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

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT THE CASE WAS MINIMALLY INVASIVE. THE CASE WAS STARTED SUCCESSFULLY, BUT AT THE SECOND SCREW, THE SCREWDRIVER WAS STUCK ON THE SCREW AND THE SURGEON PULLED OUT THE SCREW WITH TOO MUCH FORCE CAUSING A SHOULDER SHIFT. AT THIS POINT, S1 AND L5 RIGHT SIDE SCREWS WERE ALREADY PLACED. A NEW REGISTRATION WAS DONE, BUT THE SURGICAL ARM HAD PROBLEMS REACHING THE OTHER TRAJECTORIES DUE TO THE SCREW EXTENDERS. THE SURGEON WAS ALSO NOT HAPPY WITH THE RIGHT L5 SCREW SO THEY REMOVED THEY REMOVED BOTH L5 SCREWS AND DECIDED TO START FROM THE BEGINNING. THE RIGHT L5 WAS TOO MEDIAL AND THE LEFT L5 WAS TOO LATERAL AND SUPERIOR. THE S1 LEFT SCREW WAS DEVIATED SO THE PLANNING WAS CHANGED INTRAOPERATIVELY DUE TO THE PATIENT BEING OBESE AND THE COLLISION WITH THE EXTENDERS OF L5 AND PELVIS. THE PATIENT EXPERIENCED ISSUES TWO WEEKS AFTER SURGERY. NAVIGATION WAS CHECKED AND EVERYTHING WAS OKAY.

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 SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS TIP COVER ACCESSORY FELL INTO THE SITUS. THE TIP COVER ACCESSORY WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) ATTEMPTED TO FOLLOW-UP WITH THE CUSTOMER TO OBTAIN ADDITIONAL DETAILS RELATED TO THE EVENT. HOWEVER, AS OF THE DATE OF THIS REPORT, NO FURTHER INFORMATION HAS 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 PROSTATECTOMY SURGICAL PROCEDURE THE SYNCHROSEAL INSTRUMENT JAW HINGE PIN, END PIECE, FELL OFF THE INSTRUMENT INTO THE PATIENT. THE SURGEON RETRIEVED THE PIECE WITH A BACKUP INSTRUMENT AND CONTINUED THE PROCEDURE. NO OTHER PIECES WERE OBSERVED TO BE MISSING FROM THE INSTRUMENT. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) ADVISED THE CALLER TO PROMPT THE CUSTOMER TO RETURN THE INSTRUMENT FOR FAILURE ANALYSIS. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. 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 A SURGEON WAS PERFORMING AN SEEG CASE. WHILE POSITIONED ON THE FIRST TRAJECTORY, LF1C-CB, THE ROSA SOFTWARE SHUTDOWN, RETURNED TO THE ROSA BRAIN HOME SCREEN AND DISCONNECTED THE CONTROLLER. BECAUSE OF AN EARLIER, ALREADY REPORTED ISSUE, THE PATIENT FOLDER WAS NOT ABLE TO BE REOPENED AND PATIENT REGISTRATION HAD TO BE PERFORMED AGAIN. THIS CAUSED AROUND A 45 MINUTE DELAY TO THE CASE, ADDITIONAL ANAESTHETIC WAS PROVIDED TO THE PATIENT. ONCE REGISTRATION WAS REDONE, CASE PROCEEDED AS EXPECTED.

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 BENIGN HYSTERECTOMY SURGICAL PROCEDURE, IT WAS NOTED THAT ONE OF THE PADS ON THE HARMONIC SCALPEL FELL OFF INTO THE PATIENT. THE CUSTOMER INFORMED THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) THE ISSUE HAD OCCURRED AND THE CUSTOMER RETRIEVED THE GREY INSTRUMENT TIP PAD WITH NO ISSUES TO THE PATIENT. IT WAS NOTED THE CUSTOMER DISCARDED THE INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CLINICIAN INFORMED THE INSTRUMENT WAS INSPECTED PRIOR TO USE. PRIOR TO THE FRAGMENT FALLING, THE INSTRUMENT HAD BEEN IN USE FOR ABOUT 45  60 MINUTES. AT THE TIME OF THE REPORTED ISSUE, THE CLINICIAN NOTED THAT THE SURGEON WAS PERFORMING AN EXCISION OF FIBROIDS AND STATED THE HARMONIC INSTRUMENT AND TENACULUM INSTRUMENT COLLIDED. THE SURGEON DID NOT NOTICE AN ISSUE WITH THE INSTRUMENT FUNCTIONALITY DURING THE CASE. IT WAS NOTED THE FRAGMENT FELL OFF INTO THE PATIENT IN THE MIDDLE OF THE CASE AND DID NOT OCCUR DURING AN INSTRUMENT COLLISION. THE WHITE TIP OF THE HARMONIC INSTRUMENT WAS RETRIEVED IN ONE PIECE WITH A G

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 BY THE PATIENT THAT THEIR LIFE WAS RUINED AND THEY EXPERIENCED A SIGNIFICANT LIFE CHANGING INJURY THROUGH USE OF THE GUIDANCE SYSTEM FOR SPINAL SURGERY. THE PATIENT REPORTED HAD TWO SEPARATE PROCEDURE USING THE GUIDANCE SYSTEM.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS UNABLE TO PROPERLY MOVE THEIR FOOT AND THEY WERE UNABLE TO VOID THEIR BLADDER AFTER THE PROCEDURE. THE PATIENT'S HOSPITAL STAY WAS EXTENDED.

Mazor Renaissance — 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 BY THE PATIENT THAT THEIR LIFE WAS RUINED AND THEY EXPERIENCED A SIGNIFICANT LIFE CHANGING INJURY THROUGH USE OF THE GUIDANCE SYSTEM FOR SPINAL SURGERY. THE PATIENT REPORTED HAD TWO SEPARATE PROCEDURE USING THE GUIDANCE 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: 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 MALIGNANT HYSTERECTOMY SURGICAL PROCEDURE, THE SYNCHROSEAL INSTRUMENT WAS FOUND TO HAVE THE BUTTON FELL OFF. THE BUTTON WAS IN A CUP. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: IT WAS CONFIRMED THAT THE BUTTON SIMPLY FELL OFF AND WAS DISCOVERED WITHIN THE PATIENT. THE INSTRUMENT WAS INSPECTED PRIOR TO USE. THE FRAGMENT WAS LIKELY RETRIEVED WITH A ROBOTIC/LAP INSTRUMENT DURING THE CASE. NO POST-OPERATIVE TESTS LIKE AN X-RAY OR ULTRASOUND WERE PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT NOR ANY OTHER DAMAGE TO THE INSTRUMENT AFTER THE EVENT OCCURRED. THE WRIST WAS NOT STRAIGHTENED PRIOR TO REMOVAL BUT WAS STRAIGHTENED UPON FINAL REMOVAL OF THE INSTRUMENT. NO PATIENT INJURY WAS IDENTIFIED. THE PART L90200818-0262 WAS USED ON (B)(6) 2021.

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 SPLENECTOMY PROCEDURE, BLEEDING OCCURRED. THE SURGEON REPORTED THAT HE THINKS HE GRABBED A VEIN WHICH CAUSED THE BLEEDING. THE SITE GAVE THE PATIENT A BLOOD TRANSFUSION AND CONVERTED TO OPEN SURGERY. THE SURGEON REPORTED TWO DAYS AFTER THE PROCEDURE THAT THE PATIENT WAS DOING FINE. THE SURGEON REPORTED THAT HE DOES NOT BELIEVE AN INTUITIVE SURGICAL INC. (ISI) PRODUCT CAUSED OR CONTRIBUTED TO THE REPORTED INJURY. FOLLOW-UP: ON 04/22/2021, INTUITIVE SURGICAL INC. (ISI) CONTACTED THE CONSOLE SURGEON OF THE PROCEDURE AND ADDITIONAL INFORMATION WAS OBTAINED ABOUT THE EVENT: THE BLEEDING EVENT OCCURRED WHILE TAKING THE SPLENIC MINOR ATTACHMENT WITH THE SYNCHROSEAL INSTRUMENT. THE SURGEON SAID WHILE HE WAS SEALING TISSUE BLOOD STARTED FLOWING FROM IT. THE SURGEON CLARIFIED THAT THE BLOOD APPEARED WHILE THE SYNCHROSEAL INSTRUMENT WAS SEALING WITH ENERGY. THE SURGEON GRASPED THE BLEEDING VESSEL AT THE INFLOW SIDE, BUT THE BLOOD VOLUME INCREASED; THE PROCEDURE WAS THEN CONVERTED TO OPEN TO CONTROL THE BLEEDING VESSEL WITH SUTURES. THE SURGEON SAID THE VESSEL WAS NOT LARGER THAN 5MM AND THAT THE SYNCHROSEAL WAS WORKING FINE DURING THE WHOLE PROC

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE PATIENT HAD A MILD HERNIA THAT NEEDED REPAIR. IT WAS DONE ROBOTICALLY USING THE DAVINCI SYSTEM. THE PATIENT HAD A PUNCTURED ARTERY AND A LACERATED BOWEL FROM SURGICAL ERRORS DURING THE PROCEDURE. THERE WAS EXTENSIVE INTERNAL BLEEDING. THE PATIENT BECAME SEPTIC AND WITHIN THREE DAYS WAS DEAD. THE PATIENT WAS HEALTHY WHEN HE WALKED IN EVEN THOUGH HE WAS AN OLDER PATIENT. THE PATIENT WENT TO THE HOSPITAL WITH UPPER ABDOMINAL PAIN. IT WAS DETERMINED HE HAD A HERNIA AND HE WAS SENT TO A DOCTOR TO HAVE IT REPAIRED. 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 SURGICAL PROCEDURE, THE MASTER KNIFE WAS CUTTING THE LIVER, AND THE ULTRASONIC KNIFE HEAD SUDDENLY BROKE OFF WITHOUT ANY HINT. FORTUNATELY, THE BROKEN KNIFE HEAD WAS PICKED OUT. THE FRAGMENT WAS RETRIEVED DURING THE OPERATION. THE PROCEDURE WAS COMPLETED WITH A BACKUP DA VINCI INSTRUMENT OF THE SAME KIND, AND THERE WAS NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CUSTOMER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE. THE INSTRUMENT WAS USED FOR APPROXIMATELY ONE HOUR PRIOR TO THE BREAKAGE. THE SURGEON HAD NO ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE PROCEDURE. THE SURGEON HAD NO ISSUES WITH REMOVING THE INSTRUMENT FROM THE ARM PRIOR TO THE BREAKAGE. THERE WAS NO REPORT OF COLLISION WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIAL. ALL FRAGMENT(S) WERE RETRIEVED WITH THE ENDOSCOPIC INSTRUMENT DURING THE SAME PROCEDURE. NO SURGICAL PROCEDURES WERE REQUIRED TO REMOVE THE FRAGMENT. NO POST-OPERATIVE TESTS WERE PERFORMED TO CHECK FOR REMAINING FRAGMENTS. NO INFORMATION WAS PROVIDED PERTAINING TO IF THE PATIENT HAS RETURNED TO THE HOSPITAL DUE TO PO

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ABSTRACT: TO COMPARE THE PATIENT-REPORTED OUTCOMES (PROS) BETWEEN PATIENTS UNDERGOING MULTILEVEL LUMBAR FUSION WITH ROBOT-ASSISTED VS. FREEHAND TECHNIQUES. THIS WAS A SINGLE-INSTITUTION COHORT STUDY OF ADULT PATIENTS (=18 YEARS OLD) UNDERGOING ROBOT-ASSISTED SPINE SURGERY FROM 2016 TO 2018 WITH MINIMUM 2-YEAR FOLLOW-UP. A PROPENSITY-SCORE MATCHING (PSM) ALGORITHM ACCOUNTED FOR SEVERAL PERIOPERATIVE FACTORS. PROS WERE MEASURED USING THE OSWESTRY DISABILITY INDEX (ODI). THE MINIMUM CLINICALLY IMPORTANT DIFFERENCE (MCID) BETWEEN GROUPS WERE ASSESSED AT EACH FOLLOW-UP PERIOD (6-WEEKS/6-MONTHS/1-YEAR/2-YEARS). CHI-SQUARE/FISHER EXACT TEST AND T-TEST/ANOVA WERE USED FOR CATEGORICAL AND CONTINUOUS VARIABLES, RESPECTIVELY. AFTER PSM, A TOTAL OF 70 PATIENTS REMAINED. THE MEAN (STANDARD DEVIATION) CHARLSON COMORBIDITY INDEX WAS 1.4 (1.0) AND 57% OF PATIENTS WERE FEMALE. THE MOST COMMON DIAGNOSES INCLUDED DEGENERATIVE DISC DISEASE (37.1%), DEGENERATIVE SCOLIOSIS (27.1%), AND HIGH GRADE SPONDYLOLISTHESIS (GRADE > 2) (19%), AND THE MEAN NUMBER OF INSTRUMENTED LEVELS WAS 4.6 (4.4). RATES FOR INTRAOPERATIVE/POSTOPERATIVE COMPLICATIONS, AND ANY REOPERATION WITHIN 2 YEARS AFTER SURGERY WERE LOW 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: 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: 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 PARTIAL NEPHRECTOMY SURGICAL PROCEDURE, AFTER INSERTING THE SYNCHROSEAL INSTRUMENT INTO THE BODY CAVITY IMMEDIATELY AFTER THE START OF SURGERY, THE PART WHICH HOLDS THE JAW COVER FELL INTO THE BODY WHEN THE WRIST WAS MOVED. THE PART WAS REPORTEDLY IMMEDIATELY RETRIEVED. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE REPORTER ON 15-APRIL-2021 AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION RELATED TO THE EVENT. THE FRAGMENT WAS RETRIEVED BY USING THE SYNCHROSEAL INSTRUMENT. NO POST-OPERATIVE TESTS WERE REQUIRED AS IT WAS VISUALLY CONFIRMED THAT NO OTHER FRAGMENTS REMAINED INSIDE THE PATIENT. IT WAS UNKNOWN WHETHER THE INSTRUMENT WAS INSPECTED PRIOR TO USE, BUT REPORTEDLY THE INSTRUMENT DID COLLIDE WITH OTHER INSTRUMENTS OR OTHER HARD MATERIAL DURING THE PROCEDURE. THE INSTRUMENT WAS NOT REMOVED INTRAOPERATIVELY. UPON FINAL REMOVAL OF THE INSTRUMENT, THE WRIST WAS STRAIGHTENED THERE WAS NO RESISTANCE FELT UPON REMOVAL THROUGH THE CANNULA, AND THERE WAS NO DAMAGE NOTED TO EITHER THE INSTRUMENT OR THE CANNULA. IT WAS ALSO CONFIRMED THAT THERE WAS NO PATIENT INJURY THAT

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 INSTRUMENT BROKE AND FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED AND A BACKUP INSTRUMENT OF THE SAME KIND WAS USED TO CONTINUE. 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 RETRIEVED THE WHITE POWDER FRAGMENTS BY SUCTION. THERE WAS NO ADDITIONAL PROCEDURE REQUIRED TO REMOVE THE FRAGMENT. NO POST-OPERATIVE TESTS WERE PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE INSTRUMENT WAS IN USE FOR LESS THAN 5 MINUTES PRIOR TO THE ISSUE. THE INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. THE SURGEON WAS DISSECTING TISSUES WHEN THE DEVICE FRAGMENTS FELL INSIDE THE PATIENT. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIAL DURING THE SURGICAL PROCEDURE. THE INSTRUMENT WAS NEVER REMOVED PRIOR TO THE EVENT. THE SURGICAL STAFF DID NOT FEEL ANY RESISTANCE UPON FINAL REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA OR TO THE INSTRUMENT A

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 INITIALLY REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY PROCEDURE, THE ¿ENERGY BOX WAS NOT WORKING¿. THE CUSTOMER CONTACTED AN INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) WHO THEN REACHED OUT TO AN ISI TECHNICAL SUPPORT ENGINEER (TSE). THE CUSTOMER HAD TRIED TO RESEAT THE BIPOLAR ENERGY CABLE MULTIPLE TIMES, TRIED DIFFERENT ENERGY CABLES, AND TRIED TO RESEAT THE INSTRUMENTS MULTIPLE TIMES; ALL WITH NO CHANGE. A MESSAGE HAD PRESENTED ON THE VISION SIDE CART (VSC) TOUCHSCREEN (TS) MONITOR STATING, "VIO DV IS NOT CONNECTED" AND A RED QUESTION MARK DISPLAYED WITH AN INCOMPATIBLE INSTRUMENT MESSAGE ON THE ERBE GENERATOR. THE TSE CHECKED THE LIVE SYSTEM LOGS AND DID NOT SEE ANY RELEVANT ERRORS PRESENT IN THE LOGS. THE TSE HAD CUSTOMER RESEAT THE POWER CABLE ON THE BACK OF THE ERBE AND CHECK ERBE CONNECTIONS, BUT ALL FELT SECURE. THE TSE WALKED THE CUSTOMER THROUGH A SYSTEM POWER CYCLE AND THE CUSTOMER MOVED THE ERBE POWER CABLE TO A DIFFERENT OUTLET. THE CUSTOMER THEN POWER CYCLED THE ERBE GENERATOR. THE SYSTEM THEN POWERED ON WITH MONOPOLAR AND BIPOLAR ENERGY WORKING NORMALLY. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ¿A LITTLE BLEEDING DURING

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE FOLLOWING MEDICAL LITERATURE WAS REVIEWED: ROBOTIC BRONCHOSCOPY: AN INITIAL EXPERIENCE AT A TERTIARY CENTER. AUTHORS: GUSTAVO CUMBO-NACHELI, RONAK CHHAYA, AND JOHN EGAN. CITATION: CHEST ANNUAL MEETING 2019/ WEDNESDAY ELECTRONIC POSTERS 3/ VOLUME 156, ISSUE 4, SUPPLEMENT , A1767, OCTOBER 01, 2019/ DOI.ORG/10.1016/J.CHEST.2019.08.1538. TWO PATIENTS WERE REPORTED AS HAVING PNEUMOTHORAX AND REQUIRING CHEST TUBE PLACEMENT AS TREATMENT. NO DEVICE ISSUES WERE REPORTED.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE FOLLOWING MEDICAL LITERATURE WAS REVIEWED: ROBOT-ASSISTED BRONCHOSCOPY FOR PULMONARY LESION DIAGNOSIS: RESULTS FROM THE INITIAL MULTICENTER EXPERIENCE AUTHORS: UDIT CHADDHA, STEPHEN P. KOVACS, CHRISTOPHER MANLEY, D. KYLE HOGARTH, GUSTAVO CUMBO-NACHELI, SIVASUBRAMANIUM V. BHAVANI, ROHIT KUMAR, MANISHA SHENDE, JOHN P. EGAN III AND SEPTIMIU MURGU CITATION: BMC PULMONARY MEDICINE (2019) 19:243. DOI: HTTPS://DOI.ORG/10.1186/S12890-019-1010-8. FOUR PATIENTS WERE REPORTED AS HAVING PNEUMOTHORAX AND REQUIRING CHEST TUBE PLACEMENT AS TREATMENT. NO RELATED DEVICE ISSUES WERE REPORTED.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A USER REPORTED BY PHONE THAT DURING A SURGERY 'BRAIN BIOPSY', AT THE TIME OF THE REGISTRATION THE ROBOT DISPLAYED AN 'ERROR MESSAGE SIGNALING A SHUTDOWN'. THE ROBOT SHUT DOWN AND RESTARTED. OBLIGATION FOR THE SURGEON TO RE-SET UP PATIENT INFORMATION: THIS SITUATION HAS OCCURRED TWICE. THIS SITUATION CAUSES AN IMPACT FOR THE PATIENT BY A LONGER ANESTHESIA DURATION, A LONGER PROCEDURE

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

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A PATIENT SIDE MANIPULATOR (PSM) WAS NOT FREE TO MOVE MESSAGE. THE TECHNICAL SUPPORT ENGINEER (TSE) REQUESTED THE CLINICAL TERRITORY ASSOCIATE (CTA) POWER DOWN THE SYSTEM THEN EXERCISE THE PSM RANGE OF MOTION. LOGS DO NOT REFLECT ANY RELATED INFORMATION. CTA DID NOT OFFER THE STEPS TO THE SURGEON AS THE SURGEON ELECTED TO CONVERT TO OPEN. CTA REPORTS THAT PRIOR TO CALLING NONE OF THE TROUBLESHOOTING STEPS SHE TOOK WITH THE CUSTOMER WORKED, TO INCLUDE: RESEATING THE INSTRUMENT, RESEATING THE STERILE ADAPTER, UNDOCKING AND REDOCKING THE ARM AND HARD POWER CYCLE. CTA DID NOT STATE THEY INSPECTED THE ARM FOR OBSTRUCTION OR THE PROPER ORIENTATION OF THE STERILE ADAPTER WHEELS. THE PROCEDURE WAS CONVERTED TO OPEN WITH NO REPORTED INJURY.

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 THE NEUROLOGIST NOTED THAT MERGE SEEMED INACCURATE WHILE CONFIRMING PLAN, REQUIRED RE-MERGE OF IMAGING. DELAY OF 30 MINUTES.

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: 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: 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 THYROIDECTOMY SURGICAL PROCEDURE, THE HARMONIC INSERT WAS USED TO DISSOCIATE TISSUE. THE CUSTOMER THEN STATED THAT THE TEFLON PAD FELL OFF BUT ALLEGEDLY THERE WAS NO REPORT OF FRAGMENT(S) FALLING INSIDE THE PATIENT. THE PROCEDURE WAS CONVERTED TO OPEN/LAPAROSCOPIC SURGERY WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CUSTOMER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER CONFIRMED THAT THE TEFLON PAD FELL INSIDE THE PATIENT. THE CUSTOMER IN UNSURE IF THE INSTRUMENT WAS INSPECTED PRIOR TO USE. THE INSTRUMENT WAS USED TO RETRACT TISSUE. THERE WERE NO FUNCTIONALITY ISSUES WITH THE INSTRUMENT. THE INSTRUMENT WAS REMOVED FROM THE ARM BEFORE THE BREAKAGE AND THE SURGEON EXPERIENCE NO ISSUES WITH REMOVING THE INSTRUMENT FROM THE ARM. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIAL. THE FRAGMENT WAS RETRIEVED WITH A LAPAROSCOPIC INSTRUMENT DURING THE SAME PROCEDURE. THE CUSTOMER DID NOT PERFORM AN ADDITIONAL SURGICAL PROCEDURE TO REMOVE THE FRAGMENT. THERE WERE NO POST-OPERATIVE TESTS PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE PATIENT DID NOT RETURNED TO TH

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING REVIEW OF A LITERATURE ARTICLE INVOLVING DA VINCI ASSISTED ROBOTIC PROCEDURES TITLED, ¿SINGLE-PORT ROBOT ASSISTED PARTIAL NEPHRECTOMY: INITIAL EXPERIENCE AND TECHNIQUE WITH THE DA VINCI SINGLE-PORT PLATFORM (IDEAL PHASE 1)¿ THE FOLLOWING EVENTS WERE REPORTED. ONE PATIENT EXPERIENCED AN INTRA-OPERATIVE "MILD LIVER CAPSULE INJURY." DESPITE THIS EVENT, THE ARTICLE STATES THAT NO INTRA-OPERATIVE COMPLICATIONS OCCURRED, AND THERE WERE NO PROCEDURE CONVERSIONS. ADDITIONALLY, TWO PATIENTS EXPERIENCED POST-OPERATIVE RETROPERITONEAL HEMATOMAS WHICH WERE TREATED WITH SELECTIVE EMBOLIZATION.

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 PROSPECTIVE IRIS STUDY ROBOTIC PARTIAL NEPHRECTOMY ON (B)(6) 2021, THE PATIENT PRESENTED WITH PRE-SYNCOPAL SYMPTOMS ON (B)(6) 2021. THE PATIENT¿S ¿HEMATOCRIT (HCT) DROPPED FROM 41 TO 25, COMPUTED TOMOGRAPHY (CT) A/P¿ INDICATING A CONCERN FOR BLEEDING AT THE SURGICAL SITE. THE PATIENT UNDERWENT ¿IR COIL EMBOLIZATION OF THE RIGHT RENAL ARTERY PSEUDOANEURYSM¿ (B)(6) 2021 AND TOLERATED THE PROCEDURE WITH NO IMMEDIATE COMPLICATIONS. THE PATIENT WAS ADMITTED TO THE HOSPITAL THEN DISCHARGED ON (B)(6) 2021. ON (B)(6) 2021, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: IT WAS CONFIRMED THAT THERE WERE NO REPORTED INTRA-OPERATIVE COMPLICATIONS AND NO ISSUES WITH IRIS MEDICAL IMAGING. DUE TO THE POST-PROCEDURE COMPLICATIONS, THE PATIENT WAS ADMINISTERED AN UNSPECIFIED AMOUNT OF BLOOD BY TRANSFUSION. IT WAS CONFIRMED THAT THE SURGEON VERBALLY STATED, AND DOCUMENTED IN THE ELECTRONIC DOCUMENTATION (EDC), THAT THERE IS NO ALLEGATION OF A MALFUNCTION OF A DA VINCI PRODUCT AND NO ALLEGED CAUSAL RELATIONSHIP BETWEEN THE IRIS STUDY AND THE PATIENT¿S POST-OPERATIVE BLEEDING COMPLICATION AND SUBSEQUENT BLOOD TRAN

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON 03/26/2021, IT WAS REPORTED THAT MAJOR BLEEDING WAS DISCOVERED IN A PATIENT SIX HOURS AFTER A MONARCH-ASSISTED BRONCHOSCOPIC PROCEDURE. THE LOCATION OF THE TARGET WAS THE RIGHT UPPER LOBE. THE POST PROCEDURE COMPUTED TOMOGRAPHY SCAN SHOWED A LARGE RIGHT SIDED PLEURAL EFFUSION AND A DROP IN HEMOGLOBIN THAT PROMPTED A RIGHT THORACOTOMY WITH EVACUATION OF THE HEMOTHORAX AND A RIGHT UPPER LOBE WEDGE RESECTION. NO OBVIOUS SITE OF THE BLEEDING WAS FOUND INTRAOPERATIVELY. THE PHYSICIAN BELIEVED THAT THE CAUSE OF THE BLEEDING WAS THE MASS ITSELF. THE PATIENT WAS NOT ON ANTICOAGULANTS AND THE BIOPSY POSSIBLY PRECIPITATED THE BLEEDING. THIS ADVERSE EFFECT IS RELATED TO THE PROCEDURE AND IS A RECOGNIZED OUTCOME OF A BRONCHOSCOPIC GUIDED LUNG BIOPSY. CONTRIBUTING FACTORS ARE THAT THE LESION WAS FOUND TO BE ADENOCARCINOMA AND MORE PRONE TO BLEEDING THAT NORMAL LUNG TISSUE. THE PATIENT DID REQUIRE A FOUR-UNIT BLOOD TRANSFUSION AND WAS DISCHARGED ON (B)(6) 2021.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE SURGEON HAS TWO EVENTS RESULTING FROM IMPLANTED SCREWS NOT ACHIEVING THEIR PLANNED TRAJECTORY. LEFT L4 BREACHED LATERALLY AND RIGHT L5 BREACHED MEDIALLY. LEFT L4 BREACH ALSO CAUSED A K-WIRE TO ADVANCE BY AND PAST THE VERTEBRAL BODY. NO DAMAGE TO VERTEBRAE. SURGERY WAS EXTENDED IN ORDER TO REDIRECT THE AFFECTED SCREWS AND DIRECT THEM USING STANDARD TECHNIQUE TO ACCEPTABLE TRAJECTORIES. NO AFTER EFFECTS KNOWN.

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 SURGERY, AFTER TWO BIOPSY SAMPLES WERE RETRIEVED THE ROBOT CRASHED AND THE SCREEN WENT BLACK. THE ENTRY AND THE TARGET POINTS WERE LOST, THEREFORE THE USER HAD TO CREATE A NEW TRAJECTORY, WITH A SLIGHTLY DIFFERENT TARGET POINT. DUE TO THIS EVENT, THERE WAS A DELAY OVER 30 MINUTES TO THE SURGERY AND THE PATIENT RECEIVED ADDITIONAL ANESTHETICS.

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 WAS NOTED TO BE BROKEN UPON FIRING. THE CUSTOMER RETRIEVED THE TIP FROM THE BODY, AND THE NURSE CHANGED THE NEW INSTRUMENT TO FINISH THE PROCEDURE. AFTER THE PROCEDURE THE NURSE DISCARDED THE BROKEN TIP. THERE WAS NO REPORTED INJURY.

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 PROCEDURE ON AN UNKNOWN EVENT DATE, THE MONOPOLAR CURVED SCISSOR (MCS) INSTRUMENT TIP COVER ACCESSORY FELL INSIDE THE PATIENT WHILE THE CUSTOMER WAS REMOVING THE INSTRUMENT THROUGH THE TROCAR. THE ITEM WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2021, IT WAS REPORTED THAT DURING A MONARCH-ASSISTED BRONCHOSCOPY PROCEDURE, THE PATIENT EXPERIENCED A PNEUMOTHORAX. THE LOCATION OF THE TARGET AND PNEUMOTHORAX WERE IN THE ANTERIOR SEGMENT OF THE RIGHT UPPER LOBE. A CHEST TUBE WAS PLACED IN THE PATIENT AND THE PATIENT WAS HOSPITALIZED. AFTER BEING ADMITTED, THE PATIENT SUBSEQUENTLY BECAME SEPTIC, WAS DIAGNOSED WITH TUBERCULOSIS, AND REQUIRED CARE IN THE MEDICAL INTENSIVE CARE UNIT. THE PATIENT IS REPORTED AS DOING WELL BUT HAS NOT BEEN DISCHARGED DUE TO THEIR (B)(6) DIAGNOSIS.

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 ESOPHAGECTOMY SURGICAL PROCEDURE, ERROR 23002 OCCURRED. THE CUSTOMER INFORMED THE TECHNICAL SUPPORT ENGINEER (TSE) OF THE EVENT, AND THE TSE TRIED TO COLLECT MORE INFORMATION TO PROVIDE TROUBLESHOOTING ASSISTANCE, BUT THE NURSE STATED SHE WAS BUSY AND STATED HAD ALREADY PROVIDED THE INFORMATION TO THE FIELD SERVICE ENGINEER (FSE). THERE WAS NO REPORTED INJURY. IT WAS FURTHER REPORTED THAT ERROR 23002 OCCURRED MANY TIMES DURING THE PROCEDURE. THE ERROR WAS POINTING TO THE RIGHT MASTER TOOL MANIPULATOR (MTM). THE CUSTOMER HAD REBOOTED THE SYSTEM WITH NO RESOLVE. THE FSE SUGGESTED TO RECOVER THE FAULT AND REBOOT THE SYSTEM, BUT THE CUSTOMER STATED THAT THEY REBOOTED THE SYSTEM AND THE ISSUE PERSISTED. THE PROCEDURE WAS CONVERTED TO OPEN SURGERY WITH NO REPORTED INJURY. THE SYSTEM WAS IN USE FOR 30 MINUTES BEFORE THE PROCEDURE WAS CONVERTED. THE FSE INDICATED THAT FULL TROUBLESHOOTING WAS NOT EXHAUSTED TO ADDRESS THE REPORTED ISSUE PRIOR TO THE CONVERSION. ON 12-APRIL-2021, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION FROM THE FSE: THE REPORTED ISSUE WAS CALLED IN BY THE NURSE. THE NURSE STATED THAT

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING REAMING, THE FEMUR WAS INTERFERING WITH THE REAMER HANDLE AND THE SURGEON HAD TO PUSH HARD ANTERIOR IN ORDER TO GET POWER AND WE SAW RED IN THE POSTERIOR PORTION OF THE ACETABULUM ONCE REAMING WAS FINISHED. WHEN THE SURGEON REMOVED THE REAMER, HE DISCOVERED THAT HE HAD REAMED THROUGH THE POSTERIOR WALL. UPON REVIEWING THE PLANNED CUP, IT DID NOT SEEM PLAUSIBLE TO HAVE THAT RESULT. IT WAS THOUGHT THAT THE PERHAPS THE LEVERAGING AGAINST THE FEMUR CAUSED A MORE AGGRESSIVE POSTERIOR REAM. SURGICAL DELAY 16-30 MINUTES. CASE TYPE / APPLICATION: THA,

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 T11-L3 PSF WAS COMPLETED. THE CASE WAS MINIMALLY INVASIVE AND A SCHANZ ARM WAS USED TO MOUNT THE SURGICAL SYSTEM TO THE PATIENT. L1 WAS FRACTURED SO THE SCREWS AND RODS WERE PLACED MIS AND THEN THE PATIENT WAS FLIPPED LATERAL FOR THE CORPECTOMY. INTRA-OP IMAGES LOOKED GOOD AND PLACEMENT WAS CONFIRMED BY THE SURGEON. A FEW DAYS AFTER THE PROCEDURE, POST-OP SCANS SHOWED THAT LEFT T11 WAS LATERAL 4MM AND RIGHT T11 WAS MEDIAL BY 4 MM. THE SURGEON PLANNED TO REVISE THE SCREWS. THE CAUSE OF THE DEVIATION WAS NOT DETERMINED. THE INITIAL PROCEDURE WAS NOT DELAYED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED THYROIDECTOMY SURGICAL PROCEDURE, THE HARMONIC ACE WAS NOTED TO BE BROKEN UPON FIRING. THE CUSTOMER RETRIEVED THE TIP FROM THE BODY, AND THE NURSE CHANGED THE NEW INSTRUMENT TO FINISH THE PROCEDURE. AFTER THE PROCEDURE THE NURSE DISCARDED THE BROKEN TIP. THERE WAS NO REPORT OF FRAGMENT(S) FALLING INSIDE THE PATIENT. THERE WAS NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CUSTOMER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE REPORTED PRODUCT WAS INSPECTED PRIOR TO USE. THE INSTRUMENT WAS USED FOR 30 MINUTES AND BROKE UPON FIRING THE INSTRUMENT. SITE CONFIRMED A FRAGMENT OF THE HARMONIC INSERT BROKE IN THE PATIENT AND THE ASSISTANT RETRIEVED THE FRAGMENT FROM THE PATIENT'S BODY. IT IS UNKNOWN IF THE INSTRUMENT COLLIDED WITH OTHER INSTRUMENTS OR OTHER HARD MATERIAL DURING THE PROCEDURE. NO POST-OPERATIVE TESTS WERE PERFORMED TO CHECK FOR ANY REMAINING FRAGMENTS. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT. NO INFORMATION WERE PROVIDED PERTAINING TO THE PATIENT'S PRE-EXISTING MEDICAL CONDITIONS AND RELEVANT TESTS/

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 HARMONIC ACE BROKE APART. PIECES FELL INSIDE THE PATIENT BUT THE SURGEON WAS ABLE TO RETRIEVE ALL OF THE PIECES. THE SITE STATED THAT THEY HAD THREE DIFFERENT OPERATING ROOM STAFF CONFIRM THAT ALL OF THE PIECES WERE REMOVED FROM THE PATIENT, MATCHED UP, AND NO SMALL FRAGMENTS BROKE OFF. NO POST-OP X-RAY WAS COMPLETED. THEY REPLACED THE HARMONIC INSTRUMENT WITH A DIFFERENT HARMONIC TO COMPLETE THE PROCEDURE. 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 INITIALLY REPORTED THAT DURING A DA VINCI-ASSISTED PARTIAL RETROPERITONEAL NEPHRECTOMY PROCEDURE, A TIP COVER ¿SPLIT¿ ON THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WHICH RESULTED IN AN, ¿INVERTED BLEED FROM AN ARTERY¿. TO RESOLVE THE ISSUE, THE SURGEON CONVERTED THE PROCEDURE TO OPEN SURGERY TO CONTROL THE BLEEDING. THE PATIENT WAS REPORTED AS BEING IN STABLE CONDITION FOLLOWING THE PROCEDURE. ON 15-MAR-2021, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: DURING A DA VINCI-ASSISTED PARTIAL RETROPERITONEAL NEPHRECTOMY PROCEDURE, AN ¿MCS TIP COVER WAS TORN AT SOME POINT DURING THE PROCEDURE AND NOBODY NOTICED IT¿. THE SITE BELIEVED THAT THERE WAS ARCING THAT CAUSED, ¿EXCESSIVE BLEEDING TO AN UNSPECIFIED ARTERY WHICH REQUIRED A BLOOD TRANSFUSION¿, UNKNOWN AMOUNT, AND THE PROCEDURE CONVERTED TO OPEN SURGERY. THE SURGEON DID NOT KNOW WHERE THE BLEEDING WAS COMING FROM AND DID NOT KNOW WHAT CAUSED THE BLEEDING. THE DA VINCI-ASSISTED PARTIAL NEPHRECTOMY PROCEDURE CONVERTED TO OPEN RADICAL NEPHRECTOMY SURGERY. THE OPEN PROCEDURE COMPLETED. THE PATIENT WAS DESCRIBED AS DOING WELL POST-OPERATIVELY. INTUITIVE SURGICAL, INC

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 AFTER COMPLETION OF A DA VINCI-ASSISTED TOTAL BENIGN HYSTERECTOMY PROCEDURE, THERE WAS A ¿PORT SITE TROCAR BURN¿. THE ISSUE WAS FOUND WHEN UNDOCKING THE SYSTEM ARM AND THE SURGEON STARTED TO ¿SUTURE-CLOSE¿ THE PORT SITE. THE BURN WAS IN THE SHAPE OF A CIRCLE ABOUT 2MM WIDE ALL AROUND THE PORT SITE. THE SURGEON EXCISED THE BURNT SKIN AND SUTURED THE PORT SITE. THE PROCEDURE WAS REPORTEDLY COMPLETED ROBOTICALLY. ON (B)(6) 2021, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE SURGEON REPORTEDLY DID NOT KNOW WHAT CAUSED THE ISSUE TO OCCUR, BUT THE SURGEON DID STATE THAT ALL INSTRUMENTS WORKED AS EXPECTED AND AS INTENDED BUT THEN NOTICED THE PORT SITE TISSUE BURN AND COULD NOT EXPLAIN WHAT CAUSED IT. THE PORT IN WHICH THE SYNCHROSEAL (SS) INSTRUMENT WAS USED WAS UNKNOWN. IT WAS ALSO UNKNOWN WHICH PORT SITE WAS INVOLVED WITH THE EVENT. WHILE THE SEVERITY OF THE PORT SITE BURN WAS UNKNOWN, THE BURN WAS DESCRIBED AS ¿A DARK CIRCLE OF BURNT SKIN AROUND ONLY ONE OF THE PORT SITES AND IT WAS ABOUT 2MM WIDE¿ FOR WHICH THE SURGEON ¿EXCISED THE BURNT SKIN AND SUTURED THE PORT SITE AS USUAL¿. THE PROCEDURE WAS COM

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

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: WE HAD A DIFFICULT TIME REGISTERING TODAY. WE USED THE MEDTRONIC BONE FIDUCIALS WITH AN OMNITOM CT SCANNER. THE FIDUCIALS WERE DIFFICULT TO DEFINE ON THE CT SCAN SO WE ENDED UP USING 4 FIDUCIALS AND WERE STILL UNABLE TO GET UNDER 1MM OF ACCURACY. THE SURGEON WANTED TO MOVE FORWARD WITH A 1.25MM RNS. THE VERIFICATION LOOKED GOOD THOUGH. WE ALSO HAD A RANDOM SHUTDOWN WHILE SITTING ON TRAJECTORY AND WERE FORCED TO DO A FULL SHUTDOWN AND REDRIVE TO THE TRAJECTORY. THE REGISTRATION DIFFICULTY CAUSED ABOUT A 30MIN DELAY IN SURGERY. THE FULL SHUTDOWN WAS ABOUT 8 MINUTES TO REDRIVE TO THE TRAJECTORY.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REPORTEDLY, THE ISO CENTRIC POINT CALIBRATION METHOD FOR THE ENDOSCOPIC MODE HAS CHANGED WITH THE RECENT SOFTWARE UPDATE. THEREFORE THE SURGEON DID NOT SET UP THE ISOCENTRIC POINT ON THE ENDOSCOPE BEFORE SENDING THE ROBOT ARM TO TRAJECTORY AND DID NOT ANTICIPATE THE ROBOT ARM TRAJECTORY. THE ENDOSCOPIC SHEATH WAS BEND BY THE ROSA ONE DEVICE . THE SURGERY WAS REVERTED TO TRADITIONAL SURGERY FOLLOWING THIS EVENT.