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 REVIEW OF A LITERATURE ARTICLE "INTERIM ANALYSIS OF ROBOT-ASSISTED RADICAL HYSTERECTOMY IN JAPAN: A MULTICENTER, PROSPECTIVE INTERVENTIONAL SINGLE-ARM CLINICAL TRIAL" WAS PERFORMED. THE PURPOSE OF THIS STUDY WAS TO ASSESS THE EFFICACY AND SAFETY OF ROBOT-ASSISTED RADICAL HYSTERECTOMY (RARH) USING THE DA VINCI SURGICAL SYSTEM (DVSS) COMPARED TO CONVENTIONAL RADICAL HYSTERECTOMY (RH). A PROSPECTIVE OBSERVATIONAL STUDY WAS CONDUCTED, PERFORMING 292 RASS BETWEEN MARCH 2009 AND DECEMBER 2015. THE SURGERIES WERE PERFORMED USING THE DVSS S, SI, OR XI MODELS. THE MEAN AGE AND BODY MASS INDEX OF THE PATIENTS WERE 47 YEARS AND 22 KG/M2, RESPECTIVELY. THE ARTICLE NOTED THAT DURING THESE DV SURGERIES, SEVERAL SERIOUS ADVERSE EVENTS WERE NOTED. THE SERIOUS PERIOPERATIVE AND POSTOPERATIVE ADVERSE EVENTS OBSERVED INCLUDED URINARY TRACT, VASCULAR, INTESTINAL AND NERVE INJURIES; AND PELVIC INFLAMMATORY DISEASE (PID), URINARY TRACT INFECTION, ILEUS, VAGINAL CUFF DEHISCENCE, AND PULMONARY EMBOLISM. NO CASES WERE CONVERTED TO OPEN SURGERY AND NO DEATHS WERE REPORTED 1 YEAR POSTOPERATIVELY. THERE WERE NO SPECIFIC DA VINCI DEVICE MALFUNCTIONS REPORTED FOR THESE EVENTS, NOR DID THE AUTHOR ALLEGE THAT O

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 UNILATERAL INGUINAL HERNIA SURGICAL PROCEDURE, A PIECE OF THE CANNULA BROKE INTO THE PATIENT. A GREY RUBBERY PART WAS RETRIEVED IMMEDIATELY. THE PART AND DETACHED PIECE COULD NOT BE RETURNED AS IT WAS SENT TO PATHOLOGY. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ACCESSORY WAS INSPECTED PRIOR TO USE AND THERE WAS NO DAMAGE NOTED. THE SURGEON BELIEVED INSTRUMENT INTRODUCTION WAS THE CAUSE OF THE FRAGMENT FELLING INTO THE PATIENT AND THE CAUSE OF THE ACCESSORY BREAKING WAS THE INTRODUCTION OF THE TIP OF THE SCISSORS. THE ACCESSORY WAS IN USE FOR ABOUT 45 MINUTES WHEN THE BREAKAGE OCCURRED. NO ISSUES WERE NOTED WITH THE FUNCTIONALITY OF THE ACCESSORY DURING THE SURGICAL PROCEDURE; MULTIPLE INSTRUMENTS PASSED THROUGH THE CANNULA. THE SURGICAL STAFF DID NOT FEEL ANY RESISTANCE TO THE REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA DURING THE PROCEDURE. UPON THE FINAL REMOVAL, THE WRIST OF THE INSTRUMENT WAS STRAIGHT. THERE WAS ALSO NO RESISTANCE UPON REMOVING THE INSTRUMENT THROUGH THE CANNULA. THE DAMAGE TO THE CANNULA WAS NOTED AFTE

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 TIP OF THE HARMONIC ACE WAS BROKEN OFF. A FRAGMENT FELL INTO THE PATIENT¿S ANATOMY AND WAS REMOVED THROUGH THE CANNULA DURING THE SAME SURGICAL PROCEDURE WITHOUT ANY DIFFICULTIES. THE SURGICAL PROCEDURE WAS COMPLETED WITH NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS 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 THE CUSTOMER HAS EXPERIENCED UNSPECIFIED INSTRUMENTS THAT HAVE DEVELOPED BROKEN CABLES, RESULTING IN X-RAYING OF PATIENTS TO CONFIRM NO FRAGMENTS WERE LEFT BEHIND. REPORTEDLY THE SUSPECTED INSTRUMENTS HAVE ALREADY BEEN RETURNED. THERE WERE NO REPORTS OF FRAGMENTS FALLING INTO THE PATIENT. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FOLLOWING ADDITIONAL INFORMATION VIA FOLLOW UP: NOT ALL CASES INVOLVING A BROKEN INSTRUMENT HAVE AN X-RAY PERFORMED AS A RESULT; THAT DECISION IS MADE BY THE SURGEON. X-RAYS ARE NOT ROUTINELY PERFORMED; THEY ARE ONLY USED TO DETECT RETAINED OBJECTS.

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, AN ITEM FROM THE UNIVERSAL SEAL FELL INTO THE PATIENT. THE CUSTOMER NOTICED IT WHILE REMOVING THE GALLBLADDER, RETURNING THE REDUCER CAP, AND THE LITTLE PIECE THAT CAME OFF IT. THE WRIST OF THE INSTRUMENT WAS STRAIGHTENED UPON REMOVAL. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) ATTEMPTED FOLLOW-UP TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SP RADICAL SALVAGE PROSTATECTOMY SURGICAL PROCEDURE, A NON-RECOVERABLE FAULT WAS DISPLAYED. THE USER PERFORMED A POWER CYCLE ON THE SYSTEM, BUT THE ISSUE PERSISTED. THE USER UNDOCKED THE SYSTEM AND PERFORMED SEVERAL HARD POWER CYCLES ON THE SYSTEM, BUT THE ISSUE REMAINED. THE USER REMOVED THE INSTRUMENTS POST-ANESTHESIA AND PORT PLACEMENT. ISI FOLLOWED UP WITH THE SITE AND THE ROBOTICS COORDINATOR CONFIRMED THAT THE SP PROCEDURE WAS CONVERTED. THE SINGLE PORT INCISION WAS CLOSED, AND THE PROCEDURE WAS CONVERTED USING A MULTI-PORT MULTI-PORT SYSTEM (XI SYSTEM). THE CONVERSION REQUIRED ADDITIONAL SURGICAL PORT PLACEMENT.

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 STOPPED WORKING. THE CUSTOMER INDICATED THAT IF THE TIP OF THE HARMONIC ACE INSTRUMENT WAS BROKEN, THEY WOULD REMOVE ANY FRAGMENTS THAT MIGHT HAVE FALLEN INSIDE THE PATIENT. THE HARMONIC ACE INSTRUMENT DID NOT COLLIDE WITH OTHER SURGICAL INSTRUMENTS DURING THE PROCEDURE. THE HARMONIC ACE INSTRUMENT WAS REPLACED AND THE PROCEDURE WAS COMPLETED ROBOTICALLY. IT IS UNCLEAR IF ANY FRAGMENTS FROM THE HARMONIC ACE INSTRUMENT FELL INSIDE THE PATIENT.

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 TRANSECTION PROCEDURE, THE BLADE OF THE HARMONIC ACE INSTRUMENT BROKE IN THE PATIENT'S ABDOMEN. A FRAGMENT FELL INSIDE THE PATIENT BUT WAS RETRIEVED DURING THE SAME SURGICAL 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: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, A PIECE OF THE SYNCHROSEAL INSTRUMENT WAS LOST INSIDE THE PATIENT. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) REVIEWED THE SYNCHROSEAL INSTRUMENT AND INFORMED THE CUSTOMER THAT THE DESCRIBED PIECE WAS MADE OF METAL AND SHOULD BE VISIBLE VIA X-RAY. THE SURGEON NOTICED THE ISSUE DURING THE FIRST GRASP OF THE TISSUE AND THERE WAS NO INSTRUMENT IMPACT THAT CAUSED THE FRAGMENT TO FALL. THE X-RAY WAS PERFORMED BUT THE FRAGMENT WAS NOT FOUND AND WAS NOT RETRIEVED. THE PATIENT DID NOT RETURN TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT. THE PROCEDURE WAS COMPLETED. THE CUSTOMER IS NOT ABLE TO RETURN THE INSTRUMENT FOR FAILURE ANALYSIS INVESTIGATION AT THIS TIME.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LIVER RESECTION PROCEDURE, THE UNIVERSAL SURGICAL MANIPULATOR (USM) 2 KEPT FAULTING OUT. AN OPERATING ROOM (OR) STAFF MEMBER CONTACTED AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) FOR ASSISTANCE AFTER THEY HAD ALREADY CONVERTED THE CASE TO TRADITIONAL LAPAROSCOPIC SURGERY DUE TO THE SURGEON'S FRUSTRATIONS CAUSED BY THE FAULTS. THE TSE REVIEWED THE LOGS AND FOUND THE ENDOSCOPE KEPT GIVING AN ERROR. WHEN THE EVENT OCCURRED, THE CUSTOMER ELECTED NOT TO TRY AND USE ANOTHER ENDOSCOPE THAT THEY HAD IN THE ROOM. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER INDICATED THAT THE CONVERSION RESULTED IN INCREASING PORT SIZE INCISION OR ADDING ADDITIONAL PORTS. ACCORDING TO THE INITIAL REPORTER, USM 2 WAS FUNCTIONAL AND THERE WAS NO ISSUE AFTER THE PROCEDURE. THE ENDOSCOPE WAS BEING RETURNED TO ISI FOR FAILURE ANALYSIS EVALUATION.

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 WEDGE RESECTION PROCEDURE, THE HARMONIC ACE INSTRUMENT WAS NOT RESPONDING SATISFACTORILY TO COMMANDS. IN ADDITION, THE TIP OF THE INSTRUMENT BROKE, REQUIRING REMOVAL FROM THE PATIENT'S CAVITY. IT IS UNCLEAR IF A FRAGMENT FROM THE INSTRUMENT ACTUALLY BROKE OFF AND WAS REMOVED/RETRIEVED. THE PROCEDURE 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: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE KNIFE HEAD OF THE HARMONIC ACE INSTRUMENT WAS OBSERVED TO HAVE A FRACTURE. USE OF THE INSTRUMENT WAS DISCONTINUED, AND IT WAS REPLACED TO THE BACKUP. THE USER COMPLETED THE PROCEDURE, AND NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INITIAL COMPLAINT REPORTED THAT THE BLADE WAS BROKEN. THE BLADE FRACTURE OCCURRED DURING THE PROCEDURE, RESULTING IN A FRAGMENT FALL INTO THE PATIENT. ALL FRAGMENTS WERE REMOVED FROM THE PATIENT¿S BODY WITHOUT ANY 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 DURING A DA VINCI-ASSISTED PANCREATODUODENECTOMY SURGICAL PROCEDURE, THE JAW OF THE ADVANCED ENERGY HARMONIC ACE FORCEPS BROKE AND MOVED. A FRAGMENT FROM THE INSTRUMENT FELL INSIDE THE PATIENT BUT WAS RETRIEVED DURING THE SAME SURGICAL 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: A REVIEW WAS PERFORMED OF A LITERATURE ARTICLE THAT DISCUSSED THE SAFETY AND FEASIBILITY OF SINGLE-INCISION ROBOTIC TOTALLY EXTRA-PERITONEAL REPAIR (TEP) FOR INGUINAL HERNIA USING THE DA VINCI XI PLATFORM. THE ARTICLE INVOLVED A SINGLE-CENTER PROSPECTIVE PILOT STUDY. THE ARTICLE NOTED THAT DURING THESE DA VINCI SURGERIES, 2 PATIENTS SUSTAINED INTRAOPERATIVE HERNIAL SAC TEARS. THESE TWO PATIENTS UNDERWENT SAC LIGATION AT THE PROXIMAL PORTION OF THE TORN SAC. NO ADDITIONAL SUTURING WAS REQUIRED. THERE WERE NO POST-OPERATIVE COMPLICATIONS REPORTED. THE ARTICLE CONCLUDED THAT FOR UNCOMPLICATED INGUINAL HERNIAS, SINGLE-INCISION ROBOTIC TEP USING THE DA VINCI XI PLATFORM CAN BE SELECTIVELY AND SAFELY ATTEMPTED. THERE WERE NO SPECIFIC DA VINCI DEVICE MALFUNCTIONS REPORTED, NOR THE AUTHOR ALLEGED THAT ISI PRODUCTS CAUSED OR CONTRIBUTED TO ANY ADVERSE EVENT. 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: 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 CHOLECYSTECTOMY SURGICAL PROCEDURE, THE SURGEON VISUALLY FOUND BLACK PIECES INSIDE THE PATIENT THAT POSSIBLY FELL FROM THE CANNULA SEAL. THE FRAGMENTS WERE RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) ATTEMPTED FOLLOW-UP TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE SURGEON VISUALLY FOUND BLACK PIECES INSIDE THE PATIENT THAT POSSIBLY CAME FROM THE CANNULA SEAL. THE FRAGMENTS WERE RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) ATTEMPTED FOLLOW-UP TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY PROCEDURE, THE SURGEON VISUALLY FOUND BLACK PIECES INSIDE THE PATIENT THAT POSSIBLY CAME FROM A UNIVERSAL SEAL (I.E. CANNULA SEAL). THE FRAGMENTS WERE RETRIEVED DURING THE SAME PROCEDURE WHICH WAS COMPLETED ROBOTICALLY. ACCORDING TO THE INITIAL REPORTER, THE CUSTOMER WILL BE RETURNING 4 UNIVERSAL SEALS THAT WERE USED DURING THE CASE.

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 PROCEDURE, THE SURGEON VISUALLY FOUND BLACK PIECES INSIDE THE PATIENT THAT POSSIBLY CAME FROM A UNIVERSAL SEAL (I.E. CANNULA SEAL). THE FRAGMENTS WERE RETRIEVED DURING THE SAME PROCEDURE WHICH WAS COMPLETED ROBOTICALLY. ACCORDING TO THE INITIAL REPORTER, THE CUSTOMER WILL BE RETURNING 4 UNIVERSAL SEALS THAT WERE USED DURING THE CASE.

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 SIMPLE PROSTATECTOMY SURGICAL PROCEDURE, THE CUSTOMER ENCOUNTERED AN "ACTIVATION HAS BEEN INTERRUPTED" MESSAGE ON THE INTEGRATED ELECTROSURGICAL UNIT (IESU) GENERATOR WAS DISPLAYED. THE PATIENT WAS ON THE TABLE UNDER ANESTHESIA WITH PORTS PLACED. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) ASKED THE CUSTOMER TO PULL THE IESU GENERATOR POWER AND IT POWERED ON WITH A FAULT. THE CUSTOMER DID NOT HAVE ANOTHER DA VINCI SP TOWER TO USE. THE ISI CLINICAL SALES REPRESENTATIVE (CSR) STATED THAT THE SURGEON WAS PLANNING TO RE-SCHEDULE SURGERY AND THE PROCEDURE WAS ABORTED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY WITH EXTRAPERITONEAL LYMPHADENECTOMY PROCEDURE, TISSUE WAS INSUFFICIENTLY SEALED, AND BLEEDING OCCURRED. THE SYNCHROSEAL INSTRUMENT WAS INSPECTED PRIOR TO USE, AND THERE WAS NO DAMAGE OR ANYTHING OUT OF THE ORDINARY OBSERVED. THE ISSUE OCCURRED DURING THE SEALING SEQUENCE, AND INSTEAD OF HEARING A CONTINUOUS TONE WHILE THE PEDAL WAS PRESSED, A SHORT TONE WAS HEARD. THE DESIRED TISSUE EFFECT COULD BE SEEN, BUT AT THE COMPLETION OF THE SEALING CYCLE; ONLY ONE TONE WAS HEARD INSTEAD OF THREE ASCENDING FAST AUDIBLE TONES. AN ERROR MESSAGE OF ¿TAKE THE RIGHT AMOUNT OF TISSUE¿ WAS OBSERVED. THE SURGEON BELIEVES THAT THE SYNCHROSEAL INSTRUMENT STOPPED SEALING TOO EARLY, CAUSING BLEEDING WHEN THE TISSUE WAS CUT. THE AMOUNT OF BLEEDING WAS NOT SPECIFIED BUT WAS REPORTED AS ¿NOT CRITICAL¿ AND WAS RESOLVED USING DIATHERMY; THE PATIENT DID NOT REQUIRE A TRANSFUSION OF BLOOD PRODUCTS. A TECHNICAL SUPPORT ENGINEER (TSE) WAS CALLED TO HELP TROUBLESHOOT THE ISSUE; THE ERROR LOGS WERE REVIEWED WITH NO ERRORS WERE IDENTIFIED. TSE ADVISED USE OF A NEW SYNCHROSEAL INSTRUMENT, AND THE INSTRUMENT WAS REPLACED BY A BACKUP; HOWEVER, THE

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A LITERATURE ARTICLE "SHORT-TERM OUTCOMES OF DA VINCI SP VERSUS XI FOR RECTAL CANCER SURGERY: A PROPENSITY SCORE MATCHING ANALYSIS OF TWO TERTIARY CENTER COHORTS" DESCRIBED A RETROSPECTIVE ANALYSIS. PATIENTS WHO UNDERWENT ROBOTIC SURGERY FOR RECTAL ADENOCARCINOMA FROM JANUARY 2016 TO SEPTEMBER 2023 AT TWO TERTIARY REFERRAL CENTERS WERE INCLUDED IN THE ANALYSIS. A TOTAL OF 378 PATIENTS WERE ANALYZED: 65 PATIENTS UNDERWENT DA VINCI-ASSISTED SP RECTAL CANCER SURGERY AND 378 PATIENTS UNDERWENT DA VINCI-ASSISTED XI RECTAL CANCER SURGERY. THE STUDY WAS CONDUCTED TO COMPARE KEY PARAMETERS BETWEEN PATIENT COHORTS BEFORE AND AFTER PROPENSITY SCORE MATCHING. THE ARTICLE MENTIONED THAT THERE WERE NO DIFFERENCES IN COMPLICATION RATES AND MAJOR COMPLICATION RATES. THE ARTICLE NOTED THAT IN THE SP GROUP, THE COMPLICATIONS INCLUDED 4 CASES OF ANASTOMOSIS LEAKS WHICH WERE TREATED WITH DIVERSION ILEOSTOMY, AND 2 CASES OF OTHER UNKNOWN COMPLICATIONS. THERE WERE NO INSTANCES OF INTRA-ABDOMINAL ABSCESS/FLUID COLLECTION, ILEUS, OR POSTOPERATIVE BLEEDING. ADDITIONALLY, THERE WAS 1 CASE OF READMISSION. THE AUTHORS CONCLUDED THAT THE DA VINCI SP SYSTEM CONTINUES TO OFFER MINIMAL INVASIVE BENEFITS IN RECTA

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 SURGICAL PROCEDURE, THE PATIENT CALLED TO REPORT CONTINUED PAIN. THE PATIENT WENT TO ANOTHER HOSPITAL NEARBY AND AN X-RAY WAS PERFORMED. THROUGH THE X-RAY, A FRAGMENT INSIDE OF THE PATIENT WAS FOUND. THE FRAGMENT WAS RETRIEVED THROUGH THE ADDITIONAL SURGERY AT ANOTHER HOSPITAL. THE PATIENT WAS CALLING TO INVESTIGATE WHAT THE FRAGMENT WAS AND WHETHER THE FRAGMENT WAS TOXIC. THE PATIENT WOULD LIKE TO KNOW IF THE FRAGMENT HAD FALLEN FROM AN INTUITIVE INSTRUMENT OR NOT. THE PATIENT SENT PHOTOS OF THE FRAGMENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE HOSPITAL IS AWARE OF THE ALLEGATION FROM THE PATIENT. IT IS UNKNOWN IF THERE WAS AN INVESTIGATION ALLEGATION. AN INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) CONTACTED THE HOSPITAL, AND THEY STATED THAT THERE WERE NO ISSUES DURING THE PROCEDURE AT THE TIME. IT IS UNKNOWN WHERE THE PIECE CAME FROM; THE PATIENT SUSPECTS THAT THE FRAGMENT CAME FROM A DA VINCI 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 SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT CUTTER'S HEAD BROKE OFF, AND THE INSTRUMENT WAS INSTALLED AND USED IN JUST FIVE MINUTES. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. A BACKUP DIFFERENT DV INSTRUMENT WAS USED. 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 INSTRUMENT WAS INSPECTED PRIOR TO USE AND THE OUTER PACKING HAD BEEN CHECKED. THE SURGEON WAS DISSECTING WHEN THE ISSUE OCCURRED. THE SURGEON BELIEVED THAT THE QUALITY OF THE INSTRUMENT CAUSED THE FAILURE; THE INSTRUMENT WAS IN USE FOR 5 MINUTES. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE SURGICAL PROCEDURE; THE INSTRUMENT FAULTED SUDDENLY. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIALS DURING THE SURGICAL PROCEDURE. THE FRAGMENT(S) DID NOT FALL INSIDE THE PATIENT DURING AN INSTRUMENT TIP COLLISION. THE INSTRUMENT WAS NOT REMOVED DURING THE PROCEDURE. THE WRIST WAS STRAIGHTENED. THE SURGICAL STAFF DID NOT FEEL ANY RESISTANCE UPON REMOVAL OF THE INSTRU

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 UROLOGY PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY WAS ¿LOOSE AND BROKEN AWAY FROM THE INSTRUMENT.¿ THE PROCEDURE WAS COMPLETED ROBOTICALLY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE MCS TIP COVER ACCESSORY DID NOT HAVE A CUT OR TEAR. NO ARCING WAS OBSERVED. THE CUSTOMER HAD USED THE MCS TIP COVER ACCESSORY INSTALLATION TOOL. THE MCS TIP COVER ACCESSORY APPEARED TO BE PROPERLY INSTALLED ON THE MCS INSTRUMENT DURING THE SURGICAL PROCEDURE. THE CUSTOMER DID NOT APPLY ANY LUBRICANT TO THE MCS INSTRUMENT PRIOR TO THE MCS TIP COVER ACCESSORY INSTALLATION. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENT OR TOOL DURING THE PROCEDURE. THE MCS TIP COVER ACCESSORY FELL INSIDE THE PATIENT¿S ANATOMY AND IT WAS RETRIEVED DURING THE SAME PROCEDURE. NO ADDITIONAL SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE MCS TIP COVER ACCESSORY. THE CUSTOMER USED A BACKUP MCS TIP COVER ACCESSORY TO RESOLVE THE ISSUE.

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 268 PATIENTS WHO UNDERWENT A SUBXIPHOID THYMECTOMY BETWEEN (B)(6) 2011 AND (B)(6) 2022. THE AIM OF THE STUDY WAS TO EVALUATE THE FEASIBILITY OF SUBXIPHOID UNIPORTAL THYMECTOMY (SUT) AND SUBXIPHOID ROBOTIC THYMECTOMY (SRT) PROCEDURES. SIXTY-ONE PATIENTS UNDERWENT SRT PROCEDURES USING DA VINCI SI OR XI ROBOTIC SURGICAL SYSTEMS. THE MEDIAN AGE OF THE ENTIRE PATIENT COHORT COMPRISING 268 PATIENTS WAS 57 (AGE RANGE 47¿67) YEARS. THE ARTICLE NOTED THAT THAT DURING THE ROBOTIC SURGERIES, POST-OPERATIVE COMPLICATIONS WERE OBSERVED IN 5 PATIENTS: HEMORRHAGE IN ONE CASE, RESPIRATORY FAILURE IN ONE CASE, CHYLOTHORAX IN ONE CASE, PHRENIC NERVE PARALYSIS IN ONE CASE, AND RECURRENT NERVE PALSY IN ONE CASE. THE PATIENT WHO DEVELOPED CHYLOTHORAX UNDERWENT THORACIC DUCT LIGATION USING THE LATERAL APPROACH. NONE OF THE PATIENTS UNDERWENT A CONVERSION TO STERNOTOMY. NO MORTALITIES OCCURRED IN EITHER GROUP. NO SPECIFIC DA VINCI DEVICE MALFUNCTIONS WERE REPORTED, AND THE AUTHOR DID NOT ALLEGE THAT INTUITIVE SURGICAL, INC. (ISI) PRODUCTS CAUSED OR CONTRIBUTED TO ANY ADVERSE 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 SIMPLE PROSTATECTOMY SURGICAL PROCEDURE, THE CUSTOMER EXPERIENCED NO VISION IN THE RIGHT EYE OF THE HIGH-RESOLUTION STEREO VIEWER (HRSV). THE SYSTEM HAD INITIALLY POWERED ON WITH NO ISSUES, AND THE TOUCHSCREEN VISION WAS FINE FOR BOTH THE LEFT AND RIGHT EYE. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) SUGGESTED A HARD POWER CYCLE THE SURGEON SIDE CONSOLE (SSC); THE RIGHT EYE VISION WAS RESTORED BUT THE LEFT EYE VISION WAS BRIGHTER THAN THE RIGHT EYE. AS A RESULT OF THE CUSTOMER REPORTED ISSUE, THE SURGEON DECIDED TO ABORT THE PROCEDURE. INCISION PORTS HAD ALREADY BEEN PLACED ON THE PATIENT.

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 COHORT REVIEW OF 16 PATIENTS FROM A SINGLE SURGEON UNDERGOING SINGLE-PORT ROBOTIC REVISION OF URETEROENTERIC STRICTURE (UES) FOLLOWING RADICAL CYSTECTOMY WITH URINARY DIVERSION FROM SEPTEMBER 2020 THROUGH JULY 2024. THE OBJECTIVE OF THIS STUDY IS TO PRESENT A SERIES OF CASES UTILIZING SINGLE-PORT ROBOT-ASSISTED REPAIR FOR (UES) TO DEMONSTRATE THE PROCEDURE'S SAFETY AND FEASIBILITY. THE ARTICLE DESCRIBED A PATIENT WHO HAD AN ILEAL CONDUIT WITH A STRICTURE OF 1 CM IN LENGTH ON THE RIGHT. THE TYPE OF STRICTURE REPAIR THAT THE PATIENT HAD WAS HEINEKE-MIKULICZ (HM) TISSUE REARRANGEMENT. THE PATIENT EXPERIENCED UROSEPSIS AND SEROMA THAT EVOLVED INTO SUPERFICIAL WOUND SEPARATION, WHICH WAS TREATED WITH WOUND PACKING AND HEALED BY SECONDARY INTENTION. THE ARTICLE MENTIONED ANOTHER SEROMA, AND INCISIONAL HERNIA THAT DID NOT REQUIRE OPERATIVE INTERVENTION AND WERE TREATED CONSERVATIVELY. TWO OTHER CASES REQUIRED CONVERSION TO OPEN DUE TO ANATOMY (ADHESIONS). THE STUDY INVESTIGATOR RESPONDED TO FOLLOW-UP AND REPORTED THAT THERE WERE NO DA VINCI DEVICE MALFUNCTIONS, THAT THE ROBOT WAS NOT THE CAUSE OF THE OF THE COMPLICATIONS AND THAT PATIENT DEMO

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SIMPLE PROSTATECTOMY SURGICAL PROCEDURE, INTUITIVE SURGICAL INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) REPORTED THAT THEIR MONOPOLAR CURVED SCISSORS (MCS) TIP FELL OFF DURING THE PROCEDURE. THE STAFF WAS ABLE TO RETRIEVE TIP AND CONTINUE ON WITH PROCEDURE WITH REPLACEMENT INSTRUMENT. THE CSR TO SEND INSTRUMENT IN FOR FAILURE ANALYSIS. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. THE CUSTOMER WAS CONTINUING WITH 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 SURGICAL PROCEDURE, THE BLADE ON HARMONIC ACE CURVED SHEATH SUDDENLY BROKE OFF. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) ATTEMPTED FOLLOW-UP TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

da Vinci Surgical System — Death 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 PANCREATODUODENECTOMY PROCEDURE, AN UNSPECIFIED VESSEL WAS DAMAGED LEADING TO BLEEDING. THE PROCEDURE WAS CONVERTED TO OPEN; THE PATIENT ULTIMATELY EXPIRED. AN INTUITIVE CLINICAL TERRITORY ASSOCIATE (CTA) WHO WAS PRESENT IN THE OR DURING THE PROCEDURE REPORTED THAT WHEN THE INJURY TO THE VESSEL OCCURRED, THE SURGEON CLAMPED THE BLEEDING VESSEL WITH A ROBOTIC INSTRUMENT. THE SURGEON STATED THAT DURING THE OPEN PROCEDURE THEY COULD NOT OBTAIN FULL CONTROL OF THE BLEEDING. CHEST COMPRESSIONS WERE PERFORMED, BUT THE PATIENT EXPIRED ON THE OR TABLE. THE SURGEON STATED THAT, "THE COMPLICATION WAS NOT RELATED TO THE DEVICES BUT TO [THE] COMPLEXITY OF THE SURGERY AND DEGREE OF CANCER." COINCIDENTALLY, PRIOR TO THE VESSEL INJURY EVENT, THE CTA CALLED INTUITIVE TECHNICAL SUPPORT ENGINEERING (TSE) TO REPORT THAT WHEN SWAPPING INSTRUMENTS, THE UNIVERSAL SURGICAL MANIPULATOR 3 (USM ARM3) WOULD JUMP MORE THAN NORMAL AND WOULD CANCEL GUIDED TOOL CHANGE (GTC). THE (TSE) REVIEWED THE SYSTEM LOGS AND FOUND NO RELATED ERRORS AT THE TIME OF THE CALL. THE CTA ALSO REPORTED A SYNCHROSEAL INSTRUMENT IN USE ON USM ARM3 COULD ONLY ROTATE TO THE RIGHT. THE TSE

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 SIGMOID COLECTOMY SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY WAS ¿LOOSE AND BROKEN AWAY FROM THE INSTRUMENT.¿ NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE MCS TIP COVER DID NOT HAVE A CUT OR TEAR. NO ARCING WAS OBSERVED. THE MCS TIP COVER ACCESSORY APPEARED TO BE PROPERLY INSTALLED DURING THE SURGICAL PROCEDURE. THE ORANGE SURFACE WAS NOT VISIBLE AFTER THE MCS TIP COVER ACCESSORY WAS INSTALLED. THE MCS TIP COVER ACCESSORY WAS NOT INSTALLED BEYOND THE ORANGE SURFACE. INSTALLATION TOOL WAS USED. THE LUBRICANT WAS NOT APPLIED TO THE MCS INSTRUMENT PRIOR TO THE TIP COVER INSTALLATION. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENT OR TOOL DURING THE PROCEDURE. THE TIP COVER ACCESSORY FELL INSIDE THE PATIENT¿S ANATOMY, AND IT WAS RETRIEVED DURING THE SAME PROCEDURE. NO ADDITIONAL SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE FRAGMENT. THE CUSTOMER USED A BACKUP MCS TIP COVER ACCESSORY TO RESOLVE THE ISSUE.

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 COMPARATIVE ANALYSIS BETWEEN MARCH 2014 AND OCTOBER 2023 OF PATIENTS WHO UNDERWENT DA VINCI-ASSISTED RADICAL PROSTATECTOMIES. THE AIM WAS TO COMPARE PERIOPERATIVE AND EARLY SURGICAL OUTCOMES OF EXTRAPERITONEAL SINGLE PORT (SP)- VS TRANSPERITONEAL MULTIPORT (MP) - ROBOT ASSISTED RADICAL PROSTATECTOMY (RARP) IN DIFFERENT FRAILTY SETTINGS. A TOTAL OF 549 PATIENTS WERE ASSESSED IN AN UNMATCHED ANALYSIS. AFTER THE PROPENSITY SCORE, 252 PATIENTS WERE IDENTIFIED. THE PATIENTS (WHO HAD A MEDIAN AGE OF 64 YEARS) WERE SPLIT INTO TWO GROUPS, 126 IN THE SP GROUP AND 126 IN THE MP GROUP. A 5-ITEM MODIFIED FRAILTY INDEX (5-MFI) WAS USED TO IDENTIFY PATIENTS WHO WILL BENEFIT FROM SURGERY AND FORECAST THE RELATED MORBIDITY. THE ANALYSIS REPORTED, OF THE 252 PATIENTS, THERE WAS A TOTAL OF 5 INTRAOPERATIVE COMPLICATIONS, 1 OPEN CONVERSION, AND 27 30-DAYS POSTOPERATIVE COMPLICATIONS WITH A CLAVIEN-DINDO GRADE III OR HIGHER. THE SPECIFICS OF THE COMPLICATIONS AND CONVERSION (AND ANY REQUIRED MEDICAL INTERVENTIONS) WERE NOT REPORTED IN THE ARTICLE. THE MP RARP GROUP (COMPARED TO THE SP RARP GROUP) HAD HIGHER INCIDENCES OF INTRAOPERATIVE COMPLICATIONS (4 VS. 1) OPEN CONV

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 VENTRAL HERNIA IPOM SURGICAL PROCEDURE, THE JAW OF THE HARMONIC ACE INSTRUMENT BROKE OFF WHILE INSIDE OF THE PATIENT. A FRAGMENT FELL INTO THE PATIENT AND WAS RETRIEVED DURING THE SAME SURGICAL PROCEDURE. THE USER COMPLETED THE PROCEDURE, AND NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS 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: 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 MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY WAS ¿LOOSE AND BROKEN AWAY FROM THE INSTRUMENT.¿ THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE MCS TIP COVER WAS CUT/TORN ON THE CLEAR AREA. NO ARCING WAS OBSERVED. THE MCS TIP COVER ACCESSORY APPEARED TO BE PROPERLY INSTALLED DURING THE SURGICAL PROCEDURE. THE ORANGE SURFACE WAS NOT VISIBLE AFTER THE MCS TIP COVER ACCESSORY WAS INSTALLED. THE MCS TIP COVER ACCESSORY WAS NOT INSTALLED BEYOND THE ORANGE SURFACE. THE INSTALLATION TOOL WAS USED. THE LUBRICANT WAS NOT APPLIED TO THE MCS INSTRUMENT BEFORE THE TIP COVER INSTALLATION. THE TIP COVER ACCESSORY FELL INSIDE THE PATIENT¿S ANATOMY, AND IT WAS RETRIEVED DURING THE SAME PROCEDURE. NO ADDITIONAL SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE FRAGMENT. THE CUSTOMER USED A BACKUP MCS TIP COVER ACCESSORY TO RESOLVE THE ISSUE.

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 GASTRIC BYPASS SURGICAL PROCEDURE, A SMALL BLACK CHUNK OF RUBBER FROM THE UNIVERSAL SEAL DETACHED AND FELL INTO 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 THYMECTOMY PROCEDURE, THE SURGEON WAS NOT ABLE TO REACH THE THORACIC SPACE APPROPRIATELY FROM THE SUB-XIPHOID PORT WHEN USING THE DA VINCI SINGLE-PORT (SP) SYSTEM. THE SURGEON THEN ELECTED TO CONVERT TO THE CASE USING A DA VINCI XI MULTI-PORT (MP) SYSTEM. ADDITIONAL PORTS WERE PLACED WHEN CONVERTING FROM SINGLE-PORT TO MULTI-PORT SURGERY. THE PROCEDURE WAS COMPLETED ROBOTICALLY. THE SURGEON SAID THE CONVERSION FROM SP TO MP DID NOT AFFECT THE PATIENT OUTCOME; THE PATIENT DID WELL. THE SURGEON ELECTED TO CONVERT TO MULTI-PORT DUE TO ANATOMIC RESTRAINTS OF NARROW SPACE, CARDIOMEGALY, AND A PRIOR HEART SURGERY.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THIRTY-NINE-YEAR-OLD FEMALE PRESENTED TO ((B)(6) HOSPITAL) FOR ELECTIVE ROBOT ASSISTED LAPAROSCOPY FOR MYOMECTOMY FOR FIBROID UTERUS. DURING THE PROCEDURE, THE PERMANENT CAUTERY SPATUAL 8MM BROKE OUT OF THE ELBOW OF THE ROBOT DURING USE INSIDE THE PATIENT'S ABDOMEN. THE SURGEON WAS UNABLE TO REMOVE THE BROKEN INSTRUMENT AND THE PROCEDURE WAS CONVERTED TO AN OPEN PROCEDURE AND THE PIECE WAS REMOVED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HYSTERECTOMY WITH BILATERAL SALPINGECTOMY PROCEDURE, THE SURGEON NOTICED A SMALL BLACK FOREIGN BODY INSIDE THE PATIENT WHILE TAKING DOWN ADHESIONS. THE FOLLOWING INFORMATION IS UNKNOWN: THE SOURCE OF THE FOREIGN BODY, THE CAUSE OF THE FOREIGN BODY, IF THE CUSTOMER WAS ABLE TO RETRIEVE THE FOREIGN BODY, AND THE PROCEDURE OUTCOME. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NO FURTHER DETAILS ARE AVAILABLE REGARDING THE REPORTED 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 GASTRIC BYPASS ROUX-EN-Y SURGICAL PROCEDURE, THE SYNCHROSEAL WAS CUTTING, BUT THE CAUTERY WAS NOT WORKING. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: TISSUE WAS BEING TORN BUT NOT SEALED. NO REPAIR WAS NEEDED TO THE TORN TISSUE AND MINIMAL EXPECTED SURGICAL BLEEDING OCCURRED. THERE WAS NO BLOOD TRANSFUSION NEEDED. THEY OPENED A BACKUP SYNCHROSEAL TO RESOLVE THE ISSUE. THE ORIGINAL SYNCHROSEAL DID NOT WORK AT ALL. IT DID THROW AN ERROR CODE, BUT THE REPORTING PERSON WAS NOT PRESENT. THERE WAS NO CONTINUOUS TONE, IT JUST KEPT BEEPING. NO TONES WERE NOTED THAT SEAL WAS SUCCESSFUL. THERE WERE NO VIDEO RECORDINGS.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: INTUITIVE SURGICAL, INC. (ISI) RECEIVED A VOLUNTARY MEDWATCH REPORT (MDR) WITH THE FOLLOWING EVENT DESCRIPTION: "DURING THE SURGERY, A PIECE OF THE ROBOTIC HARMONIC SHEARS BROKE OFF. IT OCCURRED WHILE THE SURGEON WAS CAUTERIZING THE TISSUE WITH THE SHEARS. THE BROKEN PIECE WAS RECOVERED."

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 INGUINAL HERNIA SURGICAL PROCEDURE, THE SITE CONTACTED INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) TO REPORT THE RIGHT EYE OF THE CONSOLE WAS BLACK. THE CUSTOMER STATED STAFF WAS IN THE PROCESS OF RESEATING THE ENDOSCOPE AND PERFORMING A POWER CYCLE OF THE SYSTEM, BUT THE ISSUE REMAINED. THE ISI TSE REVIEWED THE LOGS AND FOUND ENDOSCOPE COMMUNICATION ISSUES. THE TSE RECOMMENDED A HARD POWER CYCLE OF THE CONSOLE WHEN POSSIBLE. THE CUSTOMER WAS PLANNING TO LET THE STAFF KNOW AND CALL BACK IF THE HARD POWER CYCLE WOULD NOT RESOLVE THE ISSUE AND THE CALL ENDED. ISI CLINICAL SALES REPRESENTATIVE (CSR) CALLED BACK IN TO REPORT THEY TRIED A HARD REBOOT, BUT THE RIGHT EYE OF THE CONSOLE WAS STILL BLACK. 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 SYSTEM WAS POWERED ON; ARMS WERE CHECKED FOR FUNCTIONALITY DURING THE DRAPING PROCESS. INTEGRATED ELECTROSURGICAL UNIT (IESU) POWERED ON AND FUNCTIONED WITH VISION TOWER. THE SURGEON WAS LOGGED INTO THE SURGEON CONSOLE WITHOUT ISSUE BUT VISION THROUG

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, INCLUDING CONSECUTIVE PATIENTS THAT UNDERWENT THORACIC SURGERY IN A SINGLE CENTER FROM FEBRUARY 2014 TO JANUARY 2023. ROBOTIC THORACIC SURGERY WAS USED IN ANATOMICAL LUNG RESECTION IN 85% OF THE CASES. OVER THE STUDY PERIOD, 1,067 PATIENTS UNDERWENT ROBOTIC SURGERY: 509 HAD LOBECTOMIES AND 391 HAD SEGMENTECTOMIES. THERE WERE 30 CONVERSIONS TO THORACOTOMY (2.8%) OF WHICH 7 WERE EMERGENCIES. SIX CONVERSIONS WERE DUE TO BLEEDING AND 1 CASE WAS CONVERTED DUE TO AN UNSPECIFIED ANESTHESIA ISSUE. THE MENTIONED POSTOPERATIVE COMPLICATIONS WERE REFRACTORY LUNG INFECTION, STROKE AND ONE FISTULA. THERE WERE NO SPECIFIC DA VINCI DEVICE MALFUNCTIONS REPORTED. THE AUTHOR ALSO DID NOT ALLEGE THAT ANY INTUITIVE SURGICAL INC (ISI) PRODUCTS CAUSED OR CONTRIBUTED TO THE COMPLICATIONS. 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 THYROIDECTOMY SURGICAL PROCEDURE, THE USER NOTICED THAT THE HARMONIC ACE INSTRUMENT HAD A BROKEN BLADE. THE BLADE FELL INTO THE PATIENT'S ANATOMY AND WAS RETRIEVED DURING THE SAME PROCEDURE. THE INSTRUMENT WAS REMOVED AND REPLACED WITH A BACKUP. FOLLOWING THIS, THE USER CONTINUED AND COMPLETED THE PROCEDURE WITH NO FURTHER ISSUES. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION: THE REPORTER CONFIRMED THAT ALL FRAGMENTS WERE RETRIEVED USING FORCEPS INSTRUMENTS AND CONFIRMED VIA VISUAL INSPECTION. NO ADDITIONAL SURGICAL PROCEDURES OR POST-OPERATIVE TESTS WERE PERFORMED. THERE WAS NO REPORT OF POST-SURGICAL COMPLICATIONS, AND THE PATIENT HAS NOT RETURNED TO THE HOSPITAL. THE SURGEON WAS DISSECTING TISSUE WHEN THE FRAGMENTS FELL INTO THE PATIENT. THE INSTRUMENT WAS USED LESS THAN AN HOUR BEFORE THE EVENT. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIALS DURING THE SURGICAL PROCEDURE. THE STAFF DID NOT FEEL ANY RESISTANCE TO THE REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA. UPON FINAL REMOVAL OF THE INSTRUMENT, THE WRIST WAS STRAIGHTENED, AND THE SU

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 THE CUSTOMER HAD SOME CONCERNS WITH THE DA VINCI SYSTEM "NOT BEING INTUITIVE WITH THE MOTIONS BUT LIKE SOMETHING ELSE". THE CUSTOMER WAS UNABLE TO PROVIDE ADDITIONAL DETAILS AT THE TIME. THE FIELD SERVICE ENGINEER (FSE) NOTED THAT THE CASE WAS CONVERTED FROM A SINGLE PORT TO MULTI-PORT AND EXTENDED. 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 BARIATRIC SURGICAL PROCEDURE, A FRAGMENT FROM AN UNKNOWN INSTRUMENT FELL INSIDE THE PATIENT'S ANATOMY AND WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED AS PLANNED.

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.