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 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 RADICAL WITH LYMPHADENECTOMY PROSTATECTOMY SURGICAL PROCEDURE, THE CUSTOMER CALLED IN TO REPORT THAT THEY TRIED TO CONNECT A SCISSOR ON THE UNIVERSAL SURGICAL MANIPULATOR (USM) 4 AND THE ERROR 32098 APPEARED. THE CUSTOMER TRIED DISCONNECTING THE INSTRUMENT AND CONNECTING IT BACK AGAIN BUT THERE WAS NO IMPROVEMENT. THEY REBOOTED AND HARD POWER CYCLED THE SYSTEM SEVERAL TIMES WITH NO SUCCESS. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) TRIED CHECKING ERROR LOGS, BUT THE SYSTEM WAS NOT CONNECTED TO ONSITE. THE TSE ASKED THEM IF THEY COULD DISABLE THE USM AND USE THE OTHER THREE ARMS, WHICH WAS THE CASE. THE TSE EXPLAINED THAT USM 4 WOULD NOT BE USABLE AND ASKED THEM IF THEY COULD CONTINUE SURGERY WITH ONLY THREE ARMS. THE CUSTOMER EXPLAINED THAT THEY WOULD TRY TO FINISH THE PROCEDURE WITH THREE ARMS BUT WOULD LIKE IT TO BE FIXED BEFORE THE SURGERY TOMORROW MORNING. THE OPERATING ROOM (OR) SUPERVISOR CALLED BACK TO REPORT THAT THE SURGEON DECIDED TO CONVERT TO LAPAROSCOPIC SURGERY. SHE ALSO STATED THAT THE INTERNET CONNECTION WAS RESTORED. THE TSE CONFIRMED ERROR 32098 POINTING TO USM 4. THE PROCEDURE WAS CONVERTED

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A LITERATURE ARTICLE DESCRIBED A STUDY THAT AIMED TO ASSESS THE SAFETY AND QUALITY EVENT OF THE DA VINCI SINGLE-PORT (SP) ROBOTIC SYSTEM IN RIGHT SEGMENTAL COLECTOMIES AMONG ADULT PATIENTS VERSUS THE PROCEDURES PERFORMED WITH MULTIPORT DA VINCI SYSTEMS. FIVE RIGHT COLECTOMIES WERE PERFORMED IN ADULT PATIENTS USING THIS DA VINCI-SP SYSTEM BETWEEN MAY 2022 AND NOVEMBER 2022, AND WERE COMPARED TO 25 PATIENTS THAT UNDERWENT RIGHT COLECTOMIES USING THE MULTIPORT DA VINCI SYSTEM BETWEEN JANUARY 2019 AND DECEMBER 2022. ALL PROCEDURES WERE COMPLETED WITHOUT REQUIRING CONVERSION TO OPEN SURGERY. IN THE MULTI-PORT GROUP, TWO PATIENTS REQUIRED INTRAOPERATIVE BLOOD TRANSFUSIONS. ONE PATIENT REQUIRED TIME IN THE INTENSIVE CARE UNIT (ICU) AND THEREFORE HAD A PROLONGED LENGTH OF STAY. ANOTHER PATIENT HAD A POSTOPERATIVE BLOOD TRANSFUSION BECAUSE OF ANASTOMOTIC SITE BLEEDING. THERE WERE NO SPECIFIC DA VINCI DEVICE MALFUNCTIONS REPORTED OR ALLEGED. MULTIPLE REQUESTS FOR ADDITIONAL INFORMATION FROM THE DESIGNATED AUTHOR WERE MADE, BUT NO RESPONSE 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 CHOLECYSTECTOMY SURGICAL PROCEDURE, A SMALL CIRCULAR PART ON THE JAWS OF THE SYNCHROSEAL INSTRUMENT FELL OUT. A FRAGMENT FELL INTO THE PATIENT AND WAS RETRIEVED DURING THE SAME SURGICAL PROCEDURE. THE PROCEDURE WAS COMPLETED AS PLANNED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION: DISSECTING WAS BEING PERFORMED WHEN THE DEVICE FRAGMENT FELL INTO THE PATIENT. THE SURGEON BELIEVES THE INSTRUMENT BREAK WAS CAUSED BY A DEFECTIVE INSTRUMENT. THE INSTRUMENT WAS IN USE 30 SECONDS PRIOR TO THE ISSUE. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE SURGICAL PROCEDURE. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIAL DURING THE SURGICAL PROCEDURE. THE INSTRUMENT DID NOT FALL INTO THE PATIENT DURING AN INSTRUMENT TIP / ACCESSORY COLLISION. THE INSTRUMENT WAS NOT REMOVED DURING THE PROCEDURE (PRIOR TO THE BREAKAGE). THE SURGICAL STAFF DID NOT FEEL ANY RESISTANCE UPON REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA. UPON FINAL REMOVAL OF THE INSTRUMENT, THE WRIST WAS STRAIGHTENED. THE SURGICAL STAFF DID NOT NOTICE AN

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 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, THE HARMONIC ACE INSTRUMENT SHEARS HEAD WAS BROKEN. THE BROKEN PIECES WERE REMOVED AND DISCARDED. THE SURGEON WAS DISSECTING THE INSTRUMENT FOR ABOUT 30 MINUTES WHEN THE ISSUE WAS IDENTIFIED. THE CUSTOMER DID NOT IDENTIFY ANY ISSUES WITH THE INSTRUMENT'S FUNCTIONALITY DURING THE SURGICAL PROCEDURE. THE CUSTOMER RETRIEVED THE BROKEN PIECE(S), AND NO X-RAY OR ULTRASOUND WAS PERFORMED. THE PROCEDURE WAS COMPLETED ROBOTICALLY. THE PATIENT DID NOT RETURN TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LIVER RESECTION SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT WAS NOT ABLE TO DELIVER ENERGY WHEN ACTIVATED BY THE SURGEON AT THE SURGEON SIDE CONSOLE (SSC). THE CUSTOMER RESEATED THE ENERGY CABLE THREE TIMES, BUT THE ISSUE REMAINED. THE PROCEDURE WAS CONVERTED TO OPEN. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PATIENT WAS CONVERTED TO OPEN DUE TO THE HARMONIC ACE NOT FUNCTIONING. IT WAS A LIVER TRANSPLANT SURGERY. THERE WAS NO INJURY REPORTED.

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 DISTAL GASTRECTOMY SURGICAL PROCEDURE THE TISSUE PAD OF THE HARMONIC ACE INSTRUMENT BECAME DISLODGED DURING THE PROCEDURE. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A BACKUP INSTRUMENT. INTUITIVE RECEIVED THE FOLLOWING ADDITIONAL INFORMATION VIA FOLLOW-UP: THE FRAGMENT FELL WHEN THE SURGEON WAS TREATING THE GREATER CURVATURE SIDE OF THE STOMACH, DURING THE FIRST FIRE. IT REPORTEDLY FELT LIKE POWDER WAS FLYING AROUND. THE SURGEON PICKED UP THE FRAGMENT, WRAPPED IT IN GAUZE, AND REMOVED IT. THE HARMONIC ACE INSTRUMENT WAS IMMEDIATELY REPLACED WITH A NEW ONE, AND THE SURGERY WAS COMPLETED WITHOUT ANY PROBLEMS. THE INSTRUMENT DID NOT HAVE ANY COLLISIONS AND DID NOT APPEAR TO HAVE ANY OPERATIONAL PROBLEMS BEFORE THE REPORTED ISSUE OCCURRED. THE INSTRUMENT HAD NOT BEEN REMOVED PRIOR TO THE BREAKAGE. UPON FINAL REMOVAL OF THE INSTRUMENT, THE WRIST WAS STRAIGHTENED. NO RESISTANCE WAS FELT THROUGH THE CANNULA. NO DAMAGE WAS NOTICED TO THE CANNULA. NO ADDITIONAL INSTRUMENT DAMAGE WAS FOUND. THERE WERE NO ADDITIONAL PROCEDURES PERFORMED, NOR TESTING, DUE TO THE ISSUE. THE PATIENT HAS NOT RETURNED TO T

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL SALVAGE PROSTATECTOMY SURGICAL PROCEDURE, A SURGEON CALLED IN AFTER PORT PLACEMENT AND BEFORE INSTALLING ANY INSTRUMENT TO REPORT THAT THE RIGHT EYE ON THE SURGEON CONSOLE (SSC) WAS BLACK. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) ASKED IF ICONS WERE DISPLAYED, WHICH WAS NOT THE CASE. THE SURGEON WAS VERY NERVOUS AND WANTED TO HAVE AN IMMEDIATE SOLUTION. THE TSE GUIDED THE SURGEON TO CHECK BOTH VIDEO CHANNELS ON THE TSC (TOUCHSCREEN): BOTH EYES WERE DISPLAYING PROPERLY. THE TSE GUIDED THE SURGEON TO PERFORM A HARD POWER CYCLE OF THE SSC, UNPLUGGING THE SSC POWER CORD FROM THE WALL FOR 1 MINUTE, AND, JUST IN CASE, RESEATING THE SSC BFC (BLUE FIBER CABLE). THIS DID NOT BRING ANY IMPROVEMENT. THE TSE GUIDED THE SURGEON TO CHANGE THE HIGH-RESOLUTION STEREO VIEWER (HRSV) POSITION, EXTREME UP, AND EXTREME DOWN: THIS DID NOT HAVE ANY IMPACT EITHER. LIVE LOGS WERE CLEAN. THE SURGERY WAS POSTPONED. THE PROCEDURE WAS ABORTED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYSTEM'S FUNCTIONALITY WAS INSPECTED WHEN IT WAS POWERED ON. NO ERR

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A LITERATURE ARTICLE THAT DESCRIBED A STUDY THAT PROSPECTIVELY COLLECTED MEDICAL RECORDS OF 429 PATIENTS WHO UNDERWENT ROBOT-ASSISTED RADICAL PROSTATECTOMY (RARP) BETWEEN JANUARY 2015 AND OCTOBER 2023 USING THE SINGLE-PORT (SP) OR MULTI-PORT DA VINCI SYSTEM BY A SINGLE EXPERIENCED ROBOTIC SURGEON. THERE WERE NO CONVERSIONS TO OPEN SURGERY MENTIONED IN THE ARTICLE. THERE WAS ONE INTRAOPERATIVE COMPLICATION IN THE SP-RARP COHORT. THE INTRAOPERATIVE COMPLICATION OCCURRED DURING THE TRANSVESICAL (TV) RARP IN A PATIENT WITH A HISTORY OF A HOSTILE ABDOMEN. THERE WAS A SMALL ENTEROTOMY DURING THE INITIAL BLADDER ENTRY, WHICH WAS PROMPTLY IDENTIFIED AND REPAIRED PRIMARILY USING INTERRUPTED LEMBERT PERMANENT SUTURES BY GENERAL SURGERY. 23 PATIENTS REQUIRED RE-ADMISSION AFTER THE PROCEDURE, AND THE MAJORITY OF THE READMISSIONS IN THE SP COHORT WERE DUE TO POSTOPERATIVE FLUID COLLECTIONS THAT REQUIRED PERCUTANEOUS DRAINAGE. THE DRAINAGES WERE IDENTIFIED TO BE POSTOPERATIVE SEROUS COLLECTION AND NOT LYMPHOCELES. THERE WERE NO SPECIFIC DA VINCI DEVICE MALFUNCTIONS REPORTED, NOR DID THE AUTHOR ALLEGE THAT INTUITIVE SURGICAL INC. (ISI) PRODUCTS CAUSED OR CONTRIBUTED TO THE EVENT. MULTIPLE REQUEST

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, A PIECE FROM THE INSIDE OF THE UNIVERSAL SEAL HAD BROKEN OFF AND FALLEN INSIDE THE PATIENT'S ANATOMY. THE PROCEDURE WAS COMPLETED AS PLANNED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE REPORTED EVENT OCCURRED AT THE BEGINNING OF THE SURGICAL PROCEDURE. THE UNIVERSAL SEAL DID NOT COLLIDE WITH ANY OTHER INSTRUMENT OR HARD MATERIAL DURING THE SURGICAL PROCEDURE. FRAGMENTS DID NOT FALL INSIDE THE PATIENT DURING AN INSTRUMENT TIP OR ACCESSORY COLLISION. THE UNIVERSAL SEAL WAS NOT REMOVED DURING THE SURGICAL PROCEDURE PRIOR TO THE BREAKAGE. THERE WAS NO SURGICAL RESISTANCE, DAMAGE TO THE CANNULA, AND NO ADDITIONAL DAMAGE UPON REMOVAL OF THE UNIVERSAL THROUGH THE CANNULA. THE SURGICAL STAFF CONFIRMED THAT ALL FRAGMENTS HAD BEEN RETRIEVED BY VISUAL INSPECTION AND MANUALLY PLACING THE FRAGMENTS TOGETHER. THERE WAS NO ADDITIONAL SURGICAL PROCEDURE THAT WAS REQUIRED TO BE PERFORMED TO REMOVE THE FRAGMENT. THERE WERE NO POST OPERATIVE TESTS THAT WERE PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING 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 REPORTED THAT DURING A DA VINCI ASSISTED PROSTATECTOMY, THE NURSE CALLED THE TECHNICAL SUPPORT ENGINEER (TSE) AND STATED THE IMAGE FROM THE ENDOSCOPE WAS FLICKERING ON THE VISION SIDE CART (VSC) AND THE SURGEON SIDE CONSOLE (SSC) AND THAT THIS IS THE THIRD ENDOSCOPE WITH THIS ISSUE. THE TSE ADVISED TO CLEAN THE ENDOSCOPE CONTROLLER (EC) AND CAMERA CONNECTOR WITH ETHANOL AFTER PROCEDURE, BUT THE NURSE INSISTED ON CLEAN THE EQUIPMENT WHILE PROCEDURE WAS ONGOING. AFTER THE CLEANING THE IMAGE WAS BETTER BUT STARTED TO FLICKER AGAIN AFTER A FEW SECONDS. UNRELATED TO THE IMAGE ISSUE, THERE WAS UNCONTROLLABLE BLEEDING AND THE SURGEON DECIDED TO CONVERT TO OPEN SURGERY TO ACHIEVE HEMOSTASIS. NO ADDITIONAL CLEANING OF EC AND CAMERA WAS PERFORMED. IT WAS LATER CLARIFIED IN FOLLOW UP WITH THE CLINICAL SALES REPRESENTATIVE (CSR), THAT THE PROCEDURE WAS CONVERTED BECAUSE THERE WAS NO RELIABLE ENDOSCOPE AVAILABLE, AND THE ISSUE COULDN¿T BE RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INTRAOPERATIVE COMPLICATION OR UNCONTROLLABLE BLEEDING AND THAT THIS WAS PURELY A TECHNICAL PROBLEM.

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 BROKE. A FRAGMENT FROM THE INSTRUMENT FELL INSIDE THE PATIENT BUT WAS IMMEDIATELY RETRIEVED DURING THE SAME SURGICAL PROCEDURE. HEAD BROKE. THE USER COMPLETED THE PROCEDURE ROBOTICALLY USING A BACKUP HARMONIC ACE INSTRUMENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND THERE WAS NO INSTRUMENT COLLISION.

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 HEAD BROKE. IT IS UNCLEAR IF A FRAGMENT FELL INSIDE THE PATIENT. HOWEVER, THE CUSTOMER REPORTED THAT THE FRACTURED PART WAS COMPLETELY REMOVED AND NO FRAGMENT REMAINED IN PATIENT. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH A BACKUP HARMONIC ACE INSTRUMENT.

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 HARTMANN'S PROCEDURE THAT THE ENDOSCOPE HAD A FOGGY IMAGE. THE PROCEDURE WAS REPORTEDLY CONVERTED TO AN OPEN 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 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 AFTER A DA VINCI-ASSISTED NIPPLE SPARING MASTECTOMY PROCEDURE, THE PATIENT EXPERIENCED AN EXPANDING RIGHT BREAST HEMATOMA AND REQUIRED RE-OPERATION THE SAME DAY. THE RE-OPERATION INCLUDED A RIGHT BREAST RE-EXPLORATION, WASHOUT, AND TISSUE EXPANDER IMPLANT PLACEMENT AND UPSIZE. THE PATIENT WAS DISCHARGED ON POST-OPERATIVE DAY ONE WITHOUT COMPLICATIONS.

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 A PATIENT WHO WAS ENROLLED IN A STUDY UNDERWENT A DA VINCI-ASSISTED NIPPLE SPARING MASTECTOMY, RECEIVED AN INTRA-OPERATIVE "INDIRECT" THERMAL INJURY FROM USING THE BIPOLAR CAUTERY IN THE BREAST ENVELOPE TRANSMITTING HEAT ACROSS THE DERMIS TO THE EPIDERMIS. TWO AREAS IN LATERAL LEFT BREAST WITH DESQUAMATION SECONDARY TO BIPOLAR CAUTERY WERE USED DURING SKIN FLAP DISSECTION. THE BEDSIDE ASSIST NOTED WARMTH ON THE FLAP AND BIPOLAR STOPPED FOR 1 OF 2 LESIONS. ONE 0.8 CM DIAMETER AND ONE 0.2 CM DIAMETER. ANTIBIOTIC OINTMENT WAS USED ON THE DAY OF SURGERY. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY AND CAME BACK FOR A 14-DAY VISIT WITH NO OTHER REPORTABLE ISSUES. THERE WAS NO DEVICE MALFUNCTION.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A PATIENT WHO WAS ENROLLED IN A CLINICAL STUDY UNDERWENT A DA VINCI-ASSISTED NIPPLE SPARING MASTECTOMY PROCEDURE WITH IMMEDIATE NON-ROBOTIC RECONSTRUCTION. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS AND THE PATIENT WAS DISCHARGED THE SAME DAY. THERE WAS NO DEVICE MALFUNCTIONS REPORTED DURING THE PROCEDURE. THREE WEEKS LATER, THE PATIENT SHOWED SIGNS OF CELLULITIS AND ANTIBIOTICS WERE GIVEN. THE PATIENT PRESENTED TO THE EMERGENCY ROOM (ER) FIVE DAYS LATER WITH WORSENING OF SYMPTOMS, WAS GIVEN IV ANTIBIOTICS, AND WAS DISCHARGED THE SAME WITH ORAL ANTIBIOTICS (ZYVOX). THE NEXT DAY, THE CELLULITIS PROGRESSED TO AN ABSCESS AND THE PATIENT WAS HOSPITALIZED FOR IMPLANT REMOVAL AND WASHOUT ABSCESS.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A PATIENT IN A STUDY UNDERWENT A DA VINCI-ASSISTED BILATERAL NIPPLE SPARING MASTECTOMY (NSM) SURGICAL PROCEDURE. BILATERAL INCISIONS WERE EXTENDED TO REMOVE THE SPECIMEN. BILATERAL SKIN FLAPS WERE VIABLE AT THE END OF THE NSM AND RECONSTRUCTION PROCEDURES. A ONE STAGE RECONSTRUCTION WAS PERFORMED AND BILATERAL DRAINS WERE PLACED (REMOVED 12 DAYS LATER). THE PATIENT WAS DISCHARGED THE SAME DAY. THERE WERE NO INTRA-OPERATIVE ADVERSE EVENTS AND NO DA VINCI DEVICE MALFUNCTIONS DURING THE PROCEDURE. A RETURN TO THE OPERATING ROOM FOR REMOVAL OF ANTIBIOTIC BEADS AND REPLACEMENT OF IMPLANT OCCURRED SEVEN MONTHS LATER. DURING A FOLLOW-UP VISIT THE NEXT MONTH, A RIGHT BREAST SEROMA WAS REPORTED; A PALPABLE FLUID COLLECTION ON THE RIGHT RECONSTRUCTED BREAST WAS NOTED. A RADIOLOGY VISIT WAS ORDERED FOR EVALUATION AND ASPIRATION; 142 CC OF SEROMA WERE ASPIRATED FROM THE RIGHT BREAST POCKET. NO SEQUELAE WERE NOTED. THE STUDY INVESTIGATOR REPORTED THE EVENT AS NOT A SERIOUS ADVERSE EVENT (SAE), A CLAVIEN-DINDO GRADE III, NOT RELATED TO THE DA VINCI STUDY DEVICE, NOT RELATED TO THE NSM PROCEDURE, NOT RELATED TO THE RECONSTRUCTION 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: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL SALVAGE PROSTATECTOMY PROCEDURE, THE IMAGE OF THE SURGICAL FIELD FROZE TWICE WHILE THE SURGEON WAS DISSECTING THE ILIAC ARTERY, CAUSING AN INJURY AND BLEEDING. THE 0 DEGREE ENDOSCOPE PLUS WAS INSPECTED PRIOR TO USE AND THERE WAS NO DAMAGE OR ANYTHING OUT OF THE ORDINARY IDENTIFIED. WHEN THE IMAGE FROZE FOR APPROXIMATELY 1 MINUTE, THE SYSTEM WAS STILL DISPLAYING THE SURGICAL FIELD, BUT THE IMAGE DID NOT REACT TO THE MOVEMENT INITIATED BY THE SURGEON. THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WAS BEING USED TO DISSECT THE ILIAC ARTERY WHEN THE LOSS OF THE IMAGE OCCURRED; CAUSING THE MCS INSTRUMENT TO INJURE THE ARTERY AND BLEEDING OCCURRED. THE BLEEDING WAS UNEXPECTED, AND THE BLOOD LOSS WAS ESTIMATED TO BE APPROXIMATELY 400ML. TO RESOLVE THE BLEEDING, THE HOLE ON THE ARTERY WAS SUTURED CLOSED; THE PATIENT DID NOT REQUIRE A TRANSFUSION OF BLOOD PRODUCTS. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) WAS CALLED TO HELP TROUBLESHOOT THE ISSUE, AND UPON REVIEWING THE LOGS, A RECURRENT ERROR INDICATING AN ISSUE WITH THE 0 DEGREE ENDOSCOPE PLUS WAS OBSERVED. THE CUSTOMER INFORMED THE TSE THAT A SPARE 0 DEGRE

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT TIP COVER ACCESSORY WAS POSSIBLY LEFT IN THE PATIENT. THE CUSTOMER BELIEVED THE MCS TIP COVER ACCESSORY FELL OFF INTO THE PATIENT. THE CUSTOMER WAS NOT ABLE TO LOCATE IT INSIDE OR OUTSIDE THE PATIENT. THE CUSTOMER DID AN X-RAYS TO SEE IF THEY COULD FIND IT IN THE PATIENT. THE PROCEDURE WAS COMPLETED.

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 RIGHT HEMICOLECTOMY PROCEDURE, THE PATIENT REQUIRED A SUBSEQUENT PROCEDURE DUE TO BLEEDING. THE SURGEON INITIALLY UTILIZED THE VESSEL SEALER EXTEND (VSE) INSTRUMENT WITH AN E-100 GENERATOR. IT WAS REPORTED THAT THE E-100 GENERATOR KEPT FAULTING WITH A MESSAGE TO CHECK THE CABLE CONNECTIONS. THE CUSTOMER ALSO REPORTED BLEEDING DUE TO INTERMITTENT ENERGY FROM THE E-100 GENERATOR. THE CUSTOMER CHANGED OUT THE VSE INSTRUMENT AND POWER CYCLED THE E-100 GENERATOR BUT THE ISSUE WAS NOT RESOLVED. THE CUSTOMER THEN SWITCHED TO AN ERBE GENERATOR FOR THE REMAINDER OF THE PROCEDURE, SPECIFICALLY ON VESSELS WITHIN THE MESENTERY AND ALONG THE ILEUM. IT WAS NOTED THROUGHOUT THE PROCEDURE, THE VSE INSTRUMENT MADE THE PROPER SEALING TONES AND NO ERROR MESSAGES WERE PRODUCED. HOWEVER, THE SURGEON STATED THE SEALING TIME TOOK LONGER THAN NORMAL ON MOST SEALING ATTEMPTS. ONCE THE SEALING WAS COMPLETE, THE VESSELS LOOKED FULLY SEALED AND NO ADDITIONAL BLEEDING OCCURRED. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH NO COMPLICATIONS AND THE PATIENT WAS NOTED TO BE "DRY." WITHIN FIFTEEN MINUTES IN THE POST ANESTHESIA CARE UNIT (PACU) THE PATIENT BECAME HYPOT

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SUBTOTAL GASTRECTOMY SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT WAS NOT WORKING. THE PROCEDURE WAS COMPLETED WITH A BACKUP INSTRUMENT OF SAME KIND. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT EXHIBITED AN ENERGY OUTPUT ISSUE. THE CUSTOMER REPORTED THAT A FRAGMENT FELL INSIDE THE PATIENT AND WAS RETRIEVED USING A PROGRASP FORCEPS INSTRUMENT DURING THE SAME PROCEDURE. THE CUSTOMER VISUALLY CONFIRMED THE BROKEN PART MATCHING THE INSTRUMENT. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO RETENTION OF FOREIGN MATERIAL.

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 THAT AN INSTRUMENT BROKE IN THE PATIENT. THE CUSTOMER INQUIRED IF THE WIRES AND SHAFT OF THE INSTRUMENT COULD BE DETECTED BY X-RAY. THERE WAS NO ADDITIONAL INFORMATION PROVIDED. DESPITE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL DETAILS, THE SPECIFIC TYPE OF INSTRUMENT THAT WAS USED REMAINS UNKNOWN.

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 PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY THAT WAS INSTALLED ON AN MCS INSTRUMENT FELL OFF INSIDE THE PATIENT. THE MCS INSTRUMENT HAD REPORTEDLY BECOME STUCK AT A RIGHT ANGLE. THE MCS TIP COVER ACCESSORY WAS RETRIEVED DURING THE SAME PROCEDURE WHICH WAS COMPLETED ROBOTICALLY.

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, THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) CONTACTED THE ISI TECHNICAL SUPPORT ENGINEER (TSE) TO REPORT THAT ONE OF THE UNIVERSAL SEAL ACCESSORIES BEING UTILIZED HAD A TRIANGLE PIECE BREAK OFF THE GASKET AND FALL INTO THE PATIENT ANATOMY. THE PERFORMING SURGEON HAPPENED TO NOTICE THE FRAGMENT AND IT WAS SUBSEQUENTLY RETRIEVED AND PULLED OUT. AFTER COMPLETION OF THE PROCEDURE, THE STAFF CHECKED THE SEAL AND DISCOVERED THAT IT HAD A HOLE IN IT. NO FURTHER COMPLICATIONS OR ISSUES WERE NOTED FOLLOWING THE INCIDENT. THE CSR ADVISED THAT THE STAFF WOULD BE INFORMED TO RETAIN THE UNIVERSAL SEAL ACCESSORY FOR FURTHER RETURN AND EVALUATION. 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 INITIAL REPORTER SAID THAT THE SEAL WAS INSPECTED PRIOR TO USE, AND NO DAMAGE WAS NOTED. THE SURGICAL TASK THAT WAS BEING PERFORMED WHEN THE SEAL FRAGMENT FELL INSIDE THE PATIENT WAS INSTRUMENT REMOVAL. IT IS UNKNOWN WHAT CAUSED THE SEAL TO BREAK OR CAUSED THE FRAGME

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 AMONG 30 DA VINCI ASSISTED SINGLE PORT NIPPLE SPARING MASTECTOMIES THAT WAS A PART OF A CLINICAL STUDY, 8 PATIENTS WERE FOUND WITH THERMAL BLISTERS NEAR THE MEDIAL BREAST AREA. THE PHYSICIAN STATED THERE'S NO IMPACT ON THE PATIENT OTHER THAN COSMESIS THAT THERE WILL BE SCARS UPON HEALING. THE PROCEDURES WERE COMPLETED AS PLANNED WITHOUT DEVICE MALFUNCTION OCCURRED. THE PHYSICIAN THOUGHT THE CAUSE OF THE BLISTERS MAY BE DUE TO THE TISSUE TENSION APPLIED NEAR THE SKIN DUE TO THE NUMBER OF RETRACTION INSTRUMENTS. THE PHYSICIAN USES TWO INSTRUMENTS FOR RETRACTION IN SINGLE PORT SURGERIES, WHERE SHE USES THREE INSTRUMENTS IN MULTI-PORT SURGERIES.

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 (RADICAL EXTRAPERITONEAL WITHOUT LYMPHADENECTOMY) SURGICAL PROCEDURE, THE CUSTOMER INFORMED THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) THAT A WASHER APPROXIMATELY 5 MILLIMETERS WAS FOUND INSIDE THE PATIENT¿S ANATOMY. THE SURGEON WAS ABLE TO REMOVE THE WASHER FROM THE BODY. THE CUSTOMER STATED THAT THE MARYLAND BIPOLAR FORCEPS (MBF) INSTRUMENT WAS INSTALLED ON UNIVERSAL SURGICAL MANIPULATOR (USM) 1, 30-DEGREE ENDOSCOPE WAS INSTALLED ON USM 2, LARGE NEEDLE DRIVER (LND) WAS INSTALLED ON USM 3, AND SYNCHROSEAL INSTRUMENT WAS INSTALLED ON USM 4. THE CUSTOMER REVIEWED THE VIDEO RECORD AND CONFIRMED THAT THE SYNCHROSEAL INSTRUMENT COLLIDED WITH ANOTHER INSTRUMENT CAUSING A WASHER DETACHMENT. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE FRAGMENT WAS REMOVED USING A LAPAROSCOPIC INSTRUMENT. THE CUSTOMER REVIEWED THE VIDEO RECORD AND CONFIRMED THAT ALL FRAGMENT WAS REMOVED, AND ONLY THE WASHER FELL INTO THE PATIENT. NO ADDITIONAL SURGICAL PROCEDURE OR POST-OPERATIVE TEST WAS PERFORMED. THE NU

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 SYNCHROSEAL WASHER CAME LOOSE AND FELL INTO THE SURGICAL SITE. THE PROCEDURE WAS COMPLETED WITH 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 CHOLECYSTECTOMY SURGICAL PROCEDURE THE EDGES OF THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY WAS NOT UNIFORM. IT WAS NOT FITTING PROPERLY TO THE MCS INSTRUMENT. THE CUSTOMER STATED THIS IS A DISPOSABLE ACCESSORY AND CANNOT BE RETURNED. THE HOSPITAL HAS DISCARDED THE ACCESSORY. INTUITIVE SURGICAL, INC. FOLLOWED UP WITH THE CUSTOMER AND GATHERED THE FOLLOWING ADDITIONAL INFORMATION: THE MCS TIP COVER ACCESSORY HAD NON-UNIFORM EDGES AS VALIDATED BY THE OPERATING ROOM (OR) TEAM ONCE IT WAS OPEN FROM THE PACK. THE MCS TIP COVER ACCESSORY ALSO DID NOT FIT PROPERLY TO THE MCS, AND THE ORANGE BAND WAS PARTLY VISIBLE. THE TEAM DECIDED TO GO FORWARD WITH THE SAME MCS TIP COVER ASSUMING IT WOULD NOT DETACH FROM THE MCS. HOWEVER, THE SURGEON AND THE OR TEAM WERE QUICK TO VISUALIZE THE IMPROPER ATTACHMENT OF THE MSC TIP COVER ACCESSORY AND CHANGED IT ONCE THE DAMAGE WAS VISUALIZED AND CONFIRMED. THE DAMAGED MCS TIP COVER ACCESSORY DID FALL DURING THE SURGERY, BUT THE SURGICAL TEAM WAS VIGILANT ENOUGH TO IDENTIFY THE IMPROPER ATTACHMENT DUE TO A DEFECT IN THE MCS TIP COVER ACCESSORY. THE MCS TIP COVER ACCESSORY WAS RETRIEVED USING A LAPA

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 CHOLECYSTECTOMY SURGICAL PROCEDURE, THE CUSTOMER STATED THAT A PIECE OF SYNCHROSEAL INSTRUMENT BROKE OFF AND HAD FALLEN OFF INTO THE PATIENT. THE PIECE WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL (IS) CONTACTED THE SITE/REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THIS EVENT: THE INSTRUMENT WAS INSPECTED PRIOR TO USE BY THE NURSE. WHEN REMOVED FROM THE OUTER PACKAGING (BLISTER PACK) THERE WAS NO VISIBLE DAMAGE. THE INSTRUMENT WAS INSERTED AT THE BEGINNING OF THE PROCEDURE. AFTER 2-3 MOVEMENTS AND GRIPPING OF TISSUE, ONE OF THE COVERS OF A FALLOW CAME OFF AND FELL INTO THE PATIENT'S BODY. THE SURGEON THINKS THE REASON FOR THE FRAGMENT FALLING ISSUE IS THAT THE GRASPING OF TISSUE HAD LOOSENED THE TOP PART - NO PARTICULAR MECHANICAL DAMAGE. THE INSTRUMENT WAS IN USE PRIOR TO THE ISSUE FOR 2 TO 3 MINUTES. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE SURGICAL PROCEDURE. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIALS DURING THE SURGICAL PROCEDURE. THE FRAGMENT FELL INSID

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 DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, WHEN DISSECTING THROUGH THE ROUND LIGAMENT ON THE RIGHT SIDE OF THE UTERUS THERE WAS AN AUDIBLE SNAP/CRACK OF THE HARMONIC ACE INSTRUMENT. WHEN THE SURGEON PULLED THE INSTRUMENT BACK TO INVESTIGATE, THEY NOTICED THAT THE MOBILE BLADE OF THE INSTRUMENT WAS NO LONGER ATTACHED. THE BLADE WAS LOCATED IN THE PATIENT'S PELVIS, UNDER THE UTERUS AND REMOVED UNDER DIRECT VISION BY THE ASSISTING SURGEON AT BEDSIDE. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE. THE TECHNICIAN THAT RECEIVED THE HARMONIC ONTO THE FIELD DID NOT NOTICE ANY DAMAGE TO THE INSTRUMENT. THE ISSUE WAS IDENTIFIED DURING ROBOTIC-ASSISTED HYSTERECTOMY, WHILE THE SURGEON WAS DISSECTING THE RIGHT SIDE OF THE UTERUS. PER THE SURGEON, THE ISSUE WAS CAUSED DUE TO A MANUFACTURING ERROR. THE REPORTER EXPLAINED TO THE SURGICAL STAFF THAT HARMONIC DOES NOT HAVE A WRIST. SNAPPING THE WORKING JAW OF THE HARMONIC BY APPLYING TOO MUCH PRESSURE WHILE TRYING TO TWIST THE INSTRUMENT AT THE SAME TIME WILL RESUL

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 ISI TECHNICAL SUPPORT ENGINEER (TSE) AND REPORTED AN ISSUE WITH THE RIGHT MANIPULATOR. TSE VIEWED THE SYSTEM EVENT LOGS AND NOTICED AN ERROR 23025 POINTING AXIS 3. TSE ASKED HIM TO SHUTDOWN THE SYSTEM AND CYCLE THE SSC BREAKER. AFTER RESTARTING THE ERROR REMAINED. CALLER STATED THAT BEFORE CALLING US THEY HAVE TRIED TO RESTART WITHOUT ANY SUCCESS. TSE EXPLAINED THAT THE RIGHT MANIPULATOR WAS DOWN, AND THE SYSTEM WAS NOT USABLE ANYMORE. SURGEON DECIDED TO CONVERT TO OPEN SURGERY WITH NO REPORTED INJURY. ON JULY 19TH, 2024, INTUITIVE SURGICAL (IS) CONTACTED THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THIS EVENT: THE SURGERY WAS CONVERTED TO OPEN SURGERY. THE CONVERSION RESULTED IN AN INCREASED PORT SIZE INCISION, SPECIFICALLY A MEDIAN SCAR OF AT LEAST 10 CM. THE PATIENT DID TOLERATE THE CHANGE. HOWEVER, IT IS IMPORTANT TO NOTE THAT POSTOPERATIVE FOLLOW-UP AND FUNCTIONAL RESULTS MAY BE COMPROMISED.

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 BRANCH BROKE OFF WHILE PREPARING TISSUE FOR NO APPARENT REASON. A FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE DEVICE WAS CHECKED BEFORE USE AND THERE WAS NO DAMAGE OR ANYTHING UNUSUAL. THE FRONT OF THE DEVICE WAS DAMAGED DURING TISSUE PREPARATION. THE SURGEON BELIEVED THAT THE INSTRUMENT BROKE OR THE FRAGMENT FELL FOR NO APPARENT REASON. THE INSTRUMENT WAS IN USE FOR APPROXIMATELY 1.5 HOURS BEFORE THE PROBLEM OCCURRED. THE SURGEON DID NOT NOTICE ANY PROBLEMS WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE SURGICAL PROCEDURE. THE INSTRUMENT DID NOT COLLIDE WITH OTHER INSTRUMENTS OR HARD MATERIALS DURING THE SURGICAL PROCEDURE. NO FRAGMENTS FELL INTO THE PATIENT DURING A COLLISION BETWEEN THE INSTRUMENT TIP AND ACCESSORIES. THE INSTRUMENT WAS NOT REMOVED DURING THE PROCEDURE (BEFORE THE FRACTURE). AFTER THE FINAL REMOVAL OF THE INSTRUMENT, THE WRIST WAS EXTENDED. NO RESISTANCE WAS FELT WHEN REMOVING THE INSTRUMENT THROUGH THE CA

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT A DA VINCI ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE. ON POST-OPERATIVE DAY 10, YELLOW LIQUID WITH OBVIOUS ODOR WAS DRAWN FROM THE PRESACRAL DRAINAGE CROWN AND AN ANASTOMOTIC LEAKAGE WAS SUSPECTED BUT NOT CONFIRMED. THE PATIENT UNDERWENT A TREATMENT MODALITY OF NEGATIVE PRESSURE IRRIGATION WHICH RESOLVED THE EVENT. THE PATIENT WAS DISCHARGED ON POST-OPERATIVE DAY 18 AND THERE WERE NO ADVERSE EVENTS AT THE 30-DAY FOLLOW-UP.

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 CHOLECYSTECTOMY SURGICAL PROCEDURE, A RUBBER PIECE OF THE 8-12 MM UNIVERSAL SEAL BROKE OFF AND FELL INTO THE PATIENT. THE CUSTOMER STATED THAT THEY WERE ABLE TO REMOVE THE FRAGMENT AND CONTINUE THE PROCEDURE WITHOUT FURTHER ISSUES. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED AND THERE WAS NOTHING FOUND OUT OF THE ORDINARY. THE CUSTOMER STATED THAT THE FRAGMENT WAS RETRIEVED WITH A GRASPER INSTRUMENT. THE SURGEON SAW THE FRAGMENT FALL AND CONFIRMED THERE WAS ONLY ONE. THE PROCEDURE WAS COMPLETED ROBOTICALLY, THERE WERE NO POST OPERATIVE TESTS, AND THE CUSTOMER IS NOT AWARE OF A REPORT INDICATING THE PATIENT RETURNED DUE TO COMPLICATIONS.

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 A PATIENT ENROLLED IN A STUDY, UNDERWENT A DA VINCI-ASSISTED NIPPLE SPARING MASTECTOMY SURGICAL PROCEDURE. APPROXIMATELY THREE WEEKS LATER, HOME HEALTH VISIT NOTES INDICATE THAT DRAINS WERE REMOVED ON THE PRIOR DAY AND THAT THE PATIENT STATED FEELING PRESSURE ON THE BREAST THE NEXT DAY. THE FOLLOWING DAY, A NURSE CALL NOTED THAT THE PATIENT REPORTED THE RIGHT BREAST FELT HARDER THAN THE OTHER. A CALL WAS THEN PLACED TO THE PLASTICS NURSE PRACTITIONER (NP) WITH THE PATIENT STATING THE RIGHT BREAST FELT ENGORGED. THE PATIENT SENT PICTURES, AND THE NP DETERMINED VISUALLY THERE WERE NO ISSUES AND TO CONTINUE TO MONITOR. FOUR DAYS LATER, THE PATIENT VISITED WITH PLASTICS AND MILD ERYTHEMA TO THE RIGHT BREAST WITH A SMALL PALPABLE FLUID COLLECTION WAS OBSERVED. FIFTEEN CCS OF SEROSANGUINOUS FLUID WERE REMOVED FROM THE RIGHT BREAST AND SENT FOR CULTURE. BACTRIM WAS PRESCRIBED PROPHYLACTICALLY. SURGERY FOR EXPANDER REPLACEMENT WAS SCHEDULED AS THE INVESTIGATOR STATED THAT SHE DIDN'T WANT THE SEROMA TO GET WORSE OR BECOME INFECTED. THE TISSUE EXPANDER REPLACEMENT SURGERY OCCURRED AS PLANNED AND THE PATIENT WAS EXPANDED TO THE SIZE SHE WANTED, ELIMINATING THE NEED FOR AN

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 BLADE OF THE HARMONIC ACE INSTRUMENT BROKE WHEN THE SURGEON WAS REMOVING THE LIVER PARENCHYMA. A FRAGMENT FROM THE INSTRUMENT FELL INSIDE THE PATIENT AND IT WAS RETRIEVED DURING THE SAME PROCEDURE. THE CUSTOMER USED A BACKUP HARMONIC ACE INSTRUMENT TO CONTINUE WITH THE PROCEDURE WHICH WAS COMPLETED ROBOTICALLY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE HARMONIC ACE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENT OR OTHER HARD MATERIAL DURING THE PROCEDURE. THE CUSTOMER REMOVED THE FRAGMENT WITH ENDOSCOPIC INSTRUMENTS. ALL FRAGMENTS WERE CONFIRMED TO BE RETRIEVED BY THE ASSISTANT AND THE NURSE. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED TO REMOVE THE FRAGMENT. NO POST-OPERATIVE TEST WAS PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE FRAGMENT WAS DISCARDED WHEN THE INSTRUMENT WAS STERILIZED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A LITERATURE ARTICLE THAT DESCRIBED A RETROSPECTIVE COHORT STUDY OF 146 PATIENTS WHO UNDERWENT ROBOTIC ASSISTED PANCREATICODUODENECTOMY (RPD) FROM 2014 TO 2021 IN A HIGH-VOLUME CENTER WAS ANALYZED. MAJOR COMPLICATIONS (CLAVIEN-DINDO GRADE GREATER THAN 2) OCCURRED IN 41 PATIENTS (28 PERCENT), WHICH INCLUDED BILIARY FISTULA, CLINICALLY RELEVANT POSTOPERATIVE PANCREATIC FISTULA (CR-POPF), GASTROJEJUNOSTOMY FISTULA, INFECTION, DELAYED GASTRIC EMPTYING (DGE), AND POST PANCREATECTOMY HEMORRHAGE (PPH). AMONG THE PATIENTS THAT EXPERIENCED POST-OPERATIVE COMPLICATIONS, 23 PATIENTS REQUIRED RE-OPERATION. THE DESIGNATED AUTHOR WAS CONTACTED AND CONFIRMED THAT THERE WERE NO DA VINCI DEVICE MALFUNCTIONS IN THE PROCEDURES, NOR DID ANY ISI PRODUCTS CAUSE OR CONTRIBUTE TO THE EVENTS.

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 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 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: A LITERATURE ARTICLE THAT DESCRIBED AN OBSERVATIONAL STUDY TO EVALUATE THE OUTCOMES OF EVALUATE THE OUTCOMES OF 150 PATIENTS THAT UNDERWENT ROBOTIC PANCREATODUODENECTOMY (RPD) IN A SINGLE-CENTER SETTING, ANALYZING THE PROGRESSION OF THE PROCEDURE¿S COMPLEXITY AND COMPLICATION RATES ACROSS DIFFERENT PHASES OF THE SURGEON'S LEARNING CURVE FROM MARCH 2018 TO APRIL 2023. THE MEAN TOTAL OPERATIVE TIME WAS 402.4 MINUTES WITH A MEDIAN HOSPITAL STAY OF 7 DAYS. THE ARTICLE NOTED SEVERAL ADVERSE EVENTS DURING THESE SURGERIES. 5 PATIENTS REQUIRED CONVERSION TO OPEN SURGERY. BLOOD TRANSFUSIONS WERE GIVEN FOR 10 PATIENTS DURING HOSPITALIZATION. BIOCHEMICAL LEAKAGE WAS OBSERVED IN 42 PATIENTS, AND OVERALL COMPLICATIONS WERE REPORTED IN 30 PATIENTS. THIRTEEN PATIENTS EXPERIENCED COMPLICATIONS OF SEVERITY LEVEL IIIA OR HIGHER BASED ON THE CLAVIEN-DINDO CLASSIFICATION, WHICH INCLUDED EIGHT PATIENTS EXPERIENCED GRADE B POSTOPERATIVE PANCREATIC FISTULA (POPF) AND TWO PATIENTS WITH GRADE C POPF. ONE PATIENT EXPERIENCED WOUND INFECTIONS, AND HEMORRHAGIC COMPLICATIONS OCCURRED IN FIVE PATIENTS: TWO PATIENTS WITH BLEEDING FROM A DUODENOJEJUNOSTOMY SUCCESSFULLY CONTROLLED VIA UPPER ENDOSCOPY AND THREE PAT

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 THREE DAYS AFTER UNDERGOING A DA VINCI-ASSISTED SIGMOID COLECTOMY FOR HIS SIGMOID CANCER, THE PATIENT EXPERIENCED AN INFECTION THAT REQUIRED ANTIBIOTIC TREATMENT AND RESULTED IN A PROLONGED HOSPITALIZATION. THE DA VINCI-ASSISTED SIGMOID COLECTOMY PROCEDURE WAS COMPLETED ROBOTICALLY WITHOUT INTRA-OPERATIVE COMPLICATIONS NOR DEVICE MALFUNCTIONS REPORTED. A THIRD-PARTY 28MM GASTROINTESTINAL STAPLER WAS USED FOR THE END-TO-END ANASTOMOSIS PERFORMED DURING THE PROCEDURE. THREE DAYS LATER, THE PATIENT EXPERIENCED ABDOMINAL PAIN AND A CT-SCAN SHOWED AN ABDOMINAL INFECTION AND THE PATIENT REQUIRED CHANGE OF ANTIBIOTIC REGIMEN WHICH CEFUROXIME WAS SWITCHED TO MEROPENEM, AND INTRAMUSCULAR TRAMADOL. THE STUDY PHYSICIAN BELIEVED THE CAUSE OF THE INFECTION IS RELATED TO PATIENT'S CONDITION OF INCOMPLETE OBSTRUCTION OF THE SIGMOID COLON, INTUSSUSCEPTION AND EXCESSIVE STOOL PRE-OPERATIVELY, AS WELL AS POSSIBILITY OF ANASTOMOTIC LEAKAGE CAUSED BY EXCESSIVE STOOL INFECTION. THE STUDY INVESTIGATOR CONSIDERED THE EVENT AS NOT RELATED TO THE PROCEDURE NOR THE DEVICES.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AFTER A PATIENT, WHO WAS ENROLLED IN A CLINICAL STUDY, UNDERWENT A DA VINCI-ASSISTED NIPPLE SPARING MASTECTOMY PROCEDURE, A BIOPSY CLIP WAS REPORTED AS RETAINED IN THE PATIENT. AS A RESULT, THE PATIENT REQUIRED AN ADDITIONAL SURGICAL PROCEDURE TO RETRIEVE THE CLIP. THE INITIAL PROCEDURE WAS COMPLETED ROBOTICALLY WITHOUT COMPLICATIONS NOR DEVICE MALFUNCTIONS REPORTED. IT WAS LATER FOUND IN THE PATHOLOGY REPORT THAT THE BIOPSY CLIP WAS NOT OBSERVED IN THE SPECIMEN. THE RETRIEVAL OF THE SPECIMEN DURING THE PROCEDURE WAS REPORTED AS SMOOTH WITHOUT ISSUES. A CHEST X-RAY AND ULTRASOUND CONFIRMED THE CLIP WAS RETAINED IN THE PATIENT. AN ADDITIONAL SURGICAL EXCISION OF THE CLIP WAS REQUIRED USING WIRE LOCALIZATION. THE STUDY INVESTIGATOR ASSESSED THIS INCIDENT NOT RELATED TO THE DA VINCI DEVICES BUT RELATED TO THE PROCEDURE ITSELF.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A LITERATURE ARTICLE DESCRIBED A RETROSPECTIVE ANALYSIS OF 23 PATIENTS THAT UNDERWENT ROBOTIC-ASSISTED CYSTECTOMY WITH VARIOUS TYPES OF URINE DERIVATION OF BLADDER CANCER BETWEEN 2021 AND 2024. URINE DIVERSION BY UCS WAS PERFORMED IN 7 PATIENTS, AN ILEAL CONDUIT WAS FORMED USING THE BRICKER METHOD IN 6 PATIENTS, AND ORTHOTOPIC ILEOCYSTOPLASTY ACCORDING TO STUDER WAS PERFORMED IN 10 PATIENTS. IN THE EARLY POSTOPERA­TIVE PERIOD, COMPLICATIONS DEVELOPED IN 9 (39%) PATIENTS WITHIN 1¿16 DAYS AFTER SURGERY. IN MOST CASES, THIS WAS OBSTRUCTIVE PYELONEPHRITIS, WHICH REQUIRED PERCUTANEOUS PUNCTURE NEPHROSTOMY, WHICH CLASSIFIED AS CLAVIEN¿DINDO IIIA. NEPHROSTOMIES WERE CLOSED AFTER THE RESOLUTION OF PYELONEPHRITIS AND RESTORATION OF URINATION. IN ONE PATIENT WHO UNDERWENT CYSTOPROSTATECTOMY WITH EXTENDED PELVIC LYMPHADENECTOMY, LAPAROTOMY WAS PERFORMED ON POSTOPERATIVE DAY 2 DUE TO A DECREASE IN THE HEMOGLO­BIN LEVEL. DURING THE REVISION, DIFFUSE TISSUE HEMORRHAGE WAS DETECTED, WHICH WAS STOPPED USING HEMOSTATIC SPONGES. THERE WERE NO SPECIFIC DA VINCI DEVICE MALFUNCTIONS REPORTED, NOR DID THE AUTHOR ALLEGE THAT ISI PRODUCTS CAUSED OR CONTRIBUTED TO THE EVENT. MULTIPLE REQUESTS FOR ADDITIONA