Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THERE WAS AN ALLEGED INACCURACY ON (B)(6). IT WAS REPORTED THAT MULTIPLE SCREWS WERE DETERMINED TO BE MEDIALLY OFF VIA POST-OP SCAN. THE SITE REGISTERED VIA A CT TO FLUORO MERGE WITH A PERCUTANEOUS PIN IN THE PSIS. THE SCREWS WERE PLACED ACCURATELY BILATERALLY AT ALL LEVELS PER THE ROBOTIC PLAN. T8-L1 WERE THEN REGISTERED VIA CT TO FLUORO MERGE WITH THE BONE MOUNT CLAMP AT APPROXIMATELY T10-T11. THE SCREWS WERE PLACED ACCURATELY. THE FINAL THREE LEVELS T5-T7 WERE REGISTERED THE SAME WAY WITH THE BONE MOUNT CLAMP ON T7. WHEN BEGINNING TO PLACE THE FIRST SCREW AT T7, THERE WAS A SHOULDER SHIFT ERROR. THE ROBOT WAS REGISTERED AGAIN WITHOUT MOVING THE CLAMP AND, AGAIN, WHEN THE SITE STARTED PLACING THE T7 SCREW, THEY RECEIVED A SHOULDER SHIFT ERROR. THE CLAMP WAS REMOVED, AND IT WAS NOTICED THAT THE SPINOUS PROCESS HAD CRACKED. THE CLAMP WAS MOVED UP ONE LEVEL TO T6, AND THE ROBOT REGISTERED ONE LAST TIME TO PLACE THE SCREW BILATERALLY UP TO T5. NO INTRA-OPERATIVE IMAGING WAS TAKEN TO CONFIRM THE SCREW PLACEMENT. THE PATIENT WAS IN SOME PAIN POST OPERATIVELY. WHEN IT WA

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

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE DAVINCI 30MM ENDOWRIST STAPLER WAS PLACED ON THE PULMONARY ARTERY AND FIRED. WHEN THE STAPLER WAS PROMPTED TO UNCLAMP, AN ERROR SHOWED THAT THE ACTION THAT UNCLAMPS THE STAPLER WAS UNABLE TO FUNCTION. THE ROBOT WAS MANUALLY PUT INTO FAULT MODE TO ALLOW THE BEDSIDE ASSIST TO USE THE WRENCH, WHICH IS THE FALLBACK/SAFETY MEASURE WHEN THIS HAPPENS. WHEN GOING IN THE PROPER ORDER, THE WRENCH WAS UNABLE TO FULLY SPIN, WHICH PREVENTED THE STAPLER FROM UNCLAMPING THE PA. THE DAVINCI REPS WERE ON THE PHONE WITH THEIR TECHNICAL TEAM WORKING THE PROBLEM, AND COMMUNICATING WITH THE SURGEON AND BEDSIDE ASSIST ON HOW TO GET THE STAPLER TO UNCLAMP. FDA SAFETY REPORT ID# (B)(4).

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

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

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER CALLED AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) AND REPORTED THAT TWO DIFFERENT UNSPECIFIED STAPLER INSTRUMENTS WERE INSTALLED AND FELL APART WHILE INSIDE THE PATIENT. THE TSE REVIEWED LOGS AND NOTED STERILE ADAPTER ENGAGEMENT CODES IN THE LOGS. THE TSE ASKED IF ALL PIECES WERE COLLECTED AND ACCOUNTED FOR AND THE CUSTOMER STATED THAT ACCORDING TO THE OPERATING ROOM NIGHT STAFF THAT THEY WERE. THE TSE THEN ASKED IF THE STAPLERS WERE AVAILABLE TO BE SENT BACK FOR ANALYSIS AND THE CUSTOMER DOES NOT BELIEVE STAPLERS WERE KEPT. THE TSE ALSO ASKED IF THERE WAS ANY PATIENT INJURY AND THE CUSTOMER REPORTED THAT THERE WAS NO PATIENT INJURY. THE SITE WAS REQUESTING FOR ISI FIELD SERVICE ENGINEER (FSE) TO FOLLOW UP AS SITE WAS WARY OF USING SYSTEM AFTER THE ISSUE OCCURRED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY AND WITH A LESS THAN A 15-MINUTE DELAY.

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

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED ESOPHAGECTOMY SURGICAL PROCEDURE, BLEEDING OCCURRED FROM ONE OF THE TWO BRANCHES OF THE AORTIC ARCH LEADING TO THE ESOPHAGUS. THE ISSUE OCCURRED 15 MINUTES AFTER SEALING AND TRANSECTING THE SIDE BRANCH WITH A SYNCHROSEAL INSTRUMENT. THE SIDE BRANCH WAS PROPERLY FREED FORM SURROUNDING TISSUE AND THEN SEALED WHILE DEEP IN THE JAWS OF THE SYNCHROSEAL. THE SURGEON PERFORMED A FULL CYCLE OF SEALING, OBSERVED TISSUE EFFECT DURING THE SEALING PROCESS, AND THEN TRANSECTED. THE SURGEON BELIEVES THE SEAL COULD NOT HANDLE THE PRESSURE FROM THE AORTIC BRANCH AND BEGAN BLEEDING 15 MINUTES LATER. THE SURGEON WAS ABLE TO TAMPONADE THE BLEEDING WITH AN UNSPECIFIED INSTRUMENT INSTALLED ON UNIVERSAL SURGICAL MANIPULATOR 1 (USM1) BY USING COMPRESSION. USM2, 3, AND 4 WERE THEN REMOVED. THE SURGEON MADE THE CLINICAL DECISION TO CONVERT TO A THORACOTOMY TO CONTROL THE HEMORRHAGE. THE SURGEON PERFORMED SUTURE LIGATION OF THE BLEEDING SITE ON THE AORTA AND THE PATIENT WAS TRANSFUSED 2 UNITS OF PACKED CELLS. BLOOD LOSS WAS ESTIMATED TO BE BETWEEN 500 AND 600ML. THE SURGEON INDICATED THAT THE PATIENT WAS DOING FINE AND RECOVERING POST-OPERATIVELY. HOWEVER, THE

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI-ASSISTED LOW ANTERIOR RESECTION (LAR) PROCEDURE, THE PATIENT'S URINE OUTPUT WAS BORDERLINE LOW, SO BASIC LABS WERE ASSESSED. ON POSTOPERATIVE DAY (POD) #1 (B)(6) 2022), THE PATIENT HAD LOW URINE OUTPUT AND WAS ENCOURAGED TO TRY CLEAR FLUIDS. THE PATIENT'S CREATININE LEVELS WERE NOTED TO HAVE RISEN TO 2.32 (FROM 1.02), SODIUM WAS 127 AND THE HEMOGLOBIN WAS NOTED TO BE LOW AT 8.8. THE PATIENT WAS STARTED ON IV FLUIDS AND CANDESARTAN, CHLORTHALIDONE AND SPIRONOLACTONE WERE HELD AT THIS TIME. THE PATIENT WAS DIAGNOSED WITH ACUTE KIDNEY INJURY DUE TO HYPOVOLEMIA, AND HYPONATREMIA. ON POD #2 (B)(6) 2022), SHE WAS AGAIN ENCOURAGED TO INCREASE ORAL INTAKE. THE CREATININE WAS TRENDING DOWNWARD AT 1.81, SODIUM WAS 129 AND HEMOGLOBIN WAS STABLE AT 8.3. DIARRHEA WAS ALSO NOTED (STARTED ON POD #2). ON POD #3 (B)(6) 2022), THE PATIENT'S URINE OUTPUT WAS NOTED TO BE ADEQUATE. THE PATIENT WAS DISCHARGED THAT SAME DAY WITH A RECOMMENDATION TO FOLLOW UP WITH HER PRIMARY CARE PHYSICIAN IN 1-2 WEEKS ON AN OUT-PATIENT BASIS WITH BMP FOLLOW UP. A PATHOLOGY REPORT ON (B)(6) 2022 DEMONSTRATED INVASIVE MODERATELY DIFFERENTIATED ADENOCARCINOMA ARISING IN A

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT A POST-PROCEDURE CXR (CHEST X-RAY) REVEALED A PNEUMOTHORAX, IN THE LEFT UPPER LOBE, IN A PATIENT HAD COME IN FOR A BRONCHOSCOPY PROCEDURE. THE PATIENT WAS HOSPITALIZED, AND A CHEST TUBE WAS PLACED. THE CHEST TUBE WAS REMOVED, AND THE PATIENT WAS DISCHARGED ON (B)(6) 2022. THERE WERE NO FAULTS OR DEVICE MALFUNCTIONS REPORTED DURING THE PROCEDURE.

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

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

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SINGLE PORT (SP) SIMPLE PROSTATECTOMY SURGICAL PROCEDURE, AN ERROR 25741 WAS DISPLAYED WHEN DOCKING. THE SITE TRIED TO RECOVER THE FAULT BY PERFORMING AN EMERGENCY POWER OFF (EPO), AND CYCLING THE CANNULA MOUNT LEVER, HOWEVER, THE ERROR PERSISTED. THE PROCEDURE WAS CONVERTED TO A DA VINCI MULTIPORT SYSTEM. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

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

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT WHILE USING THE EXCELSUS GPS SYSTEM, THE CASE WAS ABORTED DUE TO ROBOTIC ERROR, AND SCREWS WERE THEN PLACED WITHOUT ROBOT.

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

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

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT THE PHYSICIAN NAVIGATED TO THE LESION, AND WHEN THE RADIAL ENDOBRONCHIAL ULTRASOUND (REBUS) PROBE WAS INTRODUCED, IT PUSHED A SMALL WHITE FOREIGN BODY (FB) OUT OF THE MONARCH SCOPE INTO THE PATIENT'S LUNGS. THE PHYSICIAN WAS ABLE TO REMOVE THE FB USING FORCEPS AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT A PATIENT HAD RETURNED TO HAVE A SCREW DEVIATION CORRECTION COMPLETED FOR A SCREW THAT WAS PLACED USING THIS SYSTEM ON (B)(6). THE CASE WAS L4 TO S1 AND THE INACCURACY WAS BELIEVED TO BE CAUSED BY PATIENT SHIFT AND LOCATED ON THE L4 SCREW PLACEMENTS. THE SHIFT WAS BELIEVED TO BE ~4-5MM MEDIAL. THERE WAS NO KNOWN IMPACT TO THE PATIENT OUTCOME. ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT THE PATIENT EXPERIENCED FOOT DROP SYMPTOMS FROM THE MEDIAL PLACED SCREW.

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

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

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LIVER RESECTION SURGICAL PROCEDURE, THE SURGEON HAD TO CONVERT TO OPEN SURGERY. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER REPORTED THAT THE SURGEON DECIDED TO CONVERT TO OPEN SURGERY BASED ON COMFORT LEVEL. THE SURGEON HAD PLANNED TO CONVERT TO OPEN AND THE ROOM WAS ALREADY SETUP. THERE WERE NO DA VINCI CONTRIBUTING FACTORS TO CONVERTING THE PROCEDURE; THIS WAS A DECISION MADE COMPLETELY BY THE SURGEON. THE CUSTOMER FOLLOWED UP WITH THE PATIENT THE NEXT DAY AND THE PATIENT WAS DOING WELL.

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

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

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

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

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 VIA A SOCIAL MEDIA POST THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SURGEON PRESSED THE INCORRECT PEDAL AND BURNED THE COLON. THE SURGEON RECOGNIZED THE ERROR AND WAS ABLE TO STAPLE MORE PROXIMALLY. ON 29-SEP-2020, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: DURING AN UNDISCLOSED DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SURGEON PRESSED THE INCORRECT ENERGY PEDAL ON THE SURGEON SIDE CONSOLE (SSC) AND THE PATIENT SUSTAINED A SMALL 2ND DEGREE BURN ON THE SMALL INTESTINE; REPAIRED BY RESECTING 2CM OF THE SMALL INTESTINE. THE PATIENT WAS REPORTED AS FINE. THE SURGEON CONFIRMED THAT THERE [WASN¿T A] DA VINCI ERROR. THE SURGEON ATTRIBUTED THE ISSUE TO HIS ¿MALFUNCTION¿; SURGEON ERROR, NOTHING ELSE. THE SURGEON WAS UNWILLING TO PROVIDE ANY ADDITIONAL INFORMATION REGARDING THE INCIDENT.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT DURING A REVISION SURGERY, THE PATIENT HAD MISPLACED THORACIC SCREWS. ORIGINAL SURGERY OF PATIENT WAS ON (B)(6), CAME IN ON (B)(6) AND HAD REVISION SURGERY ON (B)(6). THERE WAS NO KNOWN IMPACT ON THE PATIENT OUTCOME. THE ORIGINAL SURGERY OCCURRED ON (B)(6) 2022, HOWEVER THE PATIENT DID NOT COME BACK TO THE HOSPITAL UNTIL (B)(6) 2022 AND HAD REVISION SURGERY ON (B)(6) 2022. T11 TO L3 BURST FRACTURE AT L1. SURGEON WAS PLANNING ON PLACING SCREWS FROM T11 TO L3, INCLUDING SCREWS AT L1 IF IT WAS POSSIBLE. THE CASE WAS DONE MIS USING SOLERA 5.5/6.0 VOYAGER. THE RESIDENTS MADE A SMALL INCISION AND PLACED THE SINGLE AMBER CLAMP ON THE SPINOUS PROCESS OF L1. ALL THE STEPS WERE TAKEN TO ACQUIRE THE IMAGING SYSTEM SCAN WITHOUT ISSUE. THE MANUFACTURER REPRESENTATIVE PLANNED THE SCREWS AS THE SURGEON WATCHED AND INFORMED THE REP WHERE HE WANTED THEM PLACED. THE PATIENT HAD VERY SMALL PEDICLES WITH SOME INTERESTING ANATOMY. THEY NOTED A POTENTIAL SKIVE AT T12 ON THE RIGHT. THEY STARTED AND THE RIGHT AND WENT TOP DOWN. THEY SENT EACH TRAJECTORY AND THE RESIDENTS MARKED THE SKIN. 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: INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF AN ANNALS OF SURGICAL TREATMENT AND RESEARCH ARTICLE TITLED, ¿INITIAL EXPERIENCES OF ROBOTIC SP CHOLECYSTECTOMY: A COMPARATIVE ANALYSIS WITH ROBOTIC SI SINGLE-SITE CHOLECYSTECTOMY¿ (CRUZ, C. J., HUYNH, F., ET AL., 2021). WITHIN THE JOURNAL ARTICLE, AN OPERATIVE COMPLICATION INVOLVING A DA VINCI SURGICAL PROCEDURE WAS NOTED: ¿ONE PATIENT HAD A SMALL BOWEL INJURY DURING PORT PLACEMENT DUE TO UNEXPECTED INTRA-ABDOMINAL ADHESIONS, WHICH WAS REPAIRED INTRA-CORPOREALLY.¿ INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING THE PROCEDURE, THE SCRUB TECH NOTICED THAT THE INSTRUMENT PULLED OUT FROM THE ABDOMEN WAS MISSING THE TIP COVER. SHE LOOKED AROUND AND MADE SURE IT WASN'T IN HER FIELD AND INFORMED THE SURGEON AND ASSISTANT SURGEON. THE TEAM IN THE ROOM LOOKED THRU AND AROUND THE STERILE FIELD, AND ALSO WENT THRU THE TRASH, BUT WERE UNABLE TO FIND THE MISSING TIP COVER. THE SURGEON AND ASSISTANT EXPLORED INSIDE THROUGH THE SCOPE BEFORE AND AFTER SPECIMEN WAS REMOVED. XRAY DID NOT REVEAL ANY FOREIGN BODY. 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: ON 26-NOV-2020, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF THE GENERAL THORACIC AND CARDIOVASCULAR SURGERY ARTICLE TITLED, ¿IS LEFT-SIDE DAVINCI PROCEDURE CHALLENGING? INITIAL EXPERIENCES OF A SINGLE INSTITUTE.¿ WITHIN THE ARTICLE, THE FOLLOWING IS NOTED: CASE #3 INVOLVED A 69 YEAR OLD MALE PATIENT WITH STAGE 1B CANCER WHO UNDERWENT A DA VINCI-ASSISTED LEFT UPPER LOBECTOMY PROCEDURE ON AN UNSPECIFIED DATE. THE CAUSE OF THE CONVERSION PER TABLE 3 IN THE ARTICLE WAS AN ¿INJURY OF PA¿ (PULMONARY ARTERY). ¿IN CASE 3, WHEN DISSECTING THE ARTERIAL BRANCH TO THE APICO-POSTERIOR SEGMENT OF THE LEFT UPPER LOBE, THE ROOT OF THE BRANCH WAS INJURED AND THE SURGERY WAS CONVERTED TO OPEN THORACOTOMY.¿ THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED IN RELATION TO THE REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) HAS 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: ON 22-APR-2020, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF A JOURNAL OF ULTRASOUND ARTICLE TITLED, ¿INFERIOR EPIGASTRIC ARTERY PSEUDOANEURYSM SECONDARY TO PORT PLACEMENT DURING A ROBOT-ASSISTED LAPAROSCOPIC RADICAL CYSTECTOMY.¿ PER THE CLINICAL ARTICLE, DURING A DA VINCI-ASSISTED RADICAL CYSTECTOMY WITH BRICKER URETEROILEOCUTANEOSTOMY AND EXTENDED PELVIC LYMPH NODE DISSECTION, THE PATIENT DEVELOPED AN INFERIOR EPIGASTRIC ARTERY (IEA) PSEUDOANEURYSM SECONDARY TO AN 8-MILLIMETER (MM) PORT PLACEMENT. THE PRE-OPERATIVE COMPUTED TOMOGRAPHY (CT) SCAN SHOWED NO LYMPHOADENOMEGALY AND BILATERAL HYDRONEPHROSIS, AND NO OTHER LOCALIZATION THAN THE BLADDER. THE PSEUDOANEURYSM WAS INITIALLY DIAGNOSED POST-OPERATIVELY BY CONTRAST-ENHANCED ULTRASOUND (CEUS); SUBSEQUENTLY, A CT SCAN AND AN ANGIOGRAPHY TEST WERE PERFORMED. THE PSEUDOANEURYSM WAS THEN TREATED SUCCESSFULLY WITH COIL EMBOLIZATION OF THE INFERIOR EPIGASTRIC ARTERY. NO COMPLICATIONS OCCURRED DURING OR AFTER THE EMBOLIZATION PROCEDURE. ON 03-JUN-2020, IS OBTAINED THE FOLLOWING ADDITIONAL INFORMATION FROM THE AUTHOR OF THE CLINICAL ARTICLE REGARDING THIS EVENT: "THERE WAS NO MALFUNCTION OF THE DA VINCI SYSTEM, THIS COMPLICATION CAN OCC

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 RIGHT EYE IN THE SURGEON SIDE CONSOLE (SSC) WAS BLACK. THE RIGHT AND LEFT IMAGES WORKED FINE IN THE VISION SIDE CART (VSC). THE BLUE FIBER CABLE WAS PROPERLY CONNECTED TO THE SSC AND THE LED WAS BLUE. THE TECHNICAL SUPPORT ENGINEER (TSE) ASKED THE CALLER TO EMERGENCY POWER OFF (EPO) THE SSC AND VISION SIDE CART (VSC), BUT THE RIGHT MONITOR REMAINED COMPLETELY BLACK. THE SURGEON WAS UNDECIDED TO AS TO WHETHER TO CONVERT OR ABORT THE PROCEDURE AT THAT TIME. THERE WAS NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THERE WAS A ONE HOUR DELAY AS THE PROCEDURE WAS CONVERTED TO OPEN SURGERY. THE ISSUE DID NOT OCCUR DURING A CRITICAL STEP. IT IS UNKNOWN IF SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING ON THE SYSTEM. THE SYSTEM WAS ONLY ABLE TO SEE THROUGH ONE EYE OF THE HRSV.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THERE WAS A DEVIATION DURING A L3-L4 MINI-OPEN TLIF WITH RADIOLUCENT RETRACTORS. THE SURGICAL SYSTEM WAS MOUNTED TO THE PATIENT USING A SCHANZ PIN PLACED IN THE RIGHT SIDE OF THE PATIENT CONNECTED TO A BONE MOUNT BRIDGE. ALL SCREWS WERE ACCURATE EXCEPT FOR RIGHT L2. LEFT L2 WAS ACCURATELY PLACED. AT RIGHT L2, THE PATIENT JUMPED DURING DRILLING. THE RIGHT L2 TRAJECTORY WAS INITIALLY INFERIOR BY 3.5-10 MM WHEN TAKING FLUORO IMAGES. THE SURGEON WENT TO RIGHT L3 AND THE TRAJECTORY LOOKED OFF SO THEY WENT TO LEFT L3 AND L4 AND PLACED ACCURATE SCREWS. RIGHT L4 WAS THEN ACCURATELY PLACED. THE SURGEON WENT BACK TO RIGHT L2 AND REMOVED THE SCREW. REGISTRATION WAS REDONE. THE REGISTRATION SEGMENTATION LINES WERE ADJUSTED AT L2 INCASE THE LINES WERE PARTIALLY CUT OFF. THE SURGICAL ARM WAS SENT TO THE TRAJECTORY AND IMAGES WERE TAKEN WITH THE CANNULA, WHICH WAS ACCURATE. THE SCREW WAS TESTED AND CAME BACK AT 5. AN AP IMAGE WAS TAKEN AND THE SCREW WAS MEDIAL EVEN THOUGH NAVIGATION LOOKED ACCURATE. THE SCREW SKIVED BETWEEN 3.5-10 MM. THE SURGEON DECIDED TO ABORT THE USE OF THE GU

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DAVINCI ROBOTIC SURGERY WAS PREFORMED ON THIS PATIENT, WHILE THE SURGEON WAS IN THE CONSOLE, THE INSTRUMENTS WERE USED TO TAKE DOWN ADHESIONS AND AFTER THAT OCCURRED, THE ARMS EXPERIENCED AN ISSUE. THE SURGEON DESCRIBED IT "AS THE LEFT HAND WAS MOVED WITH THE VESSEL SEAL DEVICE, THE ROBOTIC ARM MOVED ERRATICALLY AND IMMEDIATELY I NOTED A THROUGH AND THROUGH PERFORATION OF THE SIGMOID COLON." THE INSTRUMENT WAS LEFT IN PLACE AND A GENERAL SURGERY CONSULT WAS COMPLETED IMMEDIATELY FOR REPAIR. AFTER DISCUSSION WITH THE TEAM, WE BELIEVE THAT THE ROBOTIC ARM DRAPE WAS FAULTY AND WE IMMEDIATELY CALLED THE REP AND THE TECH SUPPORT PERSON. THEY RECOMMENDED THAT WE PULL ALL THOSE DRAPES WITH THAT LOT NUMBER #DM1220807. FDA SAFETY REPORT ID# (B)(4).

Senhance — 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 COMPLAINANT, (B)(6) REPORTED THAT ON DAY 7, PATIENT COMPLAINED OF FEVER AND NOTED PURULENT DISCHARGE FROM THE ANUS; ADDITIONALLY, PATIENT PRESENTED WITH LEUKOCYTOSIS AND ELEVATED CRP. THIS ADVERSE EVENT WAS ANASTOMOTIC LEAKAGE AS REVEALED BY DIGITAL EXAMINATION FOR WHICH ANTIBIOTIC TREATMENT WAS ADMINISTERED (METRONIDAZOLE-500 MG 3X DAILY AND CEFUROXIME-1 G). PATIENT SYMPTOMS DISSAPEARED FOR A RESOLUTION DATE OF (B)(6) 2022. 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) 2022, 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 SLEEVE GASTRECTOMY SURGICAL PROCEDURE, THE JAWS OF HARMONIC ACE FELL INSIDE OF THE PATIENT. THE FALLEN PIECE WAS RETRIEVED DURING THE SAME PROCEDURE WITH A BACKUP INSTRUMENT. THE INSTRUMENT IS NOT AVAILABLE FOR RETURN. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER WAS ABLE TO RETRIEVE THE BROKEN PIECE WITH A LAPAROSCOPIC INSTRUMENT. NO ADDITIONAL PROCEDURES WERE REQUIRED TO RETRIEVE THE BROKEN PIECE. NO POST-OPERATIVE TESTS NEEDED TO BE PERFORMED TO CHECK FOR ANY REMAINING PIECES. THE CUSTOMER WAS NOT SURE WHAT THE SURGEON THOUGHT CAUSED THE INSTRUMENT TO BREAK. THE INSTRUMENT WAS USED MAYBE 20 MINS PRIOR TO BREAKING. THE INSTRUMENT WAS INTACT WHEN IT WAS REMOVED FROM THE STERILE PACKAGE. THE CUSTOMER WAS DISSECTING TISSUE WHEN THE INSTRUMENT BROKE. RIGHT BEFORE THE CUSTOMER NOTICED THE INSTRUMENT WAS BROKEN THE HARMONIC MACHINE HAD AN ERROR BUT SHE COULD NOT REMEMBER WHAT THE ACTUAL ERROR SAID. THE CUSTOMER COULD NOT RECALL IF THE INSTRUMENT COLLIDED WITH ANY OTHER INSTRUMENT DURING THE PROCEDURE

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: EXCELCIUS GPS CASE THE FIRST TWO SCREWS WERE MISPLACED OFF PLAN. FLUOR SHOTS WERE TAKEN TO SHOW SCREWS OFF PLAN AND NAVIGATION INACCURATE. REQUESTING EVALUATION OF LOGS SUBMITTED TO IN PORTAL THIS EVENING. EXCELCIUS GPS SERIAL NUMBER (B)(6).

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 GUIDANCE SYSTEM WAS USED DURING A FRACTURE TRAUMA CASE. THREE DAYS LATER, A REVISION WAS DONE TO REVISE TWO BREACHED SCREWS AT T6. THE LEFT AND RIGHT T6 SCREWS WERE 2 MM MEDIAL TO PLAN. A C-ARM WAS USED TO REMOVE AND PLACE THE SCREWS AT T6. DURING THE INITIAL PROCEDURE, THE SURGICAL SYSTEM WAS MOUNTED TO THE PATIENT USING A SPINOUS PROCESS CLAMP PLACED AT T9 AND THE BONE MOUNT BRIDGE. T7 WAS TOO UNSTABLE FOR THE CLAMP DUE TO THE FRACTURE AND THE SURGEON DID NOT WANT TO USE T8 SINCE THEY THOUGHT THE CLAMP WOULD BE IN THE WAY OF THE TRAJECTORY. A CT TO FLUORO WORKFLOW WAS USED AND SCREWS WERE PLACED AT LEFT T6 AND LEFT T8. THE SURGEON THEN SWITCHED TO THE RIGHT SIDE. NO NEUROMONITORING WAS DONE TO TEST MOTOR FUNCTION DUE TO THE PATIENT'S AIRWAY (TRACHEOSTOMY TUBE IN PLACE). THE SURGEON QUESTIONED ACCURACY DURING THE CASE AND A 10 POINT ACCURACY TEST WAS SUCCESSFULLY COMPLETED. NAVIGATION WAS ACCURATE WHEN CHECKED WITH THE PASSIVE PLANAR BEING PLACED ON THE SPINOUS PROCESS AND THE DIVOT ON THE ARM GUIDE. THE SURGEON WAS ON TRAJECTORY WITH THE TAP, SCREW, AND DILATO

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.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: PNEUMOTHORAX WAS REPORTED DURING MONARCH BRONCHOSCOPY PROCEDURE AND PATIENT WAS HOSPITALIZED OVERNIGHT.

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 PROCEDURE, A BURNING ACCIDENT OCCURRED WHILE THE SURGEON WAS USING A MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT AT THE BEGINNING OF THE PROCEDURE. THE TIP OF THE MCS INSTRUMENT HEATED UP AND BURST INTO FLAMES WHEN THE SURGEON ACTIVATED THE MCS INSTRUMENT FOR THE FIRST TIME. THE MCS INSTRUMENT WAS ON ITS THIRD USAGE. THERE WAS INJURY TO THE PATIENT'S SMALL INTESTINE AND ABDOMINAL WALL NEAR THE TROCAR AS A RESULT. A BACKUP MCS INSTRUMENT WITH TIP COVER WAS USED. THE FRAGMENTS THAT FELL IN THE PATIENT FROM THE BURNT TIP COVER WERE RETRIEVED DURING THE SAME PROCEDURE. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE OPERATING ROOM NURSE AND OBTAINED THE FOLLOWING INFORMATION: THERE WAS NO ERROR GENERATED BY THE SYSTEM AFTER INSTALLING THE INSTRUMENT. THE FLAME WAS SEEN ARISING FROM THE TIP OF THE MCS. WHEN THE INSTRUMENT WAS REMOVED FROM THE CANNULA, THE MCS INSTRUMENT WAS STILL FLAMING. THE SURGEON SUTURED THE HOLE IN THE INTESTINE AND CLEANED UP THE RESIDUE. THE SURGEON USED A BACKUP FORCE TRIAD GENERATOR, NEW CAUTERY CABLE, MCS INSTRUMENT AND TIP COVER TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT HAVE ANY IMPLANTS. N

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 (LAR) PROCEDURE, THERE WAS ARCING FROM THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT FROM A LOCATION OTHER THAN THE TIP. THE PATIENT SUSTAINED A RESULTING BURN INJURY TO THE INTESTINAL TRACT. A BACKUP MCS INSTRUMENT WAS USED, AND THE PROCEDURE WAS COMPLETED ROBOTICALLY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE OR NURSE AND OBTAINED THE FOLLOWING INFORMATION: THE INSTRUMENT AND CANNULA WERE INSPECTED BEFORE USE. THE SURGEON STATED THAT THERE WAS SOMETHING "WRONG" WITH THE MCS FROM THE BEGINNING OF THE PROCEDURE BUT NO INFORMATION WAS PROVIDED TO FURTHER DESCRIBE WHAT THE ISSUE WAS. THE GROUNDING PAD WAS PLACED PROPERLY ON THE PATIENT AND THERE WERE NO DEFECTS SEEN. ISI CONTACTED THE SURGEON AND ADDITIONAL INFORMATION WAS OBTAINED ABOUT THE COMPLAINT: THE INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NOTHING ABNORMAL NOTICED. THE SURGEON REPORTEDLY NOTICED DAMAGE TO THE INSTRUMENT AND/OR ACCESSORY PRIOR TO THE ARCING EVENT. THE CANNULA WAS INSPECTED PRIOR TO USE AND THE PIN GAUGE TEST WAS PERFORMED. IT WAS REPORTED THAT ARCING WAS OBSERVED COMING FROM THE MIDDLE PART OF THE TIP COVER AND THAT THIS GENERAT

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 TEAR IN THE AIRWAY. THE PATIENT WAS HOSPITALIZED OVERNIGHT FOR OBSERVATION AND DISCHARGED FOLLOWING DAY. THE PHYSICIAN NAVIGATED TO THE LESION IN PAIRED MODE. AT SOME POINT THE PHYSICIAN DROPPED THE SHEATH AND ADVANCED THE SCOPE ONLY. AT THE LESION, THE PHYSICIAN ADVANCED THE SHEATH ONLY TO PROVIDE MORE STABILITY WHILE INTRODUCING BIOPSY TOOLS. WHEN THE PHYSICIAN HAD COMPLETED AND RETRACTED BOTH THE SCOPE AND SHEATH THE PHYSICIAN NOTICED A TEAR IN THE AIRWAY.

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 SINGLE PORT (SP) COLORECTAL IDE STUDY LOW ANTERIOR RESECTION (LAR) WITH TOTAL MESORECTAL EXCISION (TME) PROCEDURE ON (B)(6) 2022, THE PATIENT DEVELOPED BILATERAL EDEMA OF THE LOWER EXTREMITIES AND GIDDINESS. THE LEG SWELLING AND GIDDINESS WERE NOTED ON (B)(6) 2022, DURING A FOLLOW-UP VISIT WITH HER PRIMARY CARE PHYSICIAN (PCP) AND THE PATIENT'S ORAL LOSARTAN WAS PLACED ON HOLD BY HER PCP, AND SHE WAS ADVISED TO FOLLOW-UP IN 2-3 WEEKS¿ TIME. ON (B)(6) 2022, THE PATIENT WENT TO THE ER FOR GENERALIZED WEAKNESS AND DIZZINESS FOR A FEW WEEKS. THE DIZZINESS WAS WORSE UPON STANDING UP. SHE ALSO HAD LOSS OF APPETITE. THERE WAS NO PAIN. SHE STATED THAT THE WEAKNESS AND LOSS OF APPETITE STARTED EVER SINCE SHE HAD A BARIUM ENEMA ON (B)(6) 2022. A BLOOD TEST SHOWED ACUTE RENAL FAILURE WITH CREATININE 2.2, BUN 106, SODIUM 119, POTASSIUM 5.4. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE SITE. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A MONARCH-ASSISTED BRONCHOSCOPY PROCEDURE, THE PATIENT EXPERIENCED A PNEUMOTHORAX. THE TARGET LOCATION WAS LEFT UPPER LOBE (LUL). AN ENDOBRONCHIAL ULTRASOUND (EBUS) AND CHEST X-RAY (CXR) WERE BOTH PERFORMED. A POST-OP CHEST X-RAY REVEAL A PNEUMOTHORAX. A CHEST TUBE WAS PLACED AND PATIENT WAS ADMITTED TO THE HOSPITAL. THE CHEST TUBE WAS REMOVED THE FOLLOWING DAY AND PATIENT WAS DISCHARGED.

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). AN ENDOBRONCHIAL ULTRASOUND (EBUS) AND CHEST X-RAY (CXR) WERE BOTH PERFORMED. A POST-OP CHEST X-RAY REVEAL A PNEUMOTHORAX. A CHEST TUBE WAS PLACED AND PATIENT WAS ADMITTED TO THE HOSPITAL. THE CHEST TUBE WAS REMOVED THE FOLLOWING DAY AND PATIENT WAS DISCHARGED

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, ARCING WAS OBSERVED FROM THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT. THE EXTERNAL ILIAC ARTERY, WHICH WAS IN CONTACT WITH THE ELECTRICAL LEAKAGE SITE WAS INJURED, RESULTING IN ARTERIAL BLEEDING. THE BLEEDING POINT WAS SUTURED AFTER CLAMPING THE ARTERY. THE VIDEO OF THE PROCEDURE WAS REVIEWED BY THE SURGEON AND SHOWED THAT A FEW MINUTES BEFORE THE MCS TIP COVER ACCESSORY WAS FOUND TO BE TORN, THE WRIST OF THE MCS INSTRUMENT WAS OBSERVED TO BE SEVERELY BENT AND COLLIDED WITH A PROGRASP FORCEPS INSTRUMENT WHICH WAS OUT OF VIEW FROM THE SURGICAL FIELD. ALSO, AFTER THE ARCING INCIDENT, THE MCS TIP COVER ACCESSORY WAS REMOVED AND UPON EXAMINATION, THERE WERE MULTIPLE HOLES SEEN ON THE MCS TIP COVER ACCESSORY.INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SURGEON AND OBTAINED THE FOLLOWING INFORMATION: THE CANNULA, MCS INSTRUMENT, AND MCS TIP COVER ACCESSORY WERE INSPECTED BEFORE USE AND THERE WAS NO ABNORMALITY FOUND. THE MCS TIP COVER ACCESSORY APPEARED TO BE PROPERLY INSTALLED DURING THE CASE. THE MCS INSTRUMENT WAS IN USE FOR ABOUT 1 HOUR BEFORE THE ARCING OCCURRED. ARCING OR

CyberKnife — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A CUSTOMER CONTACTED ACCURAY INDICATING THERE WAS A POTENTIAL MISTREATMENT THAT OCCURRED AT THEIR SITE.

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 (B)(6) 2022, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF AN INTRA-OPERATIVE COMPLICATION, WHICH WAS RECEIVED VIA A USER MEDWATCH REPORT #MW5110571. WITHIN THE USER MEDWATCH REPORT, IT WAS REPORTED THAT DURING AN UNSPECIFIED DA VINCI-ASSISTED SURGICAL PROCEDURE, WHICH ALLEGEDLY THE SURGEON USED TO TAKE DOWN THE ADHESIONS, AND ¿AFTER THAT OCCURRED, THE ARMS EXPERIENCED AN ISSUE¿. THE SURGEON DESCRIBED IT ¿AS THE LEFT HAND WAS MOVED WITH THE VESSEL SEAL DEVICE, THE ROBOTIC ARM MOVED ERRATICALLY¿ AND IMMEDIATELY THE SURGEON NOTED ¿A THROUGH AND THROUGH PERFORATION OF THE SIGMOID COLON¿. THE INSTRUMENT WAS LEFT IN PLACE AND A GENERAL SURGERY CONSULT WAS COMPLETED IMMEDIATELY FOR REPAIR. OTHER INFORMATION RECEIVED FROM THE USER REPORT FURTHER INDICATED THAT ¿AFTER DISCUSSING WITH THE TEAM, WE BELIEVE THAT THE ROBOTIC ARM DRAPE WAS FAULTY¿. ISI IS NOT ABLE TO CONDUCT FOLLOW-UP INVESTIGATION WITH THE USER FACILITY/SURGEON REGARDING THE REPORTED ISSUE DUE TO THE LACK OF FACILITY/SURGEON¿S NAME, ADDRESS AND PHONE NUMBER, ETC. ADDITIONALLY, ISI IS UNABLE TO CONDUCT THE SYSTEM OR INSTRUMENT LOG REVIEW DUE TO LACK OF SYSTEM/INSTRUMENT DETAIL (I.E. SYSTEM SERIAL #, SURGEON NAME, TYPE OF PR