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.

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 INSTRUMENT WAS DAMAGED AND NON-FUNCTIONAL AFTER ONE HOUR OF USE. THERE WAS ¿DEBRIS¿ LEFT IN THE PATIENT. THE ¿DEBRIS¿ WAS RETRIEVED IN THE SAME PROCEDURE AND THE HARMONIC ACE WAS REMOVED. THERE WAS 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 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: THE COMPANY REPRESENTATIVE WAS PRESENT FOR A BRAIN SURGERY CASE. AFTER GETTING THE MEASUREMENT, THE SURGEON WANTED TO BACK OUT IN AXIAL FAST. HE STARTED PEDALING THE VIGILANCE DEVICE BUT BEHIND THE PEDAL SCREEN, THERE WAS AN ERROR SAYING THAT THE ROBOT WAS IN A SINGULAR POSITION. WHEN IT GOT BACK TO THE INTERMEDIATE POSITION, THE SCREEN FROZE AT 1:12 PM. THEN THE COMPANY REPRESENTATIVE DID A HARD SHUTDOWN FROM THE MAIN POWER SWITCH AT THE BOTTOM OF THE ROBOT (THE SHUTDOWN/RESTARTS OCCURRED AT 1:17 PM/1:18 PM). THE COMPANY REPRESENTATIVE RESTARTED THE ROBOT AND IT WOULD NOT CONNECT SO WE DID A MANUAL RELEASE OF EACH PART OF THE ARM. THE COMPANY REPRESENTATIVE RESTARTED THE ROBOT AGAIN (ONLY OFF FOR 30 SEC.) AND IT WOULD NOT CONNECT. THEN, THE COMPANY REPRESENTATIVE HAD THE ROBOT UNPLUGGED FOR ABOUT 5-10 MINUTES, AND WE GOT IT TO CONNECT AND WERE ABLE TO CONTINUE ON WITH THE CASE. SURGERY DELAY WAS ABOUT 20-30 MINUTES FOR THIS COMPLAINT EVENT. THE ANESTHESIOLOGIST SAID SOME ADDITIONAL ANESTHESIA WAS GIVEN TO KEEP THE PATIENT ASLEEP.

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 ROSA SOFTWARE SHUTDOWN AFTER PERFORMING FIDUCIAL REGISTRATION, RMS 0.17. AFTER SHUTDOWN, SOFTWARE DISPLAYED INITIAL BOOT UP SCREEN. PATIENT FOLDER WAS NO LONGER VISIBLE. PATIENT FOLDER HAD TO BE RELOADED AND REGISTRATION REPERFORMED. SECOND REGISTRATION WAS DONE VIA CONTACTLESS METHOD. CASE PROCEEDED BUT HAD A SECOND SHUTDOWN DURING GUIDANCE. PATIENT FOLDER WAS STILL VISIBLE AFTER SECOND SHUTDOWN AND RECOVERING TIME WAS LESS THAN ONE MINUTE. REGISTRATION WAS STILL SAVED AND VERIFIED. CASE FINISHED WITHOUT ANY OTHER ERRORS. THERE WAS NO PATIENT IMPACT. DELAY TO CASE WAS AROUND 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: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT TIP BROKE AND FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED 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: THE CUSTOMER ELECTED TO CANCEL THE RMA FOR THIS INSTRUMENT. NO FURTHER DETAILS WERE AVAILABLE.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ABSTRACT: TO REPORT OUR EXPERIENCE USING THE SCAN-AND-PLAN WORKFLOW AND REVIEW CURRENT LITERATURE ON SURGICAL EFFICIENCY, SAFETY, AND ACCURACY OF NEXT-GENERATION ROBOT-ASSISTED (RA) SPINE SURGERY. THE RECORDS OF PATIENTS WHO UNDERWENT RA PEDICLE SCREW FIXATION WERE REVIEWED. THE ACCURACY OF PEDICLE SCREW PLACEMENT WAS DETERMINED BASED ON THE RAVI CLASSIFICATION SYSTEM. TO EVALUATE WORKFLOW EFFICIENCY, 3 DEMOGRAPHICALLY MATCHED COHORTS WERE CREATED TO ANALYZE DIFFERENCES IN TIME PER SCREW PLACEMENT (DEFINED AS OPERATING ROOM [OR] TIME DIVIDED BY NUMBER OF SCREWS PLACED). GROUP A HAD 4 SCREWS PLACED, GROUP B HAD 4 SCREWS PLACED, AND GROUP C HAD >4 SCREWS PLACED. INTRAOPERATIVE ERRORS AND POSTOPERATIVE COMPLICATIONS WERE COLLECTED TO ELUCIDATE SAFETY. EIGHTY-FOUR RA CASES (306 PEDICLE SCREWS) WERE INCLUDED FOR ANALYSIS. THE MEAN NUMBER OF SCREWS PLACED WAS 2.1 +- 0.3 IN GROUP A AND 6.4 +- 1.2 IN GROUP C; 4 SCREWS WERE PLACED IN GROUP B PATIENTS. THE ACCURACY RATE (RAVI GRADE I) WAS 98.4%. SCREW PLACEMENT TIME WAS SIGNIFICANTLY LONGER IN GROUP A (101 +- 37.7 MINUTES) THAN GROUP B (50.5 +- 25.4 MINUTES) OR C (43.6 +- 14.7 MINUTES). THERE WERE NO INTRAOPERATIVE COMPLICATIONS, ROBOT FAILU

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, A PNEUMOTHORAX WAS IDENTIFIED. THE LOCATION OF THE TARGET WAS IN THE LOWER LEFT LOBE. THE LOCATION OF THE PNEUMOTHORAX WAS IN UPPER LEFT LOBE. THE CUSTOMER DID REPORT THAT THE PATIENT WAS IN SOME PAIN. A CHEST TUBE WAS PLACED IN THE PATIENT, AND THE PATIENT WAS ADMITTED TO THE HOSPITAL. THE PATIENT WAS RELEASED FROM THE HOSPITAL ON (B)(6) 2021. IT WAS REPORTED THAT THE PATIENT IS DOING WELL.

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 TWO SOFTWARE CRASHES OCCURRED DURING A SURGERY. THIS EVENT CAUSED A 45 MINUTES DELAY BECAUSE REGISTRATION HAD TO BE PERFORMED TWICE AND THE SURGEON HAD TO REMOVE THE BIOPSY NEEDLE IN ORDER TO RESTART THE DEVICE.

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: AN O-ARM SCAN WAS TAKEN FOR MARKER/FIDUCIAL REGISTRATION. HOWEVER, THE IMAGE WOULD NOT MERGE AUTOMATICALLY ¿ THE IMAGE WAS ROTATED (MAY BE DUE TO A GANTRY TILT). THE SURGEON HAD TO MANUALLY MERGE THE IMAGE. ALSO, PRIOR TO THIS, LEKSELL FRAME REGISTRATION WAS TRIED, AND ALTHOUGH AN ERROR OF 0.39 WAS OBTAINED, WHEN THE FOREHEAD SKIN WAS CHECKED IT WAS ABOUT 1-2 MM OFF IN DEPTH SO THAT¿S WHY REGISTRATION WAS PERFORMED A SECOND TIME WITH MARKERS. THAT ERROR COULD HAVE BEEN DUE TO A MERGE ISSUE AS WELL. THE SURGEON ALSO COMPLAINED THAT THE WINDOW AND LEVEL OF THE IMAGE/BONE WINDOW COULDN'T BE CHANGED WITHIN THE MERGE SCREEN (ONLY THE TOP LEFT IMAGE) ¿THE ONLY WAY TO CHANGE WINDOW/LEVEL OF THE ORIGINAL IMAGE WAS THROUGH THE CONTRAST BUTTON IN THE REGULAR PART OF THE SOFTWARE. ALL OF THESE IMAGING ISSUES CAUSED A 1-1.5 HOUR DELAY IN THE CASE.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON 2/19/2021, IT WAS REPORTED THAT DURING A MONARCH-ASSISTED BRONCHOSCOPY PROCEDURE ON (B)(6) 2021, A PNEUMOTHORAX WAS IDENTIFIED. THE PATIENT HAD A SMALL PNEUMOTHORAX IN THE RIGHT UPPER LOBE THAT DID NOT REQUIRE INTERVENTION. THE PATIENT WAS RELEASED FROM THE HOSPITAL ON THE SAME DAY. DURING A POST-PROCEDURE FOLLOW-UP ON (B)(6) 2021, IT WAS OBSERVED THAT THE PNEUMOTHORAX HAD GROWN ABOUT 40 TO 50% FROM THE ORIGINAL SIZE. A CHEST TUBE WAS PLACED AND THE PATIENT WAS RELEASED THE SAME DAY. IT WAS REPORTED THAT THE PATIENT IS DOING FINE AND DID NOT REQUIRE ANY ADDITIONAL CARE.

Senhance — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE EVENT WAS REPORTED AS A COMPLAINT ON (B)(6) 2021. THE EVENT OCCURRED AT (B)(6) HOSPITAL, WHICH IS LOCATED IN THE (B)(6). THE EVENT INVOLVED TWO SENHANCE MANIPULATOR ARMS (X9000005, UDI: (B)(4), SERIAL NUMBERS (B)(4)) AND TWO JOHAN GRASPERS 15 MM Ø 5 MM X 310 MM (X0007005, UDI: (B)(4), LOT: 1845171). THE TIME OF OCCURRENCE WAS DURING A SURGICAL CASE AND THE SURGICAL PROCEDURE WAS FOR TREATMENT OF MALROTATION VOLVULUS. THE PATIENT WAS A (B)(6) CAUCASIAN FEMALE WITH WEIGHT OF (B)(6) AND BMI OF 29.2. THE SENHANCE SYSTEM AND ASSOCIATED DEVICES ARE NOT INDICATED FOR PEDIATRIC USE IN THE US. AS INITIALLY REPORTED BY THE COMPLAINANT, DURING THE CASE THE SMALL INTESTINE WAS PERFORATED 2 TIMES WITH THE JOHAN GRASPER. WHEN HOLDING THE TISSUE WITH THE GRASPER, THE TISSUE TURNED WHITE DUE TO THE GRASPING FORCE. AFTER STITCHING BOTH PERFORATIONS, THE SURGEON COULD CONTINUE WITH THE CASE. THE USE OF TWO JOHAN GRASPING FORCEPS CAUSED HEMATOMA OF THE SEROSA AND EVENTUALLY 2 PERFORATIONS OF THE SMALL INTESTINE. THE FOOTPRINT OF EVERY BITE WAS VISIBLE ON THE TISSUE. THE PROCEDURAL DELAY WAS LESS THAN 15 MINS. ADDITIONAL QUESTIONS WERE POSED TO FURTHER INVESTIGATE THE IMPACT ON THE PATIENT. THERE

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, ITS WAS REPORTED THAT AFTER A MONARCH-ASSISTED BRONCHOSCOPY PROCEDURE, A PNEUMOTHORAX WAS IDENTIFIED DURING POST-PROCEDURE SCREENING. INITIALLY, THE PATIENT HAD A 5 TO 10% PNEUMOTHORAX IN THE LEFT UPPER LOBE. DURING THE CASE, MONARCH FORCEPS AND MEDTRONIC ARCPOINT NEEDLE WERE USED. THE PATIENT WAS RELEASED FROM THE HOSPITAL THE SAME DAY BUT WAS ASKED TO RETURN THE FOLLOWING DAY FOR AN X-RAY. DURING THE X-RAY, IT WAS OBSERVED THAT THE PNEUMOTHORAX WAS GROWN 40 TO 50% FROM THE ORIGINAL SIZE. A CHEST TUBE WAS PLACED AND THE PATIENT WAS RELEASED THE SAME DAY. IT WAS REPORTED THAT THE PATIENT IS DOING FINE AND DID NOT REQUIRE ANY ADDITIONAL CARE OR INTERVENTION.

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 THE COMPLETION OF A DA VINCI-ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, THE SURGEON NOTICED THAT THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY WAS NOT INSTALLED ON THE MCS INSTRUMENT. THE CUSTOMER STATED THAT THE SURGEON SEARCHED FOR THE MCS TIP COVER ACCESSORY BUT COULD NOT LOCATE IT. THE CUSTOMER ALSO STATED THAT THE SURGEON INSERTED A PORT INTO THE PATIENT, CHECKED INSIDE OF THE PATIENT'S ABDOMINAL CAVITY, AND FOUND THAT THE MCS TIP COVER ACCESSORY HAD FALLEN INSIDE THE PATIENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE MCS TIP COVER ACCESSORY WAS INSPECTED PRIOR TO USE AND NO ABNORMALITIES WERE NOTED WITH IT. THE MCS TIP COVER ACCESSORY WAS NOT INSTALLED BEYOND THE ORANGE SURFACE DURING THE SURGICAL PROCEDURE. ALL PORTS HAD BEEN REMOVED FROM THE PATIENT AND THE SURGEON HAD ALREADY CLOSED THE PATIENT'S ABDOMEN AT THE TIME OF IDENTIFYING THE ISSUE. A PORT WAS RE-INSERTED INTO THE PATIENT TO RETRIEVE THE MCS TIP COVER ACCESSORY AND THE ITEM WAS RETRIEVED SUCCESSFULLY WITH NO INJURY OCCURRING TO THE PATIENT.

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 WERE DEVIATIONS DURING A L5-S1 CASE. A SCHANZ PIN WAS CONNECTED TO A SCHANZ ARM TO MOUNT THE SURGICAL SYSTEM TO THE PATIENT. THE SURGEON BEGAN WITH LEFT L5 AND LEFT S1 AND A ROD WAS INSERTED WITH NO MOVEMENT DETECTED. RIGHT L5 AND S1 TRAJECTORIES WERE COMPLETED NEXT AND A ROD WAS PLACED. THE MANUFACTURER REPRESENTATIVE NOTED THAT THE SCREW TRAJECTORIES WERE ALTERED DURING THE PROCEDURE TO ACCOMMODATE SOFT TISSUE PRESSURE. AP AND LATERAL IMAGES WERE TAKEN AND PLACEMENT WAS APPROVED BY THE SURGEON. THE DEVIATION COULD NOT BE SEEN ON THE IMAGES. AFTER THE CASE, THE PATIENT EXPERIENCE RIGHT SIDED FOOT DROP AND CHANGES IN SENSATIONS. THE SCREWS WERE REMOVED LATER IN THE DAY DUE TO BEING MISPLACED ON THE RIGHT SIDE IN THE SPINAL CANAL. THE SCREWS WERE DEVIATED BY MORE THAN 10 MM. THE PATIENT EXPERIENCED SOME RECOVERY WITH FORCED EVERSION AND SOME IMPROVEMENT IN SENSATION. THE REPRESENTATIVE SUSPECTED THE DEVIATION WAS CAUSED BY ANATOMY SHIFT, PLATFORM MOUNTING AND SOFT TISSUE PRESSURE. THE PROCEDURE WAS DELAYED MORE THAN AN HOUR.

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 TONGUE BASE RESECTION SURGICAL PROCEDURE, THE HARMONIC ACE CURVED SHEARS INSTRUMENT BLADE BROKE OFF. A BACKUP INSTRUMENT OF THE SAME TYPE WAS USED AND THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CUSTOMER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION. THE CUSTOMER REPORTED THE INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO ISSUES IDENTIFIED. THE INSTRUMENT WAS IN USE WITHOUT ISSUE FOR APPROXIMATELY 20 MINUTES FOR HEMOSTASIS WHEN THE INSTRUMENT BLADE BROKE AND 1 FRAGMENT FELL INTO THE PATIENT'S ORAL CAVITY AND WAS RETRIEVED DURING THE SAME PROCEDURE. REPORTEDLY, NO INTRAOPERATIVE COLLISIONS OCCURRED AND NO RESISTANCE WAS FELT REMOVING THE INSTRUMENT THROUGH THE CANNULA. THE CUSTOMER STATED THERE WAS NO INJURY AND THE PATIENT HAS NOT RETURNED TO THE HOSPITAL WITH ANY POST-SURGICAL COMPLICATIONS.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: SURGEON NOTED THAT TRAJECTORY PLACEMENT SEEMED INCORRECT - CONCERNED THAT EXPORT WAS INCORRECT. SURGEON RE-OPENED LAPTOP TO CONFIRM THAT TRAJECTORY PLACEMENT WAS CORRECTLY PLANNED ON PLANNING SOFTWARE. SURGEON NOTED THAT HE BELIEVED THAT PLANNING HAD NOT SAVED PROPERLY, BUT IT MIGHT BE POSSIBLE THAT HE FORGOT TO SAVE PRIOR TO EXPORT. SURGEON CONFIRMED TRAJECTORIES BEFORE PROCEEDING, DELAY 15 MINUTES.