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: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE HARMONIC ACE CURVED SHEARS BROKE AT THE BEGINNING OF THE PROCEDURE. A FRAGMENT FELL INTO THE PATIENT AND WAS RETRIEVED DURING THE SAME PROCEDURE. 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.

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AFTER BONE CUTTING USING MAKO SYSTEM, IT WAS FOUND THAT THE POPLITEUS TENDON HAD BEEN CUT. AFTER THE FIRST BONE CUTTING OF THE FEMORAL POSTERIOR CONDYLE, THE BONE ON THE ANTERIOR SIDE BROKE AND BECAME DIFFICULT TO SEE, MAKING IT DIFFICULT TO SEE THE SURGICAL FIELD. ALTHOUGH THE DOCTOR WAS CONSCIOUS OF CUTTING ONLY THE NECESSARY SURFACE OF THE BONE, THE POPLITEUS TENDON MAY HAVE SHIFTED ANTERIORLY DUE TO THE BROKEN ANTERIOR BONE, CAUSING IT ENTERED THE BOUNDARY. THE CUTTING PART OF THE POPLITEUS TENDON WAS SUTURED, AND THE MAKO TKA 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 SURGICAL PROCEDURE, THE SURGEON FOUND THAT THE HARMONIC ACE INSTRUMENT BROKE WHILE DISSOCIATING THE OMENTUM OF THE STOMACH. IT IS UNCLEAR IF A FRAGMENT FROM THE INSTRUMENT BROKE OFF, FELL INSIDE THE PATIENT, AND WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED ROBOTICALLY.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THERE WAS A CONCERNING INCREASE IN SPINE SURGICAL SITE INFECTIONS (SSIS) ASSOCIATED WITH THE GUIDANCE SYSTEM ROBOT. THE INFECTION RATE HAD TRIPLED COMPARED TO FISCAL YEAR 2024, WITH SEVEN FUSION INFECTIONS REPORTED IN FY2025, FIVE OF WHICH INVOLVED PROCEDURES UTILIZING THE GUIDANCE SYSTEM ROBOT. IT WAS NOTED THAT THE INSTRUMENT WAS NOT PROPERLY CLEANED AFTER STERILIZATION, AS OBSERVED USING A BORESCOPE DOWN THE CANNULA INSERTER. IN RESPONSE TO THESE FINDINGS, THE USE OF THE GUIDANCE SYSTEM ROBOT FOR SPINE SURGERIES WAS TEMPORARILY SUSPENDED EFFECTIVE (B)(6) 2025, WHILE FURTHER INVESTIGATION AND MITIGATION EFFORTS WERE UNDERTAKEN. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PROCEDURES BEING PERFORMED WERE SACROILIAC AND THORACOLUMBAR PROCEDURES. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT MEDTRONIC FOUND NO ISSUES WITH ANY OF THE BIOLOGICS THAT WERE USED AND THE FOCUS SHIFTED TO OTHER POSSIBILITIES.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN 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: REFER TO H11 FOR FOLLOW-UP INFORMATION.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT WHILE USING THE EXCELSIUS GPS SYSTEM, A ROBOTIC ERROR TOOK OVER 40 MINUTES TO RESOLVE WITH THE PATIENT UNDER ADDITIONAL ANESTHESIA.

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.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED.

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.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND POST OP CT SCAN SHOWS A MEDIAL BREACH OF THE L4 SCREW.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT WHILE USING THE EXCELSIUS GPS SYSTEM, THE CASE WAS ABORTED DUE TO ROBOT NOT POWERING ON.

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.

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

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 WHEN INSERTING SCREWS FOR L2-L5 AND NOTING THAT LEFT L3 AND L4 WERE OFF BY A FEW MILLIMETERS LATERALLY. THE SURGEON REMOVED THE SCREWS AND REINSERTED THE SCREWS MANUALLY. THE SURGEON THEN BEGAN INSERTING SCREWS ON THE RIGHT. RIGHT L2 WAS OFF MEDIALLY AND THERE WAS A DURA TEAR. THE SURGEON DISCONTINUED USE OF THE SYSTEM AND PERFORMED THE ENTIRE RIGHT SIDE WITHOUT USE OF NAVIGATION. CC NOTED THAT A BILATERAL RETRACKER WAS PLACED ON THE PATIENT DURING REGISTRATION. IT WAS REPORTED THAT THE AMOUNT OF TRAJECTORY DEVIATION WAS UNKNOWN, BUT WAS BELIEVED TO BE LESS THAN 3.5 MILLIMETERS (MM). THERE WAS NO DELAY.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED.

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.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED.

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.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME 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 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.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THERE WAS A CONCERNING INCREASE IN SPINE SURGICAL SITE INFECTIONS (SSIS) ASSOCIATED WITH THE GUIDANCE SYSTEM ROBOT. THE INFECTION RATE HAD TRIPLED COMPARED TO FISCAL YEAR 2024, WITH SEVEN FUSION INFECTIONS REPORTED IN FY2025, FIVE OF WHICH INVOLVED PROCEDURES UTILIZING THE GUIDANCE SYSTEM ROBOT. IT WAS NOTED THAT THE INSTRUMENT WAS NOT PROPERLY CLEANED AFTER STERILIZATION, AS OBSERVED USING A BORESCOPE DOWN THE CANNULA INSERTER. IN RESPONSE TO THESE FINDINGS, THE USE OF THE GUIDANCE SYSTEM ROBOT FOR SPINE SURGERIES WAS TEMPORARILY SUSPENDED EFFECTIVE (B)(6) 2025, WHILE FURTHER INVESTIGATION AND MITIGATION EFFORTS WERE UNDERTAKEN. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PROCEDURES BEING PERFORMED WERE SACROILIAC AND THORACOLUMBAR PROCEDURES. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT MEDTRONIC FOUND NO ISSUES WITH ANY OF THE BIOLOGICS THAT WERE USED AND THE FOCUS SHIFTED TO OTHER POSSIBILITIES.

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

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED.

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.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED.

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.