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 FAILED TO BE RECOGNIZED. THE USER COMPLETED THE PROCEDURE USING A BACKUP HARMONIC ACE WITH NO FURTHER ISSUES REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: A FRAGMENT OF THE HARMONIC ACE FELL INSIDE OF THE PATIENT AND WAS RETRIEVED DURING THE SAME PROCEDURE. THERE WAS NO ADDITIONAL SURGICAL PROCEDURE REQUIRED. IT WAS CONFIRMED THAT ALL FRAGMENTS WERE RETRIEVED. THERE WERE NO POST-OPERATIVE TESTS PERFORMED. UPON FINAL REMOVAL OF THE INSTRUMENT, THERE WAS NO RESISTANCE OF THE INSTRUMENT THROUGH THE CANNULA, NO DAMAGE TO THE CANNULA, AND NO ADDITIONAL DAMAGE TO THE INSTRUMENT. THERE WAS NO INJURY TO 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: ON 24-JAN-2024, INTUITIVE SURGICAL, INC. (ISI) RECEIVED MW5150169 STATING: THE REPORTED EVENT WAS A POSTOPERATIVE DUODENAL SEGMENT STAPLE LINE LEAK, WHICH REQUIRED A SECOND OPERATION 20 DAYS AFTER THE INITIAL ROBOTIC-ASSISTED PROCEDURE. THE AREA OF THE LEAK WAS STAPLED VIA THE USE OF A COVIDIEN STAPLER.

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.

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 SYSTEM FAULTS OCCURRED DURING SETUP FOR A MONARCH BRONCHOSCOPY. THE PHYSICIAN ELECTED TO NOT START THE DIAGNOSTIC PROCEDURE. THE PATIENT HAD ALREADY BEEN ANESTHETIZED. NO CLINICAL CONSEQUENCES TO THE PATIENT WERE REPORTED DUE TO THIS EVENT.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MERGED CT WITH FLAT PANEL. CENTROID PLACEMENT SEEMED EXTRA OFF IN LATERAL VIEW EVEN MORE THAN USUAL. PHYSICIAN STATED THAT SOMETHING FELT OFF FROM FIRST SCREW. THROUGH 7 SCREWS PLACED, SURGEON X-RAYED AND NOTICED MULTIPLE SCREWS WERE BREACHED. NO ALARMS FROM SURVEILLANCE UNTIL THE LAST SCREW WHICH IS WHY SURGEON DID X-RAY. DID O-ARM SPIN AND NEW CASE TO REPLACE SCREWS THAT WERE BREACHED AND FINAL SCREWS.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY PROCEDURE, THE CUSTOMER NOTICED THAT THE SP MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT TIP WAS SEPARATED AND FELL OFF. UPON REMOVING THE INSTRUMENT TO CHECK, THE CUSTOMER FOUND SOME OF THE ACCESSORIES WERE NOT INTACT. THEY WERE ABLE TO RETRIEVE THE TIP, BUT SOME OF THE BROKEN PARTS COULD NOT BE CONFIRMED. THE CUSTOMER THEN CONDUCTED A LARGE AMOUNT OF IRRIGATION/SUCTION JUST IN CASE. THE PROCEDURE WAS COMPLETED WITH A BACKUP INSTRUMENT OF THE SAME KIND. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE MCS INSTRUMENT AND MCS TIP ACCESSORY WERE INSPECTED PRIOR TO USE, AND NO DAMAGE WAS FOUND. DURING THE PROCEDURE, THE MCS TIP ACCESSORY AND FRAGMENTS FROM THE MCS INSTRUMENT FELL INTO THE PATIENT'S BODY AFTER BEING USED FOR LONGER THAN ONE HOUR TO DISSECT TISSUE. THE CUSTOMER RETRIEVED THE FRAGMENTS BUT COULD NOT CONFIRM IF THEY RETRIEVED ALL FRAGMENTS. THE CUSTOMER PERFORMED A LARGE AMOUNT OF IRRIGATION/SUCTION AS A PRECAUTIONARY MEASURE. POST-OPERATIVE TESTS AND ADDITIONAL SURGICAL PROCEDURES WERE NOT PERFORMED. THE SURGEON DID NOT NOTICE ANY I

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 PANCREATICODUODENECTOMY SURGICAL PROCEDURE, THE HARMONIC ACE TIP WAS BROKEN, AND A FRAGMENT FELL INSIDE THE PATIENT. THE FRAGMENT WAS REMOVED FROM THE PATIENT DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED USING A BACKUP HARMONIC ACE WITH NO FURTHER CONSEQUENCES KNOWN. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE FRAGMENTS OF THE HARMONIC ACE WERE RETRIEVED USING A LAPAROSCOPIC INSTRUMENT. ALL THE FRAGMENTS WERE CONFIRMED TO BE RETRIEVED. THERE WAS NO ADDITIONAL SURGICAL PROCEDURE NEEDED AS THE FRAGMENTS WERE RETRIEVED USING LAPAROSCOPIC INSTRUMENTS DURING THE SAME PROCEDURE. THERE WERE NO POST-OPERATIVE TESTS PERFORMED. THE SURGEON BELIEVES THAT THE INSTRUMENT QUALITY WAS THE CAUSE OF THE BREAK. THE INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO ABNORMALITIES, IT WAS USED FOR AN HOUR PRIOR TO BREAK WHEN BEING USED FOR SEPARATING A BLOOD VESSEL. THERE WAS NO FUNCTIONALITY PROBLEM PRIOR TO THE BREAK. THERE WAS NO INSTRUMENT COLLISION, AND THE INSTRUMENT WAS NOT REMOVED DURING THE PROCEDURE PRIOR TO THE BREAK. UPON FINAL REMOVAL, THERE WAS NO R

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: UPON SYSTEM BOOT UP, SYSTEM WOULD GET STUCK ON BLACK SCREEN WHERE NO BOOT MODE HAD BEEN SELECTED. THE SYSTEM WAS RESTARTED MULTIPLE TIMES AND STILL COULD NOT MAKE IT PAST THE BLACK BOOT MODE SELECT SCREEN. REQUESTING FSE SUPPORT TO ADDRESS COMPUTER/HARD DRIVES AND FIGURE OUT THE ROOT OF THIS PROBLEM.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ROBOT BROUGHT INTO ROOM AND TURNED ON WITHOUT ANY ISSUES. AFTER A COUPLE MINUTES THE SCREEN CHANGED TO A BLUE WINDOWS SCREEN STATING "YOUR PC RAN INTO A PROBLEM AND NEEDS TO RESTART. WE'LL RESTART FOR YOU." TRIED MULTIPLE RESTARTS AND ERROR STILL OCCURRED. CASE HAD TO BE ABORTED.

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: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION PROCEDURE, ANASTOMOTIC INSUFFICIENCY AT THE EDGE OF THE ANASTOMOSIS / STAPLE LINE OCCURRED. THE ISSUE WAS OBSERVED AFTER USING A SUREFORM STAPLER AND CHECKING PERFUSION OF THE ANASTOMOSIS WITH INDOCYANINE GREEN (ICG). THE STAPLE SUTURE HAD BEEN PROPERLY PLACED AND WAS CHECKED IN SITUS. THE THIRD-PARTY CIRCULAR STAPLER WAS NOTED TO BE WORKING PROPERLY.

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 UNSPECIFIED SURGICAL PROCEDURE, ANASTOMOTIC INSUFFICIENCY WITH AN INTRACORPORAL ANASTOMOSIS OCCURRED. THE ANASTOMOSIS WAS THEN SUTURED. THE SURGEON BELIEVES THIS ISSUE WAS DUE TO THE UNSPECIFIED SUREFORM STAPLER.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE SCREW PLACEMENT WAS SLIGHTLY OFF FROM THE PLAN.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: EGPS BATTERY DOES NOT HOLD ANYMORE. PLEASE SEND A FSR IMMEDIATELY TO REPLACE AND DO A SERVICE ON OUR MACHINE AT WESTCHESTER MEDICAL CENTER.

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 APPENDECTOMY SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY FELL OFF WHEN REMOVED FROM THE PATIENT. THE MCS TIP COVER ACCESSORY WAS RETRIEVED BUT ALMOST FELL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE MCS TIP COVER ACCESSORY FELL INSIDE THE PATIENT, AND WAS NOTED BY THE SCRUB UPON INSTRUMENT REMOVAL THAT THE TIP WAS GONE. THE MCS TIP COVER ACCESSORY WAS INSPECTED PRIOR TO USE AND NO DAMAGE WAS NOTED. THE MCS TIP COVER ACCESSORY WAS RETRIEVED. THE SURGEON WAS UNSURE WHAT SURGICAL TASK WAS BEING PERFORMED WHEN THE MCS TIP COVER ACCESSORY FELL INSIDE THE PATIENT. THE MCS INSTRUMENT WAS IN USE FOR 10 MINUTES. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE MCS INSTRUMENT DURING THE SURGICAL PROCEDURE. THE MCS INSTRUMENT COLLISION WITH ANY OTHER INSTRUMENTS DURING THE SURGICAL PROCEDURE WAS MINIMAL. THE MCS TIP COVER ACCESSORY WAS PROPERLY INSTALLED DURING THE SURGICAL PROCEDURE AND NO PART OF THE ORANGE SURFACE WAS VISIBLE AFTER THE MCS TIP COVER ACCESSORY WAS IN

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: 11-L3 PSF, BURST FRACTURE AT L1WITH DR. (B)(6) AT (B)(6). ALL SCREWS WERE PLACED IN A SERPENTINE ORDER WITHOUT ANY DIFFICULTY UP UNTIL RL3. 4.5 HS BURR WAS USED THEN DRILL WAS USED IN SCLEROTIC BONE. RESIDENT STRUGGLED GETTING THE DRILL THROUGH THE PEDICLE. DURING THIS TIME THE DRILL HAD SKIVED MEDIALLY. DR. (B)(6) AND RESIDENT TRIED RE-DRILLING AND TAPPING TO GET TO THE CORRECT TRAJECTORY. NAVIGATION LOOKED INTACT AT ALL TIMES. UPON GETTING A FINAL SPIN IT WAS NOTED THAT RL3 HAD JUST BREACHED MEDIALLY. DR. (B)(6) HAD DECIDED HE WOULD FREEHAND RL3 TO BRING IT LATERALLY. ANOTHER SPIN WAS PERFORMED AND THE SCREW WAS STILL MEDIAL. SCREW WAS TAKEN OUT AND PUT IN UNDER XRAY.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE SURGEON MISSED SCREWS IN LOWER HALF OF THE CONSTRUCT AS IT APPEARED TO SHIFT. WE PERFORMED AN O-ARM SPIN AFTER SEEING SCREWS APPEARED OFF TRAJECTORY AND IT REVEALED THAT THERE WAS A SCREW THAT MISSED LATERALLY AND ONE MEDIALLY AT L1 AND L2. THEN TRIED TO REPOSITION SCREWS AFTER SPIN (2ND FILE) AND THEY DIDN'T WANT TO GOIN THE NEW TRAJECTORY SO IT WAS ABORTED.

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 AN INTERBODY SPACER WAS MISPLACED INTRA-OPERATIVELY WHILE USING THE EXCELSIUS GPS SYSTEM TO PREPARE THE DISC SPACE RESULTING IN A DURAL TEAR.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: WE DID AN L3-5 PSF WITH ROBOT USING MCS SCREWS. BOTH OF THE SCREWS AT L3 SHIFTED TO THE LEFT. THE RIGHT SCREW WENT MEDIAL AND THE LEFT SCREW WAS LATERAL. IT WAS IDENTIFIED BY NEUROMONITORING UPON STIMULATION AND THEN CONFIRMED WITH ANOTHER INFRA OP SPIN. WE BACKED THE SCREWS OUT AND REPLACED THEM WITH ROBOTIC GUIDANCE USING THE SECOND O-ARM SPIN. ALL OTHER SCREWS WERE FINE.

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 THE FIRST CASE OF THE DAY THE PHYSICIAN EXPERIENCED JUMPY NAVIGATION DURING THE PROCEDURE. THE CASE WAS ABORTED DUE TO THE NAVIGATION BEING OFF AND THE SCOPE COULD NOT PHYSICALLY MANEUVER IN THE AIRWAY. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT BECAUSE OF THE SYSTEM ISSUES.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: BEFORE A CASE, WE WERE TRYING TO UPLOAD THE PATIENT SCAN AND THE ROBOT WAS NOT RECOGNIZING THE CD DRIVE. WE TRIED BOTH USB PORTS, DID A SOFTWARE RESET AND THEN A HARD RESET. WHEN TURNING BACK ON WE GOT A BLACK PAGE SAYING, "REBOOT AND SELECT PROPER BOOT DEVICE OR INSERT BOOT MEDIA IN SELECTED BOOT DEVICE AND PRESS A KEY_".

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.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE ARM AND VERIFICATION PROBE WERE AGAIN USED TO CONFIRM THE ENTRY POINTS. A STRYKER PERFORATOR WAS USED TO CREATE A SINGLE BURR HOLE ON THE PATIENTS RIGHT. A STIM-LOCK WAS OPENED AND USED TO TEMPLATE AN AREA THAT THE SURGEON BURRED DOWN WITH A ACORN BIT TO RECESS THE STIM-LOCK. THE ARM WAS SENT AGAIN TO CONFIRM ACCURACY AT THE CENTER OF THE BURR HOLE. THE IGEE TOP TO TARGET WAS SET TO 183MM AND A 216.5MM ALPHA OMEGA CANNULA WAS PLACED TO APPROXIMATELY 10MM ABOVE TARGET. E3D WAS MOVED BACK INTO PLACE AND A SPIN WAS PERFORMED SHOWING A DEVIATION MEDIALLY APPROXIMATELY 1.25MM. THE SURGEON CHECKED ON THE BRAINLAB SERVER AND SAID THAT THEY SHOWED APPROXIMATELY 2.5MM OF DEVIATION. THE AO HEAD STAGE WAS REMOVED AND THE ARM RESETTLED, THIS TIME TO 168MM IGEE TOP TO TARGET. A 201.5MM AO CANNULA WAS PLACED AND E3D WAS MOVED BACK INTO TO POSITION AND ANOTHER SCAN WAS PERFORMED. IT WAS LOADED ONTO THE ROBOT AND AN EVALUATION SHOWED ALMOST IDENTICAL DEVIATION, SUGGESTING THE CANNULA FELL INTO THE PREVIOUS TRACK. THE SURGEON BELIEVED THE TRAJECTORY SET BY THE ROBOT WAS CORRECT, BUT THE CANNULA DEVIATED DUE TO POSSIBLE ANATOMY. HE ADJUSTED THE ALPHA OMEGA XY BASE TO CORRECT FOR THE DEVIATION AN

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: TOMOYUKI ASADA , CHAD Z. SIMON , AMY Z LU , SAMUEL ADIDA , MARCEL DUPONT , PHILIP M PAREL , JOSHUA ZHANG , SATYAJ BHARGAVA , KYLE W. MORSE , JAMES E. DOWDELL , SRAVISHT IYER , SHEERAZ A QURESHI , ROBOT-NAVIGATED PEDICLE SCREW INSERTION CAN REDUCE INTRAOPERATIVE BLOOD LOSS AND LENGTH OF HOSPITAL STAY: ANALYSIS OF 1,633 PATIENTS UTILIZING PROPENSITY SCORE MATCHING, THE SPINE JOURNAL (2023), DOI: HTTPS://DOI.ORG/10.1016/J.SPINEE.2023.09.004 BACKGROUND CONTEXT: NAVIGATION AND ROBOTIC TECHNOLOGIES HAVE EMERGED AS AN ALTERNATIVE OPTION TO CONVENTIONAL FREEHAND TECHNIQUES FOR PEDICLE SCREW INSERTION. HOWEVER, THE EFFECTIVENESS OF THESE TECHNOLOGIES IN REDUCING THE PERIOPERATIVE COMPLICATIONS OF SPINAL FUSION SURGERY REMAINS LIMITED DUE TO THE SMALL COHORT SIZE IN THE EXISTING LITERATURE. PURPOSE: TO INVESTIGATE WHETHER UTILIZATION OF ROBOTICALLY NAVIGATED PEDICLE SCREW INSERTION CAN REDUCE THE PERIOPERATIVE COMPLICATIONS OF SPINAL FUSION SURGERY¿INCLUDING REOPERATIONS¿WITH A SIZEABLE COHORT. STUDY DESIGN: RETROSPECTIVE STUDY. PATIENT SAMPLE: PATIENTS WHO UNDERWENT PRIMARY LUMBAR FUSION SURGERY BETWEEN 2019 AND 2022. OUTCOME MEASURES: PERIOPERATIVE COMPLICATIONS INCLUDING READMISSION, REOP

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 PRIOR TO STARTING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THERE WAS A PATIENT SIDE CART (PSC) RUNNING ON BATTERY MESSAGE. INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) INFORMED THE ISI TECHNICAL SUPPORT ENGINEER (TSE) THAT THEY HAVE ALREADY TRIED MULTIPLE OUTLETS AND HARD POWER CYCLED THE SYSTEM WITH AN EMERGENCY POWER OFF (EPO) OF THE PSC WITH NO CHANGE. THE ISI TSE RECOMMENDED ANOTHER REBOOT WITH EPO IF POSSIBLE. THE ISI TSE ALSO RECOMMENDED INFORMING THE SURGEON IF THEY ONLY HAVE BATTERY POWER ON THE PSC, THEY WILL NOT HAVE POWER FOR VERY LONG DEPENDING ON THE CURRENT STATUS OF THE BATTERY AND MAY NOT WANT TO START A PROCEDURE WITH ONLY BATTERY POWER. ERROR LOGS SHOW 417 ERRORS FOR BOTH POWER SUPPLY 1 AND 2. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SP SYSTEM WAS REMOVED FROM THE ROOM AND DA VINCI XI WAS BROUGHT IN TO CONTINUE THE PROCEDURE.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY PROCEDURE, A "SHEATH" FELL INSIDE THE PATIENT AND WAS RECOVERED. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORT OF ANY PATIENT HARM OR INJURY. INTUITIVE SURGICAL, INC. (ISI) HAS ATTEMPTED TO CONTACT THE SURGEON TO GATHER ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. HOWEVER, AS OF THE DATE OF THIS REPORT, NO NEW INFORMATION HAS BEEN RECEIVED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LEFT HEMICOLECTOMY PROCEDURE, THE HARMONIC ACE INSTRUMENT BROKE WHILE THE SURGEON WAS DISSECTING. A FRAGMENT FELL INSIDE THE PATIENT AND WAS RETRIEVED DURING THE SAME PROCEDURE. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIALS DURING THE SURGICAL PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A BACK-UP HARMONIC ACE INSTRUMENT. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL 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 THYROIDECTOMY SURGICAL PROCEDURE, THE TIP OF THE HARMONIC ACE INSTRUMENT WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH A BACKUP INSTRUMENT OF THE SAME KIND. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO DAMAGE OBSERVED. DURING THE PROCEDURE, THE INSTRUMENT TIP BROKE OFF AND FELL INSIDE THE PATIENT'S CAVITY AFTER USING IT FOR 15 MINUTES. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE AND CONFIRMED WITH A VISUAL INSPECTION. ADDITIONAL SURGICAL PROCEDURES AND POST-OPERATIVE TESTS WERE NOT PERFORMED. ADDITIONALLY, THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIALS DURING THE SURGICAL PROCEDURE. THE INSTRUMENT WAS NOT REMOVED DURING THE PROCEDURE (PRIOR TO THE BREAKAGE). UPON FINAL REMOVAL OF THE INSTRUMENT, THE WRIST WAS STRAIGHTENED, AND THE SURGICAL STAFF DID NOT FEEL ANY RESISTANCE UPON REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA. BOTH THE INSTRUMENT AND CANNULA HAD NO OTHER DAMAGE AFTER THE EVENT

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: NAGATA K, GLASSMAN SD, BROWN ME, DANIELS CL, SCHMIDT GO, CARREON LY, HINES B, GUM JL. RISK FACTORS OF SCREW MALPOSITION IN ROBOT-ASSISTED CORTICAL BONE TRAJECTORY: ANALYSIS OF 1344 CONSECUTIVE SCREWS IN 256 PATIENTS. SPINE (PHILA PA 1976). 2023 SEP 28. DOI: 10.109 7/BRS.0000000000004827. EPUB AHEAD OF PRINT. PMID: 37767783. OBJECTIVE: TO DESCRIBE THE INCIDENCE OF AND IDENTIFY RISK FACTORS FOR INTRAOPERATIVE SCREW MALPOSITION SECONDARY TO SKIVE OR SHIFT DURING ROBOT-ASSISTED CORTICAL BONE TRAJECTORY (RACBT) INSERTION. METHODS: A CONSECUTIVE SERIES OF PATIENTS OLDER THAN 18 YEARS WHO UNDERWENT RA-CBT SCREW PLACEMENT BETWEEN JANUARY 2019 AND JULY 2022 WERE ENROLLED. BASELINE DEMOGRAPHIC AND SURGICAL DATA, HOUNSFIELD UNITS (HU) AT L1, AND VERTEBRAL SHAPE RELATED TO SCREW PLANNING WERE COLLECTED. SKIVE OR SHIFT WAS RECORDED IN THE OPERATING ROOM ON A DATA COLLECTION FORM. RESULTS: OF 1344 CBT SCREWS IN 256 PATIENTS, MALPOSITION WAS RECOGNIZED INTRAOPERATIVELY IN 33 SCREWS (2.4%) IN 27 PATIENTS (10.5%); 19 VIA SKIVE IN 17 AND 14 VIA SHIFT IN 10 PATIENTS. THESE PATIENTS HAD HIGHER BMI THAN PATIENTS WITHOUT MALPOSITION (33.0 KG/M2 VS 30.5 KG/M2, P=0.037). PATIENTS WITH SKIVE HAD HIGHER HU

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THIS WAS AN EGPS CRANIAL BIOPSY CASE USING CT-FLUORO REGISTRATION WORKFLOW. DURING PATIENT REGISTRATION, USER COULD NOT ACHIEVE AN ACCURATE MERGE OF PRE-OP CT TO INTRA-OPERATIVE FLUORO SHOTS. REQUESTING SOFTWARE INVESTIGATION OF THE MERGE ATTEMPTS.

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 WAS NOT RECOGNIZED, NOT WORKING AT THE MIDDLE OF THE SURGERY, AND THE TIP WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL INC. (ISI) FOLLOWED UP WITH THE CUSTOMER TO CONFIRM THAT THE INSTRUMENT WAS INSPECTED BEFORE THE PROCEDURE. THE SURGEON WAS DISSECTING WHEN THE REPORTED ISSUE OCCURRED. THE SURGERY HAD STARTED ABOUT 2 HOURS BEFORE THE ISSUE OCCURRED. THERE WERE NO COLLISIONS WITH OTHER INSTRUMENTS. THE INSTRUMENT WRIST WAS STRAIGHTENED TO REMOVE WITH NO RESISTANCE. THE FRAGMENT WAS RETRIEVED WITH A LAPAROSCOPIC GRASPER AND WAS VISUALLY CONFIRMED. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH NO INJURY TO THE PATIENT.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: L4R WAS PLANNED ON A POTENTIAL SKIVE ZONE DUE TO THE PATIENT'S ANATOMY AND THE SURGEON'S TRAJECTORY PREFERENCE (STRAIGHT UP AND DOWN, MID-LINE ALONG THE FACET JOINT, WHICH WAS HYPERTROPHIC IN THIS CASE). THE SURGEON'S TECHNIQUE IS EXTREMELY FAST WITH THE HS BURR, RD, AND DRIVER ALL ON POWER. HE PLACED THE SCREWS AT L4R VERY QUICKLY AND MOVED ONTO THE NEXT. THE EGPS BASE HAD TO BE BACKED AWAY FROM THE PATIENT DUE TO THE ARM CONTRACTING THE PATIENT ANATOMY AND THE LAST TWO SCREWS WERE PLACED WITHOUT ISSUE. THE C-ARM WAS BROUGHT IN FOR CONFIRMATION SHOTS AND IT WAS FOUND THAT THE L4R SCREW HAD SKIVVED OFF OF THE HYPERTROPHIC FACET AND HAD ANGLED CRANIAL, MISSING THE PEDICLE. HOWEVER, THE SOFTWARE HAD GIVEN A CHECKMARK FOR THIS TRAJECTORY.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: WHEN NAVIGATING DRIVER, NAVIGATION LOOKED ACCURATE, IF ANYTHING SLIGHTLY OFF TRAJECTORY LATERALLY IN OUR AXIAL SLICE (STILL SAFELY IN BONE), BUT ACCURATE TO PLAN IN SAGITTAL. SINCE SCREW WAS OFFSET LATERALLY, THERE WAS DIFFICULTY INSERTING THE ARRAY ALL THE WAY THROUGH EE AND DOCTOR FELT TACTILE FEEDBACK WAS OFF, DRIVER WAS REMOVED AND C-ARM WAS BROUGHT IN FOR IMAGES. THE SCREW WAS INSERTED ON PLAN BUT AND HALFWAY THROUGH THE PEDICLE BROKE OUT SUPERIOR AND WAS IN DISC SPACE (FLUORO SHOT INCLUDED). THIS DID NOT SHOW ON NAVIGATION. MINOR ADJUSTMENTS WERE MADE TO THE PLAN. HIGH SPEED BURR WAS INSERTED THROUGH EE INTO PRIOR HOLE AND FLUORO SHOW ACCURATE TO PLAN, SAME WITH 3.5MM PILOT DRILL. A NEW SCREW WAS INSERTED TO PLAN AND NO ADVERSE EFFECTS TO THE PATIENT WERE PRESENTED THROUGH NEUROSTIMULATION.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: L3-S2AI FUSION - REVISION OF PREVIOUS FUSION. EGPS 1.4 SOFTWARE. INSTRUMENTS VERIFIED, ARM AND MONITOR DRAPED PRIOR TO CASE START. SCREWS PLANNED BY DR. (B)(6) BEFORE PATIENT ENTERED THE ROOM. EGPS POSITIONED ON THE SAME SIDE AS OR DOOR AND OPPOSITE DR. (B)(6). EGPS AT THE HEAD OF THE BED AND OPPOSITE SAM, THE SCRUB TECH, AND IMPLANT/INSTRUMENT TRAYS. C-ARM #8 USED FOR THE CASE. IT IS THE ONLY FUNCTIONING C-ARM AT THE ACCOUNT. THE DRB WAS PLACED IN THE RIGHT PSIS VIA THE LONG QUATTRO SPIKE AND SM PLACED IN THE OPPOSITE PSIS. DR. (B)(6) PLACED BOTH WITHIN HIS OPEN INCISION BY DISSECTING THE SKIN FROM THE FASCIA.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: 1-ROBOT WILL NOT HOLD A CHARGE OR STAY CHARGED, WHEN UNPLUGGED FROM THE WALL IT IMMEDIATELY DIES, POWERS DOWN.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, A RUBBER PIECE FROM A CANNULA SEAL BROKE OFF AND FELL INSIDE THE PATIENT. THE CUSTOMER WAS ABLE TO RETRIEVE THE BROKEN PIECE FROM THE PATIENT¿S ANATOMY DURING THE SAME PROCEDURE. THERE WAS NO PATIENT INJURY. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE ROBOTICS COORDINATOR AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CANNULA SEAL DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR HARD MATERIAL. THE FRAGMENT WAS RETRIEVED BY A GRASPER. ALL FRAGMENTS WERE CONFIRMED TO BE RETRIEVED FROM THE PATIENT DURING THE PROCEDURE USING A GRASPER INSTRUMENT. THERE WAS NO ADDITIONAL SURGICAL PROCEDURE REQUIRED TO REMOVE THE FRAGMENT. NO POST-OPERATIVE TESTS WERE PERFORMED. THERE WAS NO PATIENT INJURY. THE PATIENT DID NOT RETURN TO THE HOSPITAL FOR ANY POST-SURGICAL COMPLICATIONS. THE CANNULA SEAL WILL NOT BE RETURNED. THE PROCEDURE WAS DELAYED ABOUT FIVE MINUTES.

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 DURING A MONARCH BRONCHOSCOPY PROCEDURE, A RECURRENT ELECTROMAGNETIC (EM) NAVIGATION FAULT OCCURRED AT SYSTEM REGISTRATION. THE PHYSICIAN ELECTED TO ABORT THE DIAGNOSTIC PROCEDURE. NO CLINICAL CONSEQUENCES TO THE PATIENT WERE REPORTED DUE TO THIS EVENT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE, THE CUSTOMER OBSERVED THAT THE SYNCHROSEAL INSTRUMENT HAD PARTS THAT WERE FALLING OFF FROM THE HINGES. IT WAS NOTED THAT FRAGMENTS FELL INSIDE THE PATIENT AND WERE RETRIEVED IN THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYNCHROSEAL INSTRUMENT WAS INSPECTED PRIOR TO USE AND THERE WERE NO ABNORMALITIES FOUND. AT THE TIME OF THE REPORTED EVENT OF THE FRAGMENT FALLING INSIDE THE PATIENT, THE SURGICAL TASK THAT WAS BEING PERFORMED WAS DISSECTING AND GRASPING. THE FRAGMENT(S) WERE ABLE TO BE REMOVED BY USING "LAPALO FORCEPS" BY THE ASSISTANT DOCTOR, AND ALL FRAGMENTS WERE CONFIRMED TO HAVE BEEN REMOVED FROM THE BODY. POST-OPERATIVE X-RAYS WERE CONDUCTED TO CHECK FOR REMAINING FRAGMENTS. THE SURGEON COMMENTED THAT A SIMILAR PHENOMENON HAD OCCASIONALLY OCCURRED WITH A THIRD COMPANY'S PRODUCTS. THE SURGEON DID NOT NOTICE ISSUES WITH THE FUNCTIONALITY OF THE SYNCHROSEAL. THERE WAS NO INSTRUMENT COLLISION WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIAL DURING THE S

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: UPON REVIEW OF THE POST-OP O-ARM 2 SPIN, IT WAS OBSERVED THAT THE L4L SCREW MISSED PLAN LATERALLY. THE L4L SCREW WAS THEN REPLANNED, REINSTRUMENTED, AND A POST-OP SPIN SHOWED IT ACCURATELY PLACED TO PLAN. DR.(B)(6) IS ASKING FOR GUIDANCE AS TO THE LIKELY CAUSE OF THE LATERAL MISPLACED SCREW.

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 REGISTRATION WAS HAVING ISSUES. THE SITE WAS WORKING ON L2-S1, WHEN THEY TRIED TO LABEL L3 IN THE OBLIQUE, IT WOULD LABEL L3 IN THE AP, BUT APPEARED TO ACTUALLY BE ON L2. THE SYSTEM GAVE A CROSSVIEW ERROR. THE SURGERY WAS ABORTED. THERE WAS NO PATIENT HARM AND THE PROCEDURE WAS DELAYED LESS THAN ONE HOUR. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PATIENT EXPERIENCED AN INCREASE IN BLOOD LOSS.

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 SYSTEM HAD AN ERROR 316. THE CUSTOMER DID NOT MANAGE TO CALL TECHNICAL SUPPORT AND AFTER SEVERAL TRIES, THE CUSTOMER DECIDED TO CONVERT THE PROCEDURE TO LAPAROSCOPIC SURGERY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PROCEDURE WAS CONVERTED TO TRADITIONAL LAPAROSCOPIC APPROACH BECAUSE THE SYSTEM ISSUE COULD NOT BE SOLVED IN 30 - 40 MINUTES AND THE SURGEON HAD A BUSY SCHEDULE AFTER, THE CUSTOMER COULD NOT WAIT MORE TIME. THE SURGERY WAS PERFORMED LAPAROSCOPICALLY. AN INCISION WAS MADE TO EXTRACT THE SPECIMEN AND TO PERFORM AN EXTRA CORPORAL ANASTOMOSIS (AS THE SURGEON USUALLY DOES IN LAPAROSCOPY). BUT IF THE SURGERY WERE PERFORMED ROBOTICALLY, THE SURGEON WOULD HAVE PROBABLY PERFORMED AN INTRACORPORAL ANASTOMOSIS, AND MAKE A SMALL INCISION TO EXTRACT THE SPECIMEN. THE ISSUE WAS NOT SOLVED WHEN THE SURGEON PLACED THE ROBOTIC CANNULAS IN THE PATIENT. THE EVENT OCCURRED AFTER INCISION AND PORT PLACEMENT. NO OTHER SURGICAL TASKS PERFORMED BEFORE THE SYSTEM ISSUE. THE CUSTOMER NOTED THAT THE OPERATION WAS PROLONGED FOR AROUND 30 MINUTES

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 HYSTERECTOMY SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT SUDDENLY WAS NOT RECOGNIZED AND A "RELEASE THE PRESSURE" ERROR MESSAGE WAS DISPLAYED. AFTER REMOVING THE HARMONIC ACE INSTRUMENT, THE INSTRUMENT BLADE WAS FOUND TO BE BROKEN AND HAD FALLEN INSIDE THE PATIENT'S CAVITY. THE BROKEN OFF BLADE WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A BACKUP INSTRUMENT OF SAME KIND. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: DURING THE PROCEDURE, THE INSTRUMENT BLADE BROKE AND FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. ALL FRAGMENT(S) WERE CONFIRMED TO HAVE BEEN RETRIEVED VIA A VISUAL INSPECTION. ADDITIONAL SURGICAL PROCEDURES OR POST-OPERATIVE TESTS WERE NOT PERFORMED. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE PROCEDURE. IT WAS UNKNOWN HOW LONG THE INSTRUMENT WAS USED PRIOR TO THE ISSUE BUT THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIAL DURING USE. UPON FINAL REMOVAL OF THE INSTRUMENT, THE WRIST WAS STRAIGHTENED,

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE NAVIGATION WAS OFF DURING SURGERY AND SOME SCREWS WERE MISPLACED.

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 MOUTH OF THE HARMONIC ACE INSTRUMENT BROKE. A FRAGMENT FROM THE INSTRUMENT FELL INSIDE OF THE PATIENT BUT WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED USING A BACKUP HARMONIC ACE INSTRUMENT. THERE WAS NO REPORTED INJURY. INTUITIVE SURGICAL INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION ABOUT THE EVENT. THE SURGEON AND ASSISTANT REMOVED THE INSTRUMENT FRAGMENT WITH THE USE OF AN ENDOSCOPE. THERE WERE NO ADDITIONAL PROCEDURES OR POST-OPERATIVE TESTS PERFORMED. THE SURGEON BELIEVES THE ISSUE WAS DUE TO AN INSTRUMENT QUALITY PROBLEM. THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND NO DAMAGE WAS DETECTED. THERE WAS NO PATIENT INJURY.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING AN INTRA-OP L5-S2A1 REVISION CASE, AFTER AN O-ARM SPIN WAS PERFORMED AND WHEN ATTEMPTING TO TRANSFER THE SCAN TO THE ROBOT, THE SYSTEM WAS STUCK ON THE UPLOADING SCREEN AND WOULD NOT PROCEED OR RESPOND TO ANY INPUTS. THE SYSTEM WAS THEN SHUTDOWN, THE CASE RE-OPENED AND THE LIFESAVER BUTTON WAS PRESSED, AND A NEW SNAPSHOT WAS TAKEN AS NOTHING HAD MOVED ON THE TABLE. THE INITIAL SCAN WAS DELETED OFF THE ROBOT AND THE SAME SCAN FROM THE O-ARM WAS UPLOADED UNDER A DIFFERENT FILE NAME. AFTER THE NEW SCAN WAS TRANSFERRED TO THE ROBOT VIA USB, THE SAME ISSUE PERSISTED WHERE IT WOULD GET STUCK ON THE UPLOADING SCREEN. AT THIS POINT, THE SURGEON DECIDED TO ABORT ROBOTIC NAVIGATION AND PROCEED WITH THE CASE USING FLUORO.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THERE WAS AN INCIDENT DURING A CASE AT CONWAY MEDICAL CENTER YESTERDAY WHERE EGPS PLACED TWO SCREWS AT L3 USING E3D AND INTRAOPERATIVE WORKFLOW. BOTH SCREWS GOT A CHECK MARK ON THE ROBOT WHEN THEY WERE PLACED, BUT THE LEFT SCREW WAS SIGNIFICANTLY LATERAL TO THE PLAN AND THE RIGHT SCREW WAS SLIGHTLY INFERIOR. I'M NOT SURE IF THE LEFT SCREW WAS INFERIOR AS WELL BECAUSE IT WAS REMOVED BEFORE A LATERAL XRAY WAS TAKEN. THE LOCAL TEAM WANTED AN EEF FILED TO CHECK FOR ACCURACY ON THE SYSTEM AND THE CAMERA CALIBRATION. AFTER THE LEFT SCREW WAS REMOVED, WE DID A BAILOUT TO 2D NAVIGATION WITH E3D. THE SCREW FOLLOWED THE ORIGINAL SCREWS TRAJECTORY, WHICH WAS VISIBLE ON EGPS, AND THE SURGEON DECIDED TO BAIL ON NAVIGATION AND PLACE THE SCREW USING A K-WIRE AND FLUORO IMAGING. THE LOCAL TEAM ALSO WANTED TO NOTE THAT THE OFFSET METER HAS BEEN MUCH MORE SENSITIVE SINCE THE UPGRADE TO THE POINT WHERE IT'S ALMOST ALWAYS HIGH AND THEY ARE CONSISTENTLY LOSING THE GREEN BORDERS EVEN WHEN THE SCREW IS BEING PLACED ACCURATELY.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING A SINGLE POSITION LATERAL CASE (L2-L5 PRE-OP WORKFLOW WITH E3D), MERGE WAS UNSUCCESSFUL MULTIPLE TIMES LEADING TO AN ABORTED CASE. DURING THE FIRST ATTEMPT, CENTROIDS APPEARED LATERAL THE ON THE MERGE ITSELF IN THE A/P VIEW. THE CENTROIDS WERE NOT EVEN REMOTELY CLOSE TO THEIR CORRESPONDING VERTEBRAE. NEW IMAGES WERE TAKEN, LEVELS WERE CHECKED AND CONFIRMED TO BE CORRECT BY USING THE SACRUM AS A GUIDE, AND CENTROIDS WERE CONFIRMED TO BE PLACED IN THE CENTER OF THE VERTEBRAE AS THEY ARE SUPPOSED TO BE. THE SECOND ATTEMPT OF THE MERGE WITH ADDITIONAL IMAGES TAKEN SHOWED THE CENTROIDS TO BE CENTERED, BUT THE SPINAL COLUMN APPEARED TO BE INVERTING/MOVING QUITE A BIT. A THIRD ATTEMPT WAS DONE WITH COMPLETELY NEW IMAGING, BUT AGAIN WAS UNSUCCESSFUL. WE BELIEVE THERE IS AN ISSUE WITH MERGING IMAGES TAKEN BY THE E3D TO A CT COMPLETED OUTSIDE THE HOSPITAL BEFORE THE CASE STARTED. WE ARE UNSURE WHY THE CENTROIDS WERE NOT CENTERED ON THE FIRST IMAGE, AND ALSO UNSURE BY THERE WAS SO MUCH MOVEMENT OF THE VERTEBRAE WHEN NEW IMAGING WAS DONE.

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 WHEN THE SURGEON MOVED THE MONOPOLAR CURVED SCISSORS (MCS), THE MCS TIP COVER ACCESSORY FELL OFF OF THE SCISSORS. THE MCS TIP COVER WAS RETRIEVED AND REMOVED FROM INSIDE THE PATIENT. A NEW MCS TIP COVER WAS PLACED ON THE MCS INSTRUMENT, AND NO OTHER PROBLEMS WERE IDENTIFIED. THE PROCEDURE WAS COMPLETED.INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED: THE MCS TIP COVER ACCESSORY WAS INSPECTED PRIOR TO USE, NO APPARENT DAMAGE WAS FOUND. THE BEDSIDE ASSISTANT USED A LAPAROSCOPIC GRASPER WHILE THE SURGEON USED HIS GRASPER TO HELP BRING IT WITHIN THE ASSISTANT'S REACH. DISSECTION WAS BEING PERFORMED WHEN THE MCS TIP COVER ACCESSORY FELL INSIDE THE PATIENT. NO FUNCTIONALITY ISSUES WERE FOUND. THE MCS INSTRUMENT DID NOT HAVE ANY COLLISIONS. A REDUCER WAS NOT USED. THERE WAS NO DIFFICULTY IN REMOVING THE MCS, OR THE TIP COVER. THE INSTRUMENT WRIST WAS STRAIGHTENED UPON REMOVAL. TINY HOLES WERE FOUND IN THE TIP COVER AFTER IT WAS REMOVED. THE INSTRUMENT WAS IN USE FOR APPROXIMATELY 30-45 MINUTES. ANOTHER TIP COVER WAS PLACED ON THE SCISSORS INSTRUMENT

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING A ROBOTIC PROCEDURE, THE SYSTEM BEGAN LAGGING CAUSING NAVIGATION TO BECOME SLOW AND CHOPPY. THE FIRST TIME, A HARD SHUTDOWN RESOLVED THE ISSUE. THE FIRST STAGE OF THE PROCEDURE WHICH WAS INTRA-OP WORKFLOW. NEAR THE END OF THE SECOND PORTION OF THE PROCEDURE, THE SOFTWARE BEGAN TO LAG AGAIN RESULTING IN THE SURGEON BAILING ON THE ROBOT TO COMPLETE THE CASE WITH FLUOROSCOPY.

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 SCREW USING THE EXCELSIUS GPS SYSTEM WAS MISPLACED INTRA-OPERATIVELY CAUSING A CSF (CEREBRAL SPINAL FLUID) LEAK. THIS EVENT OCCURRED IN GERMANY.