ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: L3-S2AI FUSION - REVISION OF PREVIOUS FUSION. EGPS 1.4 SOFTWARE. INSTRUMENTS VERIFIED, ARM AND MONITOR DRAPED PRIOR TO CASE START. SCREWS PLANNED BY DR. (B)(6) BEFORE PATIENT ENTERED THE ROOM. EGPS POSITIONED ON THE SAME SIDE AS OR DOOR AND OPPOSITE DR. (B)(6). EGPS AT THE HEAD OF THE BED AND OPPOSITE SAM, THE SCRUB TECH, AND IMPLANT/INSTRUMENT TRAYS. C-ARM #8 USED FOR THE CASE. IT IS THE ONLY FUNCTIONING C-ARM AT THE ACCOUNT. THE DRB WAS PLACED IN THE RIGHT PSIS VIA THE LONG QUATTRO SPIKE AND SM PLACED IN THE OPPOSITE PSIS. DR. (B)(6) PLACED BOTH WITHIN HIS OPEN INCISION BY DISSECTING THE SKIN FROM THE FASCIA.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: 1-ROBOT WILL NOT HOLD A CHARGE OR STAY CHARGED, WHEN UNPLUGGED FROM THE WALL IT IMMEDIATELY DIES, POWERS DOWN.

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 CHOLECYSTECTOMY SURGICAL PROCEDURE, A RUBBER PIECE FROM A CANNULA SEAL BROKE OFF AND FELL INSIDE THE PATIENT. THE CUSTOMER WAS ABLE TO RETRIEVE THE BROKEN PIECE FROM THE PATIENT¿S ANATOMY DURING THE SAME PROCEDURE. THERE WAS NO PATIENT INJURY. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE ROBOTICS COORDINATOR AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CANNULA SEAL DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR HARD MATERIAL. THE FRAGMENT WAS RETRIEVED BY A GRASPER. ALL FRAGMENTS WERE CONFIRMED TO BE RETRIEVED FROM THE PATIENT DURING THE PROCEDURE USING A GRASPER INSTRUMENT. THERE WAS NO ADDITIONAL SURGICAL PROCEDURE REQUIRED TO REMOVE THE FRAGMENT. NO POST-OPERATIVE TESTS WERE PERFORMED. THERE WAS NO PATIENT INJURY. THE PATIENT DID NOT RETURN TO THE HOSPITAL FOR ANY POST-SURGICAL COMPLICATIONS. THE CANNULA SEAL WILL NOT BE RETURNED. THE PROCEDURE WAS DELAYED ABOUT FIVE MINUTES.

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 DURING A MONARCH BRONCHOSCOPY PROCEDURE, A RECURRENT ELECTROMAGNETIC (EM) NAVIGATION FAULT OCCURRED AT SYSTEM REGISTRATION. THE PHYSICIAN ELECTED TO ABORT THE DIAGNOSTIC PROCEDURE. NO CLINICAL CONSEQUENCES TO THE PATIENT WERE REPORTED DUE TO THIS EVENT.

Aiper Elite Pro Cordless Robotic Pool Vacuum Cleaners Recalled Due to Burn and Fire Hazards; Distributed by Shenzhen Aiper Intelligent Co. (Recall Alert) — Hazard: When the charging cord is plugged into the device without the adapter and/or directly into the charging port on the machine, the battery can overheat and short circuit, posing burn and fire hazards. Reported incidents: The firm has received 17 reports of the recalled pool vacuums overheating including one report of a minor burn to a consumer's fingertip, which did not require medical treatment. No property damage has been reported.

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 LOW ANTERIOR RESECTION SURGICAL PROCEDURE, THE CUSTOMER OBSERVED THAT THE SYNCHROSEAL INSTRUMENT HAD PARTS THAT WERE FALLING OFF FROM THE HINGES. IT WAS NOTED THAT FRAGMENTS FELL INSIDE THE PATIENT AND WERE RETRIEVED IN THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYNCHROSEAL INSTRUMENT WAS INSPECTED PRIOR TO USE AND THERE WERE NO ABNORMALITIES FOUND. AT THE TIME OF THE REPORTED EVENT OF THE FRAGMENT FALLING INSIDE THE PATIENT, THE SURGICAL TASK THAT WAS BEING PERFORMED WAS DISSECTING AND GRASPING. THE FRAGMENT(S) WERE ABLE TO BE REMOVED BY USING "LAPALO FORCEPS" BY THE ASSISTANT DOCTOR, AND ALL FRAGMENTS WERE CONFIRMED TO HAVE BEEN REMOVED FROM THE BODY. POST-OPERATIVE X-RAYS WERE CONDUCTED TO CHECK FOR REMAINING FRAGMENTS. THE SURGEON COMMENTED THAT A SIMILAR PHENOMENON HAD OCCASIONALLY OCCURRED WITH A THIRD COMPANY'S PRODUCTS. THE SURGEON DID NOT NOTICE ISSUES WITH THE FUNCTIONALITY OF THE SYNCHROSEAL. THERE WAS NO INSTRUMENT COLLISION WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIAL DURING THE S

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: UPON REVIEW OF THE POST-OP O-ARM 2 SPIN, IT WAS OBSERVED THAT THE L4L SCREW MISSED PLAN LATERALLY. THE L4L SCREW WAS THEN REPLANNED, REINSTRUMENTED, AND A POST-OP SPIN SHOWED IT ACCURATELY PLACED TO PLAN. DR.(B)(6) IS ASKING FOR GUIDANCE AS TO THE LIKELY CAUSE OF THE LATERAL MISPLACED SCREW.

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 REGISTRATION WAS HAVING ISSUES. THE SITE WAS WORKING ON L2-S1, WHEN THEY TRIED TO LABEL L3 IN THE OBLIQUE, IT WOULD LABEL L3 IN THE AP, BUT APPEARED TO ACTUALLY BE ON L2. THE SYSTEM GAVE A CROSSVIEW ERROR. THE SURGERY WAS ABORTED. THERE WAS NO PATIENT HARM AND THE PROCEDURE WAS DELAYED LESS THAN ONE HOUR. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PATIENT EXPERIENCED AN INCREASE IN BLOOD LOSS.

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 SYSTEM HAD AN ERROR 316. THE CUSTOMER DID NOT MANAGE TO CALL TECHNICAL SUPPORT AND AFTER SEVERAL TRIES, THE CUSTOMER DECIDED TO CONVERT THE PROCEDURE TO LAPAROSCOPIC SURGERY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PROCEDURE WAS CONVERTED TO TRADITIONAL LAPAROSCOPIC APPROACH BECAUSE THE SYSTEM ISSUE COULD NOT BE SOLVED IN 30 - 40 MINUTES AND THE SURGEON HAD A BUSY SCHEDULE AFTER, THE CUSTOMER COULD NOT WAIT MORE TIME. THE SURGERY WAS PERFORMED LAPAROSCOPICALLY. AN INCISION WAS MADE TO EXTRACT THE SPECIMEN AND TO PERFORM AN EXTRA CORPORAL ANASTOMOSIS (AS THE SURGEON USUALLY DOES IN LAPAROSCOPY). BUT IF THE SURGERY WERE PERFORMED ROBOTICALLY, THE SURGEON WOULD HAVE PROBABLY PERFORMED AN INTRACORPORAL ANASTOMOSIS, AND MAKE A SMALL INCISION TO EXTRACT THE SPECIMEN. THE ISSUE WAS NOT SOLVED WHEN THE SURGEON PLACED THE ROBOTIC CANNULAS IN THE PATIENT. THE EVENT OCCURRED AFTER INCISION AND PORT PLACEMENT. NO OTHER SURGICAL TASKS PERFORMED BEFORE THE SYSTEM ISSUE. THE CUSTOMER NOTED THAT THE OPERATION WAS PROLONGED FOR AROUND 30 MINUTES

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 HYSTERECTOMY SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT SUDDENLY WAS NOT RECOGNIZED AND A "RELEASE THE PRESSURE" ERROR MESSAGE WAS DISPLAYED. AFTER REMOVING THE HARMONIC ACE INSTRUMENT, THE INSTRUMENT BLADE WAS FOUND TO BE BROKEN AND HAD FALLEN INSIDE THE PATIENT'S CAVITY. THE BROKEN OFF BLADE WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A BACKUP INSTRUMENT OF SAME KIND. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: DURING THE PROCEDURE, THE INSTRUMENT BLADE BROKE AND FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. ALL FRAGMENT(S) WERE CONFIRMED TO HAVE BEEN RETRIEVED VIA A VISUAL INSPECTION. ADDITIONAL SURGICAL PROCEDURES OR POST-OPERATIVE TESTS WERE NOT PERFORMED. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE PROCEDURE. IT WAS UNKNOWN HOW LONG THE INSTRUMENT WAS USED PRIOR TO THE ISSUE BUT THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIAL DURING USE. UPON FINAL REMOVAL OF THE INSTRUMENT, THE WRIST WAS STRAIGHTENED,

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE NAVIGATION WAS OFF DURING SURGERY AND SOME SCREWS WERE MISPLACED.

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 MOUTH OF THE HARMONIC ACE INSTRUMENT BROKE. A FRAGMENT FROM THE INSTRUMENT FELL INSIDE OF THE PATIENT BUT WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED USING A BACKUP HARMONIC ACE INSTRUMENT. THERE WAS NO REPORTED INJURY. INTUITIVE SURGICAL INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION ABOUT THE EVENT. THE SURGEON AND ASSISTANT REMOVED THE INSTRUMENT FRAGMENT WITH THE USE OF AN ENDOSCOPE. THERE WERE NO ADDITIONAL PROCEDURES OR POST-OPERATIVE TESTS PERFORMED. THE SURGEON BELIEVES THE ISSUE WAS DUE TO AN INSTRUMENT QUALITY PROBLEM. THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND NO DAMAGE WAS DETECTED. THERE WAS NO PATIENT INJURY.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING AN INTRA-OP L5-S2A1 REVISION CASE, AFTER AN O-ARM SPIN WAS PERFORMED AND WHEN ATTEMPTING TO TRANSFER THE SCAN TO THE ROBOT, THE SYSTEM WAS STUCK ON THE UPLOADING SCREEN AND WOULD NOT PROCEED OR RESPOND TO ANY INPUTS. THE SYSTEM WAS THEN SHUTDOWN, THE CASE RE-OPENED AND THE LIFESAVER BUTTON WAS PRESSED, AND A NEW SNAPSHOT WAS TAKEN AS NOTHING HAD MOVED ON THE TABLE. THE INITIAL SCAN WAS DELETED OFF THE ROBOT AND THE SAME SCAN FROM THE O-ARM WAS UPLOADED UNDER A DIFFERENT FILE NAME. AFTER THE NEW SCAN WAS TRANSFERRED TO THE ROBOT VIA USB, THE SAME ISSUE PERSISTED WHERE IT WOULD GET STUCK ON THE UPLOADING SCREEN. AT THIS POINT, THE SURGEON DECIDED TO ABORT ROBOTIC NAVIGATION AND PROCEED WITH THE CASE USING FLUORO.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THERE WAS AN INCIDENT DURING A CASE AT CONWAY MEDICAL CENTER YESTERDAY WHERE EGPS PLACED TWO SCREWS AT L3 USING E3D AND INTRAOPERATIVE WORKFLOW. BOTH SCREWS GOT A CHECK MARK ON THE ROBOT WHEN THEY WERE PLACED, BUT THE LEFT SCREW WAS SIGNIFICANTLY LATERAL TO THE PLAN AND THE RIGHT SCREW WAS SLIGHTLY INFERIOR. I'M NOT SURE IF THE LEFT SCREW WAS INFERIOR AS WELL BECAUSE IT WAS REMOVED BEFORE A LATERAL XRAY WAS TAKEN. THE LOCAL TEAM WANTED AN EEF FILED TO CHECK FOR ACCURACY ON THE SYSTEM AND THE CAMERA CALIBRATION. AFTER THE LEFT SCREW WAS REMOVED, WE DID A BAILOUT TO 2D NAVIGATION WITH E3D. THE SCREW FOLLOWED THE ORIGINAL SCREWS TRAJECTORY, WHICH WAS VISIBLE ON EGPS, AND THE SURGEON DECIDED TO BAIL ON NAVIGATION AND PLACE THE SCREW USING A K-WIRE AND FLUORO IMAGING. THE LOCAL TEAM ALSO WANTED TO NOTE THAT THE OFFSET METER HAS BEEN MUCH MORE SENSITIVE SINCE THE UPGRADE TO THE POINT WHERE IT'S ALMOST ALWAYS HIGH AND THEY ARE CONSISTENTLY LOSING THE GREEN BORDERS EVEN WHEN THE SCREW IS BEING PLACED ACCURATELY.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING A SINGLE POSITION LATERAL CASE (L2-L5 PRE-OP WORKFLOW WITH E3D), MERGE WAS UNSUCCESSFUL MULTIPLE TIMES LEADING TO AN ABORTED CASE. DURING THE FIRST ATTEMPT, CENTROIDS APPEARED LATERAL THE ON THE MERGE ITSELF IN THE A/P VIEW. THE CENTROIDS WERE NOT EVEN REMOTELY CLOSE TO THEIR CORRESPONDING VERTEBRAE. NEW IMAGES WERE TAKEN, LEVELS WERE CHECKED AND CONFIRMED TO BE CORRECT BY USING THE SACRUM AS A GUIDE, AND CENTROIDS WERE CONFIRMED TO BE PLACED IN THE CENTER OF THE VERTEBRAE AS THEY ARE SUPPOSED TO BE. THE SECOND ATTEMPT OF THE MERGE WITH ADDITIONAL IMAGES TAKEN SHOWED THE CENTROIDS TO BE CENTERED, BUT THE SPINAL COLUMN APPEARED TO BE INVERTING/MOVING QUITE A BIT. A THIRD ATTEMPT WAS DONE WITH COMPLETELY NEW IMAGING, BUT AGAIN WAS UNSUCCESSFUL. WE BELIEVE THERE IS AN ISSUE WITH MERGING IMAGES TAKEN BY THE E3D TO A CT COMPLETED OUTSIDE THE HOSPITAL BEFORE THE CASE STARTED. WE ARE UNSURE WHY THE CENTROIDS WERE NOT CENTERED ON THE FIRST IMAGE, AND ALSO UNSURE BY THERE WAS SO MUCH MOVEMENT OF THE VERTEBRAE WHEN NEW IMAGING WAS DONE.

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 WHEN THE SURGEON MOVED THE MONOPOLAR CURVED SCISSORS (MCS), THE MCS TIP COVER ACCESSORY FELL OFF OF THE SCISSORS. THE MCS TIP COVER WAS RETRIEVED AND REMOVED FROM INSIDE THE PATIENT. A NEW MCS TIP COVER WAS PLACED ON THE MCS INSTRUMENT, AND NO OTHER PROBLEMS WERE IDENTIFIED. THE PROCEDURE WAS COMPLETED.INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED: THE MCS TIP COVER ACCESSORY WAS INSPECTED PRIOR TO USE, NO APPARENT DAMAGE WAS FOUND. THE BEDSIDE ASSISTANT USED A LAPAROSCOPIC GRASPER WHILE THE SURGEON USED HIS GRASPER TO HELP BRING IT WITHIN THE ASSISTANT'S REACH. DISSECTION WAS BEING PERFORMED WHEN THE MCS TIP COVER ACCESSORY FELL INSIDE THE PATIENT. NO FUNCTIONALITY ISSUES WERE FOUND. THE MCS INSTRUMENT DID NOT HAVE ANY COLLISIONS. A REDUCER WAS NOT USED. THERE WAS NO DIFFICULTY IN REMOVING THE MCS, OR THE TIP COVER. THE INSTRUMENT WRIST WAS STRAIGHTENED UPON REMOVAL. TINY HOLES WERE FOUND IN THE TIP COVER AFTER IT WAS REMOVED. THE INSTRUMENT WAS IN USE FOR APPROXIMATELY 30-45 MINUTES. ANOTHER TIP COVER WAS PLACED ON THE SCISSORS INSTRUMENT

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING A ROBOTIC PROCEDURE, THE SYSTEM BEGAN LAGGING CAUSING NAVIGATION TO BECOME SLOW AND CHOPPY. THE FIRST TIME, A HARD SHUTDOWN RESOLVED THE ISSUE. THE FIRST STAGE OF THE PROCEDURE WHICH WAS INTRA-OP WORKFLOW. NEAR THE END OF THE SECOND PORTION OF THE PROCEDURE, THE SOFTWARE BEGAN TO LAG AGAIN RESULTING IN THE SURGEON BAILING ON THE ROBOT TO COMPLETE THE CASE WITH FLUOROSCOPY.

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 SCREW USING THE EXCELSIUS GPS SYSTEM WAS MISPLACED INTRA-OPERATIVELY CAUSING A CSF (CEREBRAL SPINAL FLUID) LEAK. THIS EVENT OCCURRED IN GERMANY.

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE FOLLOWING WAS REPORTED: - CT SCAN WAS UPLOADED WITH INCORRECT TITLE WITH WRONG SIDE. PATIENT REFERRAL HAD CORRECT SIDE. - RADIOLOGIST ARE STATING THEY WEREN'T ABLE TO AMEND THE SIDE ON THE UPLOADED SCAN. - AS A RESULT, SCAN WAS SENT FOR A PLAN WITH THE INCORRECT SIDE (NO BOOKING RECEIVED TO CROSS REFERENCE AT THE TIME) - ON THE DAY OF OPERATING, NO-ONE WAS MADE AWARE UNTIL THE FIRST INCISION WAS MADE. DR INFORMED IMMEDIATELY. - DR MADE THE DECISION TO BAIL OUT OF THE PROCEDURE, SEW UP AND WAKE THE PATIENT (POST ANESTHETIC). DR STATED THE PATIENT HAD REQUESTED A ROBOTIC PROCEDURE.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: WE EXPERIENCED 3 MISSED SCREWS DURING A CASE.

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE PATIENT SUFFERED AN ACETABULAR FRACTURE AS A RESULT OF THE PROCEDURE. THE SURGEON REPAIRED THE FRACTURE AND THE PROCEDURE COMPLETED SUCCESSFULLY.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: WHEN MAKING A SCAN TO VERIFY THE SCREW PLACEMENT WE NOTICED A MEDIAL BREACH OF THE L4 SCREW ON THE RIGHT SIDE, WHEN DOING THE DECOMPRESSION, WE ALSO SAW THE BREACH. SCREW WAS TAKEN OUT AND REPOSITIONED USING FREE HAND STEALTH NAVIGATION. L4 SCREW ON THE LEFT A LITTLE MORE LATERAL THAN PLANNED. L5 SCREWS ARE OK. WE STARTED WITH THE L4 SCREW ON THE LEFT SIDE, THEN L4 RIGHT FOLLOWED BY L5 RIGHT AND LAST L5 LEFT. WE DIDN'T GET ANY MESSAGES INDICATING THERE WAS A SHIFT.

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: 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 LOW ANTERIOR RESECTION SURGICAL PROCEDURE, THE HARMONIC ACE SHEERS BROKE, AND A FRAGMENT FELL INSIDE THE PATIENT. IT WAS CONFIRMED THAT THE FRACTURED PART WAS COMPLETELY REMOVED, AND NO FRAGMENT REMAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED USING A BACKUP HARMONIC ACE.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DIAGNOSTIC PROCEDURE USING THE MONARCH BRONCHOSCOPY SYSTEM, THE PHYSICIAN DECIDED TO ABORT THE DIAGNOSTIC PROCEDURE DUE TO NAVIGATIONAL DIFFICULTY. THE PATIENT WAS REPORTED TO HAVE A LOT OF MUCUS. THE PHYSICIAN DECIDED TO ABORT THE DIAGNOSTIC PROCEDURE. THERE WAS NO REPORTED DEVICE MALFUNCTION ASSOCIATED WITH THE ADVERSE EVENT. NO MEDICAL OR SURGICAL INTERVENTION REPORTED. NO HOSPITALIZATION REQUIRED.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: PROCEDURE WAS A L2-L4 LUMBAR FUSION. BEGINNING OF THE CASE WAS NORMAL: INTRAOP WORKFLOW WITH E3D. DRB WAS PLACED IN THE R PSIS, AND SURVEILLANCE MARKER PLACED IN L PSIS (SUCCESSFULLY ACTIVATED). SET UP, IMAGING, AND PLANNING OF THE SCREWS ALL COMPLETED WITHOUT ANY ISSUES. HOWEVER, WHEN MOVING THE ROBOT WITHIN NAVIGATION RANGE, SURGICAL TEAM MOVED EE VIA BRACELET INTO THE DRB, CAUSING IT TO VISIBLY SHIFT. HOWEVER, UPON REPOSITIONING OF THE ARM, DRB APPEARED TO MOVE BACK INTO ORIGINAL LOCATION. THE POST IN THE PSIS WAS CHECKED, AND APPEARED STABLE. FOLLOWING THIS, LANDMARK CHECKS WERE COMPLETED AND IT WAS DECIDED THAT ANATOMY/NAVIGATIONAL INTEGRITY APPEARED ACCURATE. FOLLOWING PLACEMENT OF ALL 6 SCREWS, 1 SCREW (R L2) WAS FAR TOO LATERAL, AND THE DECISION WAS MADE TO REMOVE THE SCREW AND NAVIGATE A NEW SCREW. A SECOND CASE WAS MADE, AND THE POST-OPERATIVE E3D SPIN WAS USED FOR A PRE-OP PROTOCOL. MERGE WAS SUCCESSFUL, HOWEVER THE SCREW PLACEMENT WAS AGAIN LATERAL. WE ARE CERTAIN THERE WAS A DRB SHIFT DURING THE FIRST PORTION OF THE CASE, CAUSING THE SCREWS TO APPEAR LATERAL. HOWEVER WE ARE UNSURE AS TO WHY THE REPLACEMENT SCREW WAS ALSO LATERAL. OUR THOUGHT IS THAT IT MAY HAVE SLID IN

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AFTER A SUCCESSFUL DIAGNOSTIC PROCEDURE USING THE MONARCH BRONCHOSCOPY SYSTEM, THE PATIENT REPORTED HAVING HYPOXIA WHICH IS A PRE-EXISTING CONDITION THAT IS ATTRIBUTED TO MEDICAL HISTORY OF COPD. THE PATIENT WAS HOSPITALIZED AND SUPPLEMENTAL OXYGEN (3L 02) WAS GIVEN AND RELEASED THE FOLLOWING DAY. NO ISSUES WERE REPORTED REGARDING THE MONARCH SYSTEM.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ROBOT WAS USED FOR CASE THIS AM WITH DR. (B)(6) WITH NO ISSUES. ROBOT WAS THEN MOVED TO ROOM ACROSS THE HALL FOR USE WITH DR. (B)(6). UNPLUGGED AND REPLUNGED INTO THE NEW ROOM, IN THAT TIME THE BATTERY WAS NO LONGER SHOWING AS BEING PLUGGED IN. THEY TRIED MULTIPLE OUTLETS AND HARD RESTARTS TO NO AVAIL. THEY ARE LOOKING FOR A RESOLUTION AS SOON AS POSSIBLE, BUT LIKELY WILL BAIL ON CURRENT CASE. LIKELY NEED A FUSE REPLACEMENT.

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 SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY FELL INTO THE PATIENT. THE CUSTOMER REMOVED THE SHEATH FROM THE PATIENT. THE MCS TIP COVER WAS THROWN OUT AND WILL NOT BE RETURNED. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) ATTEMPTED FOLLOW-UP TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAD 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: SURGEON AND OTHER STAFF WERE USING THE DAVINCI XI FOR A UROLOGICAL PROCEDURE. THE OUTFIELD AND INFIELD MONITORS IN THE OPERATING ROOM FLICKERED MULTIPLE TIMES THROUGHOUT CASE IN OPERATING ROOM AND EVENTUALLY WENT BLACK. REDUCED VISUALIZATION AND INABILITY TO SEE VISION TOWER RESULTED IN SMALL NICK TO BLADDER NECK. PHYSICIAN ABLE TO REPAIR TEAR. THIS ISSUE OF MONITORS FLICKERING AND GOING BLACK HAS HAPPENED MANY TIMES BEFORE, BUT WITHOUT INJURY TO A PATIENT. MANUFACTURER RESPONSE FOR DAVINCI XI MONITORS, DAVINCI XI (PER SITE REPORTER). MANUFACTURER WILL ARRIVE NEXT WEEK TO TROUBLESHOOT THE DEVICE.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A MONARCH BRONCHOSCOPY THE PHYSICIAN REMOVED A FOREIGN OBJECT WHILE WITHDRAWING THE SPECIMEN TISSUE FROM THE SPECIMEN.

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 SIGMOID COLECTOMY SURGICAL PROCEDURE THAT TIP-UP FENESTRATED GRASPER INSTRUMENT HAD ENGAGEMENT ISSUES. THE PROCEDURE WAS COMPLETED AS AN OPEN PROCEDURE. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED: IT WAS REPORTED TO THE INITIAL REPORTER THAT THE INSTRUMENT DIDN'T WORK AND/OR BROKE DURING THE PROCEDURE AND THAT THE PROCEDURE WAS CHANGED TO AN OPEN PROCEDURE. REPORTEDLY, THE CONVERSION TO AN OPEN PROCEDURE DID NOT HAVE ANYTHING TO DO WITH THE INSTRUMENT BREAKING.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ROBOTIC STAPLER STOPPED IN THE MIDDLE OF THE FIRING PROCESS AND DID NOT COMPLETE FIRING. STAPLER AND RELOAD WERE RETRIEVED FROM PATIENT AND PROCEDURE CONTINUED LAPAROSCOPICALLY INSTEAD OF WITH THE ROBOT.

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

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DIAGNOSTIC PROCEDURE USING THE MONARCH BRONCHOSCOPY SYSTEM, BLEEDING WAS NOTED. THE PHYSICIAN CONVERTED THE PROCEDURE TO A TRADITIONAL BRONCHOSCOPY AND A BALLOON WAS USED TO PROVIDE TAMPONADE. PER THE PHYSICIAN, THE PRIMARY CAUSE OF THE PATIENT BLEED WAS DUE TO THE PATIENT¿S FRAGILE AIRWAYS AND PRE-EXISTING CONDITION. THERE WAS NO REPORTED DEVICE MALFUNCTION ASSOCIATED WITH THE ADVERSE EVENT. NO HOSPITALIZATION REQUIRED.

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 GASTRECTOMY SURGICAL PROCEDURE, THE HARMONIC ACE BLADE FRACTURED, AND A FRAGMENT FELL INSIDE THE PATIENT. IT WAS CONFIRMED THAT THE FRACTURED PART WAS COMPLETELY REMOVED, AND NO FRAGMENT REMAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED USING A DIFFERENT BACKUP DA VINCI INSTRUMENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE FRAGMENT WAS RETRIEVED BY USING A LAPAROSCOPIC GRASPER. ALL FRAGMENTS WERE CONFIRMED TO BE RETRIEVED USING THE ENDOSCOPE. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED AND THERE WERE NO POST-OPERATIVE TESTS PERFORMED. THE SURGEON BELIEVES THE ISSUE WAS AN INSTRUMENT QUALITY PROBLEM. THE INSTRUMENT WAS BEING USED FOR DISSECTING FOR ABOUT 40 MINUTES PRIOR TO THE ISSUE. THE INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO ABNORMALITIES FOUND. THE SYSTEM SHOWED THAT THE SURGEON NEEDED TO REDUCE THE INSTRUMENT TIP PRESSURE. THERE WAS NO INSTRUMENT COLLISION. THE INSTRUMENT WAS REMOVED PRIOR TO THE BREAKAGE DURING THE PROCEDURE WHEN CLEANING THE INSTRUMENT. UPON FINAL REMOVAL, THERE WAS NO RESISTANCE, NO DAMAGE TO THE CANNULA, AND NO ADDITIO

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A PATIENT UNDERWENT A SINGLE PORT DA VINCI-ASSISTED PARTIAL NEPHRECTOMY ON (B)(6) 2023. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DA VINCI SYSTEM, INSTRUMENTS OR ACCESSORIES MALFUNCTION OCCURRED DURING THE SURGERY. THERE WERE ALSO NO INTRA-OPERATIVE COMPLICATIONS REPORTED. ON (B)(6) 2023, THE PATIENT EXPERIENCED BILATERAL DEEP VEIN THROMBOSIS OF THE LEFT LOWER EXTREMITIES. A VASCULAR ULTRASOUND WAS PERFORMED AND CONFIRMED THE DIAGNOSIS. ENOXAPARIN 4000IU WAS GIVEN FOR THE THROMBOSIS. ON (B)(6) 2023, THE PATIENT WAS FOUND WITH A HEMATOMA IN THE LEFT RENAL AREA FROM A ULTRASOUND. NO MEDICAL INTERVENTION WAS PERFORMED FOR THE FINDING. THE PATIENT WAS DISCHARGED ON (B)(6) 2023 WITHOUT REQUIRING PROLONGED HOSPITALIZATION. THE PATIENT HAD MEDICAL HISTORY OF URINARY SYSTEM DISEASE AND SIMPLE RENAL CYST AT LEFT KIDNEY. THE STUDY INVESTIGATOR THOUGHT THE BILATERAL DEEP VEIN THROMBOSIS WAS LIKELY CAUSED BY INTRAOPERATIVE PNEUMOPERITONEUM AND THE CAUSE OF THE RENAL HEMATOMA WAS DUE TO ANTICOAGULATIVE MEDICATION. IT WAS CONFIRMED THAT THERE WAS NO UNEXPECTED BLEEDING THAT COULD HAVE LED TO THE RENAL HEMATOMA.

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

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 A PATIENT WHO UNDERWENT A DA VINCI SINGLE PORT ASSISTED RADICAL PROSTATECTOMY FOR HIS PROSTATE CANCER AS PART OF A CLINICAL STUDY ON (B)(6) 2023. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY INTRA-OPERATIVE COMPLICATIONS NOR ANY MALFUNCTIONS OF DA VINCI SYSTEMS, INSTRUMENTS OR ACCESSORIES. ON (B)(6) 2023, AN ULTRASOUND SHOWED MULTIPLE CYSTIC FOCI IN BOTH KIDNEYS AND WAS SUSPECTED AS RENAL CYSTS, WHICH LIKELY CAUSED BY PATIENT'S MEDICAL CONDITIONS. A LYMPHATIC LEAK WAS ALSO SUSPECTED AND ASCITES ASPIRATION WAS PERFORMED ON (B)(6) 2023, DRAINAGE ON (B)(6) 2023 AS MEDICAL INTERVENTION. FURTHERMORE, A CT-GUIDED PUNCTURE AND PELVIC EFFUSION WAS PERFORMED ON (B)(6) 2023 AND THE SYMPTOMS WERE REPORTED AS RESOLVED ON (B)(6) 2023. THE PATIENT'S HOSPITALIZATION WAS PROLONGED DUE TO PERSONAL REASONS AND WAS DISCHARGED ON (B)(6) 2023.

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

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT A RECURRENT FAULT STATE OCCURRED DURING THE SETUP OF THE MONARCH BRONCHOSCOPY SYSTEM, PREVENTING THE USE OF THE SYSTEM. THE DIAGNOSTIC PROCEDURE WAS ABORTED. THE PATIENT HAD ALREADY BEEN ANESTHETIZED. NO CLINICAL CONSEQUENCES TO THE PATIENT WERE REPORTED DUE TO THIS EVENT.

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 HEAD BROKE. THE PROCEDURE WAS COMPLETED USING A BACKUP HARMONIC ACE WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE HARMONIC ACE TIP BROKE INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED, AND ALL FRAGMENTS WERE FOUND. THERE WAS NO ADDITIONAL SURGICAL PROCEDURE NEEDED. NO POST-OPERATIVE TESTS WERE PERFORMED. THE SURGEON BELIEVES THE ISSUE IS DUE TO PRODUCT QUALITY. THE INSTRUMENT WAS USED FOR 10 MINUTES PRIOR TO THE ISSUE. THE SURGEON DID NOT NOTICE ANY ISSUES WITH INSTRUMENT FUNCTIONALITY PRIOR TO THE BREAK. THERE WAS NO INSTRUMENT COLLISION. UPON FINAL REMOVAL OF THE INSTRUMENT, THERE WAS NO RESISTANCE THROUGH THE CANNULA, NO DAMAGE TO THE CANNULA, AND NO ADDITIONAL DAMAGE TO THE INSTRUMENT. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL 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: AT 8:45AM THE ROBOT WAS PLUGGED IN AND TURNED ON. EVERYTHING SEEMED TO BE WORKING FINE. ROBOT WAS LEFT ON AND PLUGGED IN. 11:15AM ROBOT WAS ROLLED INTO SURGERY ROOM 5 AND PLUGGED IN. A O-ARM SPIN WAS COMPLETED AND THE SCAN WAS LOADED AS A PRE-OP CT. SCAN WAS LOADED TO THE ROBOT WITH NO ISSUES, AND SCREWS WERE PLANNED ACCORDING TO LEVEL AND BILATERAL ORIENTATION. SURGEON THEN BEGAN TO FINE TUNE THE SCREWS, AND AT THIS POINT THE MONITOR SHUT OFF AND MONITOR LIGHT TURNED RED, A BLUE TEXT BOX APPEARED SAYING "NO SYNC". THE SCREW BEGAN TO REBOOT GOING THROUGH NORMAL BOOTING SCREWS AND THEN TO LOGIN SCREEN, AS THE SCREEN WAS REBOOTING THE MONITOR LIGHT WAS BLUE. WE LOGGED BACK IN AND THE SURGEON BEGAN FINE TUNING, THEN IT SHUT DOWN AGAIN. AT THIS POINT I CHANGED THE OUTLET THAT THE ROBOT WAS PLUGGED INTO AS IT REBOOTED. I NOTICED THAT THE FANS WERE TURNING OFF THEN BACK ON DURING THE REBOOTING PROCESS. ONCE REBOOTED AND PLAN PULLED UP WE RECEIVED A "MOTION COMMUNICATION ERROR" WE CLICKED OUT OF IT AND STARTED TO FINE TUNE AGAIN. THE SURGEON WAS ABLE TO GET A WHOLE LEVEL DONE AND THEN IT DID IT AGAIN. WE TRIED ONE MORE TIME BEFORE IT REBOOTED A SURGEON DECIDED TO BAIL ON THE ROBOT.

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 SURGICAL PROCEDURE, A PART OF THE SYNCHROSEAL INSTRUMENT CAME OUT. THE PART WAS RETRIEVED. A BACK UP INSTRUMENT WAS USED TO CONTINUE THE PROCEDURE. 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: THE PROCEDURE WAS A BENIGN HYSTERECTOMY. IT IS UNKNOWN HOW THE FRAGMENT FELL INTO THE PATIENT. THE EYELET WAS SPOTTED IN THE PATIENT, AND THEN THEY REALIZED WHAT IT WAS WHEN THEY SAW THE EYELET MISSING ON THE SYNCHROSEAL. NO ADDITIONAL SURGICAL PROCEDURE REQUIRED TO REMOVE THE FRAGMENT. THERE WERE NOT ANY POST-OPERATIVE TESTS LIKE AN X-RAY OR ULTRASOUND PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE FRAGMENT WILL BE RETURNING WITH THE INSTRUMENT. IMAGES WERE PROVIDED. PARTIAL DEVICE INFORMATION PROVIDED WITH RETURN IMAGES.

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 SUDDENLY STOPPED WORKING AND THE SYSTEM PROMPTED THE CUSTOMER TO CHANGE THE INSTRUMENT. THE CUSTOMER REMOVED THE FRACTURED PART OF THE INSTRUMENT COMPLETELY AND NO FRAGMENTS REMAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED USING A BACKUP HARMONIC ACE 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.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DIAGNOSTIC MONARCH BRONCHOSCOPY PROCEDURE, BLEEDING WAS DETECTED DURING THE BIOPSY, AND THE SYSTEM WAS REMOVED FROM THE PATIENT. THE PHYSICIAN USED A MANUAL SCOPE TO SUCTION BLOOD AND A BLOOD CLOT FROM THE LUNG. THE PROCEDURE WAS ABORTED AND THE PATIENT WAS TRANSFERRED TO THE ICU WHERE A PNEUMOTHORAX WAS DETECTED. THE PATIENT WAS TREATED WITH A CHEST TUBE AND REMAINS IN THE ICU. THERE WAS NO DIFFICULTY EXPERIENCED DURING THE BIOPSY AND THERE WERE NO REPORTED DEVICE ISSUES RELATED TO THIS EVENT.

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

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IN RESPONSE TO AN INTUITIVE SURGICAL, INC. (ISI) CLINICAL SURVEY ON XI / X MONOPOLAR INSTRUMENTS, A CUSTOMER RECALLED AN EVENT REGARDING A DA VINCI-ASSISTED SURGICAL PROCEDURE THAT WAS CONVERTED TO OPEN SURGERY DUE TO A MALFUNCTION AND / OR BREAKAGE OF AN UNSPECIFIED DA VINCI MONOPOLAR INSTRUMENT. THE CUSTOMER DID NOT SPECIFY THE NUMBER OF CONVERSIONS FROM DA VINCI SURGICAL PROCEDURE TO OPEN SURGERY FOR MALFUNCTION / BREAKAGE. THE CUSTOMER WHO RESPONDED TO THE SURVEY WAS ANONYMOUS. THE CUSTOMER DID NOT COMPLETE THE ENTIRE SURVEY LEADING TO INCOMPLETE 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 SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT SUDDENLY BROKE AND A PIECE FELL INSIDE THE PATIENT. THE FRACTURED PART WAS TAKEN OUT OF THE PATIENT DURING THE SAME PROCEDURE. THE CUSTOMER USED A SPARE INSTRUMENT TO CONTINUE WITH THE PROCEDURE WHICH WAS COMPLETED ROBOTICALLY. INTUITIVE SURGICAL, INC (ISI) FOLLOWED UP WITH THE SITE NURSE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE INSTRUMENT WAS INSPECTED BEFORE USE WITH NOTHING FOUND OUT OF THE ORDINARY. THE ISSUE OCCURRED ABOUT 1 HOUR AFTER THE PROCEDURE STARTED AND AS THE SURGEON WAS GRASPING TISSUE. THE SURGEON NOTICED UNSPECIFIED FUNCTIONALITY ISSUES WITH THE INSTRUMENT DURING THE SURGICAL PROCEDURE. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR HARD MATERIAL. THE INSTRUMENT WAS NOT REMOVED BEFORE THE BREAKAGE OCCURRED. THE INSTRUMENT'S WRIST WAS STRAIGHTENED PRIOR TO REMOVAL AND THE OR STAFF DID NOT FEEL RESISTANCE WHILE REMOVING THE INSTRUMENT THROUGH THE CANNULA. THERE WAS NO DAMAGE NOTED TO THE CANNULA. ALL FRAGMENTS WERE CONFIRMED TO BE RETRIEVED BY THE ASSISTANT AND WERE REMOVED WITH ANOTHER FORCEPS. NO ADDITIONAL SURGICA