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 GENERATOR ALARMED THAT THE TIP OF THE HARMONIC ACE INSTRUMENT WAS OVER-STRESSED. THE PRESSURE WAS RELIEVED AND THEN THE CUSTOMER REINSTALLED THE HARMONIC ACE INSTRUMENT. THE BLADE OF THE HARMONIC ACE INSTRUMENT SUDDENLY BROKE WHEN THE USER REACTIVATED IT. A FRAGMENT FROM THE INSTRUMENT FELL INSIDE THE PATIENT BUT WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC (ISI) FOLLOWED UP WITH THE SITE NURSE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE INSTRUMENT FUNCTIONALITY WAS INSPECTED BEFORE USE. IT IS UNKNOWN WHAT SURGICAL TASK WAS BEING PERFORMED WHEN THE FRAGMENT FELL INSIDE THE PATIENT. IT IS ALSO UNKNOWN HOW LONG THE INSTRUMENT WAS IN USE PRIOR TO THE EVENT. NO ISSUES WERE NOTED WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE PROCEDURE. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR HARD MATERIAL. THE INSTRUMENT WAS NOT REMOVED BEFORE THE BREAKAGE OCCURRED. THE STAFF DID NOT FEEL RESISTANCE UPON THE REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA. THERE WAS NO DAMAGE NOTED TO THE CANNULA.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: WHEN ROBOT WAS PLUGGED IN, IT WOULD POWER UP BUT THEN START BEEPING AND BATTERY STATUS BAR WAS STUCK ON 2 BARS AND NOT CYCLING LIKE NORMAL. TURNED OFF ROBOT AND POWERED UP AGAIN AND BEEPING STOPPED BUT STILL WAS NOT WORKING PROPERLY. SHUT DOWN ONE LAST TIME AND POWERED BACK UP AND STARTED BEEPING AGAIN.

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 AN UNSPECIFIED DA VINCI-ASSISTED UROLOGIC PROCEDURE, THE SURGEON EXPERIENCED NON-INTUITIVE MOTION OF INSTRUMENTS INVOLVING THE USE OF A 30-DEGREE ENDOSCOPE. THE ISSUE OCCURRED WHEN THE SURGEON GAVE THE COMMAND TO TURN THE ENDOSCOPE 180 DEGREES, WHICH CAUSED THE INSTRUMENTS TO START WORKING IN THE OPPOSITE, OR MIRRORED, DIRECTION. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) VIEWED THE LIVE LOGS AND DID NOT NOTE ANY ASSOCIATED ERRORS. THE SYSTEM WAS RESTARTED, AND THE ENDOSCOPE WAS RESEATED. THERE WAS A PROCEDURAL DELAY DUE TO TROUBLESHOOTING. AFTER THE REVERSED MOTION OF THE INSTRUMENTS, A HEMATOMA FORMED ON THE KIDNEY. THE SURGEON MADE THE CLINICAL DECISION TO ABORT THE PROCEDURE AFTER DETERMINING THAT PROCEEDING WAS TOO RISKY DUE TO THE HEMATOMA. PER THE SITE, THE PROCEDURE WILL BE RESCHEDULED TO ANOTHER DAY AFTER THE HEMATOMA HAS DISSIPATED.

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 SURGICAL DEVIATION THAT OCCURRED ON (B)(6) 2022. THE ORIGINAL PLAN INCLUDED FOUR SCREW INSERTIONS; HOWEVER, ONLY ONE SCREW WAS INSERTED USING THE GUIDANCE SYSTEM. THE USE OF THE GUIDANCE SYSTEM WAS CANCELED AFTER THE DEVIATION WITH THE FIRST SCREW. THE PLAN ANGLE WAS TOO CONVERGENT, SO THE ANATOMY HAD TO BE MOVED SO THE SCREW COULD FIT THROUGH THE INCISION. ONCE THE SCREW MADE CONTACT, THE PATIENT JUMPED, CAUSING A DEVIATION. THE DOCTOR STATED THAT HE PULLED TOO HARD ON THE RETRACTOR, WHICH CAUSED THE SPINE TO SHIFT OVER. THE SURGEON DECIDED THAT A REPAIR NEEDED TO OCCUR ON THE FIRST SCREW INSERTION. A FOLLOW-UP SURGERY OCCURRED ON (B)(6) 2022 WITHOUT THE USE OF THE GUIDANCE SYSTEM USE. THE SURGEON REPORTED THAT THE PATIENT'S MOTOR FUNCTIONS ON HIS LEGS WERE DECREASED DUE TO THE SURGERY. ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT THE AMOUNT OF DEVIATION WAS ESTIMATED TO BE LESS THAN 3.5MM.

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 FDA VOLUNTARY MEDWATCH REPORT (MDR REPORT #MW5115834) WITH THE FOLLOWING EVENT DESCRIPTION: "PATIENT HAD A ROBOTIC HYSTERECTOMY ON (B)(6) 2022 AT THE SURGICAL HOSPITAL SINCE HER SURGERY PATIENT HAD CONTINUED ABDOMINAL PELVIC PAIN. ON (B)(6) 2023, A CT WAS OBTAINED WHEN PATIENT PRESENTED TO THE ED AND THERE WAS CONCERN FOR A FOREIGN BODY. PATIENT WAS TAKEN TO THE OPERATING ROOM FOR A LAPAROSCOPIC REMOVAL OF FOREIGN BODY ON (B)(6) 2023. THE FOREIGN BODY WAS RETRIEVED AND IDENTIFIED AS A TIP COVER ACCESSORY PLACED OVER THE MONOPOLAR CURVED SCISSOR INSTRUMENT USED IN ROBOTIC PROCEDURES. THE INSTRUMENT USED ON (B)(6) 2022 WAS MONOPOLAR CURVED SCISSOR 8MM DA VINCI XI SERIAL NUMBER (B)(6). THE INSTRUMENT IS NO LONGER IN OUR INVENTORY. THE MONOPOLAR IS CONSIDERED A SEMIDISPOSABLE WHICH CAN BE USED UP TO 10 TIMES. IT WAS UTILIZED AGAIN ON (B)(6) 2022, (B)(6) 2022, (B)(6) 2022, AND (B)(6) 2022." THE DATES OF THE CT SCAN AND THE ADDITIONAL PROCEDURE WERE NOT PROVIDED. IT WAS UNKNOWN IF THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT AND THE MCS TIP COVER ACCESSORY WERE INSPECTED PRIOR TO USE. THE MCS TIP COVER ACCESSORY FELL INSIDE THE PATIENT WHILE 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: PATIENT HAD A ROBOTIC HYSTERECTOMY ON (B)(6) 2022 AT THE SURGICAL HOSPITAL SINCE HER SURGERY PATIENT HAD CONTINUED ABDOMINAL PELVIC PAIN. ON (B)(6) 2023, A CT WAS OBTAINED WHEN PATIENT PRESENTED TO THE ED AND THERE WAS CONCERN FOR A FOREIGN BODY. PATIENT WAS TAKEN TO THE OPERATING ROOM FOR A LAPAROSCOPIC REMOVAL OF FOREIGN BODY ON (B)(6) 2023. THE FOREIGN BODY WAS RETRIEVED AND IDENTIFIED AS A TIP COVER ACCESSORY PLACED OVER THE MONOPOLAR CURVED SCISSOR INSTRUMENT USED IN ROBOTIC PROCEDURES. THE INSTRUMENT USED ON (B)(6) 2022 WAS MONOPOLAR CURVED SCISSOR 8MM DA VINCI XI SERIAL NUMBER (B)(4). THE INSTRUMENT IS NO LONGER IN OUR INVENTORY. THE MONOPOLAR IS CONSIDERED A SEMI-DISPOSABLE WHICH CAN BE USED UP TO 10 TIMES. IT WAS UTILIZED AGAIN ON (B)(6) 2022, (B)(6) 2022, (B)(6) 2022, AND (B)(6) 2022.

At 2:15 p.m. on November 29, 2022, an employee was lubricating conveyor rollers with WD-40 in an energized robotic cell referred to as the iPal palletizer machine. There were no other similar machines in the facility. The employee was between the robot arm and south side of the conveyor when he unknowingly activated the photo eye located at the roller plane which senses when pallets are ready to be picked up. The motion of moving the can of WD-40 over the conveyor area satisfied the photo eye which then sent the robot arm into motion, striking the employee in the back of the head, neck, and shoulder area pushing him down into the conveyor and piercing his neck, skull, and right hand. The robot arm stopped moving likely because the servos that moved the robot arm limited out due to sensing friction. The employee died due to crushing and piercing injuries.

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 DURING A PROCEDURE USING THE EXCELSIUS CRANIAL APPLICATION, SEVERAL BIOPSY SAMPLES WERE TAKEN AND CAUSED BLEEDING THAT WAS FIXED INTRAOPERATIVELY. THIS EVENT OCCURRED IN POLAND.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: CALLED SERVICE WHEN THE ROBOT BATTERY WOULD NOT CHARGE. WAS TOLD THE ROBOT WOULD STILL GET POWER WHILE PLUGGED IN, IT WAS WORKING FOR AROUND AN HOUR THEN POWERED DOWN BEFORE REGISTRATION AND WOULD NOT START. SURGERY 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 A PATIENT UNDERWENT A DA VINCI-ASSISTED PULMONARY WEDGE RESECTION PROCEDURE AND WAS THEN CLOSED UP. THE SURGEON REPORTEDLY LEFT THE OPERATING ROOM (OR); HOWEVER, AN UNSPECIFIED TIME LATER, THE PATIENT TURNED GRAY IN COLOR. THE SURGEON WAS CALLED IN AND AN EXPLORATORY LAPAROTOMY WAS PERFORMED. IT WAS FOUND THAT A SEAL WHERE A SYNCHROSEAL INSTRUMENT WAS USED FAILED, RESULTING WITH EXCESSIVE BLEEDING. THE SURGEON WAS ABLE TO STOP THE BLEEDING. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED AS PART OF A CLINICAL STUDY THAT AFTER UNDERGOING A DA VINCI-ASSISTED RIGHT LOWER LOBECTOMY PROCEDURE, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT ON POST-OPERATIVE DAY (POD) #4 WITH ABNORMAL SECRETION AND FLUID COMING OUT FROM THE CLOSURE WOUND. THE PATIENT WAS TREATED WITH ORAL ANTIBIOTICS AND HOSPITALIZATION. THE FOLLOWING DAY THE PATIENT WAS DIRECTED TO OUTPATIENT CARE. THE INTENSITY OF SECRETION WAS REDUCED ON POD #5 AND WAS ABSORBED WITHOUT A CHEST DRAIN. PER EVALUATION BY TWO PHYSICIANS, THE POSSIBLE CAUSE OF THE COMPLICATION WAS DUE TO THE PATIENT NOT FOLLOWING AGREED THORACIC EXPANSION EXERCISES. THE PLAN WAS TO ENCOURAGE THE PATIENT TO STICK TO REHABILITATION MEASURES, RE-EVALUATE THE DRAINAGE POSITION AND CONDUCT AN-PATIENT ULTRASOUND CHECK-UP BEFORE REMOVING THE CHEST DRAIN. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, FURTHER DETAILS HAVE YET TO BE RECEIVED AS OF THE DATE OF THIS REPORT.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE AURIS PROGRAM DEVELOPMENT MANAGER (PDM) REPORTED THAT FOLLOWING A MONARCH BRONCHOSCOPY PROCEDURE (THE NEEDLE USED WAS A SUPER D 19-GAUGE NEEDLE), THE PATIENT WAS COMPLAINING OF WITH SHORTNESS OF BREATH. A POST-OP X-RAY CONFIRMED PNEUMOTHORAX. A CHEST TUBE WAS PLACED, AND THE PATIENT WAS ADMITTED FOR OVERNIGHT OBSERVATION. THE PHYSICIAN ATTRIBUTES THE PNEUMOTHORAX TO THE LESION BEING IN A DIFFICULT POSITION NEAR THE PLEURA. HE IS NOT ATTRIBUTING IT DIRECTLY TO MONARCH. THERE WERE NO REPORTED MALFUNCTIONS OF THE DEVICE.

Monarch Platform — 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 MONARCH BRONCHOSCOPY PROCEDURE THE PATIENT EXPERIENCED PNEUMOTHORAX ON THE LEFT SIDE A CHEST TUBE WAS PLACED, THE PATIENT WAS HOSPITALIZED AND DISCHARGED THE NEXT DAY. THE MEDTRONIC ARCPOINT WAS ALSO USED. PHYSICIAN ATTRIBUTES THIS PNEUMOTHORAX TO USE OF THE MONARCH.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ABSTRACT: THE AIM OF THIS STUDY WAS TO COMPARE THE INTRAOPERATIVE AND POSTOPERATIVE OUTCOMES BETWEEN A ROBOT-ASSISTED VERSUS A NAVIGATED TRANS PEDICULAR FUSION TECHNIQUE. THIS RETROSPECTIVE ANALYSIS INCLUDED PATIENTS WHO UNDERWENT TRANSPEDICULAR POSTERIOR FUSION OF THE SPINE DUE TO TRAUMA, PYOGENIC SPONDYLODISCITIS AND OSTEOPOROSIS. SURGERY WAS DONE EITHER WITH A ROBOT-ASSISTED OR A PERCUTANEOUS NAVIGATED TRANSPEDICULAR FUSION TECHNIQUE. THE OUTCOME ANALYSIS INCLUDED THE DURATION OF SURGERY, THE RADIATION EXPOSURE, THE POSTOPERATIVE SCREW POSITION AND COMPLICATIONS. A TOTAL OF 60 PATIENTS WERE OPERATED AND 491 SCREWS WERE ANALYSED. NO STATISTICAL DIFFERENCE WAS SEEN IN THE APPLIED CUMULATIVE EFFECTIVE RADIATION DOSE PER PATIENT. THE RADIOLOGICAL ASSESSMENT REVEALED A MORE ACCURATE SCREW PLACEMENT WITH ROBOT ASSISTANCE. A LEARNING CURVE COULD BE OBSERVED IN ROBOT-ASSISTED FUSION. ROBOT-ASSISTED AND NAVIGATED TRANSPEDICULAR FUSION TECHNIQUES ARE BOTH EFFECTIVE AND SAFE. ROBOT-ASSISTED TRANSPEDICULAR SPINE FUSION GOES ALONG WITH HIGHER PLACEMENT ACCURACY BUT ITS IMPLEMENTATION NEEDS AN ADEQUATE LEARNING CURVE. REPORTED EVENT: 5/60 PATIENTS HAD TO UNDERGO REVISION SURGERY AFTER TRANSPE

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS INITIALLY REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED BILATERAL INGUINAL HERNIA SURGICAL PROCEDURE THAT A U-02 ERROR OCCURRED AGAINST THE ERBE INTEGRATED ELECTROSURGICAL UNIT (IESU) GENERATOR, SHORTLY AFTER POWERING ON THE GENERATOR. THE SITE TRIED TO POWER CYCLE THE IESU SEVERAL TIMES PRIOR TO CALLING, BUT THE ERROR KEPT RETURNING. THE TECH SUPPORT ENGINEER (TSE) WALKED THE CUSTOMER THROUGH POWERING DOWN THE SYSTEM AND THE IESU. THE CUSTOMER DISCONNECTED ALL OF THE CABLES AT THE BACK OF THE IESU, THEN POWERED IT ON WITHOUT THE FOOT SWITCHES CONNECTED. THE ERROR SEEMED TO GO AWAY, BUT SOON RETURNED. THERE WERE NO REPORTS OF PATIENT INJURY. AT THIS TIME THE PROCEDURE OUTCOME IS UNKNOWN. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION. THE SURGICAL PORTS HAD BEEN PLACED ON THE PATIENT WHEN THE IESU ERRORS OCCURRED. THE PROCEDURE WAS ULTIMATELY CONVERTED TO AN OPEN PROCEDURE DUE TO THE GENERATOR ISSUE. THERE WAS NO REPORTED HARM TO THE PATIENT AS A RESULT OF THE CONVERSION.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AFTER A DA VINCI ASSISTED RIGHT MIDDLE LOBE PULMONARY LOBECTOMY PROCEDURE, THE PATIENT, WHO WAS PART OF A COMPLETED PILOT STUDY OF SINGLE PORT ROBOTIC SURGERY FOR ANATOMICAL LUNG RESECTION, EXPERIENCED HEMOPTYSIS. AN X-RAY DONE ON THE PATIENT SHOWED PLEURAL EFFUSION. THE PATIENT UNDERWENT A RE-OPERATION. INTRA-OPERATIVELY, SEVERE PULMONARY CONGESTION WAS FOUND DUE TO A "MAL-RESECTION" OF PREVIOUS S2 SEGMENTAL VEIN DRAINAGE. THE PLEURAL EFFUSION AND BLOOD CLOT WERE RETRIEVED BY SINGLE PORT VIDEO-ASSISTED THORACOSCOPIC SURGERY (VATS) TECHNIQUE. THE SURGEON THEN DISSECTED THE POSTERIOR PART OF THE LUNG FISSURE AND EXPLORED THE A2 ( POSTERIOR ASCENDING BRANCH OF PULMONARY ARTERY). ECCHYMOSIS OF A2 WAS FOUND. THE SURGEON COMPLETED THE ANTERIOR HORIZONTAL FISSURE USING THE HARMONIC SCALPEL TO LOOSEN THE HILAR AREA AND USED TWO HEM-O-LOCKS CLIPS AS WELL AS THE HARMONIC SCALPEL TO RESECT THE A2 BRANCH. THEN THE RIGHT UPPER LOBE CONGESTION CONDITION IMPROVED. THE SURGEON BELIEVES THAT THE CAUSE OF THE POST-OPERATIVE COMPLICATION WAS DUE TO THE UNCOMMON ANATOMY CAUSING BLOOD FROM UPPER LOBE TO FLOW BACK TO MID-LOBE, RESULTING IN THE BLOOD CLOT. THE SUSPECTED DEVICE INVOL

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. IT WAS REPORTED THAT SCREWS WERE DEVIATED FROM THE PLAN. THE CALL DROPPED BEFORE MORE INFORMATION WAS RECEIVED. THERE WAS NO KNOWN IMPACT ON THE PATIENT OUTCOME. A TWO LEVEL ALIF WITH PERCUTAENOUS SCREWS AT L3-L5 AND REMOVAL/REVISION OF POSTERIOR SCREWS AT L5-S1 PROCEDURE WAS BEING COMPLETED. THERE ABOUT AN HOUR ADDED TO THE CASE. THE PATIENT EXPERIENCED RIGHT SIDED PAIN POST-OPERATIVELY. THE PATIENT WILL BE GOING BACK FOR A SECOND PROCEDURE TO REVISE SCREWS. AT THE TIME THE SCREWS WERE REVISED FREEHANDED. THE CAUSE OR SUSPECTED CAUSE OF THE DEVIATION WAS SUSPECTED TP BE DUE TO ROTATING THE BED CAUSING A PATIENT SHIFT. TRAJECTORIES WERE DEVIATED ABOUT 4MM. THE SCREWS WERE OUT OF THE PEDICLE.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DOCTOR WAS PERFORMING A SINGLE POSITION LATERAL FUSION AND WE HAD ISSUES WITH THE MERGE. THE LEVELS IN QUESTION WERE L3 AND L4. THERE WAS SIGNIFICANT SHIFT IN THE A/P AND LATERAL IMAGES WHEN COMPARED TO THE CT SCAN. THIS WAS ATTEMPTED TO BE FIXED BY SEGMENTING THE LEVELS SO THAT EACH LEVEL WAS ON A SEPARATE X-RAY. ALSO, WE ADDED L2 AND L5 TO HELP CORRECT THE SHIFT BUT IT DID NOT WORK. CSR WAS AT THE CASE AND HAS THE LOGS. WE FOLLOWED HIS RECOMMENDATIONS FOR TRYING TO FIX THE SHIFT. WE WERE UNABLE TO FIX THE SHIFT AND THE ROBOT PORTION OF THE CASE 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 SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT TIP BROKE. THE CUSTOMER REMOVED THE FRACTURED PART OF THE INSTRUMENT COMPLETELY AND NO FRAGMENTS REMAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED USING A BACKUP HARMONIC ACE INSTRUMENT WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE FRAGMENT WAS RETRIEVED. THERE WAS NO ADDITIONAL SURGICAL PROCEDURE NEEDED. AN ULTRASOUND WAS PERFORMED TO CONFIRM THERE WERE NO REMAINING FRAGMENTS. THE SURGEON BELIEVES THE BREAK WAS THE RESULT OF A PRODUCT QUALITY PROBLEM. THE HARMONIC ACE INSTRUMENT WAS INSPECTED PRIOR TO USE AND NO ABNORMALITIES WERE FOUND. THE INSTRUMENT WAS USED FOR 15 MINUTES PRIOR TO THE BREAK. THE SURGEON WAS USING THE INSTRUMENT FOR DISSECTING WHEN THE ISSUE OCCURRED. THERE WAS NO INSTRUMENT COLLISION, AND THE INSTRUMENT WAS NOT REMOVED DURING THE PROCEDURE PRIOR TO THE BREAKAGE. UPON FINAL REMOVAL OF THE CANNULA, THERE WAS NO RESISTANCE, NO DAMAGE TO THE CANNULA, AND NO FURTHER DAMAGE TO THE INSTRUMENT. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO COMPLICATIONS FROM RETAI

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: HAD TO SHUT OFF 7 TIMES THROUGH OUT CASE TO EITHER GET IT TO SHOW US INSTRUMENTS THAT HAD ALREADY BEEN CHECKED IN BUT WAS SAYING THEY HAD NOT.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REHOMING ARM WOULDN'T WORK.

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 DURING A T10 TO PELVIS, T10 ON THE LEFT SEEMED TO BE GROSSLY MEDIAL. THE DOCTOR SENT THE ARM TO THE RIGHT SIDE AND ALL OF THE TRAJECTORIES WERE PERFECT. HE SENT IT BACK TO THE LEFT AND IT STILL LOOKED MEDIAL. HE DRILLED A HOLE AND THE PATIENT BUCKED AND CSF APPEARED. THE ISSUE EXTENDED THE SURGICAL TIME BY LESS THAN 1 HOUR.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SUBTOTAL GASTRECTOMY PROCEDURE, THE POSTERIOR GASTRIC ARTERY WAS DISSECTED WITH A HARMONIC ACE INSTRUMENT. THE ISSUE OCCURRED WHEN THE SURGEON WAS ABOUT TO ANASTOMOSE THE STOMACH AND SUDDENLY EXPERIENCED BLEEDING FROM THE POSTERIOR GASTRIC ARTERY. THE SURGEON WAS UNABLE TO STITCH THE BLEEDING SECTION USING THE ROBOT. THE BLEEDING WAS SUPPRESSED WITH AN UNSPECIFIED INSTRUMENT INSTALLED ON UNIVERSAL SURGICAL MANIPULATOR (USM) 4. THE SURGEON MADE THE CLINICAL DECISION TO CONVERT TO OPEN SURGERY DUE TO BLEEDING. THE AMOUNT OF BLOOD LOSS AT THE TIME OF THE DECISION WAS ABOUT 100ML. THE TOTAL AMOUNT OF BLOOD LOSS WAS ABOUT 500ML. THE OPEN PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT THE PATIENT REQUIRING A BLOOD TRANSFUSION.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ROBOT NEVER CONFIRMED WE WERE IN TARGET OR WOULDN'T SEND TO ANY TRAJECTORIES.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE SYSTEM WAS INITIALLY TURNED ON, ALL CHECKS PERFORMED, INSTRUMENTS VERIFIED ETC. THE SYSTEM WAS THEN SHUT DOWN FOR STAGE 1 OF THE PROCEDURE (AS INFORMED PREVIOUSLY BY INR TEAM TO NOT LEAVE ROBOT SWITCHED ON FOR A LONG TIME BEFORE THE CASE STARTS). WHEN TURNING THE SYSTEM BACK ON FOR COMMENCEMENT OF STAGE 2 THE SCREEN DISPLAYED "REBOOT AND SELECT PROPER BOOT DEVICE OR INSERT BOOT MEDIA IN SELECTED BOOT DEVICE AND PRESS A KEY". LOCAL INR SUPPORT INFORMED US TO SWITCH OFF BATTERY AND RESTART SYSTEM USING AC POWER ONLY OR TO RESTART SYSTEM WHILE HOLD "ESC". NEITHER OF THESE RESOLVED THIS ISSUE AND THE CASE WAS ABANDONED. AFTER THE CASE WE TROUBLESHOOTED WITH INTERNATIONAL INR SUPPORT AND WERE ABLE TO "DISABLE LEGACY BOOT MODE".

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. IT WAS REPORTED THAT THERE WAS A DEVIATION. DURING THE CASE, TWO DIFFERENT REGISTRATIONS WERE TAKEN FOR C7-L1 TO T3-T6. THE SURGEON FINISHED INSERTING ALL THE SCREW ON THE LEFT SIDE OF THE PATIENT, WHEN MOVING TO THE RIGHT AT T4, WHEN USING THE MIDAS DRILL, THE PATIENT SPINAL CORD WAS KNICKED, RESULTING IN LOSS OF MOTOR ON THE RIGHT SIDE OF THE PATIENT. THE MANUFACTURER REPRESENTATIVE NOTED THAT DURING PLANNING, THE SCREW WAS PLANNED A BIT LATERAL TO THE PEDICLE, WHICH COULD CONTRIBUTE TO THE SITUATION. THE SURGEON ENDED UP REMOVING ALL SCREWS AND CLOSE THE PATIENT UP FOR MRI. THE PATIENT WAS AFFECTED. ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT THE TRAJECTORIES WERE DEVIATED ABOUT 3.5MM MEDIALLY. THE SURGERY HAS NOT BEEN RESCHEDULED AS OF YET. THE SITE IS CURRENTLY MONITORING THE PATIENT¿S MOTOR FUNCTION AND WILL RESCHEDULE ONCE EVERYTHING IS BACK TO BASELINE.

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, A PIECE OF THE CANNULA SEAL FELL INTO THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING LAST SCREW PLACEMENT (L5R) THE HIGH SPEED DRILL, PILOT DRILL AND THE TAP WERE NAVIGATED ACCURATELY, BUT SCREW WAS NOT. THE SCREW WAS PUT SLIGHTLY IN FORAMEN, IT WAS FOUND IN THE X-RAY VERIFICATION SHOT. SCREW WAS IMMEDIATELY REMOVED AND RE-PLANNED AND AGAIN - HIGH SPEED DRILL, PILOT DRILL AND TAP WERE NAVIGATED ACCURATELY, BUT DURING SCREW PLACEMENT THE DOCTOR SAW AND FELT THAT THE SCREW JUMPED INTO OLD CANAL. ONCE MORE SCREW WAS IMMEDIATELY REMOVED AND RE-PLANNED AND AGAIN HIGH SPEED DRILL, PILOT DRILL AND TAP WERE NAVIGATED ACCURATELY, BUT SCREW WAS PUT WITHOUT ROBOT/NAVIGATION WITH STANDARD SCREWDRIVER AND UNDER X-RAY CONTROL. AFTER DISCUSSION WITH THE REP HE COULDN'T CONFIRM THAT THE OFFSET TURNED TO RED WHEN SCREWDRIVER WAS IN EE.

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 SURGICAL PROCEDURE, THE CUSTOMER STATED THAT THE CAUTERY WAS NOT WORKING, AND A QUESTION MARK WAS DISPLAYED ON THE INTEGRATED ELECTROSURGICAL UNIT (IESU/ERBE) FRONT PANEL, INDICATING THAT THE ERBE COULD NOT DETERMINE WHICH UNIVERSAL SURGICAL MANIPULATOR (USM) THE INSTRUMENT WAS ENGAGED ON. THE CUSTOMER HAD REPLACED THE CORDS AND EXHAUSTED THEIR SUPPLY. THE CUSTOMER TRIED DIFFERENT CAUTERY INSTRUMENTS, STILL THE ISSUE PERSISTED. THE CUSTOMER POWER CYCLED THE SYSTEM AND REMOVED AC POWER FROM THE ERBE AND THE ISSUE PERSISTED. THE SYMPTOMS INDICATED BAD ENERGY CORD(S) OR BAD ENERGY CONNECTORS ON THE ERBE. THE PROCEDURE WAS CONVERTED TO OPEN SURGERY WITH NO REPORTS OF PATIENT INJURY. AN 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.

CyberKnife — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: SIDE EFFECT - ANESTHESIA DELAROSA (AD).

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE ROBOT SEEMED TO BE MORE SENSITIVE THEN USUAL AND A SCREW ACTUALLY SEEMED TO MISS LATERALLY. TO HELP WITH EXAMINING WHAT WENT WRONG, THE DIFFICULTIES WE HAD PERSISTED ON THE PATIENTS RIGHT SIDE. THE PA SEEMED TO THINK THE TRAJECTORY LOOKED PERFECT UNTIL IT CAME TIME FOR THE DRIVER ARRAY TO PASS DOWN THE END EFFECTOR, THEN SHOWING A SUDDEN CHANGE IN TRAJECTORY. I AM UNSURE IF AN ISSUE COULD BE RELATED TO TECHNIQUE OR NOT. WE HAVE SINCE USED THE ROBOT THIS WEEK AND DID NOT SEEM TO HAVE ISSUES.

Senhance — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE EVENT OCCURRED OUTSIDE THE UNITED STATES. THE EVENT OCCURRED ON (B)(6) 2022, INTERNALLY MADE AWARE ON (B)(6) 2023. THE PATIENT EXPERIENCED SUTURE FAILURE WHICH REQUIRED INTERVENTION FOR TREATMENT (RESOLVED ON (B)(6) 2022). INTERVENTION INCLUDED, RELAPAROSCOPY, COLONOSCOPY, AND ENDOVAC THERAPY. IT WAS REPORTED THAT THE CAUSALITY TO THE SENHANCE SURGICAL SYSTEM WAS POSSIBLE.

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 LYMPHADENECTOMY PROCEDURE, THE MONOPOLAR CURVED SCISSOR (MCS) TIP COVER ACCESSORY CAME LOOSE WHEN REMOVING THE MCS INSTRUMENT AND FELL INSIDE THE PATIENT'S ABDOMEN. AT THE TIME THE EVENT OCCURRED, THE SURGICAL STAFF WAS IN THE PROCESS OF EXCHANGING THE MCS INSTRUMENT WITH A LARGE NEEDLE DRIVER INSTRUMENT. THERE WAS NO DIFFICULTY FELT WHILE REMOVING THE MCS INSTRUMENT. AFTER THE EVENT OCCURRED, THE MCS INSTRUMENT REMAINED OUTSIDE THE PATIENT FOR THE REMAINDER OF THE PROCEDURE AND WAS NO LONGER USED DURING THE PROCEDURE. PER THE SURGEON, THE MCS TIP COVER ACCESSORY LIKELY CAME LOOSE DURING THE INSTRUMENT CHANGE. THE MSC TIP COVER ACCESSORY APPEARED TO HAVE BEEN PROPERLY INSTALLED DURING THE SURGICAL PROCEDURE WITH NO PART OF THE ORANGE SURFACE VISIBLE AFTER INSTALLATION NOR WAS IT INSTALLED BEYOND THE ORANGE SURFACE. THE INSTALLATION TOOL HAD BEEN USED; ELECTROLUBE OR ANY OTHER LUBRICANT HAD NOT BEEN APPLIED PRIOR TO INSTALLATION OF THE MCS TIP COVER ACCESSORY. THE MCS INSTRUMENT AND MCS TIP COVER ACCESSORY HAD BEEN INSPECTED PRIOR TO USE. THE SURGEON DID NOT NOTICE ISSUES WITH THE FUNCTIONALITY OF THE MCS INS

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THIS EVENT OCCURRED IN AN INTRA-OP T10-PELVIS REVISION CASE. EXISTING HARDWARE WAS PRESENT FROM L3-S1. AFTER ALL STEPS OF THE INTRA-OP WORKFLOW HAD BEEN COMPLETED, A THOROUGH AND DETAILED ANATOMY CHECK WAS DONE. THE SURGEON AND HIS FELLOW ADJUSTED ALL SCREWS THAT HAD BEEN PRELIMINARILY PLANED. AFTER THE SURGEONS MODIFIED, REVIEWED, AND APPROVED ALL SCREWS; THE ROBOT WAS PUSHED INTO THE CORRECT POSITION. SCREWS WERE PLACED T10-L2 ON THE LEFT PRIOR TO PLACING SCREWS T10-L2 ON THE RIGHT (SURGEON PREFERENCE). S2AI SCREWS WERE PLACED LAST. ACCURACY CHECKS WERE CONDUCTED THROUGHOUT THE SCREW PLACEMENT PROCESS A SPIN WAS CONDUCTED AFTER ALL SCREWS WERE PLACED. THE LEFT T10 SCREW APPEARED TO BREACH THE MEDIAL WALL OF THE PEDICLE AND THE SCREW APPEARED SLIGHTLY MEDIAL TO THE PLAN. THE EXTENT OF THE BREACH COULD NOT BE DETERMINED DUE TO THE SCAN QUALITY (VERY POOR DUE TO THE PATIENT SIZE AND METAL SCATTER). THE SURGEON CAREFULLY REVIEWED THE SCREW AND NEURO MONITORING DATA BEFORE DECIDING TO LEAVE IT IN PLACE. THE LEFT T10 PEDICLE WAS SMALL, AND THE SURGEON SELECTED A SCREW DIAMETER THAT WAS CLINICALLY APPROPRIATE AND HIM EFFECTIVE FIXATION. THE SURGEON FELT IT WAS POSSIBLE THAT THE 4.5 HIGH

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT THERE WAS A VIBRATING ROBOTIC ARM WITH HIGHLY INACCURATE TRAJECTORIES (2CM FROM TARGET). MULTIPLE ISSUES NOTED BY SURGEON, SURGERY WAS CANCELLED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

Monarch Platform — 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 MONARCH BRONCHOSCOPY PROCEDURE THE PATIENT SUSTAINED A PNEUMOTHORAX. RIGHT UPPER-LOBE, GROUND-GLASS OPACIFICATION WITH SOME SOLID AREA. AN ARCPOINT NEEDLE AND AN AURIS CYTOLOGY BRUSH WERE USED DURING THIS PROCEDURE BUT WERE DISPOSED OF AFTERWARDS, THE LOT NUMBER WAS NOT RECORDED. PATIENT RECEIVED A SMALL-BORE TUBE, A POST-PLACEMENT X-RAY, WITH NO PLEURAL VACUUM NEEDED. THE PATIENT WAS DISCHARGED THE NEXT DAY.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING L3-L4 SPL CASE, C-ARM IMAGES WERE MIRRORED AFTER THE MERGE. BEFORE THE MERGE, EVERYTHING WENT NORMALLY: IMAGES WERE TRANSFERRED NORMALLY, CENTROIDS WERE PLACED BUT AFTER MERGING C-ARM SHOTS WERE REVERSED. RE-IMAGING THE PATIENT, RESETTING SOFTWARE, RESTARTING C-ARM, RESTARTING EGPS, CREATING NEW CASE DID NOT SOLVE THE PROBLEM. ALSO DURING PANNING PHASE, THE ANTERIOR PART OF THE CAGE NEEDED TO BE PLANNED POSTERIORLY TO GET LEFT SIDE ACCESS. PROCEDURE WAS PERFORMED THE OLD FASHION WAY.

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 DURING A PROCEDURE USING THE EXCELSIUS GPS SYSTEM, A PEDICLE PROBE WAS PLACED AND A MEDIAL BREACH WITH CEREBROSPINAL FLUID LEAK WAS OBSERVED AND FIXED INTRAOPERATIVELY.

Monarch Platform — 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 MONARCH BRONCHOSCOPY PROCEDURE ON (B)(6) 2022, THE PATIENT RETURNED TO THE EMERGENCY ROOM (ER) ON (B)(6) 2022, EXPERIENCING SHORTNESS OF BREATH. A CHEST TUBE WAS PLACED AND THE PATIENT WAS ADMITTED TO THE HOSPITAL. THE PHYSICIAN WHO PERFORMED THE BRONCHOSCOPY DOES NOT ATTRIBUTE THIS EVENT TO THE MONARCH SYSTEM, STATING IT WAS A RESULT OF THE NEEDLE BEING DEPLOYED INTO THE EDGE OF THE PLEURA. THE PATIENT DID NOT EXPERIENCE ANY OTHER ISSUES OTHER THAN SHORTNESS OF BREATH. THE CHEST TUBE WAS REMOVED ON (B)(6) 2022, A X-RAY WAS PERFORMED, AND THE PATIENT WAS DISCHARGED. THERE WAS NO EVIDENCE THAT THE MONARCH SYSTEM DID NOT PERFORM AS INTENDED.

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 A PATIENT EXPERIENCED ADVERSE EFFECTS FOLLOWING SURGERY WHERE A SCREW USING THE EXCELSIUS GPS SYSTEM WAS MISPLACED INTRA-OPERATIVELY CAUSING A LEFT MEDIAL BREACH.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED ANTERIOR RESECTION SURGICAL PROCEDURE, THE CUSTOMER REPORTED THAT THE VISION WAS LOST. THEY ATTEMPTED TO RECONNECT THE CAMERA TO THE ENDOSCOPE CONTROLLER (EC), BUT THE CAMERA HAD A SELF-TEST FAILURE, AND THE COLOR BAR WAS DISPLAYED. THEY REPLACED THE CAMERA WITH A BACKUP ONE, BUT ALL THE AVAILABLE CAMERAS HAD THE SAME SYMPTOM. LASTLY, THEY REBOOTED THE SYSTEM AND CLEANED THE CAMERA CONNECTOR; HOWEVER, THE ISSUE PERSISTED. THE CUSTOMER ELECTED TO CONVERT TO LAPAROSCOPIC PROCEDURE. NO KNOWN IMPACT OR PATIENT CONSEQUENCE REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP ON 19-OCT-2022 AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CAMERAS WERE INSPECTED PRIOR TO USE WITH NO ABNORMALITY. DURING THE PROCEDURE, THE VISION LOSS OCCURRED ON BOTH OF THE SURGEON SIDE CONSOLE (SSC) AND VISION SIDE CART (VSC). INFORMATION REGARDING PATIENT DEMOGRAPHICS, RELEVANT TESTING, AND MEDICAL HISTORY WERE REQUESTED; HOWEVER, THE REPORTER WAS NOT ABLE TO PROVIDE THAT 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 DURING A DA VINCI-ASSISTED PROCEDURE THAT ARM 3 OF THE SINGLE PORT (SP) SYSTEM ENCOUNTERED INSTRUMENT ENGAGEMENT ISSUES. THE OR STAFF STATED THEY UNDOCKED THE ARM AND RE-DRAPED BEFORE CALLING. THEY HAD ALSO POWER CYCLED AND TRIED MORE THAN ONE INSTRUMENT ON ARM 3, BUT ISSUES PERSISTED. THE PATIENT WAS ON THE TABLE, UNDER ANESTHESIA, AND PORTS HAD BEEN PLACED AT THE TIME. THE TSE REVIEWED THE LIVE LOGS AND FOUND ERRORS 23300 AND 31009. THE TSE INFORMED THE OR STAFF THAT ALL TROUBLESHOOTING STEPS HAD BEEN PERFORMED AND ARM 3 NEEDS SERVICE. IT WAS CONFIRMED FOLLOWING A FOLLOW-UP CALL THAT THE SURGEON CONVERTED TO AN XI MULTIPORT SYSTEM. THERE WAS NO REPORT OF PATIENT INJURY. AN ATTEMPT HAS BEEN MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER CONCERNING THE REPORTED EVENT WITH NO SUCCESS.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE SCRUB COUNT WAS OFF, AND THE CUSTOMER WAS MISSING A MONOPOLAR CURVED SCISSORS (MCS) TIP COVER. THE CUSTOMER LOCATED THE MCS TIP COVER INSIDE OF THE PATIENT AND REMOVED IT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SITE ON (B)(6) 2022 AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER STATED THAT THE ISSUE WAS IDENTIFIED WHILE CLOSING THE PATIENT. THE MCS INSTRUMENT AND TIP COVER WERE INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. THE MCS TIP COVER WAS RETRIEVED BY GOING BACK IN THE ABDOMEN. ALL FRAGMENTS WERE RETRIEVED, AND THIS WAS CONFIRMED THROUGH INSPECTION OF THE MCS TIP COVER. THE CASE WAS EXTENDED FOR A FEW MINUTES DUE TO THE ISSUE. IT WAS UNKNOWN WHAT TASK WAS PERFORMED WHEN THE MCS TIP COVER FELL INTO THE PATIENT. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE MCS INSTRUMENT DURING THE PROCEDURE. THE MCS INSTRUMENT DID NOT COLLIDE WITH ANOTHER INSTRUMENT. A REDUCER WAS NOT USED. THERE WAS NO DIFFICULTY REMOVING THE MCS INSTRUMENT. THE MCS INSTRUMENT WRIST WAS STRAIGHTENED UPON REMOVAL. NO D

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING NAVIGATION, WHILE MOVING TO TRAJECTORY FOR OUR L5 R AND S1 R SCREWS THE AXIAL SLICE WAS UNRECOGNIZABLE (COULD NOT MAKE OUT ANY PEDICLE, VERTEBRAL BODY, S.P). WE CHECK OUR LEFT SIDED SCREWS TRAJECTORY, AND EVERYTHING LOOKED PERFECT. I WENT BACK TO THE PLANNING PAGE TO CHECK OUR RIGHT SIDED SCREWS AXIAL IMAGES AND AGAIN, EVERYTHING LOOKED PERFECT. THOUGH, WHILE BRINGING INSTRUMENTS IN THE EE ALL INSTRUMENT TRACKED CORRECTLY DOWN PLANNED SCREW TRAJECTORY EVEN THOUGH IT DID NOT VISIBLY LOOK LIKE A CORRECT AXIAL SLICE (ANATOMY UNRECOGNIZABLE). AFTER A FEW SOFTWARE RESETS AND A HARD SHUT DOWN, AND SWITCHING EES I INFORMED DR. GENTRY IT WAS JUST THE SLICE OF THE SCAN WE WERE IN, AND I BELIEVED EVERYTHING WAS SAFE. WHEN ADDING LAYERS TO OUR AXIAL CUT THE IMAGE WAS IMPROVING (COULD MAKE OUT DISTINCT ANATOMY) BUT DOC STILL DID NOT TRUST IT. ADJUSTING THE PLAN HAD LITTLE TO NO EFFECT AS WELL. HE WOULD NOT MAKE AN INCISION TO CHECK TRAJECTORY OF INSTRUMENTS UNDER FLOURO AND BAILED ON THE ROBOT.

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 CASE STUDY OF A 73-YEAR-OLD FEMALE PATIENT WHO UNDERWENT A DA VINCI-ASSISTED ROBOTIC POSTERIOR MEDIASTINAL MASS RESECTION ON THE LEFT CHEST. A CHEST DRAINAGE TUBE WAS PLACED. MAGNETIC RESONANCE IMAGING (MRI) OF THE THORACIC SPINE SHOWED A POST-OPERATIVE ABNORMAL SIGNAL AND A LEFT PARAMASS OF THE 10TH THORAX VERTEBRAE. CEREBROSPINAL FLUID LEAKAGE OCCURRED AFTER SURGERY DUE TO THE CLOSE RELATIONSHIP BETWEEN THE MEDIASTINAL MASS AND THE INTERVERTEBRAL FORAMINA, RESULTING IN A DURAL TEAR. BEDREST WAS ORDERED. MRIS WERE REPEATED AT ONE AND TWO WEEKS AFTER THE SURGERY. THE ABNORMAL SIGNAL WAS SMALLER THAN BEFORE. THE CHEST DRAIN WAS REMOVED, AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL 15 DAYS AFTER SURGERY. THE PATIENT REMAINED ON BEDREST FOR TWO WEEKS AFTER DISCHARGE. THE EVENT WAS REPORTED AS CURED AFTER THREE WEEKS OF BEDRIDDEN TREATMENT. THERE WERE NO DA VINCI DEVICE MALFUNCTIONS REPORTED.

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 AFTER AN L2/L3 INTERBODY INSERTION, DURING A L2/-L4 SCREW REVISION AND TLIF SPINAL FUSION, THE SURGEON USED THE GUIDANCE SYSTEM TO INSERT THE FIRST SCREW AT L2 ON THE LEFT. THE PROCEDURE WENT FINE. THE SURGEON THEN USED THE GUIDANCE SYSTEM AGAIN TO PLACE ANOTHER SCREW ON THE RIGHT L2 (SURGEON WAS ON THE PATIENT'S LEFT, DEVIATING FROM STANDARD SITE'S PROCESS), THE PATIENT BUCKED DURING INSERTION. THE SURGEON WAS INFORMED THAT THE PATIENT BUCKED AND DECIDED TO CONTINUE WITH THE CASE. POST-OPERATIVELY THE PATIENT'S RIGHT FOOT HAD SOME SENSATION AND WAS UNABLE TO MOVE. THE SURGEON THEN WENT INTO THE OPERATING ROOM TO REMOVE THE RIGHT L2 SCREW, BUT THE PATIENT'S RIGHT FOOT WAS STILL UNABLE TO MOVE. A POST-OP CT WAS COMPLETED AND REVEALED THAT L2 SCREW WAS MEDIAL.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: CHECKED THE SYSTEM AFTER REPLACING THE FUSES AND FOUND THAT THE POWER IS BACK ON THE SYSTEM WITH POWER AND BATTERY LED INDICATOR ON THE CONTROL PANEL. SYSTEM'S FANS WERE ALSO RUNNING BUT THERE WAS NO DISPLAY ON THE MONITOR. LED ON THE MONITOR IS RED. I.E. NO VIDEO SIGNALS FROM COMPUTER. 2. CONNECTED AN EXTERNAL HDMI CABLE FROM PC TO MONITOR DIRECTLY BUT STILL NO VIDEO SIGNAL ON MONITOR. 3. CONNECTED EXTERNAL MONITOR ON THE PC DIRECTLY AND NO DISPLAY ON THE EXTERNAL MONITOR TOO. 4. CHECKED THE VOLTAGE ON PC POWER SUPPLY AND IT WAS 54 VOLT DC. 5. PC FAN WAS ALSO RUNNING. 6. IT HAS BEEN OBSERVED THAT THE PC IS NOT BOOTING UP SO THERE IS NO DISPLAY ON THE MONITOR. KINDLY SUGGEST FURTHER.

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 THE SYSTEM APPEARED TO REGISTER BUT ACCURACY SEEMED TO BE OFF SIGNIFICANTLY RESULTING IN MISPLACED SCREWS. AT THE TIME OF THE COMPLAINT COMING IN, THE CONFIRMATION SPIN HAD NOT YET BEEN TAKEN, SO EXACT DETAILS OF PLACEMENT WERE NOT YET KNOWN, LIKELY MEDIAL ON THE LEFT AND LATERAL ON THE RIGHT. THE PROCEDURE WAS ON L4-L5, PLACED RIGHT FIRST THEN LEFT, USING CT TO FLUORO WORKFLOW. THERE WAS NO DELAY AND NO IMPACT ON THE PATIENT OUTCOME. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT IT WAS ASSUMED THAT THE TRAJECTORIES WERE OFF GREATER THAN10MM BECAUSE TWO WERE NOT IN BONE. THE SCREWS WERE REMOVED PRIOR TO THE CONFIRMATION SPIN. TWO OF THESE SCREWS PATHWAYS WERE NOT ABLE TO BE LOCATED. NO SCREWS WERE REPLACED AT THE TIME OF THE CASE. THE CASE WAS NOT COMPLETED. THE SCREWS WERE TAKEN OUT AND THE CASE WAS ABORTED. THERE HAS BEEN NO NOTIFICATION ON RESCHEDULING THE CASE.

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 A PATIENT UNDERWENT A DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE ON AN UNSPECIFIED DATE AND DIED FROM CANCER IN 2016. ACCORDING TO THE INITIAL REPORTER, THE PATIENT'S TREATMENT WAS NEGATIVELY AFFECTED BY THE DA VINCI-ASSISTED SURGERY. THE INITIAL REPORTER INDICATED THAT THE PATIENT UNDERWENT THE HYSTERECTOMY FOR CANCER THAT REOCCURRED FOR A SECOND TIME. PER THE INITIAL REPORTER, IT IS BELIEVED THAT THE ROBOTIC PROCEDURE "STIRRED UP THE CANCER" AND EXPEDITED HER DEATH BY SPREADING. THE PATIENT REPORTEDLY DIED WITHIN SIX MONTHS OF THE SURGERY. NO FURTHER CLINICAL INFORMATION WAS PROVIDED. 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.