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 LOW ANTERIOR RESECTION SURGICAL PROCEDURE, THE WHEEL HOLDING THE SHEATH OF THE SYNCHROSEAL INSTRUMENT CAME OFF AND FELL INTO THE PATIENT WHEN THE INSTRUMENT TOUCHED THE ENDOSCOPE. THE FRAGMENT WAS REMOVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION ON 19-MAY-2022: THE BROKEN WHEEL FELL ON THE DIGESTIVE TRACT AND WAS RETRIEVED WITH A LAPAROSCOPIC SURGICAL FORCEPS. IT WAS CONFIRMED THAT THE ENTIRE WHEEL WAS RETRIEVED AND NO ADDITIONAL POSTOPERATIVE TESTS WERE PERFORMED TO REMOVE IT. THE SURGEON BELIEVED THAT HE MIGHT HAVE HIT THE ENDOSCOPE WITH THE SYNCHROSEAL INSTRUMENT JUST BEFORE THE WHEEL WAS SEEN ON THE DIGESTIVE TRACT. THE SYNCHROSEAL INSTRUMENT WAS IN USE FOR APPROXIMATELY 3 HOURS PRIOR TO ISSUE OCCURRED AND THE SURGEON WAS PERFORMING A HEPATECTOMY: SECTION OF THE LIVER. THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND NO ISSUES WERE NOTED. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE SURGICAL PROCEDURE. THERE WAS NO PATIENT INJURY AND

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-MAR-2022, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF A "GASTROENTEROLOGY REPORT" JOURNAL ARTICLE TITLED, ¿ROBOTIC TOTAL GASTRECTOMY FOR CARCINOMA IN THE REMNANT STOMACH: A COMPARISON WITH LAPAROSCOPIC TOTAL GASTRECTOMY¿ (LI, Z., LIU, J., ET AL., 2021). THE PURPOSE OF THE ARTICLE WAS TO COMPARE THE EFFICACY AND SAFETY OF ROBOTIC TOTAL GASTRECTOMY (RTG) AND LAPAROSCOPIC TOTAL GASTRECTOMY (LTG) FOR THE TREATMENT OF CARCINOMA IN THE REMNANT STOMACH (CRS). A RETROSPECTIVE ANALYSIS OF DATA FROM PATIENTS WHO UNDERWENT RTG OR LTG FOR CRS AT A SPECIFIED HOSPITAL BETWEEN MAY 2006 AND OCTOBER 2019 WAS CONDUCTED. ALL SURGERIES WERE PERFORMED BY ONE SURGEON. THE SURGEON PERFORMED A TOTAL OF 27 ROBOTIC GASTRECTOMIES (RG). THE SURGICAL METHOD OF ROBOTIC VERSUS LAPAROSCOPIC WAS SELECTED BY EACH PATIENT. THE DA VINCI SURGICAL SYSTEM WAS USED FOR 29 PATIENTS. FIVE CASES IN THE RTG GROUP UNDERWENT CONVERSION TO OPEN SURGERY. THE REASONS FOR CONVERSION TO OPEN SURGERY IN THE ROBOTIC GROUP INCLUDED 3 CASES OF EXTENSIVE ADHESIONS, 1 CASE OF TUMOR INVASION TO THE TRANSVERSE COLON, AND 1 CASE OF TUMOR INVASION TO THE DIAPHRAGM. POST-OPERATIVELY, 1 PATIENT EXPERIENCED PNEUMONIA, 1 HAD AN INTRA-AB

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, THE METAL PIECE OF THE SYNCHROSEAL INSTRUMENT FELL INTO THE PATIENT AND IT WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORT OF PATIENT INJURY. SYNCHROSEAL IS A BIPOLAR ELECTROSURGICAL INSTRUMENT FOR USE WITH A COMPATIBLE DA VINCI SURGICAL SYSTEM AND A COMPATIBLE ELECTRO SURGICAL GENERATOR. IT IS INTENDED FOR GRASPING, DISSECTION, SEALING AND TRANSECTION OF TISSUE. SYNCHROSEAL CAN BE USED TO SEAL VESSELS UP TO AND INCLUDING 5 MM IN DIAMETER AND TISSUE BUNDLES THAT FIT IN THE JAWS OF THE INSTRUMENT. SYNCHROSEAL, WHEN USED WITH A COMPATIBLE ELECTROSURGICAL GENERATOR, CREATES A SEAL AND TRANSECTS TISSUE BY APPLICATION OF RADIOFREQUENCY (RF) ENERGY TO VESSELS AND TISSUE BUNDLES THAT FIT IN THE JAWS OF THE INSTRUMENT. ELECTRODE SEALING SURFACES AND A CUT ELECTRODE WITHIN THE JAWS ENABLE SEALING AND CUTTING. 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.

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 A TKA ROBOTIC ASSISTED SURGERY THE POSTERIOR RESECTION WAS 4.5MM MORE THAN PLANNED ON BOTH SIDES, RESULTING IN AN UNEQUAL BALANCE BETWEEN EXTENSION AND FLEXION AND THE USE OF A THICKER POLY. NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT AT THIS TIME. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

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 RETROPERITONEAL PARTIAL NEPHRECTOMY, THE RENAL ARTERY WAS IDENTIFIED AND SKELETONIZED. THE SURGEON PLACED TWO SCANLAN BULLDOG CLAMPS (A 3RD-PARTY MANUFACTURER PRODUCT) ON THE RENAL ARTERY. FIREFLY WAS USED TO CONFIRM OCCLUSION OF THE ARTERY. HOWEVER, FIREFLY SHOWED THAT THE ARTERY WAS NOT PROPERLY OCCLUDED AND THE KIDNEY WAS STILL PERFUSED. AS A RESULT, THE SURGEON REMOVED THE SCANLAN BULLDOG CLAMPS AND PLACED UNSPECIFIED LAPAROSCOPIC CLAMP(S). ON 25-APR-2022, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON AND OBTAINED ADDITIONAL INFORMATION: DURING THE SURGICAL PROCEDURE, THE SURGEON CONFIRMED THAT THERE WAS NO MALFUNCTION OF THE SP FENESTRATED BIPOLAR INSTRUMENT THAT WAS USED IN CONJUNCTION WITH THE SCANLAN BULLDOG CLAMPS. THE SURGEON EXPLAINED THAT AFTER PROPER SKELETONIZATION, THE SP BULLDOG CLAMPS WERE APPLIED AND THEN FIREFLY WAS TURNED ON. THE FIELD APPEARED GREEN. THE SURGEON STATED THAT HE FELT THE CLAMPING FORCE WAS INADEQUATE. THE SURGEON SWITCHED TO UNSPECIFIED LAPAROSCOPIC BULLDOG CLAMP(S) TO CONTINUE THE PROCEDURE WITH NO FURTHER ISSUES. THE SURGEON CONFIRMED THERE WAS NO ISSUE WITH ANY OF THE DA VINCI SP INSTRUMEN

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 11-MAR-2022, INTUITIVE BECAME AWARE OF A "TRANSLATIONAL LUNG CANCER RESEARCH" JOURNAL ARTICLE TITLED, ¿ROBOTIC-ASSISTED THORACIC SURGERY REDUCES PERIOPERATIVE COMPLICATIONS AND ACHIEVES A SIMILAR LONG-TERM SURVIVAL PROFILE AS POSTEROLATERAL THORACOTOMY IN CLINICAL N2 STAGE NON-SMALL CELL LUNG CANCER PATIENTS: A MULTICENTER, RANDOMIZED, CONTROLLED TRIAL¿ (HUANG, J., TIAN, Y., ET AL., 2021). THIS STUDY WAS DONE TO EXPLORE THE LONG-TERM EFFICACY AND POTENTIAL BENEFIT IN SURVIVAL OF ROBOTIC-ASSISTED THORACIC SURGERY (RATS) COMPARED WITH LOBECTOMY IN CLINICAL N2 (C-N2) STAGE NON-SMALL CELL LUNG CANCER (NSCLC) PATIENTS. WITHIN THE JOURNAL ARTICLE, POST-OPERATIVE COMPLICATIONS INVOLVING DA VINCI SURGICAL PROCEDURES WERE NOTED: POSTOPERATIVE COMPLICATIONS THAT OCCURRED IN THE RATS GROUP WERE PROLONGED AIR LEAK (7.9%) AND BRONCHOPLEURAL FISTULA. ADDITIONALLY, THE FOLLOWING COMPLICATIONS WERE OBSERVED AMONG THE PATIENTS IN THE RATS GROUP: 3 PATIENTS EXPERIENCED PNEUMONIA, 3 PATIENTS HAD ATRIAL FIBRILLATION, 3 PATIENTS HAD ATRIAL ARRHYTHMIA, 3 PATIENTS UNDERWENT CHEST TUBE INSERTION, 3 PATIENTS EXPERIENCED SUBCUTANEOUS EMPHYSEMA, 3 PATIENTS HAD CHYLOTHORAX, 2 PATIENTS EXPERIENCED HYPERPYRE

VELYS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: SURGEON STARTED VELYS RAS ATTUNE PS PRIMARY KNEE AFTER COMPLETION OF ALL INITIALIZATION, CALIBRATION AND DRAPING AS PER THE IFU. NATURAL JOINT ASSESSMENT AND PLANNING WAS THEN COMPLETED AND THE SURGEON CHOSE TO PERFORM A 2 DEGREE VARUS CUT ON THE TIBIA. THE KNEE WAS POSITIONED WITH 'Z' RETRACTORS PLACED MEDIAL AND LATERAL TO PROTECT THE COLLATERAL LIGAMENTS. AFTER FINISHING THE CUT WITH AN OSTEOTOME THE SENSOR TENSOR WAS THEN USED TO CHECK BALANCE WITH THE ACCUBALANCE GRAPH. IT WAS THEN NOTED AN UNEXPECTED INCREASE IN MEDIAL LAXITY RELATIVE TO THE LATERAL COMPARTMENT. AFTER FURTHER ASSESSMENT IT WAS IDENTIFIED THAT THE MCL WAS DAMAGED AND NEED REPAIR WITH FIBREWIRE. THIS WAS COMPLETED AND THE FEMORAL CUTS WERE COMPLETED WITH NAVIGATION. THE REST OF THE CASE PROCEEDED WITHOUT FURTHER DELAY OR INCIDENT. DOE: (B)(6) 2022.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT WHILE USING THE EXCELSIUS GPS SYSTEM, THE CASE WAS ABORTED DUE TO 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: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED TOTAL BENIGN HYSTERECTOMY THE CUSTOMER OBSERVED A SMALL METAL RING ON TOP OF THE PATIENT'S UTERUS. THE RING WAS THOUGHT TO BE FROM THE SYNCHROSEAL INSTRUMENT THAT WAS IN USE AT THE TIME. THE RING WAS RETRIEVED, THE INSTRUMENT WAS REMOVED, AND A NEW SYNCHROSEAL INSTRUMENT WAS OPENED TO COMPLETE THE PROCEDURE. INTUITIVE SURGICAL INC. (ISI) FOLLOWED UP WITH THE CUSTOMER. IT WAS CONFIRMED THAT THE METAL RING WAS RETRIEVED FROM THE PATIENT DURING THE SAME CASE. THE SURGEON VISUALLY CONFIRMED THAT THE METAL RING FROM THE INSTRUMENT WAS RETRIEVED. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS ISSUE. NO OTHER INFORMATION WAS 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: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PARTIAL NEPHRECTOMY PROCEDURE, THE SCANLAN BULLDOG CLAMPS DID NOT SUFFICIENTLY OCCLUDE THE RENAL ARTERY. ON (B)(6) 2022, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON AND OBTAINED ADDITIONAL INFORMATION: THE SURGEON CLAIMED THAT THE SCANLAN BULLDOG CLAMPS DID NOT SUFFICIENTLY OCCLUDE THE RENAL ARTERY WHILE EXCISING TWO TUMORS ON THE INFERIOR AND SUPERIOR POLE OF THE KIDNEY. HE INITIALLY WORKED ON THE TUMOR ON THE INFERIOR POLE OF THE KIDNEY. THE SURGEON STATED THAT HE HAD SKELETONIZED THE RENAL ARTERY AND CLAMPED IT DOWN WITH THE SCANLAN BULLDOG CLAMP. HE MADE SURE HE CLAMPED IT WELL, AND THE TIP OF THE CLAMP WAS PAST THE ARTERY. HOWEVER, THE KIDNEY STILL WAS PERFUSED. AS A RESULT, THERE WAS AN ADDITIONAL 300CC OF BLOOD LOSS AND A POTENTIALLY HAZARDOUS DELAY IN THE PROCEDURE DURING WARM ISCHEMIA. THE TOTAL ISCHEMIA TIME AND THE ACTUAL EXTRA DELAY IN TIME WERE NOT PROVIDED. THE SURGEON THEN EXCISED THE TUMOR AND ADDRESSED THE BLEEDING WITH A FEW ADDITIONAL SUTURES. FOR THE SECOND TUMOR ON THE SUPERIOR POLE OF THE KIDNEY, THE SURGEON RECLAMPED THE RENAL ARTERY AGAIN WITH THE SCALAN BULLDOG CLAMP. HE CLAMPED APPROXIMATELY 4-5MM AW

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: NO ADDITIONAL INFORMATION ON THE REPORTED EVENT.

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.

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 AFTER A COMPLETED SLEEP ENDOSCOPY + MODIFIED UVULOPHARYNGOPALATOPLASTY (UPPP) + TONSILLECTOMY, BILATERAL + (SINGLE PORT, SP) ROBOT ASSISTED EXCISION OF LESION OF TONGUE (GRADE 1) IN A PARTICIPANT OF THE SP-TRANSORAL ROBOTIC SURGERY (TORS) OBSTRUCTIVE SLEEP APNEA (OSA) STUDY, THE PATIENT DEVELOPED ORAL BLEEDING ON THE 9TH POST-OPERATIVE DAY (POD). THE BLEEDING WAS INITIALLY TREATED WITH ICE WATER GARGLING AND FASTING, BUT THE ORAL BLEEDING PERSISTED. A TONGUE BASE HEMATOMA WAS FOUND ON PHYSICAL EXAMINATION AND THE PATIENT UNDERWENT A SECOND PROCEDURE UNDER GENERAL ANESTHESIA TO LIGATE THE BLEEDING VESSEL. THE BLEEDING WAS FOUND TO BE OOZING. DUE TO THIS ADVERSE EVENT, THE HOSPITALIZATION OF THE PATIENT WAS PROLONGED. IT WAS NOTED BY THE SURGEON THAT BLEEDING AFTER PROCEDURES IS EXPECTED AND NORMAL FOR PATIENTS WITH OSA SURGERY, AND THIS EVENT WAS NOT CAUSED OR INDUCED BY A MEDICAL DEVICE MALFUNCTION OR USE. THE PATIENT RECOVERED AFTER THE SECOND PROCEDURE. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SURGEON AND OBTAINED THE FOLLOWING INFORMATION: THE UPPP AND BILATERAL TONSILLECTOMY WAS CARRIED OUT VIA TRADITIONAL METHOD BY HAND. THE TONGUE WAS RESECTED

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THIS EVENT OCCURRED WITH THE RIGHT STN LEAD BEING OFF BY MORE THAN 3 MM ON THE FIRST PASS, ESSENTIALLY FALLING INTO THE SAME TRAJECTORY ON THE SECOND PASS, NOT SHIFTING ENOUGH ON THE THIRD PASS, AND FINALLY BEING PLACED IN AN ACCEPTABLE AREA ON THE FOURTH PASS. THE SECOND PASS ONLY THE TARGET WAS ADJUSTED, THE THIRD THE ENTRY WAS ADJUSTED WITH A SLIGHT ADJUSTMENT TO THE TARGET, AND THE FINAL PASS BOTH THE ENTRY AND TARGETS WERE ADJUSTED AGAIN. THERE WAS A LOT OF SPECULATION AS TO WHY THE TRAJECTORY WAS DEVIATING TO SUCH A HIGH DEGREE, THE INITIAL SUSPECT WAS THE MERGE ACCURACY, BUT UPON THE PLACEMENT OF THE LEFT LEAD IT WAS FOUND TO BE LESS THAN 0.9MM OFF AXIS AND VERY CLOSE TO THE PLAN. DR. VARDIMAN'S HYPOTHESIS WAS SOMETHING ANATOMICAL CAUSING THE DEVIATION OR SOMETHING MECHANICAL WITH THE ROBOT. REGARDLESS I BELIEVE THAT IT WARRANTS FURTHER INVESTIGATION I HAVE ALREADY UPLOADED THE CASE.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: WHEN GOING TO VERIFY THE DILATOR (THE ONLY INTERBODY INSTRUMENT THAT THE SURGEON USES FOR TLIFS) WE VERIFIED OFF THE PURPLE T HANDLE ARRAY. THIS DID NOT WORK; IT SHOWED 2 SOLID DOTS AS IT WAS SEEING THE INSTRUMENTS AND VERIFICATION WOULD NOT FAIL OR BE SUCCESSFUL IT DID NOT POPULATE A RED FAILURE OR A GREEN CHECK. I THEN PROCEEDED TO ASK THE TECH TO CHANGE THE SPHERES TO THE BLUE STRAIGHT HANDLE ARRAY TO TRY AND VERIFY DILATOR OFF THAT, THAT FAILED AS WELL. WE THEN TRIED CHANGING ASSIGNED INSTRUMENTS, THIS FAILED TOO. WE THEN WENT BACK TO SCREW INSTRUMENTS AND VERIFIED HIGH SPEED DRILL, THEN WENT BACK TO INTERBODY AND TRIED TO VERIFY DILATOR AGAIN STILL FAILED. AFTER THIS I SUGGESTED WE TRY VERIFYING DILATOR OFF END EFFECTOR. WHEN TRYING TO VERIFY OFF END EFFECTOR SAME THING, IT FAILED. WE THEN RESORTED TO A HARD SHUT DOWN, WHICH IN TURN RESULTED IN US GETTING A RED REHOMING ERROR AND MOTION SELF-CHECK INCOMPLETE. TO POTENTIALLY AVOID HAVING TO REHOME THE ARM, I DID ANOTHER HARD SHUT DOWN, BUT WE STILL GOT THOSE SAME ERROR MESSAGES UPON BOOTING BACK UP. WHEN ATTEMPTING TO REHOME, IT FAILED 4 TIMES AT THIS POINT THE PATIENT WAS IN THE ROOM, AND THEY WERE READY TO POSITION. WE HAD TO

Senhance — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE EVENT OCCURED IN (B)(6) HOSPITAL IN AUSTRIA. THE EVENT OCCURED ON 2/24/2022, AND INTERNALLY MADE AWARE ON 9/6/2022. THE PATIENT EXPERIENCED RECTAL PERFORATION WHICH WAS TREATED (RESOLVED ON (B)(6) 2022). IT WAS REPORTED THAT THE CAUSALITY TO THE SENHANCE SURGICAL SYSTEM WAS PROBABLE.

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 A ROBOTIC ASSISTED TKA THE TIBIA WAS OVER RESECTED BY 3 MM. DUE TO THIS DISCREPANCY, A 16MM POLY INSERT WAS USED INSTEAD OF THE PLANNED 13MM INSERT. NO ADDITIONAL PATIENT IMPACT HAS BEEN REPORTED OTHER THAN THE DEVIATION FROM PLANNED IMPLANT SIZE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

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 SLEEVE GASTRECTOMY THE CUSTOMER HAD ISSUES WITH THE FRAGMENT COMING OFF THE SYNCHROSEAL INSTRUMENT. CUSTOMER RETRIEVED FRAGMENT. INTUITIVE SURGICAL INC. (ISI) CONFIRMED THAT THE FRAGMENT CAME OFF THE DEVICE INTO THE PATIENT DURING PROCEDURE. THERE WERE NO POST-OPERATIVE COMPLICATIONS. THE SURGEON USED ANOTHER INSTRUMENT TO MANUALLY RETRIEVE THE FRAGMENT AND INSPECTED VISUALLY TO ENSURE FOREIGN MATERIAL WAS REMOVED. NO PATIENT HARM WAS NOTED. THERE WAS NO ALLEGATION OF AN ENERGY ISSUE.

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 MISPLACED SCREWS.

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-ASSISTED BRONCHOSCOPY PROCEDURE THE PATIENT EXPERIENCED A PULMONARY HEMORRHAGE. WHEN THE RADIAL WAS REMOVED AND NEXT FLUORO SHOT MADE A HEMORRHAGE WAS SEEN BEFORE THE BIOPSY AND SCOPE FLOAT WAS NOTED. A CHEST TUBE WAS PLACED AT AND REMOVED THE SAME DAY. THE PATIENT WAS ADMITTED AND PLACED ON A BIPAP.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AFTER BOOTING UP THE ROBOT AND LOGGING IN, THE ERROR POPPED UP "MOTION CONTROL SELF-TEST INCOMPLETE". WE DID A HARD SHUT DOWN 8 TIMES ALLOWING AMPLE AMOUNT OF TIME TO SHUT OFF AND LOGGING IN AS WELL. UPON CONTACTING BRITTANY, WE WERE ABLE TO GET ON FACETIME WITH SHANE AND MIKE GILORMA TO GO THROUGH TROUBLESHOOTING STEPS. IT WAS FIXED AFTER GOING THROUGH PROPER STEPS WITH THEM.

CyberKnife — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A FEMALE PATIENT (CURRENTLY (B)(6)) RECEIVED CYBERKNIFE STEREOTACTIC RADIOSURGERY (SRS) IN 2018. ON (B)(6) 2022 DURING BRAIN SURGERY THE PATIENT WAS FOUND TO HAVE "RADIATION-RELATED NECROSIS WITH CAVERNOMA-LIKE VASCULAR PROLIFERATION AND VASCULAR INFLAMMATION".

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 GASTRIC BYPASS (ROUX-EN-Y) SURGICAL PROCEDURE, A WASHER FROM THE SYNCHROSEAL INSTRUMENT FELL INSIDE THE PATIENT. THE CUSTOMER WAS ABLE TO RETRIEVE THE WASHER, BUT WAS NOT SURE IF A SCREW WAS ATTACHED TO THE WASHER. THE PROCEDURE WAS COMPLETED AND THERE WAS NO REPORTED INJURY TO THE PATIENT. ON 16-FEB-2022, THE ROBOTICS COORDINATOR SENT INTUITIVE SURGICAL, INC. (ISI) PHOTOS OF THE INSTRUMENT AND THE WASHER. THE PHOTOS WERE FORWARDED TO FAILURE ANALYSIS ENGINEER (FAE) FOR REVIEW. FROM THE PHOTOS, FAE STATED IT LOOKED LIKE ALL COMPONENTS WERE RETRIEVED. THE PIVOT PIN WAS STILL WITHIN THE JAWS, AND THE WASHER DISLODGED AND WAS RETRIEVED IN ONE PIECE. ISI PASSED THE FAE'S INFORMATION TO THE CUSTOMER. ON 22-FEB-2022, ISI OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE ITEM (WASHER) WAS RETRIEVED IN THE SAME PROCEDURE. THEY USED A LAPAROSCOPIC GRASPER TO RETRIEVE THE WASHER. NO ADDITIONAL PROCEDURE WAS REQUIRED TO REMOVE THE ITEM. AN X-RAY WAS PERFORMED TO VERIFY THAT EVERYTHING WERE RETRIEVED. THE SURGEON BELIEVES THE INSTRUMENT BROKE DUE TO A PRODUCT MALFUNCTION. THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND NOTHING WAS O

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED. THIS WAS A UNILATERAL LEFT SIDED STN INTRAOP CASE THAT RESULTED IN SUB-OPTIMAL ACCURACY FOR THE FIRST LEAD PLACEMENT WITH 2+MM OFF AXIS. WE REPLANNED THE TRAJECTORY AND PLACED A SECOND LEAD WITHOUT REMOVING THE FIRST LEAD AND THEN SCANNED AGAIN WITH THE O ARM. ONCE IT WAS DETERMINED THAT THE SECOND LEAD WAS IN A MORE FAVORABLE LOCATION THE SURGEON OPTED TO REMOVE THE FIRST LEAD AND KEEP THE SECOND LEAD. THE LOCAL IMPLANT TEAM HAS THE CASE LOGS FOR THIS CASE.

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 A TKA PROCEDURE USING ROSA KNEE INSTRUMENTATION, THE PATIENT'S PROXIMAL TIBIA WAS OVER-RESECTED AND THE 4-IN-1 POSTERIOR FEMUR WAS UNDER RESECTED. THIS LEAD TO AN ANTERIOR FEMUR NOTCH, ALTHOUGH IT WAS WARNED AS POTENTIALLY AN ISSUE. SURGEON DECIDED TO PROCEED. ALL BONE CHIPS WERE CALIPERED. THERE WAS NO ADDITIONAL PATIENT IMPACT REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

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 PATIENT HAD HYPOTENSIVE ESOPHAGEAL MOTILITY WITH RESIDUAL PRESSURE AT 37MMHG AND NICOTINE ABUSE, AND PATIENT COMPLAINS OF DYSPHAGIA POST-OP. STANDARD TREATMENT WITH PREDNISOLONE 100MG FOR 3 DAYS WAS GIVEN, AFTER WHICH THE PATIENT WAS SYMPTOM-FREE. IT WAS REPORTED THAT CAUSALITY TO THE SENHANCE SURGICAL SYSTEM WAS PROBABLE. ON (B)(6) 2022, PATIENT AGAIN COMPLAINS OF DYSPHAGIA, NICOTINE ABSTINENCE WAS RECOMMENDED. IN (B)(6) 2022, GASTROSCOPY WAS PERFORMED WITH FUNCTIONAL SPASM, ACHALASIA AND EXCLUSION OF RECURRENT HERNIA WITH BALLOON DILATATION. ON (B)(6) 2022, PATIENT WAS RE-OPERATED VIA LAPAROSCOPY WITH ADHESIOLYSIS AND REPOSITIONING OF THE STOMACH IN THE ABDOMEN FOR RESOLUTION. THIS EVENT DID NOT OCCUR WITHIN THE UNITED STATES. THE EVENT OCCURRED AT (B)(6) IN GERMANY. ADDITIONALLY, THIS EVENT OCCURRED ON (B)(6) 2022, AND ASENSUS SURGICAL WAS INTERNALLY MADE AWARE ON (B)(6) 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 AFTER A DA VINCI-ASSISTED SLEEVE GASTRECTOMY SURGICAL PROCEDURE, THE PATIENT EXPERIENCED POST-OPERATIVE BLEEDING AND RETURNED TO THE FACILITY FOR TREATMENT. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON AND OBTAINED THE FOLLOWING INFORMATION. ON AN UNSPECIFIED POSTOPERATIVE DAY, THE PATIENT PRESENTED WITH HYPOTENSIVE SYMPTOMS. A CT SCAN REVEALED A HEMATOMA ON THE GREATER CURVE AREA. THE PATIENT HAD DEEP VEIN THROMBOSIS (DVT) AND A PULMONARY EMBOLISM. THE SURGEON STATED HE BELIEVES THE POST-OPERATIVE BLEEDING WAS FROM THE RIGHT GASTROEPIPLOIC OR THE SHORT GASTRIC VESSEL, AND WAS RELATED TO THE SYNCHROSEAL INSTRUMENT USED ON THOSE VESSELS. THE SURGEON DOES NOT SKELETONIZE THE VESSELS BEFORE SEALING. HE STATED HE DOES NOT LIKE HOW THE SYNCHROSEAL CUTS, AND HE HAS TO CUT THE VESSEL MORE THAN ONCE. THE SURGEON HAS NEVER HAD POST-OPERATIVE BLEEDING IN THE PAST, AND WILL REVERT TO USING THE VESSEL SEALER EXTEND INSTRUMENT. THE SURGEON CONFIRMED THAT THERE WAS NO SURGICAL INTERVENTION OR BLOOD TRANSFUSIONS RENDERED TO THE PATIENT. HOWEVER, THE PATIENT WAS HOSPITALIZED FOR IV FLUIDS, BLOOD WORK, CT SCAN AND OBSERVATION.

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-ASSISTED BRONCHOSCOPY PROCEDURE THE PATIENT EXPERIENCED A PNEUMOTHORAX ON THE RIGHT SIDE. THE PNEUMOTHORAX WAS DISCOVERED DURING INTRA-OP ON THE FLUORO. A CHEST TUBE WAS PLACED WITH MINIMAL AIR LEAK AND LUNG RE-EXPANSION ON FLUORO TO PREVENT WORSENING OF THE PNEUMOTHORAX. THE PATIENT WAS HOSPITALIZED AND RELEASED THE FOLLOWING DAY.

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, THE SURGICAL STAFF REALIZED THAT A MONOPOLAR CURVED SCISSORS (MCS) TIP COVER WAS MISSING FROM THE MCS INSTRUMENT. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) WAS CONTACTED. THE CUSTOMER WAS REPORTEDLY SEARCHING FOR THE MCS TIP COVER AND THEY WAS QUESTIONING IF THE ITEM WAS RADIOLUCENT. THE CUSTOMER WAS INFORMED THAT THE ITEM WOULD NOT APPEAR IN AN X-RAY. ISI HAS PERFORMED MULTIPLE FOLLOW-UPS TO REQUEST ADDITIONAL INFORMATION RELATED TO THE EVENT. HOWEVER, AS OF THE DATE OF THIS REPORT, NO FURTHER DETAILS HAVE BEEN RECEIVED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE BLADE OF THE HARMONIC ACE CURVED SHEARS FELL OFF. THE FRAGMENT HAS BEEN LOCATED AND RETRIEVED DURING THE SAME PROCEDURE. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. 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 THYROIDECTOMY SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT SUDDENLY HAD WHITE FRAGMENTS SPATTERED AND SMOKE APPEARED WHILE USING THE ENERGY. THE FRAGMENTS WERE RETRIEVED DURING THE SAME PROCEDURE. A BACKUP INSTRUMENT OF THE SAME KIND WAS USED TO CONTINUE THE PROCEDURE. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO DAMAGE OBSERVED. WHEN THE CUSTOMER STARTED TO USE THE INSTRUMENT, IT BROKE, AND SMOKE APPEARED AT THE INSTRUMENT TIP. ALL THE FRAGMENTS WERE RETRIEVED DURING SAME PROCEDURE BY SUCTION AND CONFIRMED WITH VISUAL INSPECTION. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED. IT WAS UNKNOWN WHAT CAUSED THE SMOKING EVENT AND THE BREAKAGE TO OCCUR AS THE INSTRUMENT DID NOT COLLIDE WITH ANY HARD MATERIALS OR OTHER INSTRUMENTS. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT. THE FRAGMENT(S) DID NOT FALL INSIDE THE PATIENT DURING AN INSTRUMENT TIP OR ACCESSORY COLLISION. THE INSTRUMENT WAS NOT REMOVED DURING THE PROCEDURE (PRIOR TO THE BREAKAGE). UPON F

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 OVARIAN CYSTECTOMY SURGICAL PROCEDURE, THE TIP OF THE HARMONIC ACE INSTRUMENT BROKE AFTER A ¿BLADE PRESSURE¿ MESSAGE APPEARED. THE FRAGMENT THAT FELL INSIDE THE PATIENT WAS RETRIEVED DURING THE SAME PROCEDURE. A BACKUP INSTRUMENT OF SAME KIND WAS USED TO CONTINUE THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORT OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO DAMAGE OBSERVED. THE INSTRUMENT WAS BEING USED FOR DISSECTING TISSUE. ALL THE FRAGMENTS WERE RETRIEVED DURING SAME PROCEDURE AND CONFIRMED WITH VISUAL INSPECTION. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED TO REMOVE THE FRAGMENT. IT WAS UNKNOWN WHAT CAUSED THE BREAKAGE TO OCCUR AS THE INSTRUMENT DID NOT COLLIDE WITH ANY HARD MATERIALS OR OTHER INSTRUMENTS. THERE WAS NO PATIENT INJURY. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT. THE FRAGMENT(S) DID NOT FALL INSIDE THE PATIENT DURING AN INSTRUMENT TIP OR ACCESSORY COLLISION. THE INSTRUMENT WAS NOT REMOVED DURING THE PROCEDURE (PRIOR TO THE BREAKAG

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 CYSTECTOMY WITH OTHER URINARY DIVERSION SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER FELL OFF THE INSTRUMENT AND INSIDE THE PATIENT'S BODY. THE MCS TIP COVER WAS RETRIEVED AND REPLACED WITH A NEW ONE; HOWEVER, THE SAME ISSUE OCCURRED AGAIN. THE CUSTOMER REPLACED THE MCS INSTRUMENT WITH A BACKUP AND THE MCS TIP COVER NO LONGER FELL OFF THE INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE OPERATING ROOM NURSE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PROCEDURE WAS A TOTAL CYSTECTOMY PERFORM ON (B)(6) 2022. AFTER THE FIRST MCS TIP COVER FELL INSIDE THE PATIENT'S BODY, THE SURGEON QUICKLY RETRIEVED IT WITH AN ASSISTANT FORCEPS. THEN, THE USER INSTALLED A NEW MCS TIP COVER ON THE MCS INSTRUMENT OUTSIDE OF THE PATIENT'S BODY BUT THE MCS TIP COVER SLIPPED OFF EASILY. THE MCS TIP COVER APPEARED TO BE INSTALLED PROPERLY WITH NO VISIBLE ORANGE SURFACE. THE MCS TIP COVER WAS NOT INSTALLED BEYOND THE ORANGE SURFACE THAT WOULD CAUSE A BULGE OVER THE SHAFT. NO INSTALLATION TOOL WAS USED. THE MCS INSTRUMENT WAS EXCHANGED OUT WITH A BACKUP. T

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED NEPHRECTOMY SURGICAL PROCEDURE, THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) STATED THE CUSTOMER LOST THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY. THE CSR WANTED TO KNOW IF THE MCS TIP COVER ACCESSORY WAS DETECTABLE BY X-RAY. THE ISI TECHNICAL SUPPORT ENGINEER (TSE) INFORMED CALLER THAT THE MCS TIP COVER ACCESSORY WAS RADIOLUCENT AND THUS CANNOT BE DETECTED BY X-RAY. THE CSR STATED THAT NO INJURY WAS REPORTED AND THAT THE SYSTEM WAS FUNCTIONING PROPERLY. THE PROCEDURE WAS COMPLETED AS PLANNED. ON 31-JAN-2022, ISI OBTAINED THE FOLLOWING INFORMATION FROM THE ROBOTICS COORDINATOR. BOTH THE MCS INSTRUMENT AND THE MCS TIP COVER ACCESSORY WERE INSPECTED BEFORE USE AND NOTHING LOOKED OUT OF THE ORDINARY. THERE WAS NO DAMAGE ON EITHER ITEM. THE MCS TIP COVER ACCESSORY WAS RETRIEVED DURING THE SAME PROCEDURE WITH A LAPAROSCOPIC INSTRUMENT. THERE WAS NO ISSUE WITH THE FUNCTIONALITY OF THE MCS INSTRUMENT. A REDUCER WAS NOT USED FOR THIS INSTRUMENT. THE MCS TIP COVER ACCESSORY FELL OFF WHEN THEY WERE REMOVING THE INSTRUMENT, BUT THEY DID NOT FEEL ANY RESISTANCE WHEN IT WAS BEING REMOVED. SHE WAS NOT SURE IF T

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON 25-JAN-2022, INTUITIVE SURGICAL, INC (ISI) RECEIVED USER FACILITY REPORT (B)(4) STATING: "PATIENT WAS UNDERGOING A ROBOTIC ASSISTED LAPAROSCOPIC RIGHT NATIVE NEPHRECTOMY. THE SURGEON USED AN 8 MM SYNCHOSEAL CAUTERY/LIGATION DEVICE. WHEN THE DEVICE WAS REMOVED FROM THE PATIENT, IT WAS NOTED TO BE MISSING A SECTION OF THE GRASPER HOUSING. THE PROVIDER SEARCHED INSIDE THE PATIENT FOR THE FRAGMENT AND AN X-RAY WAS TAKEN. THE X-RAY DID NOT IDENTIFY ANY FOREIGN MATTER, BUT THE RADIOLOGIST NOTED PLASTIC WOULD NOT SHOW UP ON X-RAY." IT WAS ALSO REPORTED BY THE CUSTOMER TO INTUITIVE SURGICAL, INC. (ISI) THAT DURING A DA VINCI-ASSISTED RIGHT NATIVE NEPHRECTOMY SURGICAL PROCEDURE, THE CUSTOMER NOTICED A MISSING SECTION OF THE SYNCRHOSEAL INSTRUMENT WHEN THEY REMOVED IT FROM THE PATIENT. THEY SEARCHED INSIDE THE PATIENT FOR THE FRAGMENT AND AN X-RAY WAS TAKEN. THE X-RAY DID NOT DETECT ANY FOREIGN MATTER, BUT THE RADIOLOGIST NOTED THAT PLASTIC WOULD NOT SHOW UP ON AN X-RAY. ON 04-FEB-2022, ISI CONTACTED ORIGINAL REPORTER FROM THE USER FACILITY REPORT AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION ABOUT THE COMPLAINT. SHE DID NOT KNOW HOW LONG THE INSTRUMENT WAS IN USE WHEN THE ISSUE OCCUR

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 JAW FROM A HARMONIC ACE INSTRUMENT BROKE OFF AND FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED IN THE SAME PROCEDURE. NO OTHER INFORMATION WAS PROVIDED. ON 01-FEB-2022, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING INFORMATION FROM THE ROBOTICS COORDINATOR. THE FRAGMENT WAS RETRIEVED IMMEDIATELY AFTER IT BROKE OFF THE INSTRUMENT USING A LAPAROSCOPIC LOCKING GRASPER. NO POST-OPERATIVE TESTS WERE NEEDED AS THE FRAGMENT WAS LARGE ENOUGH TO SEE. SHE ESTIMATED THAT THE INSTRUMENT WAS IN USE BETWEEN 45 - 60 MINUTES. THE INSTRUMENT WAS INSPECTED BEFORE USE AND NOTHING WAS OUT OF THE ORDINARY. THE INSTRUMENT BROKE WHEN THEY WERE DISSECTING THE LIVER TISSUE. RIGHT BEFORE THE FRAGMENT BROKE, THEY RECEIVED A MESSAGE - RELAX PRESSURE ON JAWS. THERE WAS NO INSTRUMENT COLLISION AND THE INSTRUMENT DID NOT COLLIDE WITH ANY HARD OBJECTS WHILE IN THE PATIENT. THERE WAS NO INJURY TO THE PATIENT AND THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH A NEW HARMONIC INSTRUMENT. THE PATIENT HAS NOT EXPERIENCED ANY ISSUES POST-SURGICAL PROCEDURE. THE INSTRUMENT AND FRAGMENT WAS GIVEN TO THE HOSPITAL RISK MANAGE

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LIVER RESECTION SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT¿S BLADE BROKE OFF WHILE THE SURGEON WAS MARKING LIVER TISSUE WITH OPENED JAWS. THE INSTRUMENT WAS ONLY IN USE FOR FIVE MINUTES. THE FRAGMENT WAS RETRIEVED IN THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER ON 18-JAN-2022 AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE HARMONIC ACE INSTRUMENT WAS INSPECTED BEFORE THE OPERATION. THE HARMONIC ACE INSTRUMENT DID NOT COLLIDE WITH ANOTHER INSTRUMENT DURING THE OPERATION. THE FRAGMENT WAS RETRIEVED WITH A LAPAROSCOPIC GRASPING FORCEPS. A REPLACEMENT INSTRUMENT WAS USED TO COMPLETE THE SURGERY. THE PATIENT DID NOT SUSTAIN ANY INJURIES AND DID NOT EXPERIENCE ANY POST-OPERATIVE COMPLICATIONS. THE PATIENT¿S CURRENT HEALTH STATUS WAS REPORTED TO BE GOOD. NO POST-OPERATIVE EXAMINATIONS WERE PERFORMED TO LOCATE ANY REMAINING FRAGMENTS. NO PHOTO OR VIDEO WAS SENT TO ISI FOR REVIEW. THE PATIENT DEMOGRAPHICS, RELEVANT TESTS, AND RELEVANT HISTORY WERE NOT PROVIDED.

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 SLEEVE GASTRECTOMY SURGICAL PROCEDURE, A PIECE OF THE SYNCHROSEAL INSTRUMENT WAS SPOTTED RESTING ON THE PATIENT'S STOMACH ALONG THE STAPLE LINE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: THE FRAGMENT WAS RETRIEVED IN THE SAME PROCEDURE BY A GRASPER INSTRUMENT. IT IS UNKNOWN WHEN THE INSTRUMENT BROKE. THEY FOUND THE FRAGMENT NEAR THE STAPLE LINE NEAR THE END OF THE PROCEDURE. THE SYNCHROSEAL DID NOT COLLIDE WITH ANOTHER INSTRUMENT OR HARD OBJECT WHILE INSIDE THE PATIENT. NO POST OPERATIVE TESTS WERE PERFORMED. THERE WAS NO REPORTED POST-OPERATIVE COMPLICATIONS. THE SURGEON DOES NOT KNOW WHAT CAUSED THE ISSUE. THE INSTRUMENT AND FRAGMENT WILL BE RETURNED BACK TO ISI FOR EVALUATION.

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 FOLLOWING A TKA DONE BY ROSA KNEE SURGICAL INSTRUMENTATION, FEMORAL NOTCHING WAS NOTICED IN THE POST OPERATIVE X-RAYS. NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT HAS BEEN REPORTED AT THIS TIME. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

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 SIGMOIDECTOMY SURGICAL PROCEDURE, THE SYNCHROSEAL INSTRUMENT WAS BROKEN AND A FRAGMENT FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ON JANUARY 20, 2022 INTUITIVE SURGICAL (IS) CONTACTED THE REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THIS EVENT: THE FIRST ASSISTANT REMOVED THE FRAGMENT WITH A LAPAROSCOPIC INSTRUMENT. THE SURGICAL STAFF DOUBLE CHECKED THE PATIENT'S ANATOMY THEY WERE WORKING ON TO CONFIRM THAT NO FRAGMENT REMAINED. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED. IT WAS NOT NECESSARY TO PERFORM POST-OPERATIVE TESTS LIKE AN X-RAY OR ULTRA SOUND TO CHECK FOR REMAINING FRAGMENTS. AS PER THE SURGEON, THE CAUSE OF THE INSTRUMENT BREAKAGE IS UNKNOWN. THE INSTRUMENT WAS IN USE DURING THE WHOLE THE PROCEDURE. THE INSTRUMENT WAS INSPECTED BY THE NURSE BEFORE THEY HANDED IT TO THE SURGEON. NO DAMAGE WAS NOTICED. NO ISSUE OF THE INSTRUMENT FUNCTIONALITY NOTICED DURING THE SURGICAL PROCEDURE. THE SURGICAL STAFF INDICATED THAT THE INSTRUMENT DID NOT COLLIDE WITH ANOTHER ONE DURING PROCEDURE. THE INSTRUMENT WAS REMOVED WITH N

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 A TKA SURGERY WITH ROSA INSTRUMENTATION, THE DISTAL FEMUR CUT WAS VALIDATED 3MM OVER THE PLANNED RESECTION. THE CUT WAS VALIDATED USING ROSA AND STANDARD CALIPERS. DUE TO THIS OVER-RESECTION OF THE DISTAL FEMUR, THE SURGEON DOWNSIZED BY 2 SIZES TO BALANCE THE SPACE. NO CONSEQUENCES OR IMPACT TO THE PATIENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS 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: IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED SLEEVE GASTRECTOMY SURGICAL PROCEDURE, THE PATIENT EXPERIENCED POSTOPERATIVE BLEEDING. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: ON POST-OPERATIVE DAY #1, THE PATIENT BECAME HYPOTENSIVE AND FELL. AS A RESULT, THE PATIENT ALLEGEDLY BROKE HER VERTEBRAE. THE PATIENT WAS TAKEN BY AMBULANCE TO A NEARBY HOSPITAL (DIFFERENT FROM THE HOSPITAL WHERE THE DA VINCI-ASSISTED SLEEVE GASTRECTOMY WAS PERFORMED). THE PATIENT WAS ADMITTED IN THE ICU. A CT SCAN REVEALED A HEMATOMA. AN ARTERIOGRAM CONFIRMED THERE WAS NO ACTIVE BLEEDING. THE PATIENT UNDERWENT A SECOND PROCEDURE FOR THE BROKEN VERTEBRAE. THE SURGEON REPORTED THAT HE BELIEVES THE POSTOPERATIVE BLEEDING WAS FROM THE RIGHT GASTROEPIPLOIC OR THE SHORT GASTRIC VESSEL AND WAS RELATED TO AN ALLEGED INSUFFICIENT SEAL INVOLVING THE USE OF A SYNCHROSEAL INSTRUMENT. THE SURGEON DOES NOT SKELETONIZE THE VESSELS BEFORE SEALING.

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-ASSISTED BRONCHOSCOPY PROCEDURE, THE PATIENT EXPERIENCED A PNEUMOTHORAX. THE TARGET LOCATION WAS LEFT UPPER LOBE (LUL) (TARGET IN THE LINGULA), AND THE PNEUMOTHORAX WAS DISCOVERED ON THE RIGHT SIDE WHEN THE PHYSICIAN RECEIVED A RADIAL IMAGE AND DIGITAL RADIOGRAPHY (DX). A CHEST TUBE WAS PLACED AND THE PATIENT WAS ADMITTED TO THE HOSPITAL. THE FOLLOWING DAY THE CHEST TUBE WAS REMOVED AND THE PATIENT WAS RELEASED FROM THE HOSPITAL.

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 WHILE USING THE ROSA PLATFORM DURING A TKA SURGERY, THERE WAS AN OVER RESECTION OF TIBIA BY 3MM. A THICKER THAN EXPECTED POLY IMPLANT HAD TO BE USED. NO ADDITIONAL CONSEQUENCES OR IMPACT TO THE PATIENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.