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 WE ALSO GOT A "UAIB VERSION OUTDATED ERROR" MESSAGE WHILE TRYING TO RECEIVE A SCAN.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...

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: EGPS WAS MOVED INTO POSITION. DR. (B)(6) COMPLETED LANDMARK CHECKS BY SELECTING THE DESIRED LEVEL AND USING THE CHICKEN FOOT TO PROBE THE SPS AND LAMINAS. SCREW PREPARATION CONSISTED OF A 4.5MM HS DRILL, TIPPED QUARTEX DRILL, FOLLOWED BY THE SCREW. ONCE WE MOVED TO L5 AND CONDUCTED A LANDMARK CHECK WE REALIZED NAVIGATION WAS INACCURATE AFTER A POTENTIAL SLIGHT DRB SHIFT -SURVEILLANCE WENT UP TO 50% OR A SHIFT IN THE MERGE. IN AN ATTEMPT TO NOT HAVE TO RE-REGISTER DR. (B)(6) USED THE ADDED HARDWARE ADDED FUNCTION IN REGISTRATION AND RE-MERGED L5 THEN CONDUCTED A LANDMARK CHECK WHICH WAS ACCURATE AT THE SP. WE BELIEVE THAT DR.(B)(6) HIP BOLSTERS ON HIS CUSTOM BED IMPACT REGISTRATION DUE TO THE FAIRLY OPAQUE LINES NEAR L5 IN THE LATERAL FLUORO IMAGES. AFTER THE LANDMARK CHECK WAS CONFIRMED ACCURATE HE IMPLANTED L5. HOWEVER THE L5L SCREW WAS LOOSE SO DR. (B)(6) IMPLANTED IT FREEHAND. UPON REACHING S1 AND ILIUM WE INVERTED THE ROBOTIC ARM BUT THE VEGA CAMERA COULD NOT EASILY VISUALIZE THE END EFFECTOR FORCING US TO REARRANGE THE CAMERA STAND AND SET UP IN ORDER TO GET LINE OF SIGHT. THE CAMERA HAD TO BE PLACED NEARLY HALF WAY DOWN THE BED AND RAISED TO THE CEILING. THIS WAS NEVER AN ISS

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: SYSTEM WILL NOT CONNECT WITH CAM. ALL THESE PROBLEMS HAVE HAPPENED AFTER THE INSTALLATION OF THE NEW SOFTWARE. WE'VE HAD ISSUES ON EVERY CASE.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MONITOR TURNS OFF RANDOMLY. MOTION COMMUNICATION ERROR. SYSTEM WILL NOT CONNECT WITH CAM ORANGE INFORMATION LIGHT. ALL THESE PROBLEMS HAVE HAPPENED AFTER THE INSTALLATION OF THE NEW SOFTWARE.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: 3 MISSED SCREWS IN THIS CASE. ALL SIGNS ARE INDICATIVE OF ICT SHIFTING, BUT LANDMARK CHECKS DID NOT SHOW THAT. WE HAD ONLY A SURVEILLANCE METER SHOWING (LIKE WE ARE IN FREE HAND NAV MODE) AND NO DEFLECTION FORCE METER SHOWING. WE WERE GETTING HIGH DEFLECTION WANING ON THE SCREEN. IT SEEMED LIKE THIS WAS NORMAL DUE TO SCREW TORQUE FORCE. THE L5-R SCREW ON THE SCREEN SHOWED IT WAS PLACED TO PLAN WITH NO ISSUES. POST OP SHOTS SHOWED IT LATERAL OF THE PEDICLE. THE S1 SCREWS BOTH WERE PLACED ON THE RIGHT TRAJECTORY THAT WE HAD, BUT WERE EXTREMELY DEEP. WE STRUGGLED GREATLY AT L5-L AND DID NOT END UP PLACING THAT SCREW WITH THE ROBOT. WE BAILED TO FLUORO FOR FREE HAND SCREWS.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: WHEN MERGING TODAY THERE WAS A BIGGER SHIFT THAN NORMAL. THEY TRIED TO TAKE MULTIPLE SHOTS BUT COULD NOT CLEAR THE SHIFT THAT WAS HAPPENING.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING A PROCEDURE, WHEN READY TO ACQUIRE IMAGES FOR A REGISTRATION, SYSTEM ROI TURNED RED AND POPULATED WARNING "MOTION CONTROLLER APPLICATION TIMEOUT". MULTIPLE SHUTDOWNS WERE COMPLETED. WAITING UPWARDS OF 10 MINUTES ON THE LOG IN SCREEN. ROI WOULD BE BLUE UPON START UP AND THEN TURN RED ABOUT 2-3 MINUTES LATER.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: TODAY DR. (B)(6) WANTED TO DO ANOTHER CASE WITH THE EGPS. BECAUSE THE PLANNED CASES CANNOT BE TRANSFERRED TO THE ROBOT FROM THE LAPTOP (SEE THE LAST EEF´S) HE TOOK THE CT SCAN VROM THE PAX SYSTEM OF THE HOSPITAL. HE PLANNED THE CASE ON THE EGPS AND WANTED TO REGISTER THE PATIENT IN THE PRE-OP CT MODUS. WHEN HE TOOK THE FLUORO SHOTS TO MERGE HE COULD ONLY SEE THE LEVELS L1 TO L3 IN A CT FLIP. THE THORACIC CT SCAN WAS TOTALLY LOST, SEE ATTACHED SCREEN SHOTS. HE HAD TO ABOARD THE CASE AND THE PATIENT HAD ANESTHESIA WITHOUT A REASON, IN GERMANY THAT IS ASSAULT IF BROUGHT TO COURT, SO NOT FUN. DR. (B)(6) WILL NOT DO ANY MORE CASES UNTIL THIS PROBLEM IS SOLVED. THREE CASES FOR THIS WEEK.

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 (B)(6) 2023, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF AN ARCHIVES OF PLASTIC SURGERY ARTICLE TITLED, ¿SINGLE-PORT ROBOT-ASSISTED PROSTHETIC BREAST RECONSTRUCTION WITH THE DA VINCI SP SURGICAL SYSTEM: FIRST CLINICAL REPORT¿ (JOO, O.Y., ET AL., 2021). WITHIN THE JOURNAL ARTICLE, TWO PATIENTS UNDERWENT A DA-VINCI ASSISTED NIPPLE SPARING MASTECTOMY (NSM) FOLLOWED BY IMMEDIATE ROBOT-ASSISTED EXPANDER INSERTION AND PRE-PECTORAL DIRECT-TO-IMPLANT BREAST RECONSTRUCTION. FOLLOWING THE NSM, ONE OF THE PATIENTS WAS FOUND WITH AN UNINTENTIONAL BURN AND WAS CAREFULLY MANAGED BY PLASTIC SURGERY TEAM DURING BREAST RECONSTRUCTION. THERE WAS NO MENTION OF THE CAUSE OF THE BURN. THE PATIENT ALSO EXPERIENCED MILD INFECTION ON A SINGLE BREAST, WHICH RESOLVED WITH INTRAVENOUS ANTIBIOTIC TREATMENT WITHOUT THE NEED FOR IMPLANT REMOVAL. THERE WERE NO CONVERSIONS TO OPEN SURGERY, NOR ANY MAJOR POST-OPERATIVE COMPLICATIONS SUCH AS A HEMATOMA OR TOTAL NIPPLE OR SKIN NECROSIS THAT OCCURRED WITH THESE TWO PATIENTS. THERE WERE NO ALLEGATIONS OF ANY MALFUNCTIONS OF ANY DV SYSTEMS, INSTRUMENTS, OR ACCESSORIES MENTIONED IN THE ARTICLE. INTUITIVE SURGICAL, INC, (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBT

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 L4-5 OPEN TLIF WITH CREO ONE AND RISE HARDWARE. THE WORKFLOW WAS BOOKED AS PREOP CT, YET AFTER MULTIPLE FAILED MERGE ATTEMPTS, AN INTRAOP CASE WAS CREATED AND THE O-ARM 2 WAS USED FOR REGISTRATION. DR. (B)(6) HAD ALREADY PLACED THE DRB USING THE REGULAR QUATTRO SPIKE AT RIGHT SIDE PSIS. THE SM WAS AT LEFT SIDE PSIS, YET IN THE RUSH TO ADAPT AND SWITCH WORKFLOWS, UNFORTUNATELY I FORGOT TO RESET IT FOR THIS CASE. I COACHED DR. (B)(6) THROUGH POSITIONING OF THE ICT FRAME ON THE QUATTRO SPIKE. I HELPED THE SCRUB REVERIFY ALL INSTRUMENTS, I TOOK THE SURGICAL SNAPSHOT, AND THE O-ARM WAS BROUGHT IN FOR REGISTRATION. O-ARM REGISTRATION WAS SUCCESSFULLY TRANSFERRED TO EGPS VIA USB. 6/7 FIDUCIALS WERE AUTO DETECTED AND VERIFIED BY ME. DR. (B)(6) CONFIRMED NAVIGATIONAL INTEGRITY THROUGH LANDMARK CHECKS WITH THE LANDMARK PROBE AFTER REMOVING THE ICT. HE THEN INSTRUMENT PLANNED ALL HIS TRAJECTORIES. DR. (B)(6) INSTRUMENTED ALL SCREWS WITH THE 4.5 HIGH SPEED DRILL, 3.5 REAMING DRILL AND CREO AMP DRIVER. THROUGHOUT NAVIGATION, I DID NOT OBSERVE ANY SPIKING IN THE DEFLECTION OR OFFSET METERS. GREEN BORDERS WERE PRESENT THROUGHOUT NAVIGATION. IT IS MY OPINION THAT DR. (B)(6) HAD VER

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

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: T1-T6 PSF WITH T3 CHANCE FX. USED QUARTEX EGPS SYSTEM. INTRA-OP WORKFLOW WITH O-ARM SPIN. DRB PLACED AT T7 VIA LONG SP CLAMP NO SM WAS USED. ICT WAS ATTACHED USING SECOND SP CLAMP AT T2 AND REMOVED AFTER SPIN. 10 SCREWS WERE PLACED WITH EGPS IN SNAKE PATTERN STARTING AT T1 AND SKIPPING T3. AFTER SCREWS WERE PLACED WE DID A SPIN TO CONFIRM ALL WERE IN SAFE POSITION. ALL 5 SCREWS ON LEFT SIDE WERE MEDIAL TO PLAN AND HAD TO BE REMOVED AND REPLACED. THE SCREWS WERE REPLACED VIA STEALTH NAVIGATION. SUBMITTING THE SCANS AND CASE LOGS FOR REVIEW.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: L5-S1 TLIF INTRAOP WITH CREO MIS SCREWS. EVERY STEP WAS DONE EXACTLY LIKE THE PREVIOUS CASES, EXCEPT THAT THE SM WAS NOT ACTIVATED BEFORE THE IMAGING. PATIENT WAS NOT DRAPED DURING O-ARM SCAN, BUT TABLE WAS TRANSLATED INTO THE LUMEN OF THE O-ARM. SNAPSHOT, SCAN AND TRANSFER WERE ALL DONE UNDER APNEA. AFTER THE TRANSFER THE SOFTWARE DID NOT SHOW THE CHECKMARK FOR THE REGISTRATION CONFIRMED, 6 OUT OF 7 FIDUCIALS WERE RECOGNIZED BY THE SYSTEM, ALTHOUGH THE ENTIRE ICT WAS IN THE SCAN. LANDMARK CHECK SEEMED FINE. PLACED FOUR SCREWS (L5L-L5R-S1L AND S1R). POSTOP SCAN REVEALED THAT ALL SCREWS WERE TOO DEEP AND L5-L WAS LATERAL COMPARED TO THE PLANNING. L5-L SCREW WAS REPLACED WITH STEALTH AND THE OTHER SCREWS WERE BACKED OUT A LITTLE. NOTHING SUGGESTED THAT THE SYSTEM CONSIDERED THE PATIENT TO BE POSITIONED LOWER, ALTHOUGH THE EE WAS ALMOST TOUCHING THE SCAN FOR EACH TRAJECTORY ON A MEDIUM SIZED PATIENT. DURING SCREW PLACEMENT, THE ARM COULD NOT BE MOVED AWAY FROM THE TRAJECTORY AFTER DESELECTING THE SCREW AND PRESSING THE FOOT SWITCH. THE ONLY WAY TO MOVE THE ARM AWAY WAS BY USING THE BRACELET.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IMPLANTATION; EGPS WAS MOVED INTO POSITION. DR. (B)(6) COMPLETED LANDMARK CHECKS BY SELECTING THE DESIRED LEVEL AND USING THE CHICKEN FOOT TO PROBE THE SPS AND LAMINAS. WE THEN ADVISED DR. (B)(6) TO USE THE FLUORO IMAGE SELECTOR TO VISUALIZE THE FLUORO IMAGES RATHER THAN THE CT. THE FLUORO IMAGES SHOWED THE CORRECT POSITION FOR THE SCREW FOR L3 SO DR. (B)(6) PROCEEDED WITH IMPLANTATION. SCREW PREPARATION CONSISTED OF A 4.5MM HS DRILL, TIPPED QUARTEX DRILL, FOLLOWED BY THE SCREW. BETWEEN EACH INSTRUMENT DR. (B)(6) USED A BALL TIP PROBE TO CHECK TO MAKE SURE THE SCREW NEVER BREACHED THE PEDICLE AND STEMMED THE SCREW ONCE PLACED. AFTER REMOVING THE EGPS WE NOTICED THAT S1 SCREWS WERE PLACED TOO FAR SUPERIOR IN LAT X-RAY AIMING TOWARDS THE DISC SPACE SO DR. (B)(6) IMMEDIATELY REMOVED THE SCREWS. HE THEN MOVED THE SCREWS DOWN INFERIORLY ON THE PLAN AND CHECKED THEIR POSITION ON FLUORO VIEW. HE THEN RE-IMPLANTED THE S1 SCREWS INTO THE CORRECT DESIRED POSITIONS WITHOUT RE-REGISTERING. ALL SCREWS WERE CONFIRMED ACCURATE WITH FLUOROSCOPY AND NEUROMONITORING. AFTER THE CASE AND PRIOR TO THE SECOND CASE, I URGED HIM TO WAIT A FEW SECONDS AFTER THE MOVEMENT METER DROPS TO 0% PRIOR TO TAKING SH

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: PRE OP CASE. PEDIATRIC SCOLI. 13 Y.O. FAMALE. T5-L5 PEDICLE SCREWS MIS. 2021R1P1. PHILIPS PULSERA C-ARM 12 INCH. DR.(B)(6) WORKFLOW FOR THIS KIND OF CASES ITS TO START FROM TORACIC SCREWS CLAMPING DRB ON T11 AND SM T10 CAMERA TO THE FEET AND ROBOT COMING FROM THE HEAD OF THE PATIENT. FOR LOWER LEVELS HE LIKES TO INVERT POSITION TO DRB AND SM IN ORTHER TO USE THE SAME SPINOUS PROCESSES AND NOT HAVING TO MAKE OTHER INCISIONS TO PEDIATRIC PATIENTS. WE TOOK APS AND LATERALS SHOTS AS USUAL. THE MERGE WAS SHOWING SHIFT ON LATERAL IMAGES FOR T5 AND T10. WE CHOOSE A NEW AP FOR T5 AND IT MERGED WELL. WE DECIDED TO DO NOT TAKE NEW SHOTS FOR T10, THE IDEA WAS TO MERGE T10 WITH THE SECOND SECTION OF THE COLUMN T10-L4/L5. WE STARTED PLACE SCREWS FROM T5 BOTH SIDES. ALL GOOD SINCE T8. WHEN WE INSERTED HIGH SPEED DRILL IN THE EE WE NOTICE THAT NAVIGATION WAS NOT PRECISE. SO WE MOVED AWAY EE AND WE PERFORMED NAVIGATION CHECK BY USING NAVIGATED INSTRUMENT. WE NOTICED AN INCH OF DIFFERENCE BETWEEN WHERE WE WERE WITH THE INSTRUMENT FROM WHAT WE SAW ON THE SCREEN. THE DISCREPANCY SEEMED TO BE ON THE DEPTH. THE INSTRUMENT IN CONTACT WITH THE PATIENT'S ANATOMY WAS ON THE SCREEN ABOUT A CENTIMETER AWAY.

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 HYSTERECTOMY BENIGN SURGICAL PROCEDURE, THE SURGEON FOUND A "FOREIGN OBJECT" INSIDE THE PATIENT. THE OBJECT WAS DESCRIBED AS POSSIBLY BEING A NEEDLE AND THE SURGEON WAS UNCERTAIN HOW THE OBJECT GOT INSIDE THE PATIENT. THERE WERE SEVERAL POSSIBILITIES CONSIDERED BY THE CUSTOMER, BUT NOTHING HAS BEEN DETERMINED TO DEFINITIVELY IDENTIFY THE OBJECT. WHILE CLOSING THE LEFT SIDE OF THE CUFF THE SURGEON NOTED APPROXIMATELY ¼ INCH OF A FOREIGN OBJECT, THOUGHT TO BE A NEEDLE STICKING OUT. THE SURGEON PULLED ON THE FOREIGN OBJECT AND WAS ABLE TO MOMENTARILY RETRIEVE THE OBJECT. WHILE ATTEMPTING TO REMOVE THE FOREIGN OBJECT WITH A LAPAROSCOPIC INSTRUMENT THE STAFF LOST THE FOREIGN OBJECT. THE STAFF ATTEMPTED TO VIEW THE OBJECT THROUGH X-RAY BUT WERE UNABLE TO LOCATE THE OBJECT. THE STAFF ORIGINALLY THOUGHT THE FOREIGN OBJECT COULD HAVE BEEN FROM THE DA VINCI INSTRUMENTS. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) RECOMMENDED THE STAFF RMA THE INSTRUMENTS FOR FAILURE ANALYSIS. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: TH

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) WAS MADE AWARE OF A SOCIAL MEDIA POST INDICATING THAT 4-5 WEEKS AFTER A DA-VINCI ASSISTED HYSTERECTOMY, THE PATIENT EXPERIENCED VAGINAL CUFF TEAR WITH "LOTS OF BLEEDING". THE PATIENT WAS BROUGHT BACK FOR AN EMERGENT SURGERY TO RE-STITCH THE VAGINAL CUFF. IT IS UNKNOWN ON WHICH DATE WAS THE DA-VINCI ASSISTED SURGERY AND AT WHICH HOSPITAL. THE AMOUNT OF BLOOD LOSS IS UNKNOWN AT THIS TIME. INTUITIVE SURGICAL, INC, (ISI) MADE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, AT THE TIME OF THIS REPORT, NO ADDITIONAL 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: AS PART OF A CLINICAL STUDY, IT WAS REPORTED THAT A PATIENT UNDERWENT DA-VINCI ASSISTED PULMONARY LOBECTOMY ON (B)(6) 2023 AND THE PATIENT PRESENTED WITH RAPID WORSENING SHORTNESS OF BREATH WITH ESCALATING OXYGEN REQUIREMENTS ON (B)(6) 2023 WITH PROLONGED HOSPITALIZATION REQUIRED. A CHEST X-RAY SHOWED COLLAPSE OF THE REMAINING RIGHT LUNG WITH CONCERN FOR MUCOUS PLUGGING POST RIGHT UPPER LOBECTOMY WITH PARTIAL CHEST WALL RESECTION. A BEDSIDE BRONCHOSCOPY REVEALED TENACIOUS SECRETIONS IN BRONCHI WITH MUCOUS PLUGGING WHICH WAS CLEARED WITH LAVAGE. THERE WAS NO IMMEDIATE COMPLICATIONS AND THE PATIENT WAS PLACED BACK ON NASAL CANULA OXYGEN, WHICH WAS RAPIDLY TITRATED DOWN. A COMPUTERIZED TOMOGRAPHY (CT) SCAN ON (B)(6) 2023 REVEALED A MODERATE TO LARGE RIGHT PLEURAL EFFUSION WITH COMPRESSIVE ATELECTASIS OF THE RIGHT LUNG. WHEN THE PLEURAL SPACE WAS ENTERED, A GUSH OF AIR AND SEROUS FLUID WERE OBSERVED. A 14 FRENCH PIGTAIL CHEST TUBE AS INSERTED AND CONNECTED TO A CHEST DRAINAGE SYSTEM WHICH IMMEDIATELY DRAINED APPROXIMATELY 600ML OF SEROSANGUINOUS FLUID. THE PATIENT REPORTED BREATHING WAS IMPROVING, BUT STILL WITH SHORTNESS OF BREATH WITH OXYGEN SUPPLEMENT REQUIRED. THE PATIENT WAS REPOR