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.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY PROCEDURE, THE TIP OF THE HARMONIC ACE INSTRUMENT BROKE AND FRAGMENTS FELL INTO THE PATIENT. THE FRAGMENTS WERE RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL INC.(ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND NO DAMAGES WERE OBSERVED. THE INSTRUMENT WAS IN USE FOR 15 MINUTES WHEN THE ISSUE HAPPENED. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE SURGICAL PROCEDURE. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIAL DURING THE SURGICAL PROCEDURE. THE SURGICAL STAFF DID NOT NOTICE ANY DAMAGE TO THE CANNULA AFTER THE EVENT OCCURRED. THE SURGICAL STAFF DID NOT NOTICE ANY OTHER DAMAGE TO THE INSTRUMENT AFTER THE EVENT OCCURRED. THE FRAGMENT WAS JUST ONE BROKEN PIECE WHICH WAS REMOVED SUCCESSFULLY. NO ADDITIONAL PROCEDURES WERE DONE. NO POST OPERATIVE TESTS WERE DONE. A BACKUP INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY OR HARM. THE PATIENT DID NOT RETURN TO THE HOSPITAL.

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.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SYNCHROSEAL INSTRUMENT HAD BOTH "RINGS" FALL OFF. ONE RING WAS RECOVERED, THE SECOND ONE WAS LOST IN SITU. WHEN PULLING OUT THE INSTRUMENT, THE METAL CABLE WAS OBSERVED AT THE DISTAL END OF THE SHAFT. IT WAS REPORTED THAT A FRAGMENT FELL INTO THE PATIENT AND WAS UNKNOWN IF RETRIEVED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY AND LESS THAN A 15-MINUTE DISPLAY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CUSTOMER AND OBTAINED ADDITIONAL INFORMATION: THE "RING" WAS DESCRIBED AS THE "PROTECTIVE SCREW" AT THE DISTAL END. ADDITIONALLY, AT THE TIME THE EVENT OCCURRED, THE SURGEON WAS RESECTING A LARGE-VOLUME MALIGNANT TUMOR IN THE AREA OF THE MIDDLE PART OF THE MESO ROOT. THE SYNCHROSEAL INSTRUMENT WAS USED FOR DISSECTION AND TO CUT/SEAL SMALLER BLOOD VESSELS. THE FRAGMENT/PART WAS DESCRIBED AS BEING SIMILAR TO A WASHER AND WAS DISCOVERED LYING RETROPERITONEALLY. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. THERE WERE NO KNOWN COLLISIONS DURING THE PROCEDURE. THE CUSTOMER FELT RESISTANCE UPON REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA AND CANNULA DAMAGE WAS OBSERVED. A POST-OPERATIVE X-RA

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.

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 WHILE USING A SYNCHROSEAL INSTRUMENT WITH AN E-100 GENERATOR DURING A DA VINCI ASSISTED LIVER RESECTION, THE INSTRUMENT WOULD NOT SEAL COMPLETELY, AND THE SURGEON REPORTED BLEEDING. THE CUSTOMER REPLACED THE SYNCHROSEAL INSTRUMENT WITH A VESSEL SEALER EXTEND INSTRUMENT AND USED THE ERBE GENERATOR INSTEAD AND REPORTED IMPROVED SEALING. THE PROCEDURE WAS COMPLETED ROBOTICALLY.

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 INGUINAL HERNIA SURGICAL PROCEDURE, THE TIP OF THE HARMONIC ACE INSTRUMENT BROKE OFF INSIDE THE PATIENT WHILE IN USE. THE INSTRUMENT FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL INC.(ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

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.

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: 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.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THE SURGERY WAS DONE ACCORDING TO PLAN, BUT AFTER WHEN THE SURGEON CHECKED A POST OPERATIVE CT, ONE SCREW WAS MISPLACED. AFTER THE SURGERY THE PATIENT HAD NEUROLOGICAL DEFICIT. THE PATIENT HAD ISSUES WALKING. THE PROCEDURE WAS NOT DELAYED.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THE FOUR RIGHT SIDE SCREWS WERE ALL PLACED. THE SYSTEM WAS BROUGHT TO LEFT T1. THE PILOT HOLE WAS DRILLED AND IMMEDIATELY THE PATIENT JOLTED. THE NEUROMONITORING SHOWED SIGNIFICANT REDUCTION IN LEFT LEG SIGNAL. AN ACCURACY CHECK WAS PERFORMED AND INACCURACY WAS NOTED. A NEW SCAN WAS PERFORMED FOLLOWED BY SNAPSHOT. THE SCAN WAS REVIEWED AND POSITION OF ALL RIGHT SIDE SCREWS WAS GOOD. T1 WAS THEN TEMPORARILY OMITTED, AND T2 AND T4 WERE INSTRUMENTED WITHOUT INCIDENT. DURING USE OF THE DRILL FOR T5, AGAIN THE PATIENT JOLTED, WITH THE NEUROMONITORING SHOWING CONSISTENT LOSS IN MOTORS. THE SURGEONS PERFORMED AN ACCURACY CHECK AND WERE HAPPY TO PROCEED. T5 WAS THEN INSTRUMENTED. T1 WAS THEN PREPARED WITH THE DRILL AND THE TAP, WITH THE PLAN OF FREEHAND INSERTION OF THE SCREW INTO THE PREPARED PEDICLE FOLLOWING LAMINECTOMIES AT T1 AND T3. THE NAVIGATION LOOKED ACCURATE AND THE NEUROMONITORING SHOWED NO FURTHER SIGNAL CHANGES. FOLLOWING THE LAMINECTOMIES AND INSERTION OF THE FINAL LEFT T1 SCREW, A FINAL IMAGING SYSTEM SCAN WAS PERFORMED AND SHOWED THAT THE LEFT T5 AND LEFT T

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 TRANSTHORACIC ESOPHAGECTOMY WITH CHEST ANASTOMOSIS, THE WASHER ON THE END OF THE SYNCHROSEAL INSTRUMENT CAME OFF INSIDE OF THE PATIENT WHILE IN USE. THE PIECE WAS RETRIEVED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYNCHROSEAL INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO NOTED DAMAGE. THE SURGEON WAS UNCLAMPING TISSUE FOR DISSECTION/BURNING WHEN THE INCIDENT OCCURRED. THE INSTRUMENT WAS USED FOR APPROXIMATELY FIFTEEN MINUTES. THE SURGEON DID NOT NOTE ANY ISSUES WITH FUNCTIONALITY. THE SYNCHROSEAL DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIAL DURING THE SURGICAL PROCEDURE. THE ISSUE OCCURRED ON THE FIRST INSERTION OF THE INSTRUMENT. NO TESTS WERE PERFORMED TO CONFIRM PIECES AS ALL PARTS WERE VISUALIZED WHEN BROKE. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT.

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.

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 THE START OF A DA VINCI-ASSISTED SACROCOLPOPEXY WITH HYSTERECTOMY SURGICAL PROCEDURE, THE MONOPOLAR ENERGY WAS NOT AVAILABLE. THE CUSTOMER REPORTED THAT THEY REBOOTED THE ENERGY SHIELD AND THE SYSTEM AND ALL OF THE LED INDICATORS ON THE ENERGY SHIELD WERE BLUE AFTER THE REBOOT. HOWEVER, THE ISSUE RETURNED AND THE LED INDICATORS ON TEH ENERGY SHIELD FLASHED YELLOW AGAIN. THE CUSTOMER CONVERTED THE PROCEDURE TO LAPAROSCOPY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER TO CONFIRM THAT PORTS WERE PLACED WHEN THE ISSUE WAS IDENTIFIED. THE PORT INCISIONS WERE INCREASED AND/OR ADDITIONAL PORTS WERE PLACED DUE TO THE CONVERSION TO LAPAROSCOPIC PROCEDURE.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING REVIEW OF A LITERATURE ARTICLE INVOLVING DA VINCI-ASSISTED ROBOTIC PROCEDURES TITLED, ¿COMPARISON OF SURGICAL OUTCOMES OF ROBOTIC VERSUS CONVENTIONAL LAPAROSCOPIC HYSTERECTOMY OF LARGE UTERUS WITH GYNECOLOGIC BENIGN DISEASE¿ (JEONG, S.Y., ET AL., 2023) THE FOLLOWING EVENTS WERE REPORTED. AS PART OF A RETROSPECTIVE COHORT STUDY AT A SINGLE CENTER BETWEEN JANUARY 2014 AND JULY 2022, A TOTAL OF 397 PATIENTS (197 PATIENTS UNDERWENT ROBOTIC HYSTERECTOMY, 200 PATIENTS UNDERWENT CONVENTIONAL LAPAROSCOPIC HYSTERECTOMY) WHO UNDERWENT MINIMALLY INVASIVE HYSTERECTOMY FOR BENIGN DISEASES WITH UTERINE SIZE EXCEEDING 250G WERE ENROLLED. INTRA-OPERATIVELY, SIX PATIENTS RECEIVED BLOOD TRANSFUSIONS AND 4 PATIENTS HAD URETERAL INJURY. POST-OPERATIVELY, 101 PATIENTS EXPERIENCED URINARY RETENTION WITH CATHETERIZATION WERE CLASSIFIED AS CLAVIEN-DINDO GRADE 1. TRANSFUSION AND ANTIBIOTIC USE WERE CLASSIFIED AS CLAVIEN-DINDO GRADE 2 AND WERE SEEN IN 16 PATIENTS. TWO PATIENTS HAD CLAVIEN-DINDO GRADE 3 POST-OPERATIVE COMPLICATIONS, WITH NO FURTHER DETAILS. THERE IS NO INFORMATION REGARDING THE MEDICAL INTERVENTIONS THAT WERE PERFORMED. INTUITIVE SURGICAL, INC, (ISI) MADE FOLLOW-UP ATTEMPTS TO OBTAIN

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 01-MAY-2023, INTUITIVE SURGICAL BECAME AWARE OF A SURGICAL TECHNIQUES IN UROLOGY ARTICLE TITLED, ¿TRANSVESICAL PERCUTANEOUS ACCESS ALLOWS FOR EPIDURAL ANESTHESIA WITHOUT MECHANICAL VENTILATION IN SINGLE-PORT ROBOTIC RADICAL AND SIMPLE PROSTATECTOMY¿ (KAOUK, J., ET AL., 2023). WITHIN THE JOURNAL ARTICLE, AN OPERATIVE COMPLICATION INVOLVING A DA VINCI SURGICAL PROCEDURE WAS NOTED. A TOTAL OF 12 PATIENTS WERE SELECTED TO UNDERGO EPIDURAL PLACEMENT PRIOR TO SINGLE PORT TRANSVESICAL SIMPLE PROSTATECTOMY OR RADICAL PROSTATECTOMY FROM JULY 2022 TO OCTOBER 2022. ALL CASES WERE COMPLETED WITHOUT EXTRA PORTS, OPEN CONVERSION OR CONVERSION TO GENERAL ANESTHESIA. NO ANESTHETIC COMPLICATIONS WERE NOTED. NO PATIENTS REQUIRED OPIOID PAIN MEDICATIONS AFTER DISCHARGE AND ALL PATIENTS WITH AN OUTPATIENT ENCOUNTER WERE DISCHARGED ON THE SAME DAY OF THE PROCEDURE. ONE PATIENT WAS A PRE-PLANNED ADMISSION GIVEN UNDERLYING COMORBIDITES AND WAS OBSERVED POSTOPERATIVELY WITHOUT COMPLICATIONS. THERE WAS ONE POST-OPERATIVE COMPLICATION REQUIRING READMISSION, WHICH WAS A PELVIC DRAIN PLACEMENT FOR ANASTOMOTIC LEAK AFTER SP TRANSVESICAL RADICAL PROSTATECTOMY (CLAVIEN-DINDO 3A)AND RESOLVED BY TEMPORARY DRAIN

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT WAS NOTICED TO BE BROKEN. THE FRACTURED PART FELL INSIDE THE PATIENT BUT WAS RETRIEVED AND REMOVED DURING THE SAME PROCEDURE. THE CUSTOMER USED A SPARE INSTRUMENT TO PROCEED WITH THE PROCEDURE. THE PROCEDURE WAS COMPLETED ROBOTICALLY.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT WAS NOTICED TO HAVE THE HEAD BROKEN. THE FRACTURED PART HAD BEEN COMPLETELY REMOVED AND NO FRAGMENT REMAINED IN THE PATIENT. THE CUSTOMER USED A SPARE INSTRUMENT TO PROCEED WITH THE PROCEDURE. A FRAGMENT FELL INTO THE PATIENT AND WAS RETRIEVED IN THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED.

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 27-APR-2023, INTUITIVE SURGICAL BECAME AWARE OF A JOURNAL OF HERNIA ARTICLE TITLED, "IMPACT OF COVID-19 ON CLINICAL OUTCOMES OF ROBOTIC INGUINAL HERNIA REPAIR¿ (KUDSI, O.Y., ET AL., 2023)." WITHIN THE JOURNAL ARTICLE, OPERATIVE COMPLICATIONS INVOLVING DA VINCI SURGICAL PROCEDURES WERE MENTIONED. PATIENTS WHO UNDERWENT ROBOTIC INGUINAL HERNIA REPAIR (RIHR) 2 YEARS BEFORE AND AFTER 10-MAR-2020 WERE INCLUDED IN THE RETROSPECTIVE STUDY. A TOTAL OF 321 PATIENTS UNDERWENT RIHR DURING THE STUDY PERIOD, WITH 183 (57%) PATIENTS IN THE PRE-COVID GROUP AND 138 (43%) IN THE POST-COVID GROUP. ONE PATIENT WITH A HISTORY OF PREVIOUS OPEN IHR IN THE PRE-COVID GROUP SUFFERED FROM INTRAOPERATIVE BLEEDING SECONDARY TO INFERIOR EPI-GASTRIC VESSEL INJURY DURING PRE-PERITONEAL DISSECTION DUE TO EXTENSIVE ADHESIONS. THE BLEEDING WAS CONTROLLED WITH CLIPS. IN THE POST-COVID GROUP, ONLY ONE PATIENT EXPERIENCED AN INTRAOPERATIVE COMPLICATION DUE TO A PRIOR HISTORY OF BLADDER SURGERY AND POSTERIOR REPAIR. CONSEQUENTLY, THE BLADDER WAS INJURED DURING DISSECTION OF AN ANATOMICALLY DISTORTED PRE-PERITONEAL PLANE AND WAS EVENTUALLY REPAIRED WITH SUPERFICIAL SUTURES. EIGHT PATIENTS (4.4%) REQUIRED AN EMERGENCY

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT TIP BROKE AND FELL INTO THE PATIENT. THIS HAPPENED TWICE IN THE SAME PROCEDURE. THE FRAGMENT WAS RETRIEVED DURING THE SAME SURGICAL PROCEDURE. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON 27-APR-2023, JOURNAL OF ROBOTIC SURGERY ARTICLE TITLED, ¿COMPARATIVE STUDY OF SUPRACERVICAL HYSTERECTOMY BETWEEN DA VINCI SP ® SURGICAL SYSTEM AND CONVENTIONAL SINGLE SITE LAPAROSCOPY FOR UTERINE FIBROID: SINGLE CENTER EXPERIENCES¿ (LEE, J., HONG, D.G., 2023). WITHIN THE JOURNAL ARTICLE, IT WAS MENTIONED 31 PATIENTS UNDERWENT SUPRACERVICAL HYPSTERECTOMY WITH THE DA VINCI SP SURGICAL SYSTEM FOR UTERINE FIBROID BETWEEN JUNE 2018 AND APRIL 2021. OF THE 31 PATIENTS, THERE WERE 2 (6.4%) OPERATIVE COMPLICATIONS. ONE WAS VAGINAL WALL PERFORATION DURING DISSECTION, THE SURGEON SUTURED IMMEDIATELY AND THERE WAS NO REPORTED HEMORRHAGE OR INFECTION. THE OTHER COMPLICATION WAS A MASSIVE HEMORRHAGE FROM THE PRESERVED UTERINE CERVIX, WHICH WAS TREATED WITH EMERGENT TRANSVAGINAL CERVICECTOMY. A LONGER OPERATION TIME AND HIGHER LEVELS OF C-REACTIVE PROTEIN (CRP) WERE FOUND IN THE ROBOTIC SURGICAL GROUP, NO SIGNIFICANT DIFFERENCES WERE FOUND IN OTHER SURGICAL OUTCOMES SUCH AS COMPLICATION RATES AND HOSPITAL STAYS. THE ARTICLE AUTHOR THOUGHT THE REASONS FOR THE SIGNIFICANTLY HIGHER CRP LEVELS WERE DUE TO UMBILICAL INCISION WAS LARGER IN ROBOTIC SURGERY WHICH WAS 0.5-1CM LONGER THAN SINGLE SITE LA

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.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY (WITH LYMPHADENECTOMY) SURGICAL PROCEDURE, THE SILICONE PIECE (SHEATH) ON THE SYNCHROSEAL INSTRUMENT BROKE/TORE DURING INTRAOPERATIVE USE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER STATED THAT THE SURGEON WAS ABLE TO VISUALIZE THAT THE INSTRUMENT SHEATH WAS TORN AT THE INSTRUMENT WRIST TOWARDS THE END OF THE PROCEDURE, BUT CHOSE TO FINISH THE PROCEDURE WITHOUT SWITCHING INSTRUMENTS. THE INSTRUMENT SHEATH APPEARED TORN OR SEPARATED, BUT THERE WERE NO FRAGMENTS OBVIOUSLY MISSING AND NO FRAGMENTS WERE NOTICED IN THE PATIENT'S BODY. THE SURGEON DID NOT REPORT ANY INSTRUMENT COLLISIONS OR OTHER INSTRUMENT DAMAGE DURING THE PROCEDURE. THE INSTRUMENT WAS ABLE TO BE REMOVED EASILY FROM THE CANNULA WITHOUT ANY STICKING OR RESISTANCE. WHEN THE INSTRUMENT WAS REMOVED, AN OR STAFF MEMBER PUSHED THE TORN INSTRUMENT SHEATH TOGETHER AND SAID THAT THE PIECES ALIGNED PERFECTLY WITH NO FRAGMENTS MISSING. AN X-RAY WAS PERFORMED TO LOCATE FOR A POSSIBLE FALLEN PIECE AND CONFIRM THAT NO FRAGM

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT AFTER INSERTION OF THE PEDICLE SCREWS, IT WAS CONFIRMED THAT T9 LEFT, T5 RIGHT, AND T6 RIGHT WERE DEVIATED FROM THE SPINAL CANAL. THE DEVIATION WAS APPROXIMATELY 3 TO 4MM. THE SCREWS WERE REMOVED. THE PATIENT EXPERIENCED PARALYSIS OF THE RIGHT LOWER LIMB. THE PARALYSIS WAS NOT TRANSIENT. THE PHYSICIAN FELT THAT THE SYMPTOMS WOULD RECOVER TO A CERTAIN EXTENT, BUT WILL NOT COMPLETELY RECOVER. THE CASE WAS COMPLETED WITH FREE HAND. THE SURGEON FELT THAT THE PARALYSIS WAS A RESULT OF THE MALFUNCTION AND THE GUIDANCE SYSTEM. THE PROCEDURE WAS DELAYED LESS THAN AN HOUR.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: 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: 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.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL CYSTECTOMY SURGICAL PROCEDURE, THE PACKING RING SIDE SCREWS FROM THE JAW COVER OF THE SYNCHROSEAL INSTRUMENT FELL OUT AND INTO THE PATIENT. THE FRAGMENT WAS REMOVED DURING THE SAME SURGERY. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: IT WAS CONFIRMED THAT THE INSTRUMENT WAS INSPECTED PRIOR TO USE. THERE WAS NO DAMAGE OR ANYTHING OUT OF THE ORDINARY, NOTHING EXTRAORDINARY WAS FOUND. THE SURGICAL TASK THAT WAS BEING PERFORMED WHEN THE DEVICE FRAGMENT FELL INSIDE THE PATIENT WAS "GRASPING TISSUE". THE SURGEON DOES NOT KNOW WHAT CAUSED THE INSTRUMENT / ACCESSORY TO BREAK OR CAUSED THE FRAGMENT FALLING ISSUE. PRIOR TO THE ISSUE, THE INSTRUMENT WAS IN USE FOR APPROXIMATELY HALF AN HOUR. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE SURGICAL PROCEDURE AND THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIAL DURING THE SURGICAL PROCEDURE. THE INSTRUMENT WAS NOT REMOVED DURING THE PROCEDURE PRIOR TO THE BREAKAGE. UPON FINAL REM

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THE SCREW PLACED IN L2 RIGHT WAS LATERAL AND LOW. THIS WAS THE LAST SCREW PLACED, AND SOFT TISSUE PRESSURE OCCURRED. THE SITE WAS UNABLE TO GET THE CANNULA IN, SO THE SURGEON HAD TO ADJUSTED THE TRAJECTORY TO HAVE MORE OF A SKIVE POTENTIAL. THE SCREW DID NOT GO INTO THE HOLE MADE WITH THE DRILL. IT WAS HARD TO REMOVE THE SCREWDRIVER, AND WHEN PULLED OUT THE ARM STATED IT WAS OFF TRAJECTORY. THE SURGEON MOVED FORWARD, AND THE FINAL X-RAY CONFIRMED THE FINAL SCREW WAS OFF. PATIENT COMPLAINT CAME FORWARD. A REVISION SURGERY IS NEEDED IN THE FUTURE. THE PROCEDURE WAS DELAYED BY LESS THAN AN HOUR. THE PATIENT EXPERIENCED LEG PAIN. THE DEVIATION WAS LESS THAN 3.5 MM. THE GUIDANCE SYSTEM WAS ACCURATE, BUT THE SCREW SKIVED.

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.

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 PULMONARY RIGHT UPPER LOBECTOMY FOR NON-SMALL CELL LUNG ADENOCARCINOMA ON (B)(6) 2023 AS PART OF THE SP THORACIC IDE STUDY. THE PATIENT WAS REPORTED HAVING AIR LEAKAGE AND A 20 FRENCH CHEST TUBE WAS REQUIRED ON (B)(6) 2023. THE PATIENT WAS TRANSFERRED TO ICU FOR 91 HOURS. THE CHEST TUBE WAS REMOVED ON (B)(6) 2023, AND THE PATIENT WAS DISCHARGED THE SAME DAY. THERE WAS NO REPORT OF MALFUNCTIONS OF DA VINCI DEVICES DURING THE PROCEDURE. IT WAS PROVIDED THAT A NON-ISI STAPLER INSTRUMENT WAS USED DURING THE SURGERY. THE STUDY INVESTIGATOR ASSESSED THE EVENT AS RELATED TO THE DA-VINCI ASSISTED PROCEDURE BUT NOT RELATED TO THE USE OF DV SYSTEMS, INSTRUMENTS OR ACCESSORIES.

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

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THE PATIENT UNDERWENT THE PROCEDURE TO ADDRESS THEIR LUMBAR SPINE, AS THEY WERE EXPERIENCING PAIN AND SYMPTOMS RADIATING INTO THE LEFT HIP, GROIN, AND BUTTOCKS. DURING THE PROCEDURE, AFTER SCREWS WERE PLACED, AND PRIOR TO DECOMPRESSION, THE PATIENT LOST VIRTUALLY ALL MOTOR FUNCTION OF HER RIGHT LOWER EXTREMITY AND IN OTHER NERVE DISTRIBUTIONS. THE PROCEDURE WAS CONTINUED AND COMPLETED WITHOUT ADDRESSING THE LOSS IN MOTOR FUNCTION, AND THE PHYSICIAN INDICATED THE CASE WAS COMPLETED WITHOUT COMPLICATION. POST-OPERATIVELY, THE PATIENT REPORTED THAT THEY WERE UNABLE TO MOVE THEIR RIGHT LOWER EXTREMITY. A SECOND PROCEDURE WAS PERFORMED THE FOLLOWING DAY, WITH NO INDICATION OF US OF THE GUIDANCE SYSTEM, TO REMOVE OLD HARDWARE THAT WAS PRESENT PRIOR TO THE INITIAL PROCEDURE. THE PHYSICIAN PERFORMED A REVISION OF THEIR DECOMPRESSION, AND NOTED A LARGE DURAL DEFECT ON THE RIGHT, WHICH WAS REPAIRED THROUGH THE USE OF SUTURES, A TACHOSIL PATCH, AND SURGICAL GLUE. THE SURGEON DOCUMENTED THAT THE REMOVAL OF THE OLD HARDWARE CREATED THE DURAL DEFECT AND FLUID LEAK. AFTER THE SECO

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

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.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THERE WAS AN ALLEGED INACCURACY DURING A CASE. THE SCOPE OF THE CASE WAS FROM T5 TO T10, BUT T7 WAS SKIPPED. THE PATIENT WAS IN A PRIOR EVENT THAT CAUSED A COMPLETE SPINAL SEPARATION AT T7 CAUSING THE PATIENT TO BE PERMANENTLY PARALYZED. THE SURGEON HAS STATED THAT THERE WAS NOTHING THAT COULD HAVE BEEN DONE TO RECOVER THE PATIENT'S CURRENT SPINAL STATE. THE CASE WAS A SCAN AND PLAN PROCEDURE. THE SURGEON PLACED ALL THE SCREWS ON THE RIGHT AND LEFT SIDES FROM T5 TO T10 AND WAS ABOUT TO CONFIRM PLACEMENT. HOWEVER, AFTER TAKING THE AP SCOUT SHOT, THE SURGEON IMMEDIATELY DETERMINED THAT ALL OF THE SCREWS WERE NOT ACCORDING TO PLAN. ALL LEFT SCREWS WERE LATERAL AND THE RIGHT SCREWS WERE MEDIAL. SOME WERE WORSE THAN OTHERS. THE SURGEON ONLY USED THE AP SHOT TO DETERMINE THAT THE SCREWS WERE OFF. THE MANUFACTURER REPRESENTATIVE STATED THAT SOME SCREWS WENT STRAIGHT INTO THE SPINAL CORD CANAL. THE REPRESENTATIVE FELT THAT THEY HAD KEPT CLOSE ATTENTION TO THE ENTIRE CASE AND THAT EVERYTHING WAS PERFECT. THE SURGEON DECIDED TO REPLACE ALL SCREWS USING NAVIGATION. ONCE THEY C

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

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING THE PROCEDURE IT WAS FOUND THAT THE PATIENT HAD DEVELOPED BRONCHIECTASIS WHICH HAD NOT APPEARED IN PRE-OPERATIVE SCANS. APPROXIMATELY ONE TO TWO DAYS AFTER THE PROCEDURE, THE PATIENT DEVELOPED SEPSIS AND WAS ADMITTED TO THE HOSPITAL FOR FOUR DAYS AND TREATED WITH ANTIBIOTICS. THE PATIENT¿S LUNG BIOPSIES WERE FOUND TO BE CANCEROUS, AND A SURGICAL LUNG RESECTION WAS PERFORMED. THE LUNG RESECTION ALSO REMOVED THE BRONCHIECTASIS.