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.

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

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE MATCHING WAS DONE AND WE STARTED TO APPROACH WITH THE ROBOT. THE SCREWS WERE ONLY NECESSARY ON THE RIGHT SIDE, SO WE GOT ALL THREE RIGHT SCREWS GREEN FRAME AND STABILIZED THE ROBOT IN THAT POSITION. SELECTED A SCREW AND PRESSED THE FOOTPADDLE, WITH THE IMMEDIATELY GOT THE MESSAGE TRAJECTORY OUT OF RANGE. IT STAYED LIKE THAT AFTER SOFTWARE RESET, SWITCH TO CRANIAL AND BACK AND TO 3 HARD SHUTDOWNS INCLUDING PULLING OUT THE ELECTRIC CORD. NOTHING CHANGED THE TRAJECTORY OUT OF RANGE MESSAGE.

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: ON (B)(6) 2023 IT WAS REPORTED THAT DURING A MONARCH BRONCHOSCOPY PROCEDURE THE PHYSICIAN FELT A POP WHILE TAKING A BIOPSY WITH A MEDTRONIC ARCPOINT NEEDLE. AFTER COMPLETING THE BIOPSY, THE PHYSICIAN REMOVED THE BRONCHOSCOPE SYSTEM AND THE PATIENT¿S HEART RATE SPIKED TO A REPORTED 190 BPM. AN ELECTROCARDIOGRAM (ECG) WAS PERFORMED, AND IT WAS DETERMINED THAT NO FURTHER INTERVENTION WAS REQUIRED AT THAT TIME. THE PATIENT WAS TRANSFERRED TO POST ANESTHESIA CARE UNIT (PACU), A CHEST X-RAY WAS PERFORMED, AND A PNEUMOTHORAX WAS CONFIRMED. A CHEST TUBE WAS PLACED, THE PATIENT WAS ADMITTED TO THE HOSPITAL, AND RELEASED 3 DAYS LATER.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: L4-5 INTRA-OP CASE. REGISTRATION NORMAL/NO ERRORS/NO SHIFTS. SCREW PLACEMENT: L4-R PLACED, SELECTED L5-R, PRESSED FOOT PEDAL, EE CAME OFF L4-R LIKE NORMAL. MOVED EE OUT OF WAY WITH RING. ADJUSTED L5-R PLAN, BACK TO NAVIGATE, PRESSED FOOT PEDAL, ARM FLOATED TO THE SIDE. THEN ARM LOCKED UP/WOULD NOT MOVE VIA BUTTONS, FOOT PEDAL, OR RING. ARM WOULD NOT MOVE, RE-HOME, OR RE-CALIBRATE LOADCELL AFTER MULTIPLE HARD SHUTDOWNS AND SOFTWARE RESETS.

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 THAT THE MONOPOLAR ENERGY WAS NOT WORKING. THE SITE KEPT GETTING MESSAGES TO CHECK THE MONOPOLAR ENERGY CORD, THE INSTRUMENT TIP, AND/OR SHEATH. THE SITE TRIED THREE DIFFERENT ENERGY CORDS, THREE INSTRUMENTS, THREE TIPS, AND TWO SHEATHS, ALL WITH DIFFERENT MESSAGES AND NO MONOPOLAR ENERGY. THE SITE DID A POWER CYCLE OF THE SYSTEM, AND VISION SIDE CART (VSC) BREAKER, WITH NO CHANGE. THE SITE HAD AN ORANGE INSTRUMENT CORD LED ON THE ENERGY SHIELD CONSTANTLY. THE SITE RESEATED THE CORD FROM THE ENERGY SHIELD TO THE ERBE GENERATOR WITH NO CHANGE. THE SITE SWAPPED OUT THE SYSTEM FOR AN XI SYSTEM AND ENDED THE CALL. THERE WERE NO REPORTS OF PATIENT INJURY.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON 3/27 A CASE WITH DR.(B)(6). 4 SCREWS PLACED ROBOTICALLY USING CREO MIS AND INTRA-OP CT SCAN WITH EXCELISIUS360. CT SCAN AND ROBOTIC PLACEMENT WENT WELL. AFTER SCREWS IN, I BELIEVE LL5 SCREW WAS PLACED TOO ANTERIOR TO PLAN. NO ADVERSE EFFECTS TO PT, SCREW WAS BACKED OFF A FEW MM. SURGEON DOES WANT TO USE ROBOT UNTIL ISSUE IS RESOLVED/ FIGURE OUT WHAT WENT WRONG. CASE LONGS HAVE BEEN SUBMITTED TO IN TEAM.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THIS CASE WAS PERC SCREWS AT T11-L3, SKIPPED L1. WE USED E3D AS INTRA OP SCAN WITH AUTOMATIC REGISTRATION. T11 - T12 SCREWS WERE PLACED FIRST, UPON THESE SCREWS BEING PLACED IT WAS NOTICED THERE WAS SIGNIFICANT DEFLECTION, IT WAS THEN DETERMINED TO UTILIZE THE TAP FOR THE REMAINING SCREWS, T12 R (THE LAST THORACIC SCREW) - L3 (WHICH WERE ALL PLACED TO PLAN). WE DECIDED TO SPIN AND WE CONNECTED TO ROBOT INCASE ANY SCREWS NEEDED REDONE. UPON SPINNING AFTER ALL SCREWS WERE PLACED, 2 SCREWS WERE MISSED T12 L (MEDIAL) AND T11 R (LATERAL). WE USED THE NEW REGISTRATION TO REPLACE BOTH SCREWS, T12 L WAS REPLACED EXACTLY TO PLAN, BUT T11 R WAS OFF PLAN (MEDIAL) AFTER TAKING A FINAL SPIN TO CONFIRM FINAL PLACEMENT. PLEASE ADVISE AS TO WHY SCREWS WERE MISSED.

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 PROSTATECTOMY SURGICAL PROCEDURE, THE CUSTOMER RECEIVED ERROR 86. THE CUSTOMER POWERED CYCLED THE SYSTEM AND ERROR COME BACK. ONSITE WAS NOT FUNCTIONAL DUE TO BROKEN CABLE/CONNECTOR IN THE OPERATING ROOM (OR). THE CUSTOMER WAS ABLE TO PROVIDE INFORMATION REGARDING ROOT CAUSE; THE NODE INVOLVED WAS 32 AND IT WAS POINTING TO THE ICC BOARD AND/OR POWER SUPPLY. THE PROCEDURE WAS ABORTED POST ANESTHESIA AND PORT PLACEMENT WITH NO REPORTED INJURY. ISI MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO 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: AFTER REPOSITIONING THE ROBOT INTO THE FIELD AND MOVING TO S1L A DRILL WAS PLACED DOWN THE EE. THE OFFSET WAS FULLY RED AS THE INSTRUMENT PASSED DOWN THE EE. DRILL WAS REMOVED, AND EE RESETTLED TO GREEN BORDERS AGAIN. AGAIN, THE DRILL WAS PLACED THROUGH THE EE, AND OFFSET WAS FULLY RED. THE ARRAY ON THE DRILL WAS MOVED, SURGEON ADJUSTED THE DRILL BATTERY TO REDISTRIBUTE THE WEIGHT, AND IT STAYED RED. SURGEON REQUESTED THE ROBOT BE PULLED FROM THE FIELD, AND THE CASE WAS FINISHED WITH STEALTH NAVIGATION.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: CASE WAS PERFORMED AS AN OPEN, FOR L2-S2 CONSTRUCT. DUE TO THE INABILITY TO GET THE BOTTOM HALF OF THE PELVIS IN ONE INTRA-OP SPIN USING O-ARM, CASE WAS EXECUTED USING 2 SPINS/CASES/MERGES, BUT SAME DRB/SURVEILLANCE MARKER PLACEMENT FOR EACH CASE. PATIENT WAS POSITIONED PRONE THROUGHOUT THE ENTIRETY OF THE CASE. DRB WAS PLACED IN PATIENT RIDE SIDE PSIS AND SURVEILLANCE MARKER WAS PLACED IN PATIENT'S LEFT SIDE PSIS. WE PROCEEDED WITH OUR TWO PINS FOR OUR PREOP WORKFLOW. SCREWS WERE PLANNED FOR OUR FIRST CASE AS L2-S1 AND WERE CHECKED/CONFIRMED BY DR. (B)(6). SCREWS WERE PLANNED FOR OUR SECOND CASE AS L5-S2 AND WERE CHECKED/CONFIRMED BY DR. (B)(6), AGAIN. WE INITIALLY MERGED OUR FIRST CASE AND EXECUTED PUTTING SCREWS IN AT LEVELS L2-S1. THESE SCREWS ALL WENT IN GREAT AND LOOKED SPOT ON OUR FINAL X-RAYS. WE THEN PROCEEDED WITH OUR SECOND CASE MERGING LEVELS L5-S2. THIS CASE WAS ONLY USED TO PUT IN S2AI SCREWS. WE WERE ABLE TO GET A SUCCESSFUL MERGE AND THEN PROCEEDED WITH PUTTING IN S2AI SCREWS. DR. (B)(6) WAS WORKING FROM PATIENT'S RIGHT SIDE, SO WAS ABLE TO PUT PATIENT'S LEFT SIDED SCREW IN UTILIZING HIGH SPEED BURR, MCS DRILL, TAP, SCREW ON POWER TECHNIQUE WITH EASE. WE THEN PROCEE

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 AT THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, POST-ANESTHESIA AND PORT PLACEMENT, THE SURGICAL TEAM HAD A NON-RECOVERABLE ERROR 86. PRIOR TO CALLING, THE CUSTOMER PERFORMED A REBOOT OF THE VISION SIDE CART (VSC) CIRCUIT BREAKER, BUT THE PROBLEM PERSISTED. THE TECHNICAL SUPPORT ENGINEER (TSE) INFORMED THE CUSTOMER ABOUT THE ROOT CAUSE FOR THE ISSUE, WHICH WAS A FAULTY POWER BOARD IN THE CORE OF THE VSC. THE SYSTEM WAS NOT USABLE ANYMORE. THE PROCEDURE WAS ABORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: SYSTEM FUNCTIONALITY WAS CHECKED WHEN THE SYSTEM WAS POWERED ON AND THE SYSTEM STARTED WITHOUT PROBLEMS, THE STERILE COVERING OF THE ARMS WAS PERFORMED WITHOUT ISSUES, AND THERE WERE NO ERROR MESSAGES. OPEN SURGERY WAS NOT PERFORMED, THE SURGERY WAS CANCELLED. THE FIRST TROCAR WAS ALREADY PLACED, THEN SUDDENLY THE ERROR MESSAGE APPEARED. IT WAS A SUDDEN OCCURRENCE OF THE ERROR MESSAGE WITHOUT PREVIOUS USE OF THE ROBOT, AS ONLY THE OPTICS WERE USED MANUALLY. NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. THE PATIENT WAS SCHEDULED FOR ROBOTIC-ASSISTED RADICAL PROSTATECTOMY. THE TE

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 ROBOT IS HAVING SOME PROBLEMS. THE SOFTWARE HAS BEEN EXTREMELY SLOW, VARIOUS GLITCHES WHILE OPERATING, MERGING HAS GOTTEN INCREASINGLY MORE DIFFICULT, AND SCORES KEEP GOING DOWN WITH BOTH PREOP CT AND O-ARM SPINS. THE LAST TWO CASES WE'VE HAD SCREWS PLACED IN AREAS NOT PLANNED BUT LUCKILY THE SURGEON DIDN'T FEEL RIGHT SO HE STOPPED AND DID IT BY HAND.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: GPS WAS UNABLE TO LOAD INTRO-OP SPIN TO GENERATE THE STUDY. A SCAN WAS DONE WITH THE O-ARM AND WAS SAVED ON 2 DIFFERENT USB DRIVES, TRYING BOTH USB PORTS ON THE GPS WITH THE SAME RESULT. THE STATUS BAR WAS STALLING/FREEZING AT ABOUT 85%. WE HAD TO HOLD DOWN THE POWER BUTTON TO POWER CYCLE THE GPS TO GET IT UNFROZEN FROM THAT LOADING SCREEN. WE PERFORMED A 2ND SCAN WITH THE O-ARM TO MAKE SURE THE ISSUE WAS NOT WITH THE FIRST STUDY WITH THE SAME RESULTS USING THE SAME METHODS. THE GPS AT ONE POINT WOULD NOT POWER DOWN BY HOLDING DOWN THE POWER BUTTON BUT EVENTUALLY DID. DURING THE REBOOT OF THE GPS, THE SCREEN REMAINED DARK WITH RED STATUS LIGHT ON 2 DIFFERENT OCCASIONS AS WELL. DR. (B)(6) WANTS A TECHNICIAN TO COME LOOK AT THIS UNIT AS SOON AS POSSIBLE. HE CANCELED THE CASE AND HAD THE PATIENT WOKEN UP FROM ANESTHESIA DUE TO THIS MALFUNCTION.

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: SCREWS PLANNED ON EGPS UNIT WERE NOT EXECUTED TO PLAN IN PATIENT - SCREWS SHIFTED LATERALLY. COULD YOU PLEASE EVALUATE THE LOGS AS WE HAD SIGNIFICANT SHIFT ON SCREW VS PLAN ON TIS PATIENT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HIATAL HERNIA REPAIR PROCEDURE, THE BLADE OF THE HARMONIC ACE INSTRUMENT FELL OFF INSIDE THE PATIENT. AT THE TAIL END OF THE DISSECTION OF THE LESSER BLOOD SUPPLY ALONG THE GREATER CURVATURE OF THE STOMACH, THE SYSTEM ASKED FOR THE SURGEON TO RELEASE TENSION/PRESSURE FROM THE INSTRUMENT AND REAPPLY THE INSTRUMENT. THE SURGEON DID AS THE SYSTEM INSTRUCTED. WHEN THE SURGEON STARTED DISSECTING AGAIN THE WARNING REAPPEARED. THE SURGEON ONCE AGAIN DID AS THE SYSTEM INSTRUCTED. AS THE SURGEON WENT IN TO GRAB THE TISSUE FOR A THIRD TIME, THE MOBILE BLADE OF THE INSTRUMENT FELL OFF. THE INSTRUMENT WAS REMOVED AND REPLACED. THE INSTRUMENT FRAGMENT/PIECE WAS FOUND AND REMOVED SAFETY FROM THE PATIENT'S ABDOMINAL CAVITY. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER ON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: IT WAS CONFIRMED THAT THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND NO DAMAGE WAS SEEN. THE SURGEON BELIEVE IT WAS CAUSED BY A FAULTY BUILD. THE INSTRUMENT BROKE ROUGHLY THREE QUARTERS OF THE WAY THROUGH THE CASE. NO ISSUES WERE SEEN WITH THE FUNCTIONALITY

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DR. (B)(6) DID A REVISION L1-S1 TODAY AT THE SURGERY CENTER USING E3D AND EGPS. THE PT WAS DRAPED AND THE DRB WAS PLACED IN THE RIGHT PSIS, AND WAS MARKED USING A SKIN MARKER. WE PROCEEDED WITH AN E3D SPIN AND TRANSFERRED THE INTRA-OP CT TO EGPS. THE PT WAS THEN EXPOSED, INSTRUMENTATION WAS REMOVED AND WE CONTINUED WITH THE EGPS SYSTEM PUTTING IN SCREWS. WE GOT TO L5 AND THE DRB WAS BUMPED AND ROTATED, AT WHICH POINT WE ABORTED TO ROBOT AND FREE HANDED SCREWS AT S1. X-RAYS WERE TAKEN OF THE SCREWS PLACED, RIGHT L1 AND L2 WERE LATERAL, AND THE SURGEON REPLACED THEM FREE HAND. LEFT L1 WAS DETERMINED TO BE TOO MEDIAL AND WAS ALSO REPLACED. THE REMAINING SCREWS WERE CHECKED VIA FLUORO SHOTS AND WERE CONFIRMED TO BE PLACED ADEQUATELY.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING AN UNSPECIFIED DA VINCI-ASSISTED SURGICAL PROCEDURE, THE TIP OF THE HARMONIC ACE INSTRUMENT WAS BROKEN WHILE GRASPING TISSUE. THE INSTRUMENT FRAGMENTS FELL INSIDE THE PATIENT¿S CAVITY AND WERE RETRIEVED DURING THE SAME PROCEDURE. THERE WAS NO BLEEDING. THE CUSTOMER CONFIRMED THAT THE INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO ABNORMALITY. 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: DURING THE PROCEDURE, THE INSTRUMENT TIP WAS FOUND BROKEN ON THE CAMERA SCREEN AFTER USING THE INSTRUMENT FOR ABOUT 10 MINUTES. ALL THE FRACTURED PARTS WERE FOUND, RETRIEVED, CONFIRMED TO BE INTACT BY PUTTING THE PIECES TOGETHER, AND THERE WAS NO RESIDUE IN THE FIELD OF VIEW. THE SURGEON BELIEVED THERE WAS AN INSTRUMENT COLLISION DURING THE CASE BUT THE ISSUE WAS DUE TO INSTRUMENT QUALITY. THE INSTRUMENT WAS NOT REMOVED DURING THE PROCEDURE (PRIOR TO THE BREAKAGE). NO FUNCTIONAL ISSUES WERE FOUND. UPON FINAL REMOVAL OF THE INSTRUMENT, THE INSTRUMENT'S WRIST WAS STRAIGHTENED, AND THE SURGICAL STAFF DID NOT FEEL ANY RESISTANCE UPON

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 PULMONARY LOBECTOMY SURGICAL PROCEDURE, SYSTEM GENERATED A NON-RECOVERABLE FAULT 297. PRIOR TO CALLING TECH SUPPORT THE CUSTOMER TRIED TO RESTART SYSTEM SEVERAL TIMES WITHOUT SUCCESS. THE ERROR KEPT ON TRIGGERING. SURGEON DECIDED TO CONVERT TO OPEN SURGERY. TECHNICAL SUPPORT ENGINEER (TSE) CHECKED THE LOGS THAT WERE SHOWING REPEATED NON-RECOVERABLE FAULT 297 POINTING TO AUXILIARY VIDEO BOARD (AVP)3. TSE CONNECTED TO SYSTEM TO DISABLE AVP3 NODE, BUT WHEN USER RESTARTED SYSTEM IN NORMAL MODE THERE WAS NON-RECOVERABLE FAULT 40019, THAT MAY INDICATE THAT THE MODIFICATION IN DOWNLOAD APP DID NOT GO WELL. THERE WAS NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SURGERY WAS NOT PERFORMED WITH A ROBOTIC APPROACH BECAUSE THE FAILURE WAS NOT RECOVERED BEFORE SURGERY STARTED. THEREFORE, IT WAS DECIDED THAT THE SAFEST APPROACH FOR THE PATIENT, SINCE IT WAS A COMPLEX CASE IN WHICH THE ROBOT COULD HELP, WAS OPEN SURGERY.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DR. (B)(6) PLANNED TO PLACE SCREWS AT L3-4 BILATERALLY, HE DID A MIDLINE INCISION AND PERFORMED LAMINECTOMY AT L3, AND DECOMPRESSION AT BOTH LEVELS. AFTER DECOMPRESSION COMPLETED AND SURGEON HAPPY WITH IT, WE PLACED SP CLAMP ON L5 SPINOUS PROCESS. DRB WAS PLACED AND WE WENT TO TAKE SHOTS. WE SUCCESSFUL MERGED L3 AND L4. ALL 4 SCREWS WERE PLACED USING WORKFLOW HIGH SPEED DRILL, 3.5 DRILL THEN SCREW PLACED. WE TOOK A SHOTS TO CONFIRM SCREW PLACEMENT, ON AP WE SAW OUR FIRST SCREW LEFT L3 WAS BREACHED LATERALLY. THE OTHER 3 SCREWS WERE PLACED TO PLAN. WE DIDN'T NOTICE INSTRUMENTS GOING LATERALLY WHEN PREPARING HOLE FOR SCREW. SCREW WAS REMOVED AND WE MADE SURGEON NAVIGATION WAS STILL ACCURATE. WE WENT TO PLACE SCREW AGAIN, USING HIGH SPEED BURR, AND 3.5 DRILL, PLACED SCREW. AGAIN, IT WAS BREACHED LATERALLY. WE REMOVED BOTH LEFT SIDE SCREWS AND JUST PLACED ROD AND LOCKING NUTS ON RIGHT SIDE.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING THE MERGE OF OUR CASE, THE SI JOINT LEVELS WOULD NOT POPULATE AFTER THE MERGE. CREO SCREWS WERE PLANNED AT 5-1 AND ADJUSTED TO 4-1 DURING OTHER ATTEMPTS. SI-LOK WAS PLANNED BILATERALLY. ALL NEW IMAGES WERE TRIED FIRST. THEN, A NEW CASE WITH NEW IMAGES WAS TRIED AS WELL. SOFTWARE RESET, HARD SHUT DOWN, CRANIAL AND BACK WERE TRIED AS WELL. THIS ACCOUNT HAS BEEN REGULARLY DOING SI-LOK CASES WITH NO ISSUES. THE MERGE WAS SUCCESSFUL AT L4-S1. MULTIPLE CSR'S WERE CALLED ALONG WITH OTHER MEMBERS OF THE TEAM UNABLE TO DISCERN THE ISSUE. THE CASE WAS UNABLE TO BE COMPLETED AND THE OPERATION WAS DONE UNDER FLUORO.

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 PARTIAL NEPHRECTOMY SURGICAL PROCEDURE, THE ENDOSCOPE COULD NO LONGER BE ROTATED. THE PROCEDURE WAS COMPLETED WITH NO PATIENT HARM, WITH A BACKUP ENDOSCOPE, AND WITH A DELAY OF 50 MINUTES. ISI MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT THE PATIENT UNDERWENT DA-VINCI ASSISTED LOBECTOMY ON (B)(6) 2023 AS PART OF THE CGMH SP CLINICAL STUDY. ON (B)(6) 2023, THE PATIENT DEVELOPED CHYLOTHORAX WITH HIGH TRIGLYCERIDES (TG) AND REQUIRED PROLONGED HOSPITALIZATION. DIET CONTROL WAS IMPLEMENTED INCLUDING KABIVEN (TOTAL PARENTERAL NUTRITION) ADMINISTERED ON (B)(6) 2023 FOR TWO DAYS. THE PATIENT WAS STARTED CLEAR LIQUID DIET ON (B)(6) 2023 AND STARTED NON-FAT DIET ON (B)(6) 2023. THE PATIENT`S CHEST TUBE WAS REMOVED ON (B)(6) 2023. THE STUDY INVESTIGATOR ASSESSED THE REPORTED EVENT AS TO NOT RELATED TO THE DV SYSTEM, INSTRUMENTS OR ACCESSORIES, NOT RELATED TO THE DV ASSISTED SURGERY. INTUITIVE SURGICAL, INC, (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO ADDITIONAL INFORMATION. HOWEVER, AT THE TIME OF THIS REPORT, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

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 1ST CASE OF THE DAY (PATIENT IN THE ROOM UNDER ANESTHESIA) PHYSICIAN REPORTED PNEUMOTHORAX. SYSTEM INITIALIZED CORRECTLY, SETUP AND SCOPE REGISTRATION HAD NO ISSUES. WHEN NAVIGATING TO THE TARGET IN LEFT LOWER LOBE, 100MM FROM THE TARGET, THE PHYSICIAN BACKED OUT ALL THE WAY TO MAIN CARINA AND WENT BACK WITHOUT RE-REGISTERING THE SCOPE. THE PHYSICIAN WAS MOVING BACK AND FORTH, WAS FOLLOWING FLUORO, AND IT WAS AT THIS POINT THEY NOTED THE PNEUMOTHORAX. THE PHYSICIAN FEELS THE MONARCH CAUSED THE PNEUMOTHORAX, CONVERTED TO MANUAL SCOPE, AND SUCCESSFULLY COMPLETED THE CASE. A CHEST TUBE WAS PLACED, AND THE PATIENT DISCHARGED THE SAME DAY.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: CASE FLOW: PATIENT WAS PREPPED AND POSITIONED PER STANDARD MEANS AND SCOUT SHOTS OF LUMBAR ANATOMY WAS TAKEN VIA X-RAY AND VERTEBRAL MARKS PLACED ON SKIN. DR. (B)(6) THEN EXPOSED L1 AND L2 PLACING THE SPINOUS PROCESS CLAMPS FOR THE DRB (ON L2) AND ICT/ SURVEILLANCE MARKER (SM) (ON L1). SM WAS REGISTERED AND THE O-ARM BROUGHT INTO POSITION AT TABLE. P/A, LAT, AND A/P SCOUT SHOTS WERE TAKEN TO ENSURE CORRECT LEVELS AND ICT FRAME FIDUCIALS WERE VISUALIZED FOR THE SPIN. SOME ADJUSTMENTS TO THE ICT FRAME AND PIVOT ARM WERE MADE TO ENSURE THAT EVERYTHING WAS ALIGNED. AT THIS TIME THE FIELD CAPTURE SNAPSHOT WAS TAKEN, THE ICT/DRB WERE COVERED WITH BLUE STERILE CLOTH, RESPIRATIONS HELD AND A CT SPIN WAS TAKEN. THE SCAN WAS CHECKED TO ENSURE THE ICT AND FIDUCIALS WERE ALL CAPTURED. THE SCAN WAS EXPORTED VIA USB THUMB DRIVE AND TRANSFERRED SUCCESSFULLY TO THE EXCELSIUS GPS WHERE THE REGISTRATION FIT WAS VERY GOOD. THE O-ARM WAS REMOVED FROM THE TABLE, BLUE CLOTH REMOVED, ICT PIVOT ARM REMOVED FROM CLAMP, SM REMOVED TO SLIDE OFF ICT CLAMP AND REPLACED. SKIN LANDMARK CHECKS WERE DONE AND SM WAS RE-REGISTERED. SINCE L1 SPINOUS PROCESS WAS VISIBLE IN THE SCAN AND DIRECT ACCESS WAS POSSIBLE VIA T