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 AT THE BEGINNING OF THE CASE. A FRAGMENT FELL INSIDE THE PATIENT BUT WAS RETRIEVED DURING THE SAME SURGICAL PROCEDURE. THE CASE WAS COMPLETED ROBOTICALLY USING 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 LIVER RESECTION PROCEDURE, THE HARMONIC ACE INSTRUMENT WOULD NOT PASS SELF-TESTING. THE SYSTEM LOGS SHOWED NO RELATED ERRORS. THE CUSTOMER EXPLAINED THAT WHILE PERFORMING A GENERATOR SELF-TEST, THERE WAS A PROMPT TO TIGHTEN THE INSTRUMENT. PRIOR TO CALLING AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) FOR ASSISTANCE, THE CUSTOMER REPLACED THE HARMONIC ACE INSTRUMENT WITH NO CHANGE. THE TSE HAD THE CUSTOMER CLOSE THE CLAMP BY TURNING THE INPUT DISC ON THE HOUSING IN A COUNTERCLOCKWISE DIRECTION AND THEN ROTATE THE TORQUE WRENCH IN A CLOCKWISE DIRECTION UNTIL TWO LOUD CLICKS WERE HEARD. THE SELF-TEST THEN PASSED AND THE CUSTOMER WAS ABLE TO USE THE HARMONIC ACE INSTRUMENT. THE TSE RECOMMENDED RETURNING THE PREVIOUS HARMONIC ACE INSTRUMENTS FOR FAILURE ANALYSIS. THE PROCEDURE WAS CONVERTED TO OPEN SURGERY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER PROCEEDED WITH THE CASE USING MULTIPLE HARMONIC ACE INSTRUMENTS; THE 4TH HARMONIC WAS FUNCTIONAL. THE PROCEDURE WAS CONVERTED TO OPEN SURGERY DUE TO THE LENGTH OF THE PROCEDURE AND NONFUNCTIONAL DEVICES. THE PA

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, HARMONIC ACE INSTRUMENT BROKE. A FRAGMENT FELL INSIDE THE PATIENT BUT 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: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RIGHT HEMICOLECTOMY SURGICAL PROCEDURE, THE TIP COVER ACCESSORY FELL INTO THE PATIENT AND WAS RETRIEVED DURING THE SAME PROCEDURE. A POST-OPERATIVE X-RAY WAS PERFORMED; THE RESULT OF THE X-RAY IS UNKNOWN. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE TIP COVER FELL DURING REMOVAL OF THE INSTRUMENT. THE INSTRUMENT COLLIDED WITH ANOTHER INSTRUMENT OR OTHER HARD MATERIAL DURING THE SURGICAL PROCEDURE, BUT THE FRAGMENT DID NOT FALL DURING AN INSTRUMENT TIP/ACCESSORY COLLISION. UPON FINAL REMOVAL, THE WRIST WAS NOT STRAIGHTENED, AND RESISTANCE WAS FELT; IT WAS POSSIBLE THAT THE WRIST WAS BENT. THE SURGICAL STAFF DID NOT NOTICE ANY DAMAGE TO THE CANNULA OR OTHER INSTRUMENT DAMAGE AFTER THE EVENT OCCURRED. THE TIP COVER WAS REMOVED USING A LAPAROSCOPIC INSTRUMENT. ALL FRAGMENTS WERE RETRIEVED. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED. A POST-OPERATIVE X-RAY WAS PERFORMED. THE PROCEDURE WAS COMPLETED ROBOTICALLY. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO POST-SURGICAL COMPLICATIONS. THE ASSOCIATED ACCESSORY WAS NOT AVAILABLE FOR RETURN.

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 HARMONIC ACE INSTRUMENT WOULD NOT PASS SELF-TESTING. THE SYSTEM LOGS SHOWED NO RELATED ERRORS. THE CUSTOMER EXPLAINED THAT WHILE PERFORMING A GENERATOR SELF-TEST, THERE WAS A PROMPT TO TIGHTEN THE INSTRUMENT. PRIOR TO CALLING AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) FOR ASSISTANCE, THE CUSTOMER REPLACED THE HARMONIC ACE INSTRUMENT WITH NO CHANGE. THE TSE HAD THE CUSTOMER CLOSE THE CLAMP BY TURNING THE INPUT DISC ON THE HOUSING IN A COUNTERCLOCKWISE DIRECTION AND THEN ROTATE THE TORQUE WRENCH IN A CLOCKWISE DIRECTION UNTIL TWO LOUD CLICKS WERE HEARD. THE SELF-TEST THEN PASSED AND THE CUSTOMER WAS ABLE TO USE THE HARMONIC ACE INSTRUMENT. THE TSE RECOMMENDED RETURNING THE PREVIOUS HARMONIC ACE INSTRUMENTS FOR FAILURE ANALYSIS. THE PROCEDURE WAS CONVERTED TO OPEN SURGERY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER PROCEEDED WITH THE CASE USING MULTIPLE HARMONIC ACE INSTRUMENTS; THE 4TH HARMONIC WAS FUNCTIONAL. THE PROCEDURE WAS CONVERTED TO OPEN SURGERY DUE TO THE LENGTH OF THE PROCEDURE AND NONFUNCTIONAL DEVICES. THE PA

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 HARMONIC ACE INSTRUMENT WOULD NOT PASS SELF-TESTING. THE SYSTEM LOGS SHOWED NO RELATED ERRORS. THE CUSTOMER EXPLAINED THAT WHILE PERFORMING A GENERATOR SELF-TEST, THERE WAS A PROMPT TO TIGHTEN THE INSTRUMENT. PRIOR TO CALLING AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) FOR ASSISTANCE, THE CUSTOMER REPLACED THE HARMONIC ACE INSTRUMENT WITH NO CHANGE. THE TSE HAD THE CUSTOMER CLOSE THE CLAMP BY TURNING THE INPUT DISC ON THE HOUSING IN A COUNTERCLOCKWISE DIRECTION AND THEN ROTATE THE TORQUE WRENCH IN A CLOCKWISE DIRECTION UNTIL TWO LOUD CLICKS WERE HEARD. THE SELF-TEST THEN PASSED AND THE CUSTOMER WAS ABLE TO USE THE HARMONIC ACE INSTRUMENT. THE TSE RECOMMENDED RETURNING THE PREVIOUS HARMONIC ACE INSTRUMENTS FOR FAILURE ANALYSIS. THE PROCEDURE WAS CONVERTED TO OPEN SURGERY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER PROCEEDED WITH THE CASE USING MULTIPLE HARMONIC ACE INSTRUMENTS; THE 4TH HARMONIC WAS FUNCTIONAL. THE PROCEDURE WAS CONVERTED TO OPEN SURGERY DUE TO THE LENGTH OF THE PROCEDURE AND NONFUNCTIONAL DEVICES. THE PA

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 TOWARDS THE BEGINNING OF THE CASE. A FRAGMENT FELL INSIDE THE PATIENT BUT WAS RETRIEVED DURING THE SAME SURGICAL PROCEDURE. THE PROCEDURE WAS COMPLETED USING BACKUP HARMONIC.

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MAKO BILATERAL PKA SURGERY WAS PERFORMED. HOWEVER, THE CUTTER CHECK COULD NOT BE PASSED JUST BEFORE THE FIRST TIBIAL BONE CUTTING. THE SURGEON HAD NO CHOICE BUT TO DISCONTINUE THE PKA AND CLOSED THE INCISION SITE. REVISION SURGERY (MANUAL PKA) IS PLANNED INSTEAD OF MAKO PKA.

Black Hawk 1 (standard) and Black Hawk 2 (built-in 4G) drones — 2,797 units sold between 1 Jan and 10 Oct 2024 recalled because the aircraft has no forward vision obstacle avoidance and shipped without the propeller guard fitted; flying one unguarded risks blade injury. Hubsan supplies the guard free of charge. Filed with SAMR under China's Interim Provisions on Consumer Product Recall Management.

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. 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.

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 JAW OF THE HARMONIC ACE INSTRUMENT BROKE. A FRAGMENT FELL INSIDE THE PATIENT AND 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: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LIVER RESECTION AND CHOLECYSTECTOMY PROCEDURE, WHILE PUTTING A RAY-TEC SPONGE (A 3RD-PARTY MANUFACTURER PRODUCT) THROUGH A PORT, A PIECE OF A UNIVERSAL SEAL VALVE BROKE OFF AND FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME SURGICAL PROCEDURE AND THE UNIVERSAL SEAL WAS CHANGED.

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

Kinova Jaco assistive robotic arm — Type II recall (initiated 2024-08-12): damaged Jaco robotic arms could pose a fire risk if used with wheelchairs having electrical leakage. Affects all production lots across six model variants. No injuries reported; affected users advised to contact Kinova for guidance.

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.

Miimo — White robotic lawn mower. Hazard (Cuts): A manufacturing defect in the obstruction/lift sensor's mount shaft can cause the sensor to become stuck and fail to detect obstacles. Users or bystanders, including children, can cut themselves while handling the robot if the collision/lift sensor stops working. The product does not comply with the requirements of the Machinery directive nor with the European standard EN 60335-1 and EN 50636-2-107. Action: Recall of the product from end users.

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.