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.

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...

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.

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.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT THE TRAJECTORIES WERE DEVIATED LESS THAN 3.5MM.

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: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE HEAD OF A HARMONIC ACE INSTRUMENT BROKE. THE FRACTURED PART WAS COMPLETELY REMOVED DURING THE SAME PROCEDURE, AND NO FRAGMENT REMAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: ALL THE FRAGMENTS WERE RETRIEVED THROUGH THE ASSISTANT PORT AND WAS CONFIRMED USING THE CAMERA. THERE WAS NO ADDITIONAL SURGICAL PROCEDURE REQUIRED TO REMOVE THE FRAGMENT. NO POST-OPERATIVE TESTS WERE PERFORMED AND THE PIECE WAS CONFIRMED TO BE REMOVED BY USING THE ENDOSCOPE. THE SURGEON BELIEVES THE BREAK WAS CAUSED BY A PRODUCT QUALITY PROBLEM. THE INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO DAMAGE NOTED. THE INSTRUMENT BROKE 5 MINUTES AFTER USE. THERE WAS NO ISSUE WITH THE INSTRUMENT FUNCTIONALITY. THERE WAS NO INSTRUMENT COLLISION. THE INSTRUMENT WAS NOT REMOVED PRIOR TO BREAKAGE AND THERE WAS NO DAMAGE OR RESISTANCE TO THE CANNULA WHEN REMOVING THE INSTRUMENT.

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 LOBECTOMY WITH MEDIASTINAL LYMPHADENECTOMY FOR AN ADENOCARCINOMA OF THE PERIPHERAL UPPER LOBE OF LEFT LUNG (STAGED CLINICALLY T2A, N0, M0) ON (B)(6) 2023 AS PART OF THE SP THORACIC IDE STUDY. POST-OPERATIVELY, THE PATIENT WAS FOUND WITH INCREASED LEFT APICAL PNEUMOTHORAX. FLEXIBLE BRONCHOSCOPY WITH BALLOON OCCLUSION AND INSERTION OF BRONCHIAL VALVE WERE PERFORMED ON (B)(6) 2023. THE PATIENT WAS DISCHARGED ON (B)(6) 2023 WITH MINI ATRIUM ON. ADDITIONAL INFORMATION WAS OBTAINED FROM THE OPERATIVE NOTES, AND IT INDICATED A 5CM INCISION WAS MADE IN THE LEFT SUBCOSTAL REGION WITH THE POSTERIOR END OF THE INCISION AT APPROXIMATELY THE EIGHTH RIB. THE FLEXIBLE CAMERA WAS FIRST PLACED FOLLOWED BY A MARYLAND BIPOLAR FORCEPS INSTRUMENT AND A FENESTRATED BIPOLAR FORCEPS AND A ROUND TOOTH RETRACTOR INSTRUMENT. THE MASS WAS IN THE APICOPOSTERIOR SEGMENT AND THIS AREA WAS ADHERENT TO THE APICAL PARIETAL PLEURA. DISSECTION BEGAN BY RETRACTING THE LUNG POSTERIORLY AND ISOLATING THE SUPERIOR PULMONARY VEINS. THESE WERE DIVIDED WITH SERIAL APPLICATIONS OF A LINEAR STAPLER (NON- INTUITIVE SURGICAL, INC. (ISI) STAPLER INSTRUMENT) U

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 RIGHT UPPER LOBECTOMY PROCEDURE FOR NON-SMALL CELL ADENOCARCINOMA ON (B)(6) 2023 AS PART OF THE SP THORACIC IDE STUDY. THE PATIENT WAS REPORTED AS HAVING AIR LEAKAGE WHICH WAS IDENTIFIED BY THORAGUARD DRAINAGE SYSTEM THAT MEASURES AIR LEAK RATE DIGITALLY. THE PATIENT DID NOT PRESENT WITH ANY SYMPTOMS ASSOCIATED WITH THE AIR LEAKAGE. A CHEST TUBE WAS PLACED IN POST-OPERATIVELY PER STANDARD PROTOCOL, BUT THE DURATION OF INSERTION WAS PROLONGED DUE TO THE AIR LEAK. NO OTHER MEDICAL INTERVENTION WAS PERFORMED. THE PATIENT WAS DISCHARGED HOME WITH CHEST TUBE IN PLACE, AND THE CHEST TUBE WAS REMOVED ON (B)(6) 2023 DURING AN OUTPATIENT VISIT. THERE WAS NO REPORT OF MALFUNCTIONS OF ISI SYSTEMS, INSTRUMENTS OR ACCESSORIES. THE STUDY INVESTIGATOR BELIEVED THE CAUSE OF THE AIR LEAK WAS DUE TO EXTENSIVE INTRA-PLEURA LYSIS OF ADHESIONS, AND NOT RELATED TO THE SINGLE PORT DA VINCI DEVICES.

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

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 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.