DURING AN L4-L5 SINGLE POSITION LATERAL. PATIENT WAS POSITIONED LEFT SIDE UP AND THE BED WAS BROKEN SLIGHTLY PRIOR TO DRAPING THE PATIENT. IMAGES WERE ACQUIRED FOR THE MERGE. WE WERE ABLE TO GET A GOOD/APPROVABLE MERGE FOR L5 ON THE FIRST ATTEMPT. DESPITE MULTIPLE ATTEMPTS AND EXTENSIVE TROUBLESHOOTING, WE WERE NOT ABLE TO GET A GOOD/APPROVABLE MERGE FOR L4. THE AP VIEW CONSISTENTLY HAD MORE SHIFT THEN IN THE LATERAL AT L4.

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. THIS EVENT OCCURED IN BELGIUM.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: CENTROIDS WERE PLACED IN THE CENTER OF THE BODIES WITH THE SURGEON'S GUIDANCE. THE MERGE AT ALL LEVELS SHOWED A LARGE SHIFT OF THE VERTEBRAL BODIES IN THE AP VIEW. THE DRR FILE WAS NOTICEABLY A FEW CM TO THE RIGHT OF THE X-RAY ALL LEVELS. SOME TROUBLESHOOTING WAS PERFORMED, BUT THE ISSUE WAS NOT RESOLVED. THE SURGEON DECIDED TO PLACE CAGES WITHOUT NAVIGATION.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: CASE L5-S2AI. THERE WAS BIG SHIFT AT S1, WE CONTINUED TO TAKE NEW PICTURES AND THERE CONTINUED TO BE A LARGE SHIFT AT S1, S2. WE HAD TO DO ANOTHER HARD SHUTDOWN. WE TOOK NEW PICTURES AND THERE IS STILL A BIG SHIFT AT S1, S2.

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 JOURNAL ARTICLE TITLED, ¿SINGLE PORT VS MULTIPORT ROBOTIC PYELOPLASTY: PROPENSITY-SCORE MATCHED ANALYSIS OF PERIOPERATIVE AND FOLLOW-UP OUTCOMES¿ (HARRISON, R., AHMED, M., ET AL., 2022). WITHIN THE JOURNAL ARTICLE, OPERATIVE COMPLICATIONS INVOLVING SINGLE-PORT (SP) ROBOTIC-ASSISTED PYELOPLASTY (RAP) PROCEDURES WERE NOTED. IN THE ARTICLE, THE FOLLOWING IS NOTED: ¿AN INTRAOPERATIVE COMPLICATION OCCURRED DURING ONE SP-RAP CASE. WHILE INCISING THE PERITONEUM TO ACCESS THE ABDOMINAL CAVITY, A SMALL ENTEROTOMY WAS NOTED IN A PORTION OF THE SMALL BOWEL THAT WAS ADHERENT TO THE PERITONEUM IN A PATIENT WITH PRIOR ABDOMINAL SURGERY. THE INJURED AREA WAS REPAIRED IN TWO LAYERS, USING 3-0 VICRYL FOR THE MUCOSA, AND 3-0 SILK FOR THE SEROSA IN A LEMBERT FASHION.¿ ADDITIONALLY, IT IS DOCUMENTED: ¿ONE SP-RAP PATIENT UNDERWENT SURGICAL DEBRIDEMENT FOR A POORLY HEALING, LEFT LOWER ABDOMINAL QUADRANT WOUND (CLAVIEN CLASS IIIB)." INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE AUTHOR. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING THE CASE, A MERGE COULD NOT BE OBTAINED. TRIED TO GET IT AFTER THE CASE BUT IT DID NOT WORK.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: UNSUCCESSFUL MERGE AT T1. MULTIPLE MERGES WERE ATTEMPTED WITH DIFFERENT FLUORO IMAGES AND CENTROID PLACEMENTS. AFTER FAILING T1-T3 MERGE MULTIPLE TIMES, WE TRIED MERGING C7-T2 WHICH WAS ALSO UNSUCCESSFUL.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IN THESE CASES, NO MATTER WHAT, THE MERGE BOUNCED SIMILAR TO E3D.

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 THAT ON (B)(6) 2022, A GASTROSCOPY WAS PERFORMED FOR DYSPHAGIA. THIS EVENT REVEALED A BOLUS OCCLUSION IN THE LOWER ESOPHAGUS WITH NECROSIS OF THE WALL TO INDICATE AN ESOPHAGEAL PERFORATION. THE PATIENT WAS TREATED VIA RE-LAPAROSCOPY, ESOPHAGEAL SUTURE, ESOSPONGE, AND SEVERAL VAC CHANGES. VAC THERAPY WAS COMPLETED ON (B)(6) 2022 ON (B)(6) 2022, AN X-RAY SWALLOW SHOWED TIGHTNESS AND AFTER A SLOW BUILD-UP OF FOOD, THE PATIENT WAS DISCHARGED ON (B)(6) 2022. AT HOME THE PATIENT WAS LISTLESS AND WAS RE-ADMITTED AS INPATIENT FROM (B)(6) 2022 THRU (B)(6) 2022 WHEN SHE WAS DISCHARGED. AFTER THIS PERIOD, PATIENT DID WELL WITH NO WEIGHT LOSS AND NO DYSPHAGIA. IT WAS REPORTED THAT CAUSALITY TO THE SENHANCE SURGICAL SYSTEM WAS CERTAIN. THIS EVENT DID NOT OCCUR WITHIN THE UNITED STATES. THE EVENT OCCURRED IN (B)(6). ADDITIONALLY, THIS EVENT OCCURRED ON (B)(6) 2022, AND ASENSUS SURGICAL WAS INTERNALLY MADE AWARE ON 02-DECEMBER- 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: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY WITH LYMPHADENECTOMY PROCEDURE, THERE WAS AN ORIENTATION ISSUE WITH THE 30-DEGREE ENDOSCOPE 2 HOURS INTO THE PROCEDURE. THE ENDOSCOPE WAS NOT ABLE TO SWITCH BETWEEN UP AND DOWN VIEW AND ONLY ONE ENDOSCOPE WAS AVAILABLE FOR THIS SURGERY. THERE WAS A BEEP EVERY TIME THE SURGEON WANTED TO CHANGE THE SCOPE ORIENTATION. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) DID NOT FIND ANY RELATED ERRORS IN THE LIVE LOGS. PRIOR TO CALLING ISI TECHNICAL SUPPORT, THE CUSTOMER HAD ALREADY DISCONNECTED FROM THE VISION SIDE CART (VSC) AND PATIENT SIDE CART (PSC) AND RESEATED THE ENDOSCOPE. THE TSE ASKED THE CUSTOMER IF THEY HAD ALREADY RESEATED THE STERILE ADAPTER, BUT THE CUSTOMER HAD NOT, AND THEY DID NOT WANT TO DO SO AS THE SURGERY WAS IN PROGRESS. NO MECHANICAL SOUND WAS PRESENT FROM THE ENDOSCOPE WHEN THE 30 DEGREE UP/DOWN BUTTON WAS PRESSED. THE CUSTOMER DECIDED TO CONTINUE THE PROCEDURE AS IS. ISI FOLLOWED UP WITH THE INITIAL REPORTER (SURGEON) AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SURGEON INDICATED THAT THE PROBLEM AROSE AT THE TIME OF PERFORMING A RETRO-BLADDER ANASTOMOSIS ON A PROST

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 MONARCH BRONCHOSCOPY CASE, AT APPROXIMATELY 3:20 PM, THERE WAS A NAVIGATION FUSION ERROR (FAULT 1224) THAT REQUIRED THE USER TO RE-REGISTER. THE NAVIGATION ERROR (FAULT 1224) OCCURRED 58MM AWAY FROM THE ENDOBRONCHIAL TUMOR AND DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT'S PROCEDURE-RELATED INJURY. THE FAULT MESSAGE ON THE CART: FAULT ID 711-50-0-0: SCOPE DISCONNECTED WAS REPORTED DUE TO THE BRONCHOSCOPE BEING REMOVED FROM THE PATIENT. THE USE OF THE MONARCH SYSTEM WAS ENDED TO CONTROL BLEEDING. THE CUSTOMER USED COLD SALINE AND TAMPONADE TO CONTROL THE BLEEDING. THE PHYSICIAN STATED THE BLEEDING WAS NOT CAUSED FROM THE MONARCH DEVICE, IT WAS CAUSED FROM A UNIQUE TYPE OF ENDOBRONCHIAL TUMOR THE PATIENT HAD AND WAS BLEEDING FROM THIS TUMOR. AFTER THE BLEEDING WAS CONTROLLED, THE PHYSICIAN SAMPLED THE LYMPH NODES VIA EBUS (ENDOBRONCHIAL ULTRASOUND BRONCHOSCOPY). IT REQUIRED TWO REBOOTS TO RESOLVE ERROR AND ENABLE USER TO MOVE FORWARD WITH MONARCH PROCEDURE AND COMPLETE CASE SUCCESSFULLY.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: T10 -PELVIS WITH S2AI SCREW CASE. ROBOT WAS FINICKY THROUGHOUT CASE, HAD TROUBLES WHEN DROPPING THE DRIVER ARRAY IN. WHEN PUTTING THE DRIVER DOWN THE END EFFECTOR THE SCREW ALIGNMENT WAS OFF, AND THE OFFSET WAS RED. TRIED FIXING THE BALLS AND SWITCHING DRIVER ARRAY. WHEN WE GOT DOWN TO S2AI SCREWS, THE SCREW WAS NOT ALIGNED WITH THE PLAN AND SURGEON HAD TO ABORT THE S2AI SCREWS. SUBMITTED CASE LOGS TODAY.

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 PARASTOMAL HERNIA REPAIR, THE SURGEON WAS USING A MONOPOLAR CURVED SCISSOR (MCS) INSTRUMENT AND POTENTIAL ARCING OCCURRED AGAINST A PROGRASP FORCEPS INSTRUMENT. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE SURGEON STATED HE WAS TAKING DOWN ADHESIONS WITH THE MCS AND THE PROGRASP FORCEPS INSTRUMENTS. THE SURGEON INDICATED THAT HE DID NOT WITNESS ARCING FROM THE MCS INSTRUMENT; HOWEVER, HE SAW SMOKE. THERE WAS CHARRED TISSUE ON THE BASE OF THE ABDOMEN ON VISCERAL TISSUE NEAR THE PROGRASP FORCEPS INSTRUMENT. UPON EXAMINATION, HE DID NOT NOTICE ANY HOLES IN THE TISSUE AND HENCE DID NOT WARRANT ANY REPAIR. THE SURGEON ASKED FOR THE PROGRASP FORCEPS INSTRUMENT TO BE SWAPPED, AND NO ISSUE WAS REPORTED AFTERWARDS. THE SURGEON CONFIRMED NO FRAGMENTS FELL INSIDE THE PATIENT FROM THE PROGRASP FORCEPS INSTRUMENT. ON POST-OPERATIVE DAY (POD) #6, THE PATIENT UNDERWENT A SECOND OPEN PROCEDURE FOR UNSPECIFIED SYMPTOMS. THE PATIENT WAS IDENTIFIED WITH A BOWEL INJURY ON THE LARGE INTESTINE, RIGHT BELOW THE CANNULA INSTALLATION (INFERIOR LEFT) WHERE THE PROGRASP FORCEPS INSTRU

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 PROCEDURE THE PATIENT EXPERIENCED A PNEUMOTHORAX. THE TARGET WAS A LOWER LOBE. PATIENT HAD SEVERE EMPHYSEMA, WHICH THE DOCTOR STATED AT THE BEGINNING OF THE CASE CAN LEAD TO AN INCREASED RISK FOR A PNEUMOTHORAX. THE PNEUMOTHORAX WAS DISCOVERED POST OP AND DID NOT REQUIRE A CHEST TUBE. NO MALFUNCTION, FAULT OR ERRORS WERE REPORTED. A MEDTRONIC ARCPOINT NEEDLE WAS ALSO USED DURING THE PROCEDURE. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY.

CyberKnife — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: PATIENT EXPERIENCED URINARY AND FECAL RETENTION AND INCONTINENCE AFTER CYBERKNIFE TREATMENTS.

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 PULMONARY LOBECTOMY THE USER EXPERIENCED AN INCOMPLETE SEAL USING THE SYNCHROSEAL INSTRUMENT (LOT #L10220711-0413) AND ENCOUNTERED AN ¿INSPECT JAWS FOR DAMAGE¿ ERROR MESSAGE. A SECOND SYNCHROSEAL INSTRUMENT (LOT #L10220711-0396) WAS INSTALLED BUT ALSO DISPLAYED THE SAME ERROR MESSAGE. ACCORDING TO THE INITIAL REPORTER, AT THE TIME THE EVENT OCCURRED, THE SURGEON WAS ATTEMPTING TO DISSECT TISSUE WHICH HAD EXCESS MOISTURE AND BLEEDING OCCURRED. AS A RESULT, THE PROCEDURE WAS CONVERTED TO OPEN SURGERY IN ORDER TO CONTROL THE BLEEDING. THE BLEEDING WAS DESCRIBED AS BEING MILD TO MODERATE AND THE ESTIMATED BLOOD LOSS WAS 50 CC. ACCORDING TO THE SURGEON, THE INSTRUMENT FUNCTIONED PROPERLY FOR ONE HOUR AT WHICH POINT THE CUSTOMER EXPERIENCED IMPROPER/INCOMPLETE SEALING AND TISSUE STICKING TO THE INSTRUMENT JAWS. THERE WAS MINIMAL TO NO TENSION ON THE LUNG VESSEL BEING SEALED. NO EVIDENCE OF VESSEL CALCIFICATION WAS NOTED. THE VESSEL WAS NOT GREATER THAN 5MM IN DIAMETER. TISSUE EFFECT WAS OBSERVED DURING THE SEALING CYCLE(S). THE INSTRUMENT JAWS DID NOT COME INTO CONTACT WITH A CLIP, SUTURE, STAPLE, OR OTHER METAL OBJECTS WHEN THE REPORTED IS

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 PATIENT EXPERIENCED BLEEDING IN THE LEFT LOWER LOBE DURING THE MONARCH BRONCHOSCOPY PROCEDURE. THE BLEEDING WAS CONTROLLED BY EXOCRINE PANCREATIC INSUFFICIENCY (EPI) ADMINISTRATION. THE PATIENT WAS HOSPITALIZED FOR HYPOXIA AND PLACED ON OXYGEN. PRIOR TO THE PROCEDURE THE PATIENT WAS ON OXYGEN AND CURRENTLY ON OXYGEN AT HOME. THE PATIENT WAS RELEASED THE FOLLOWING DAY.

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 PRIOR TO A MONARCH BRONCHOSCOPY PROCEDURE, THE ANESTHESIOLOGIST NOTED THAT THE PATIENT¿S BLOOD PRESSURE WAS ELEVATED. ONCE THE PATIENT¿S BLOOD PRESSURE WAS UNDER CONTROL, THE PHYSICIAN BEGAN THE BIOPSY. DURING THE PROCEDURE THE ANESTHESIOLOGIST NOTED THE PATIENT WAS NOT DOING WELL AND THE PATIENT WENT INTO CARDIAC ARREST. THE PHYSICIAN PERFORMED AN EMERGENT CONVERSION AND ABORTED THE CASE. THE PATIENT WAS INTUBATED. ON (B)(6) 2022 THE PHYSICIAN REPORTED 3 X-RAYS WERE TAKEN AND THERE WAS NO SIGN OF A PNEUMOTHORAX. THE PATIENT HAS RECOVERED. THERE WERE NO ISSUES OR FAULTS WERE REPORTED FROM THE 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 PULMONARY LOBECTOMY THE USER EXPERIENCED AN INCOMPLETE SEAL USING THE SYNCHROSEAL INSTRUMENT (LOT #L10220711-0413) AND ENCOUNTERED AN ¿INSPECT JAWS FOR DAMAGE¿ ERROR MESSAGE. A SECOND SYNCHROSEAL INSTRUMENT (LOT #L10220711-0396) WAS INSTALLED BUT ALSO DISPLAYED THE SAME ERROR MESSAGE. AS A RESULT, THE PROCEDURE WAS CONVERTED TO OPEN SURGERY IN ORDER TO CONTROL BLEEDING. THERE WAS NO PATIENT HARM REPORTED. 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 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.

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: 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: 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