ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: WHILE THE ARM WAS MOVING TO NEW TRAJECTORY WE RECEIVED THE YELLOW ERROR MESSAGE THAT SAID THAT WE WERE APPLYING TOO MUCH FORCE ON EE, AND THE ARM STOPPED MOVING.THE SURGEON CANCELED THE MESSAGE AND TRIED TO REACH THE TRAJECTORY BY PRESSING ON THE PEDAL MULTIPLE TIMES BUT WE ALWAYS RECEIVED THE SAME ERROR MESSAGE.

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: PT (PATIENT) HAD HARDWARE PLACED (B)(6) 2021 AND ON FOLLOW UP X-RAY, CT (COMPUTED TOMOGRAPHY) AND MRI (MAGNETIC RESONANCE IMAGING) REVEALED THE BACKING OUT OF THE SCREWS AT C5 LEVEL AS WELL AS A BROKEN LOCKING MECHANISM. (B)(6) 2023: PT HAD SURGERY: REVISION ANTERIOR CERVICAL APPROACH REMOVAL OF OLD HARDWARE REVISION OF C4-5 FUSION RE INSTRUMENTATION FROM C3 TO C5 THE CAGES USED (B)(6) 2021 WERE: 1. IMPLANT-INTRBDY CERV POR CASCADIA 13X16X7 ¿ SNONE 2. IMPLANT-INTRBDY CERV POR CASCADIA 13X16X7 ¿ SNONE (LOOKS LIKE THEY USED THE SAME SIZE CAGES FOR BOTH LEVELS) THE PLATE USED WAS: PLATE 2 LEVEL OZARK VIEW 40MM ¿ SNONE THE SCREWS USED WERE: SCREW VARI SELF-START OZARK 4X16MM ¿ SNONE (THERE WERE MOST LIKELY 6 SCREWS, LOOKS LIKE ALL WERE SAME SIZE) COMPANY AT THE TIME OF INITIAL SURGERY IN 2021 IS K2M- COMPANY NAME CHANGED TO STRYKER. REFERENCE REPORTS: MW5120510 AND MW5120512.

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: PT (PATIENT) HAD HARDWARE PLACED (B)(6) 2021 AND ON FOLLOW UP X-RAY, CT (COMPUTED TOMOGRAPHY) AND MRI (MAGNETIC RESONANCE IMAGING) REVEALED THE BACKING OUT OF THE SCREWS AT C5 LEVEL AS WELL AS A BROKEN LOCKING MECHANISM. (B)(6) 2023: PT HAD SURGERY: REVISION ANTERIOR CERVICAL APPROACH REMOVAL OF OLD HARDWARE REVISION OF C4-5 FUSION RE INSTRUMENTATION FROM C3 TO C5 THE CAGES USED (B)(6) 2021 WERE: 1. IMPLANT-INTRBDY CERV POR CASCADIA 13X16X7 ¿ SNONE 2. IMPLNT-INTRBDY CERV POR CASCADIA 13X16X7 ¿ SNONE (LOOKS LIKE THEY USED THE SAME SIZE CAGES FOR BOTH LEVELS) THE PLATE USED WAS: PLATE 2 LEVEL OZARK VIEW 40MM ¿ SNONE THE SCREWS USED WERE: SCREW VARI SELF-START OZARK 4X16MM ¿ SNONE (THERE WERE MOST LIKELY 6 SCREWS, LOOKS LIKE ALL WERE SAME SIZE) COMPANY AT THE TIME OF INITIAL SURGERY IN 2021 IS K2M- COMPANY NAME CHANGED TO STRYKER. REFERENCE REPORTS: MW5120511 AND MW5120512.

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 DIAGNOSTIC PROCEDURE USING THE MONARCH BRONCHOSCOPY SYSTEM, BLEEDING WAS NOTED. THE PHYSICIAN CONVERTED THE PROCEDURE TO A TRADITIONAL BRONCHOSCOPY AND A BALLOON WAS USED TO PROVIDE TAMPONADE. PER THE PHYSICIAN, THE PRIMARY CAUSE OF THE PATIENT BLEED WAS DUE TO THE PATIENT¿S FRAGILE AIRWAYS AND PRE-EXISTING CONDITION. THERE WAS NO REPORTED DEVICE MALFUNCTION ASSOCIATED WITH THE ADVERSE EVENT. NO HOSPITALIZATION REQUIRED.

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: PT (PATIENT) HAD HARDWARE PLACED (B)(6) 2021 AND ON FOLLOW UP X-RAY, CT (COMPUTED TOMOGRAPHY) AND MRI (MAGNETIC RESONANCE IMAGING) REVEALED THE BACKING OUT OF THE SCREWS AT C5 LEVEL AS WELL AS A BROKEN LOCKING MECHANISM. (B)(6) 2023: PT HAD SURGERY: REVISION ANTERIOR CERVICAL APPROACH REMOVAL OF OLD HARDWARE REVISION OF C4-5 FUSION RE INSTRUMENTATION FROM C3 TO C5 THE CAGES USED (B)(6) WERE: 1. IMPLANT-INTRBDY CERV POR CASCADIA 13X16X7 ¿ SNONE 2. IMPLANT-INTRBDY CERV POR CASCADIA 13X16X7 ¿ SNONE (LOOKS LIKE THEY USED THE SAME SIZE CAGES FOR BOTH LEVELS) THE PLATE USED WAS: PLATE 2 LEVEL OZARK VIEW 40MM ¿ SNONE THE SCREWS USED WERE: SCREW VARI SELF-START OZARK 4X16MM ¿ SNONE (THERE WERE MOST LIKELY 6 SCREWS, LOOKS LIKE ALL WERE SAME SIZE) COMPANY AT THE TIME OF INITIAL SURGERY IN 2021 IS K2M- COMPANY NAME CHANGED TO STRYKER. REFERENCE REPORTS: MW5120510 AND MW5120511.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE ROBOT IS FAILING TO COMMUNICATE WITH C-ARM. ALL FIELD TROUBLESHOOTING HAS FAILED.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE ROBOT HAS HAD 4 MISPLACED SCREWS IN THE LAST WEEK.

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 A RECURRENT FAULT STATE OCCURRED DURING THE SETUP OF THE MONARCH BRONCHOSCOPY SYSTEM, PREVENTING THE USE OF THE SYSTEM. THE DIAGNOSTIC PROCEDURE WAS ABORTED. 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: AT 8:45AM THE ROBOT WAS PLUGGED IN AND TURNED ON. EVERYTHING SEEMED TO BE WORKING FINE. ROBOT WAS LEFT ON AND PLUGGED IN. 11:15AM ROBOT WAS ROLLED INTO SURGERY ROOM 5 AND PLUGGED IN. A O-ARM SPIN WAS COMPLETED AND THE SCAN WAS LOADED AS A PRE-OP CT. SCAN WAS LOADED TO THE ROBOT WITH NO ISSUES, AND SCREWS WERE PLANNED ACCORDING TO LEVEL AND BILATERAL ORIENTATION. SURGEON THEN BEGAN TO FINE TUNE THE SCREWS, AND AT THIS POINT THE MONITOR SHUT OFF AND MONITOR LIGHT TURNED RED, A BLUE TEXT BOX APPEARED SAYING "NO SYNC". THE SCREW BEGAN TO REBOOT GOING THROUGH NORMAL BOOTING SCREWS AND THEN TO LOGIN SCREEN, AS THE SCREEN WAS REBOOTING THE MONITOR LIGHT WAS BLUE. WE LOGGED BACK IN AND THE SURGEON BEGAN FINE TUNING, THEN IT SHUT DOWN AGAIN. AT THIS POINT I CHANGED THE OUTLET THAT THE ROBOT WAS PLUGGED INTO AS IT REBOOTED. I NOTICED THAT THE FANS WERE TURNING OFF THEN BACK ON DURING THE REBOOTING PROCESS. ONCE REBOOTED AND PLAN PULLED UP WE RECEIVED A "MOTION COMMUNICATION ERROR" WE CLICKED OUT OF IT AND STARTED TO FINE TUNE AGAIN. THE SURGEON WAS ABLE TO GET A WHOLE LEVEL DONE AND THEN IT DID IT AGAIN. WE TRIED ONE MORE TIME BEFORE IT REBOOTED A SURGEON DECIDED TO BAIL ON THE ROBOT.

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 DIAGNOSTIC MONARCH BRONCHOSCOPY PROCEDURE, BLEEDING WAS DETECTED DURING THE BIOPSY, AND THE SYSTEM WAS REMOVED FROM THE PATIENT. THE PHYSICIAN USED A MANUAL SCOPE TO SUCTION BLOOD AND A BLOOD CLOT FROM THE LUNG. THE PROCEDURE WAS ABORTED AND THE PATIENT WAS TRANSFERRED TO THE ICU WHERE A PNEUMOTHORAX WAS DETECTED. THE PATIENT WAS TREATED WITH A CHEST TUBE AND REMAINS IN THE ICU. THERE WAS NO DIFFICULTY EXPERIENCED DURING THE BIOPSY AND THERE WERE NO REPORTED DEVICE ISSUES RELATED TO THIS EVENT.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: WHEN REGISTERING T12, C-ARM SHOTS WERE NOT ALIGNING WITH PREOP SEGMENT OF THE PATIENT'S BODY ALTHOUGH MERGE SCORES WERE ACCEPTABLE.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: CASE AT (B)(6) WAS A L4/L5 OPEN TLIF WITH CREO AMP USING THE PREOP WORKFLOW ON AN EGPS SYSTEM THAT IS RUNNING SPINE 1.4. EXPOSURE WAS MADE AND DRB WAS PLACED ON A SPINOUS PROCESS CLAMP AT L3 WITH THE CAMERA AT THE HEAD. SURVEILLANCE WAS PLACED IN LEFT PSIS. FLOURO IMAGES WERE ACQUIRED FOR REGISTRATION AND DUE TO SOME PRIOR ISSUES WITH THE MERGE, CAREFUL ATTENTION WAS PAID TO GETTING MORE TRUE IMAGES AND ALSO TO KEEP THE DRB AS MUCH OUT OF THE SHOTS AS POSSIBLE AS TO NOT INTERFERE WITH THE FIXTURE BBS. AFTER THE MERGE WAS RUN, IT WAS DETERMINED THAT AT L4 THE WAS SOME ANTERIOR POSTERIOR SHIFT IN THE LATERAL. ANOTHER REGISTRATION TYPE WAS SELECTED AND DEEMED SATISFACTORY. DUE TO THE INCISION, DR. (B)(6) ELECTED TO START AT L4 AND WORKED TOWARD L5. THE LAST SCREW PLACED WAS L5R AND A LOT OF RETRACTION WITH A VERSATRAC WAS USED TO BE ABLE TO PLACE SCREW INSIDE THE INCISION. UNFORTUNATELY DO THE WORKFLOW AND ROOM SET UP, SURVEILLANCE WAS UNABLE TO BE SEEN. UPON XRAY CONFIRMATION SHOTS, IT WAS DETERMINED THAT THE L5R SCREWS WAS LATERAL TO THE PLAN. THE SCREW WAS REMOVED, AND AN ACCURACY CHECK WAS PERFORMED AND DEEMED SATISFACTORY. THE SCREW WAS REINSERTED UNDER A NEW PLAN AFTER FREE HAND

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A PRE-OP BASED L3-L5 OPEN CASE WAS BEING PERFORMED AND THE MERGE LOOKED GOOD BY VERIFYING THE ANATOMICAL LANDMARK. AS IT WAS AN OPEN CASE, SURGEON HAS NOT USED SM TO AVOID AN ADDITIONAL INCISION/FIXATION ON PSIS. AFTER PLACING ALL THE SIX SCREWS A POST OP XRAY HAS BEEN TAKEN. FIRST SCREW I.E. L3-L WAS NOT PLACED AS PER THE PLAN AND ENTERED INTO L2-L3 DISK. THERE WAS NO ADVERSE EFFECT TO PATIENT AND THE SCREW WAS CORRECTED MANUALLY. REST ALL OTHER SCREWS WERE FINE.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE ROBOT HAS HAD MULTIPLE DIFFERENT FAILURES OF THE STABILIZER ENGAGEMENT.

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.

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 A RECURRENT FAULT STATE OCCURRED DURING INITIAL SYSTEM REGISTRATION OF THE MONARCH BRONCHOSCOPY SYSTEM, PREVENTING THE USE OF THE SYSTEM. THE DIAGNOSTIC PROCEDURE WAS ABORTED. 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: PROCEDURE WAS A PREOP CT T9 TO THE PELVIS. THE CASE WAS STAGED WITH THREE LEVELS OF LATERAL FROM L1-L4 COMPLETED THE DAY PRIOR, A PREOP CT TAKEN AND THEN AN ALIF AT 5-1 THE DAY OF THE POSTERIOR PORTION. AFTER THE ALIF, PATIENT WAS FLIPPED, AND A SMALL SKIN LEVEL INCISION WAS MADE FROM T9 TO THE PELVIS - NOT MUCH EXPOSURE WAS PERFORMED AS THE SCREWS WERE GOING TO BE INSERTED USING CREO MIS. FLOURO IMAGES WERE ACQUIRED, AND THE MERGE WAS ACCURATE AT ALL LEVELS EXCEPT FOR L4. NEW IMAGES WERE ACQUIRED, AND THE MERGE WAS RERUN WHICH IMPROVED AT L4. WE BEGAN INSERTING SCREWS AT T9 AND SNAKED DOWN TO THE PELVIS. IN THE PELVIS WE WERE GOING TO BE PLACING TWO CREO S2AI SCREWS AND TWO MEDIAL TO LATERAL SI LOK SELECT SCREWS. THE ORDER IN WHICH THEY WERE PLACED WAS CREO S2AI LEFT, SILOK SELECT LEFT, CREO S2AI RIGHT, SILOK SELECT RIGHT - DUE TO THE DRB BEING PLACED IN RIGHT PSIS ON LOW PROFILE QUATTRO SPIKE. FLOURO IMAGES WERE TAKEN, AND ALL THE SCREWS SEEMED TO BE PLACED CORRECTLY. DR. (B)(6) THEN PROCEEDED TO DROP THE RODS AND AFTER THIS WAS COMPLETED, WE ACQUIRED TWO O ARM SPINS TO CHECK ALL OF THE INSTRUMENTATION. AFTER REVIEW OF SCANS, ALL SCREWS WERE PLACED ACCURATELY EXCEPT FOR S2AI ON T

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS AN INTRAOP CASE WITH ZIEHM 3D, SOFTWARE 1.1R3. THE SCAN WAS TRANSFERRED WITH THE USB, UNFORTUNATELY, WE DIDN'T GET AUTOMATIC REGISTRATION AND DID IT MANUALLY. THE ANATOMICAL LANDMARK CHECK HAD BEEN DONE. THE ACCURACY WAS GOOD. THE FIRST SCREW L5-L WAS PLACED WITH GOOD NAVIGATION ACCURACY. BY THE SECOND SCREW L5-R, EE WAS ON THE TRAJECTORY, WITH A GREEN BORDER AND OFFSET. UNFORTUNATELY, WE COULD NOT SEE THE HIGH-SPEED DRILL INSIDE THE EE. THE TOOL WAS VISIBLE TO THE CAMERA OUTSIDE THE EE. THE SURGEON CHECKED THE NAVY ACCURACY, IT WAS NOT ACCURATE ANYMORE. THE SURGEON PLACED THE SCREWS IN THE TRADITIONAL WAY.

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 SUCCESSFUL DIAGNOSTIC PROCEDURE USING THE MONARCH BRONCHOSCOPY SYSTEM, A PNEUMOTHORAX WAS NOTED ON THE PATIENT¿S POST PROCEDURAL X-RAYS. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND WAS ASYMPTOMATIC. NO ADDITIONAL INTERVENTION WAS NECESSARY, AND THE PATIENT WAS DISCHARGED ONE (1) DAY LATER. THERE WAS NO REPORTED DEVICE MALFUNCTION ASSOCIATED WITH THE ADVERSE EVENT.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS WE ATTEMPTED TO SEND THE CT SCAN, WE GOT A "CAMERA DISCONNECTED ERROR," EVEN THOUGH CAMERA WAS PLUGGED IN. WE ALSO GOT A "UAIB VERSION OUTDATED ERROR" MESSAGE WHILE TRYING TO RECEIVE A SCAN. THE CAMERA THEN STOPPED BEING ABLE TO PICK UP END EFFECTOR ON THE VERIFY PAGE.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THIS WAS A L4-S1 PERC WITH SCREWS BACKING UP AN OLIF. THEY FLIPPED PATIENT FROM LATERAL TO PRONE AND THEN DID A E3D SPIN. NO ISSUES WITH THE SPIN, HOWEVER THE IMAGE QUALITY WASN'T GREAT AND MADE IT DIFFICULT TO SEE ANATOMY. RUSSELL AND THE PA PLANNED THE INITIAL SCREW TRAJECTORIES AND THEN DR. WILLIAMS CAME OVER AND MADE FINAL ADJUSTMENTS TO THE PLAN. HE STARTED WITH L4-LEFT, THEN HE PLACE L4-RIGHT. HE THEN PLACED L5-RIGHT, HE NOTICED THAT THE MIS TOWER WAS SIGNIFICANTLY LOWER THAN HIS L4-RIGHT TOWER. HE OBTAINED A GREEN CHECK MARK FOR ALL OF HIS SCREWS AND DID NOT GIVE ANY EXTRA ROTATIONS AFTER THE GREEN CHECK MARK. WE WERE NOT SURE WHY THIS WAS THE CASE. BEFORE PROCEEDING, WE WENT AND LOOKED AT THE PLAN AND THE PLAN SHOWED THAT 4 AND 5 SHOULD HAVE HAD THE SAME HEIGHT AND DEPTH. ONCE ALL THE SCREWS WERE PLACED, WE TOOK CONFIRMATION SHOTS WITH THE C-ARM. DR. WILLIAMS THEN POINTED OUT TO US THAT THE L5-RIGHT SCREW WAS ABOUT A CM LOWER THAN L4. HE THEN BACKED OUT THE L5 SCREW TO BE MORE IN LINE WITH HIS L4 SCREW. HE PLACED 6 SCREWS IN TOTAL AND 5 OF THE 6 SEEMED TO BE AT THE APPROPRIATE HEIGHT/DEPTH. DR. WILLIAMS WANTS TO KNOW WHY THE L5-RIGHT SCREW WAS PLACED LOWER THAN WHAT HIS PLA

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 AFTER A SURGERY ON (B)(6) 2023 UTILIZING THE EXCELSUS GPS THE PATIENT EXPERIENCED EXTREME PAIN AND DECREASED MOVEMENT IN THEIR LEGS. ON (B)(6) 2023 MRI SCANS REVEALED A COMPRESSION FRACTURE OF T10. REVISION WAS PERFORMED URGENTLY TO DECOMPRESS THE SITE AND REVISE THE HARDWARE SURROUNDING IT.

Senhance — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE COMPLAINANT, (B)(6) REPORTED THAT THE PATIENT UNDERWENT TOTAL MESORECTAL EXCISION ON (B)(6) 2023. ON (B)(6) 2023 THE PATIENT COMPLAINED OF FEVER, GENERAL DISCOMFORT, AND WEAKNESS. A DIGITAL EXAMINATION CONFIRMED THAT THE ANASTOMOSIS WAS NORMAL. AS FEVER WAS 39.5 AND SUDDEN, IN ORDER TO BE SURE THAT THERE WAS NO ISCHEMIC CHANGES IN THE COLON WHICH WAS BROUGHT TO SMALL PELVIS FOR COLO-ANAL ANASTOMOSIS, FLEXIBLE PROCTOSCOPY WAS DONE. IT REVEALED NECROTIC DISTAL COLON (APPROX. 5-10 CM) ABOVE ANASTOMOSIS. AN URGENT LAPAROTOMY WAS PERFORMED: THE COLON WAS BROUGHT FROM SMALL PELVIS, RESECTED, AND TERMINAL COLOSTOMY WAS DONE SAME DAY. ANUS (VERY SHORT RECTAL STUMP) WAS CLOSED WITH PURSESTRING SUTURE. THE SURGICAL FOLLOW-UP WAS UNEVENTFUL, BUT DUE TO URINARY RETENTION ON (B)(6) 2023 AN EPICYSTOSTOMY WAS PERFORMED FOR A DATE OF RESOLUTION ON (B)(6) 2023. THIS EVENT DID NOT OCCUR WITHIN THE UNITED STATES. THE EVENT OCCURRED IN (B)(6). IT WAS REPORTED THAT THE CAUSALITY TO THE SENHANCE SURGICAL SYSTEM WAS POSSIBLE. THE EVENT OCCURRED ON (B)(6) -2023 AND ASENSUS SURGICAL WAS MADE AWARE ON 08-SEPTEMBER-2023.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE EGPS UNIT WILL NOT POWER ON. EITHER THE POWER CABLE OR WHERE IT CONNECTS TO THE UNIT IS DAMAGED. A CASE COULD NOT BE PERFORMED WITH THE ROBOT TODAY BECAUSE OF THE ISSUE. IT HAD TO BE COMPLETED UNDER 2D FLUORO WITHOUT THE EGPS.

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 SUCCESSFUL DIAGNOSTIC PROCEDURE USING THE MONARCH BRONCHOSCOPY SYSTEM, A PNEUMOTHORAX AND PNEUMOMEDIASTINUM WERE NOTED POST-PROCEDURE. A CHEST TUBE WAS PLACED AND THE PATIENT WAS ADMITTED TO THE HOSPITAL. THE PNEUMOTHORAX AND PNEUMOMEDIASTINUM RESOLVED AND THE PATIENT WAS DISCHARGED.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE DOCTOR INSERTED HIS LAST SCREW THEN CAPTURED FLUORO SHOTS. FLUORO AND STIMMING THE SCREW PROVED IT WAS INFERIOR OF THE PLANNED POSITION. THE DOCTOR REMOVED THE SCREW AND THEN RE-IMPLANTED IT WITH A JAMSHID-K-WIRE.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ROBOT CAMERA DISPLAYED HARDWARE BUMP PERFORMED MERGE VERIFIED ALL INSTRUMENTS INCLUDING EE. SUCCESSFUL MERGE, WHEN WE WENT TO PLACE IMPLANTS, SURGEON WAS UNABLE TO SELECT LEVEL AND GUIDE ROBOT TRAJECTORY. SURGEON ABORTED ROBOT PROCEDURE.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: HAD A GOOD MERGE WITH 0 SHIFTS. WHEN LANDING END EFFECTOR ON TRAJECTORY THE INSTRUMENTS ON THE SCREEN WERE NOT MATCHING WHAT THE WE WERE SEEING LIVE ON THE PATIENT. REIMAGED THE PATIENT AND STILL HAD NO SHIFT. NAV STILL LOOKED OFF AT THE TOP OF THE CONSTRUCT BUT DEAD ON LOWER SCREWS. STILL MISSED OUR L5 RIGHT SCREW. SENDING LOGS.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: HAD A GOOD MERGE WITH 0 SHIFTS. WHEN LANDING END EFFECTOR ON TRAJECTORY THE INSTRUMENTS ON THE SCREEN WERE NOT MATCHING WHAT THE WE WERE SEEING LIVE ON THE PATIENT. REIMAGED THE PATIENT AND STILL HAD NO SHIFT. NAV STILL LOOKED OFF AT THE TOP OF THE CONSTRUCT BUT DEAD ON LOWER SCREWS. STILL MISSED OUR L5 RIGHT SCREW. SENDING LOGS.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IDENTIFIED AS L1-L3 BY SURGEON, REP, AND CSR. CENTROIDS WERE PLACED ON THE L1-L3 LEVELS AND A MERGE WAS RUN. THE SURGEON, REP, AND CSR REVIEWED THE MERGE AND VERIFIED THE LEVELS TOGETHER. FOLLOWING PLACEMENT OF SCREWS AT L1, SURGEON NOTED NAVIGATION WAS NO LONGER ACCURATE. WE REIMAGED THE PATIENT BEFORE PLACING SCREWS AT L3. FLUORO WAS USED TO CONFIRM SCREW PLACEMENT, BUT IT WAS NOTED THAT THE RIGHT L3 SCREW WAS MEDIAL TO WHAT WAS PLAN. THE SCREW STIMULATED AT 9MA, PER NEUROMONITORING TECH. THE SURGEON REMOVED THE SCREW AND DECIDED TO REPLACE IT FREEHAND USING FLUORO ASSISTANCE. ALL SCREW PLACEMENT WAS CONFIRMED WITH FINAL FLUORO IMAGES.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AFTER THE SCREWS WERE PLACED, ALL OF THE LUMBAR SCREWS AND S2AIS LOOKED GOOD ON THE IMAGES, BUT WE NOTICED THAT ALL OUR SILOK SCREWS LOOKED LIKE THEY WERE BURIED TOO DEEP.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE CASE WAS AN INTRAOP (O-ARM) L4-L5 TLIF EXTENSION OF EXISTING L5-S1 TLIF WITH REMOVAL OF L5-S1 SCREWS AND RODS. INTRAOP WITH CREO 5.5 SCREWS. FIRST DR (B)(6) OPENED UP THE PATIENT AND REMOVED THE EXISTING MATERIAL, THEN PLACED DRB AND SM ON PSIS. SM WAS ACTIVATED, SCOUT SHOTS WERE TAKEN, APNEA WAS INITIATED, SNAPSHOT AND SCAN WERE TAKEN. DURING SCAN TRANSFER, ANEA WAS APPLIED ONCE MORE. NOTHING WAS MOVED BEFORE THE SCAN WAS AUTO REGISTERED. DRB SHIFT WAS SHOWN WHILE TRANSLATING THE OR TABLE OUT OF THE O-ARM LUMEN BUT DISAPPEARED ONCE PATIENT WAS FULLY BACKED OUT AND SM TURNED GREEN. SCREW PLANNING WAS DONE (PEDICULE SCREWS). WE NOTICED THAT TWO "TRAJECTORIES" WERE HIGHLIGHTED IN THE 3D VIEW. WHEN MOVING THE ROBOT TO THE OR TABLE, THE CAMERA WENT DEAD. THE CAMERA COULD NOT SEE ANYTHING ANYMORE (NO DRB, NO EE, NO INSTRUMENTS) AND THE ARM MOVEMENT WAS FROZEN. THE ARM COULD NOT BE MOVED, NEITHER BY THE BUTTONS ON THE CP, NEITHER BY THE FOOTSWITCH OR BRACELET. I SWITCHED TO CRANIAL AND BACK, WHICH UNLOCKED THE CAMERA AND THE ARM MOVEMENT. WHEN DRILLING FIRST SCREW DEFLECTION WAS NOTICED, BUT DRILLED TRAJECTORY WAS COMPLETELY LATERAL OF THE PLANNED ONE (VERIFIED WITH FEELER). SURGEON

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.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: WHILE DOING AN INTRAOPERATIVE WORKFLOW, WERE ABLE TO SUCCESSFULLY DO A SPIN BUT NAVIGATION WAS OFF BY APPROXIMATELY 5 MM IN THE SUPERIOR DIRECTION AND A SCREW WAS MISPLACED. THEY THEN DECIDED TO RESIGN BUT UPON REBOOT E3D REQUIRED A FULL REHOMING. AFTER A FULL REHOMING THEY DID ANOTHER SPIN AND NAVIGATION WAS ACCURATE.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: FUSES NEED REPLACING FOR EXCELSIUS GPS.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AFTER MERGING THE PREOP CT TO THE FLUOR SHOTS, WE ATTACHED THE EE TO THE ARM AND ATTEMPTED TO VERIFY IT BEFORE STABILIZING THE ROBOT FOR TRAJECTORY. ALTHOUGH THE EE WASN'T SEEN ON SCREEN, IT STILL VERIFIED WHEN THE TECH PLACED AN INSTRUMENT INTO IT. ON THE NAVIGATION PAGE THE CAMERA WAS ONLY SEEING THE DRB AND SURVEILLANCE BUT NOT THE EE. TRIED TAKING IT OFF/PUTTING IT BACK ON, RESETTING THE SOFTWARE, SWITCHING BACK AND FORTH FROM CRANIAL, AND RESTARTING THE SYSTEM. ALSO TRIED A DIFFERENT EE. SURGEON DECIDED TO DO THE XLIF FIRST, AND WHILE HE WAS PERFORMING THE XLIF WE WERE ABLE TO GAIN VISUALIZATION OF THE EE WITH THE ROBOT PULLED BACK/AWAY FROM THE PATIENT. POST XLIF, WE RE-MERGED WITH "ADDED HARDWARE" AND BROUGHT THE ROBOT BACK IN. THIS TIME THE EE WAS GOING IN AND OUT OF VISUAL RANGE. THE EE WOULD TRAVEL TOWARDS A TRAJECTORY AND STOP SHORT SHOWING A CYCLE OF BLANK/GREEN/YELLOW. TRIED REPOSITIONING THE DRB AND REMERGING WITH A DIFFERENT EE. SURGEON DECIDED TO DO THE SCREWS FREEHAND WITH FLUORO.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DR. (B)(6) ROBOT CASES. 2 DIFFERENT ROBOTS. BOTH PRE-OP CT CASES. T10-ILIUM. WE ARE PUTTING X2 SI-LOK SELECT SCREWS AT THE BOTTOM OF THE CONSTRUCT IN THE BEDROCK TRAJECTORY. FIRST CASE WAS ON 5/16. WE SELECTED LEFT SIDE FIRST. DRILL WAS ACCURATE. AND WE PROCEEDED TO PUT THE LEFT SCREW IN UNTIL WE GOT A CHECK MARK. DR. (B)(6) FELT SOMETHING WAS WRONG. RIGHT SIDE WENT FINE.UPON X-RAY THE LEFT SIDE WAS DEEP ABOUT AN INCH. PUT THE NAV DRIVER BACK ON TO BACK UP SCREW AND IT NOW SHOWED AN INCH DEEP AS IT DID NOT BEFORE. SECOND CASE 5/31 SAME EXACT THING HAPPENED HOWEVER WE CAUGHT IT BEFORE PROCEEDING TO PUT IN THE SCREW. BOTH INSTANCES THE RIGHT-SIDE NAV WAS ON. IT WAS ONLY LEFT SIDE THAT WE SELECTED FIRST. PLEASE CALL ME FOR MORE DETAILS ON HOW WE TROUBLESHOOTED IT AND ON MY THEORY OF WHAT HAPPENED. ALL CASES AND LOGS ARE UPLOADED.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AFTER IMPLANTING THE SCREW, THE DEFLECTION METER WAS TRIGGERED SHOWING THE SCREW INFERIOR OF THE INTENDED PLAN. UPON MOVING TO L5L ANOTHER LM CHECK WAS SUGGESTED AND NAVIGATION AT THIS POINT BUT STILL LOOKED ACCURATE AS THE CROSSHAIRS WERE INTERSECTING BONE ON AXIAL AND SAGITTAL VIEWS. AFTER USING THE HS DRILL AND PILOT DRILL THE DOCTOR WAS CONCERNED. I HAD NOTICED THE SOUND OF THE DRILLS GOING THROUGH THE LAYERS OF CORTICAL BONE WASN'T REFLECTING WHAT WE WERE SEEING ON THE NAVIGATION. THE DOCTOR IMMEDIATELY CALLED FOR X-RAY AND PUT THE VERIFICATION PROBE INTO THE HOLE HE PREPPED FOR L5L. THE C-ARM WAS BROUGHT IN AND AP/LAT SHOTS SHOWED EACH SIDE WAS SYMMETRICAL BUT 5MM INFERIOR OF THE PEDICLE. THE L5R SCREW WAS REMOVED. WE BAILED TO PRE-OP CT WORKFLOW WITH E3D.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A SCREW WAS MISSED SUPERIORLY AT L5R. THIS WAS THE SECOND SCREW OF THE CONSTRUCT, AND THE OTHER SCREWS WERE PROVEN TO HAVE CORRECT PLACEMENT WITH FLUORO SHOTS. THERE WAS AN AIR BUBBLE IN THE PEDICLE, AND SOME DEFLECTION WAS SHOWN. A CHECKMARK WAS GIVEN BY THE SOFTWARE WHEN THE SCREW WAS PLACED INITIALLY. FLUORO SHOTS WERE TAKEN AFTER ALL 6 TRAJECTORIES WERE COMPLETED, AND THE L5R SCREW WAS PULLED OUT.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ROBOT SCREWS PLACED LATERALLY AND INFERIORLY.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: CASE WAS A L3-S2 PSF WITH EGPS AND E3D AT SARASOTA MEMORIAL WITH DR. (B)(6). DRB AND SM WERE PLACED IN CONTRALATERAL PSIS. WE RECEIVED AN ERROR STATING THAT THE DRB HINGE WAS TOO CLOSE TO THE SM (THIS ACCOUNT GETS THIS WARNING OFTEN). THIS WAS BYPASSED DUE TO THEM BEING ADEQUATE DISTANCE AWAY. SCAN WAS OBTAINED AND TRANSFERRED TO THE ROBOT WITHOUT ANY ISSUES. SCREWS WERE PLANNED BY REP (B)(6) AND DR. (B)(6). ROBOT WAS BROUGHT INTO THE FIELD. DR. (B)(6) STARTED AND L3 AND PLACED SCREWS DOWN TO S2. NAVIGATION LOOKED INTACT THROUGHOUT ENTIRE CASE. DRB WAS NOT HIT AND OFFSET WAS CONTINUOUSLY LOW. DEFLECTION STAYED IN THE YELLOW TO LOW RED RANGE DURING THE LOWER LEVELS DUE TO PATIENTS HARD SCLEROTIC BONE. DR. (B)(6) USED THE HS BURR, DRILL, BALL TIP PROBE, TAP AND DRIVER. PT HAD PREVIOUS L4-5 INTERSPINOUS PROCESS FIXATION DEVICE PRESENT THROUGHOUT THE SPIN AND SCREWS. AFTER SCREWS WERE FINISHED ROBOT WAS TAKEN OUT OF THE ROOM AND DR. (B)(6) PROCEEDED WITH THE DECOMPRESSION AND INTERBODY. FINAL SHOTS WERE TAKEN, AND IT WAS NOTED THAT RL4 WAS IN THE SUPERIOR DISC SPACE AND LL4 WAS BREACHED CAUDALLY PER DR. (B)(6). SCREWS WERE REMOVED AND NOT REPLACED. ALL OTHER SCREWS WERE IN THEIR PLANNE

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 REVISION SURGERY WAS NEEDED TO REMOVE AND REPLACE MISPLACED SCREWS THAT WERE PLACED USING THE EXCELSIUS GPS SYSTEM.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS PRE-OP CASE, T6-T10. AFTER SUCCESSFUL REGISTRATION, WE GOT ALL TRAJECTORIES IN GREEN ON THE NAVIGATION PAGE BUT THE ROBOT ARM MOVED ONLY TO T6-L. AS THE SURGEON PRESSED THE PEDAL, THE ROBOT ARM WITH EE DIDN'T MOVE TO ANOTHER TRAJECTORY, DESPITE ALL BEING GREEN. THE MESSAGE THAT WE GOT WAS-TRAJECTORY OUT OF RANGE(IN YELLOW). WE MOVED THE ROBOT MULTIPLE TIMES, BUT THE ARM MOVED ONLY TO ONE TRAJECTORY-T6-L EVERY TIME. WE DID A SOFTWARE RESET, NEW REGISTRATION, ATTACHED AND DETACHED THE EE, AND HARD SHUT DOWN, BUT IT DIDN'T HELP. THE CASE WAS ACCOMPLISHED TRADITIONALLY WITHOUT THE ROBOT.

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 PROCEDURE USING FLUORO REGISTRATION WORKFLOW ON SOFTWARE VERSION 20211.2R2P2. CASE WAS ABORTED DUE TO INABILITY TO OBTAIN AN ACCEPTABLE MERGE DURING PATIENT REGISTRATION. REQUESTING SOFTWARE INVESTIGATION TO DETERMINE WHAT WAS THE CAUSE OF THE INACCURATE MERGE ATTEMPTS.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: RIFAI (DISTRIBUTER REP) INFORMED THAT ONE CASE OF L4-L5 MIS FIXATION-INTRAOP (ALIF FIRST) WORKFLOW WAS PLANNED ON (B)(6) 2023. END EFFECTOR WAS VERIFIED WITHOUT ANY ISSUE, BUT THE EE WAS NOT GETTING DETECTED DURING NAVIGATION. TRIED TO ADJUST THE CAMERA BUT STILL NO DETECTION AND EE SYMBOL ON THE SCREEN WAS RED. FINALLY, THEY HAVE REPLACED THE EE WITH ANOTHER EE AND IT WORKED. THEY WILL UPDATE US LATER FOR THE STATUS OF FIRST EE. AFTER PLACEMENT OF ALL THE SCREWS IT HAS BEEN OBSERVED IN THE POST-OP SCAN THAT THE L4-R WAS SHIFTED LATERALLY AND L5-L WAS SHIFTED CRANIALLY FROM THE ORIGINAL PLAN. TWO SCREWS WERE REPOSITIONED MANUALLY.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: RIFAI (DISTRIBUTER REP) INFORMED THAT ONE CASE OF FRACTURE AT T7 WAS PLANNED WITH TWO INTRAOP WORKFLOW. FIRST INTRAOP WAS DONE FROM T5-T9 AND EVERYTHING WAS LOOKING GOOD TILL THE PLACEMENT OF LAST SCREW AT T9-L. SECOND INTRAOP WORKFLOW WAS DONE FROM T11-L3. IT WAS OBSERVED IN THE POST-OP SCAN THAT SCREWS AT T8 & T9 WERE SHIFTED TOWARDS RIGHT SIDE. T8-T9 LEFT SCREWS WERE ALMOST TOUCHING THE CANAL. FINALLY SCREWS AT T8-T9 WERE RE-POSITIONED MANUALLY.

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 REVISION SURGERY WAS NEEDED TO REMOVE AND REPLACE MISPLACED SCREWS THAT WERE PLACED USING THE EXCELSIUS GPS SYSTEM.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE FOLLOWING MEDICAL LITERATURE WAS REVIEWED: ROBOTIC BRONCHOSCOPY: DIAGNOSTIC OUTCOMES OF ROBOTIC-ASSISTED BRONCHOSCOPY FOR PULMONARY LESIONS IN A REAL-WORLD MULTICENTER COMMUNITY SETTING. AUTHOR(S): FAISAL KHAN, JOSEPH SEAMAN, TINA D. HUNTER, DIOGO RIBEIRO , BALAJI LAXMANAN , IFTEKHAR KALSEKAR AND GUSTAVO CUMBO NACHELI. CITATION: BMC PULMONARY MEDICINE. HTTPS://DOI.ORG/10.1186/S12890-023-02465-W. FIFTEEN PATIENTS WERE REPORTED AS HAVING PNEUMOTHORAX AND FOUR PATIENTS REPORTED BLEEDING. NO DEVICE ISSUES WERE REPORTED.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: SENT IN ROBOT CASE LOGS FROM DR. (B)(6) CASE ON 5/3. AT LEFT L4 WE REMOVED AN OLD SCREW. THE VOID CAN BE SEEN ON THE CT. A NEW TRAJECTORY WAS PLANNED AROUND THE OLD SCREW TRAJECTORY. WHEN WE PLACED THE NEW L4 SCREW ON THE LEFT THE ROBOT FOLLOWED OUR PLAN. EVERYTHING PER THE ROBOT VALIDATED OUR SCREWS PATH. WHEN WE TOOK FINAL XRAY WE SAW WE FELL INTO OLD PATHWAY.

Rovac 1000 Smart Robot Vacuum — Robot vacuum cleaner made of white plastic. The product is also sold online. Hazard (Environment): The product has an excessive concentration of lead in solders on the USB printed circuit board (PCB) and the engine (measured values up to 25% and 78.1% by weight, respectively). Lead poses a risk to the environment. The product does not comply with the requirements of the Directive on the restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHS 2 Direc...