ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT STARTING UP THE ROSA ONE SYSTEM BEFORE THE SURGERY AND FIND THAT ROSA CANNOT ACCESS THE ROSA SPINE INTERFACE, TO START BUILDING THE PATIENT FOLDER. THE SURGERY WAS CONVERTER TO A TRADITIONAL SURGERY.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: WE ARE HAVING A PATTERN OF DIFFICULTIES WITH OUR ROSA MACHINE. THESE DIFFICULTIES ROUTINELY FOLLOW ANY SORT OF 'MAINTENANCE' PERFORMED BY THE REGIONAL TECHNICIANS. TODAY WE HAD TO CANCEL A SURGERY WITH THE PATIENT IN THE PRE-OPERATIVE AREA BECAUSE AFTER AN HOUR OF TROUBLESHOOTING, THE ROSA MACHINE STILL WOULD NOT CONNECT ITSELF TO THE MONITOR TO BE FUNCTIONAL. THE ROSA MACHINE WAS WORKING FINE PRIOR TO ITS LAST 'MAINTENANCE' BY THE REGIONAL TECHNICIAN. WE ARE NOW BEING TOLD THAT THE TECHNICIAN WILL NOT BE ABLE TO ATTEND TO THE REPAIR UNTIL NEXT WEEK CAUSING US TO POST-PONE THIS NEEDED SURGERY EVEN FURTHER.

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: CASE NUMBER: (B)(4): (B)(6) - MPS REPORTED SURGEON REQUEST FOR SERVICE VISIT DUE TO INACCURATE CUTS DURING TKA CASE. MPS REPORTED THAT DOCTOR SAID THE CUTS FELT OFF IN TKA CASE AND THAT ANTERIOR CUT NOTCHED EVEN THOUGH IT SHOULD HAVE HAD ENOUGH FLEXION NOT TO. A COUPLE MONTHS AGO THIS SAME KIND OF ISSUE HAPPENED SO THE DOCTOR IS INSISTING FSE MAKE A VISIT.

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 MONARCH-ASSISTED BRONCHOSCOPY PROCEDURE A PATIENT DEVELOPED AN IATROGENIC PNEUMOTHORAX IN THE LEFT UPPER LOBE (LUL). THE PATIENT HAD POSTPROCEDURAL CHEST X-RAYS AT 3:30 P.M. THAT DEMONSTRATED A SMALL APICAL 3-4 MM PNEUMOTHORAX. REPEAT CHEST X-RAY AT 6:30 P.M. SHOWED INCREASED PNEUMOTHORAX TO 1 CM DESPITE BEING ON A FULL-FACE MASK. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR OBSERVATION AND PLACED ON 15 L SALTER CANNULA FOR SUPPORTIVE TREATMENT OF THE PNEUMOTHORAX. OVERNIGHT, THE PATIENT HAD REPEATED X-RAYS WHICH WAS FOUND TO BE STABLE AND THERE WAS NO EVIDENCE OF DESATURATION WITHOUT SUPPLEMENTAL O2. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: PRIOR TO THE START OF SURGERY, UPON ATTEMPT TO MERGE AUTOMATICALLY MP2RAGE IMAGE TO T1 IMAGE, ERROR EXPERIENCED WHERE MANUAL ADJUSTMENTS WERE NECESSARY. ADDITIONALLY, AUTOMATICALLY MERGING CT IMAGE HAD SIGNIFICANT ERROR WHEN MERGED TO T1 MRI AND LESS, BUT STILL SIGNIFICANT ERROR WHEN MERGED TO MP2RAGE MRI IMAGE. THIS ISSUE CAUSED A 45 MINUTE DELAY WHILE PATIENT WAS UNDER ANESTHESIA.

ROSA Robotic Surgery — 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 FOLLOWING OCCURRED AT AN INDEPENDENT SITE DURING AN ABLATION PROCEDURE WHERE NO CLINICAL REPRESENTATIVE WAS PRESENT. THE MERGE BETWEEN THE O-ARM SPIN AND THE T1 MRI WAS UNSUCCESSFUL (AND NECESSARY FOR MARKER REGISTRATION). THE SURGEON WAS NOT ABLE TO MANUALLY ADJUST THE MERGE IN A SATISFACTORY MANNER AND ABANDONED THE USE OF ROSA FOR THIS PROCEDURE, CHOOSING INSTEAD TO USE A CRW FRAME. THE IMPACT TO THE SURGERY WAS A DELAY OF ABOUT 25 MINUTES DUE TO THE TIME WASTED TO SET UP THE ROSA AND RETRIEVE THE CRW.

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 MAIN MACHINE OF THE ULTRASONIC KNIFE WAS REPORTING THAT THE PRESSURE OF THE KNIFE HEAD WAS TOO LARGE. DURING THE OPERATION, THE PATIENT SUFFERED FROM "A LOT OF BLEEDING." THE NURSE PULLED OUT THE ULTRASONIC KNIFE FOR RE-TESTING, AND THE MAIN MACHINE OF THE ULTRASONIC KNIFE SUGGESTED THAT THE INSTRUMENT SHOULD BE REPLACED. THERE WAS NO REPORT OF ANY FRAGMENT(S) FALLING INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A BACKUP DA VINCI INSTRUMENT OF THE SAME KIND, AND THERE WAS 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.

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 MAIN MACHINE OF THE ULTRASONIC KNIFE WAS REPORTING THAT THE PRESSURE OF THE KNIFE HEAD WAS TOO LARGE. DURING THE OPERATION, THE PATIENT SUFFERED FROM "A LOT OF BLEEDING." THE NURSE PULLED OUT THE ULTRASONIC KNIFE FOR RE-TESTING, AND THE MAIN MACHINE OF THE ULTRASONIC KNIFE SUGGESTED THAT THE INSTRUMENT SHOULD BE REPLACED. THERE WAS NO REPORT OF ANY FRAGMENT(S) FALLING INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A BACKUP DA VINCI INSTRUMENT OF THE SAME KIND, AND THERE WAS 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.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: UPON FURTHER REVIEW, IT IS NOTED THE PATIENT EXPERIENCED A BLISTER. BLISTERS ARE A FLUID FILLED SAC LOCATED UNDER THE TOP LAYER OF THE SKIN. THESE RESULT DUE TO HEAT OR FRICTION AT THE SITE AND MOST OFTEN RESOLVE ON THEIR OWN. REVIEWING THE OFFICE NOTE PROVIDED, THE DOCTOR DOES NOT MENTION AN INTERVENTION AND STATES HE EXPECTS THE BLISTER TO RESOLVE ON ITS OWN. AS A BLISTER IS A MILD INJURY AND NO INTERVENTION IS NOTED, THIS WOULD NOT BE CONSIDERED A SERIOUS INJURY OR REPORTABLE.

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-ASSISTED BRONCHOSCOPY PROCEDURE THE PATIENT EXPERIENCED BLEEDING. NO BLOOD TRANSFUSION AND NO MEDICAL INTERVENTION WAS REQUIRED. THE PNEUMOTHORAX WAS DISCOVERED DURING ENDOBRONCHIAL ULTRASOUND. THE LOCATION OF THE PNEUMOTHORAX WAS RIGHT UPPER LOBE. A CHEST TUBE WAS PLACED, AND PATIENT WAS HOSPITALIZED FOR OBSERVATION. THE CHEST TUBE WAS REMOVED AND THE PATIENT WAS DISCHARGED ON (B)(6) 2021.

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.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A LASER ABLATION CASE WAS PERFORMED. REGISTRATION WAS DONE VIA CONTACTLESS METHOD ON ROSA AND WAS ACCEPTED BY SOFTWARE BUT VERIFICATION SHOWED LESS THAN OPTIMAL RESULTS. SURGEON STATED THAT HE WAS SATISFIED WITH THE REGISTRATION REGARDLESS OF VERIFICATION AND CASE PROCEEDED. AFTER BOLTS WERE PLACED AND MRI DONE, BOTH TRAJECTORIES WERE FOUND TO BE INACCURATE WHEN COMPARED TO PLANNING. BOTH TRAJECTORIES WERE REDONE USING LEKSELL FRAME AND BOX WITHOUT ROSA ON SECOND ATTEMPT. THERE WAS PATIENT IMPACT, AS BOLTS WERE REMOVED AND TWO ADDITIONAL BOLTS PLACED.

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 PROCEDURE, THE USER OBSERVED THAT "THE PART THAT HOLDS THE SYNCHROSEAL INSTRUMENT JAW COVER WAS DAMAGED" AND A FRAGMENT FELL INSIDE THE PATIENT. THE BROKEN FRAGMENT WAS RETRIEVED DURING THE SAME SURGICAL PROCEDURE. THE USER NOTED THAT THE INSTRUMENT WAS NOT INVOLVED IN ANY KNOWN INSTRUMENT COLLISION. THE INSTRUMENT WAS REMOVED AND REPLACED TO THE BACKUP. THE USER COMPLETED THE PROCEDURE WITH NO FURTHER ISSUE. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND FOUND NO ISSUE. INSTRUMENT OPERATED WITH NO FUNCTIONAL ISSUE. SURGEON ALLEGES NO INCIDENT OF INSTRUMENT COLLISION. THE INSTRUMENT WAS IN USE FOR APPROXIMATELY AN HOUR. THE FALLEN FRAGMENT WAS REMOVED THROUGH THE ASSIST PORT. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED TO REMOVE THE FRAGMENT. STANDARD POST-OPERATIVE TESTS WERE PERFORMED AND CONFIRMED NO RETAINED FRAGMENT.

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: DA VINCI XI ROBOT EXPERIENCED NONRECOVERABLE FAULT ERROR CODE 307 DURING MID PROCEDURE. INSTRUMENT ARMS WERE LEFT IN PATIENT. REP ADVISED TOTAL SYSTEM SHUTDOWN AND RESTART. SYSTEM SHUT DOWN AND RESTARTED 3 TIMES, NONRECOVERABLE FAULT RESULTED EACH TIME. INSTRUMENTS AND DA VINCI REMOVED MANUALLY AS RESULT OF FAILURE. PROCEDURE CONTINUED THORACOSCOPICALLY. AFTER TROUBLESHOOTING THIS ISSUE, DA VINCI REP DETERMINED THE TITLE PRO CABLE CONNECTED TO THE STORZ CAMERA SYSTEM FRIED THE TITLE PRO INPUT BOX IN THE DA VINCI ROBOT, RESULTING IN NONRECOVERABLE FAULT ERROR CODE 307. VENDOR CAME ONSITE 5/16 AND REPAIRED UNIT. UNIT RETURNED TO SERVICE. VIDEO OUTPUT ON VISION TOWER WAS REPLACED. COMPOSITE VIDEO COMPONENT PROTRUDES FROM EQUIPMENT LEADING TO HIGHER LIKELIHOOD OF DAMAGE. FDA SAFETY REPORT ID # (B)(4).

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ABSTRACT: ROBOT-ASSISTED SPINE SURGERY CONTINUES TO RAPIDLY DEVELOP AS EVIDENCED BY THE GROWING LITERATURE IN RECENT YEARS. IN ADDITION TO DEMONSTRATING EXCELLENT PEDICLE SCREW ACCURACY, EARLY STUDIES HAVE EXPLORED THE IMPACT OF ROBOT-ASSISTED SPINE SURGERY ON REDUCING RADIATION TIME, LENGTH OF HOSPITAL STAY, OPERATIVE TIME, AND PERIOPERATIVE COMPLICATIONS IN COMPARISON TO CONVENTIONAL FREEHAND TECHNIQUE. RECENTLY, THE MAZOR X STEALTH EDITION WAS INTRODUCED IN 2018. THIS ROBOTIC SYSTEM INTEGRATES MEDTRONIC¿S STEALTH NAVIGATION TECHNOLOGY INTO THE MAZOR X PLATFORM, WHICH WAS INTRODUCED IN 2016. IT IS UNCLEAR WHAT THE IMPACT OF THESE ADVANCEMENTS HAVE MADE ON CLINICAL OUTCOMES. TO COMPARE THE OUTCOMES AND COMPLICATIONS BETWEEN THE MOST RECENT ITERATIONS OF THE MAZOR ROBOT SYSTEMS: MAZOR X AND MAZOR X STEALTH EDITION. AMONG FOUR DIFFERENT INSTITUTIONS, WE INCLUDED ADULT (=18 YEARS OLD) PATIENTS WHO UNDERWENT ROBOT-ASSISTED SPINE SURGERY WITH EITHER THE MAZOR X (NON-NAVIGATED ROBOT) OR STEALTH (NAVIGATED ROBOT) PLATFORMS. PRIMARY OUTCOMES INCLUDED ROBOT TIME PER SCREW, FLUOROSCOPIC RADIATION TIME, SCREW ACCURACY, ROBOT ABANDONMENT, AND CLINICAL OUTCOMES WITH A MINIMUM 90 DAY FOLLOW UP.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ABSTRACT: ROBOT-ASSISTED SPINE SURGERY CONTINUES TO RAPIDLY DEVELOP AS EVIDENCED BY THE GROWING LITERATURE IN RECENT YEARS. IN ADDITION TO DEMONSTRATING EXCELLENT PEDICLE SCREW ACCURACY, EARLY STUDIES HAVE EXPLORED THE IMPACT OF ROBOT-ASSISTED SPINE SURGERY ON REDUCING RADIATION TIME, LENGTH OF HOSPITAL STAY, OPERATIVE TIME, AND PERIOPERATIVE COMPLICATIONS IN COMPARISON TO CONVENTIONAL FREEHAND TECHNIQUE. RECENTLY, THE MAZOR X STEALTH EDITION WAS INTRODUCED IN 2018. THIS ROBOTIC SYSTEM INTEGRATES MEDTRONIC¿S STEALTH NAVIGATION TECHNOLOGY INTO THE MAZOR X PLATFORM, WHICH WAS INTRODUCED IN 2016. IT IS UNCLEAR WHAT THE IMPACT OF THESE ADVANCEMENTS HAVE MADE ON CLINICAL OUTCOMES. TO COMPARE THE OUTCOMES AND COMPLICATIONS BETWEEN THE MOST RECENT ITERATIONS OF THE MAZOR ROBOT SYSTEMS: MAZOR X AND MAZOR X STEALTH EDITION. AMONG FOUR DIFFERENT INSTITUTIONS, WE INCLUDED ADULT (=18 YEARS OLD) PATIENTS WHO UNDERWENT ROBOT-ASSISTED SPINE SURGERY WITH EITHER THE MAZOR X (NON-NAVIGATED ROBOT) OR STEALTH (NAVIGATED ROBOT) PLATFORMS. PRIMARY OUTCOMES INCLUDED ROBOT TIME PER SCREW, FLUOROSCOPIC RADIATION TIME, SCREW ACCURACY, ROBOT ABANDONMENT, AND CLINICAL OUTCOMES WITH A MINIMUM 90 DAY FOLLOW UP.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ABSTRACT: ROBOT-ASSISTED PLATFORMS IN SPINE SURGERY HAVE RAPIDLY DEVELOPED INTO AN ATTRACTIVE TECHNOLOGY FOR BOTH THE SURGEON AND PATIENT. ALTHOUGH CURRENT LITERATURE IS PROMISING, MORE CLINICAL DATA IS NEEDED. THE PURPOSE OF THIS PAPER IS TO DETERMINE THE EFFECT OF ROBOT-RELATED COMPLICATIONS ON CLINICAL OUTCOMES THIS MULTICENTER STUDY INCLUDED ADULT (=18 YEARS OLD) PATIENTS WHO UNDERWENT ROBOT-ASSISTED LUMBAR FUSION SURGERY FROM 2012-2019. THE MINIMUM FOLLOW-UP WAS 1 YEAR AFTER SURGERY. BOTH BIVARIATE AND MULTIVARIATE ANALYSES WERE PERFORMED TO DETERMINE IF ROBOT-RELATED FACTORS WERE ASSOCIATED WITH REOPERATION WITHIN 1 YEAR AFTER PRIMARY SURGERY. A TOTAL OF 320 PATIENTS WERE INCLUDED IN THIS STUDY. THE MEAN (STANDARD DEVIATION) CHARLSON COMORBIDITY INDEX WAS 1.2 (1.2) AND 52.5% OF PATIENTS WERE FEMALE. INTRAOPERATIVE ROBOT COMPLICATIONS OCCURRED IN 3.4% OF PATIENTS AND INCLUDED INTRAOPERATIVE EXCHANGE OF SCREW (0.9%), ROBOT ABANDONMENT (2.5%), AND RETURN TO THE OPERATING ROOM FOR SCREW EXCHANGE (1.3%). THE 1-YEAR REOPERATION RATE WAS 4.4%. ROBOT FACTORS, INCLUDING ROBOT TIME PER SCREW, OPEN VS. PERCUTANEOUS, AND ROBOT SYSTEM, WERE NOT STATISTICALLY DIFFERENT BETWEEN THOSE WHO RE

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 A MONARCH-ASSISTED BRONCHOSCOPY PROCEDURE THE PATIENT EXPERIENCED A PNEUMOTHORAX. THE TARGET AND PNEUMOTHORAX WERE LOCATED RIGHT UPPER LOBE. AN ENDOBRONCHIAL ULTRASOUND WAS PERFORMED. A CHEST TUBE WAS PLACED IN THE PATIENT AND PATIENT WAS HOSPITALIZED. THE CHEST TUBE WAS REMOVED ON (B)(6) 2021. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2021.

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 DONE TO REMOVE MISPLACED SCREWS AT L4 CAUSING ADVERSE EFFECTS TO THE PATIENT.

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-ASSISTED BRONCHOSCOPY PROCEDURE THE PATIENT EXPERIENCED A PNEUMOTHORAX. THE LOCATION WAS RIGHT UPPER LOBE. THE LOCATION OF THE PNEUMOTHORAX WAS RIGHT SIDE. DURING THE PROCEDURE THE PATIENT WENT INTO A COMPLETE HEART BLOCK AND BECAME HYPOTENSIVE. EPINEPHRINE WAS PUSHED INTO THE PATIENT¿S INTRAVENOUS TO TACKLE HYPOTENSION AND THE SCOPE WAS REMOVED IMMEDIATELY. THE CUSTOMER TOOK THE SCOPE OFF THE ROBOTIC ARMS AT THIS TIME AND WENT ON TO REMOVE THE SCOPE OUT OF PATIENT MANUALLY. THE PATIENT SUBSEQUENTLY BECAME STABLE, E.G., SHOWED INFERIOR WALL ACUTE MYOCARDIAL INFARCTION (AMI). THE PATIENT WENT TO THE CARDIAC CATHETERIZATION LAB IMMEDIATELY AND HAD AN EMERGENT ANGIOGRAM. THE PATIENT HAS RECOVERED AND HAS BEEN DISCHARGED.

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 MONARCH-ASSISTED BRONCHOSCOPY PROCEDURE, THE PATIENT EXPERIENCED A PNEUMOTHORAX. THE PNEUMOTHORAX WAS DISCOVERED VIA A CHEST X-RAY AFTER THE PROCEDURE WHEN THE PATIENT WAS AWAKE AND COMPLAINED ABOUT CHEST PAIN. THE TARGET AND PNEUMOTHORAX LOCATION WERE IN THE LEFT LOWER LOBE (LLL). A CHEST TUBE WAS PLACED IN THE PATIENT AND THE PATIENT WAS HOSPITALIZED. THE CHEST TUBE WAS REMOVED, AND PATIENT WAS DISCHARGED THE NEXT DAY.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE CLINICAL REPRESENTATIVE (CR) ASSISTED THE SURGEON FOR AN ABLATION/BIOPSY CASE. CONTACTLESS REGISTRATION WAS PERFORMED, AND ACCURACY APPEARED TO BE GOOD. VERIFICATION LOOKED GREAT, SO SURGERY WAS STARTED. AFTER VERIFICATION, THE SURGEON MARKED THE ENTRY POINTS USING A MARKER AND THE LASER. AFTER DRAPING THE PATIENT AND GOING TO THE FIRST TRAJECTORY WITH THE DRILL ADAPTOR, THE SURGEON NOTICED THAT THE POINT OF THE DRILL ADAPTOR APPEARED TO BE MISSING THE MARK MADE ON THE PATIENT SKIN BY ABOUT 4-5MM. THE SURGEON WASN'T SURE IF THE LOCAL ANESTHESIA THAT WAS APPLIED TO THE AREA WAS CAUSING THE SKIN TO DEFORM, OR IF MAYBE THE DRAPING ON THE PATIENTS HEAD WAS PULLING THE SKIN SLIGHTLY TO SHOW THIS ISSUE. THE SURGEON AND CR DID NOT NOTICE ANY HEAD-SHIFT. THE SURGEON DECIDED TO PROCEED AND PLACE THE BOLTS FOR THE LEADS (TRAJECTORY 1 AND 2). AFTER PLACING THE BOLTS, THE SURGEON DIDN'T FEEL CONFIDENT THEY WERE PLACED CORRECTLY, SO THE SURGEON PLACED THE LEADS INTO THE BOLT, BUT JUST A CENTIMETER OR SO INTO THE BRAIN TO GET AN IDEA IF THE BOLTS WERE PLACED CORRECTLY. AROUND 9:57AM EASTERN TIME, THE POST-OP SCAN WAS MERGED, AND IT WAS CONFIRMED THAT THE BOLTS FOR EACH TRAJECTORY WERE AROUND

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HIATAL HERNIA-PARAESOPHAGEAL SURGICAL PROCEDURE, PART OF THE SHEAR OF THE HARMONIC ACE INSTRUMENT BROKE AND FELL INTO THE PATIENT. THE PIECE WAS RETRIEVED FROM THE ABDOMEN. THE CUSTOMER OPENED ANOTHER HARMONIC ACE INSTRUMENT TO COMPLETE THE CASE. THE PROCEDURE WAS COMPLETED 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.

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 PANCREATECTOMY SURGICAL PROCEDURE, A PLASTIC PART FROM THE HARMONIC ACE INSTRUMENT BROKE AND FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED AND A BACKUP INSTRUMENT WAS USED TO CONTINUE. 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 RETRIEVED FRAGMENTS AND CONFIRMED BY VISUAL INSPECTION THAT ALL BROKEN PIECES WERE RETRIEVED. THERE WAS NO ADDITIONAL PROCEDURE REQUIRED TO REMOVE THE FRAGMENTS. THERE WERE NO POST-OPERATIVE TESTS PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE INSTRUMENT WAS IN USE FOR LESS THAN 1 HOUR PRIOR TO THE ISSUE. THE INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. THE SURGEON WAS REMOVING THE INSTRUMENT WHEN THE DEVICE FRAGMENT FELL INSIDE THE PATIENT. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIAL DURING THE SURGICAL PROCEDURE. THE INSTRUMENT WAS NEVER REMOVED PRIOR TO THE EVENT. THE SURGICAL STAFF DID NOT FEEL ANY RESISTANCE UPON THE FINAL REMOVA

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 A SCAN & PLAN CASE FOR L3-L4 OLIF WITH PERC SCREWS WAS COMPLETED. THE PROCEDURE STARTED BY TAKING A SPIN WITH THE O-ARM AND SENDING THE IMAGES TO THE GUIDANCE SYSTEM FOR PLANNING. WHILE PLANNING FOR THE SCREWS WAS DONE, THE SURGEON DID THE EXPOSURE FOR THE OLIF. THE SURGEON THEN EXECUTED THE SCREWS, PERFORMED THE OLIF, AND THEN WENT BACK TO PLACE RODS. SCOUT SHOTS TAKEN DURING THE PROCEDURE SHOWED THE SCREWS LOOKED OK IN THE LATERAL VIEW. ANOTHER LATERAL IMAGE WAS DONE AND THE SCREWS LOOKED TO BE IN A DIFFERENT POSITION. AN AP IMAGE WAS TAKEN AND THE SCREWS ON THE LEFT SIDE WERE FOUND TO BE LATERAL BY 3.5-10 MM. THE LEFT L3 AND L4 SCREWS WERE REMOVED DURING THE PROCEDURE. A POST OPERATIVE CT SCAN WAS DONE OF THE RIGHT SIDE AND THE SCREWS WERE MEDIAL IN THE CANAL. A REVISION WAS DONE TO REMOVE THE RIGHT SIDE SCREWS. NO TROUBLESHOOTING WAS DONE DURING THE PROCEDURE SINCE THE SURGEON THOUGHT THE DEVIATION MAY HAVE BEEN CAUSED WHEN TRYING TO TIGHTEN THE RODS. IMAGING WAS NOT DONE PRIOR TO THAT. 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: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LIVER RESECTION SURGICAL PROCEDURE, THE BLADE OF THE HARMONIC ACE INSTRUMENT BROKE OFF AND FELL INTO THE PATIENT. THE PIECE WAS RETRIEVED AND NO PARTS REMAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED 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 DATE OF THIS REPORT REGARDING 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 CUSTOMER CALLED IN TO REPORT THAT THEY COULD NOT REMOVE AN INSTRUMENT FROM ARM 1. THE TECHNICAL SUPPORT ENGINEER (TSE) RECOMMENDED TO PRESS THE INSTRUMENT DRIVE RELEASE BUTTON, AND THE CUSTOMER STATED THAT SHE HAD ALREADY TRIED THAT. THE TSE ADVISED TO PRESS THE EMERGENCY-STOP BUTTON ON THE PATIENT SIDE CART (PSC), AND THE CUSTOMER STATED THAT THEY HAD ALREADY MOVED THE PSC AWAY FROM THE PATIENT. THE TSE INSTRUCTED THE CUSTOMER TO PRESS THE RELEASE TABS AND WIGGLE THE PATIENT SIDE MANIPULATOR (PSM), AND THE CUSTOMER STATED THAT IT WAS NOT MOVING. THE CUSTOMER REPORTED THAT THEY FINALLY WERE ABLE TO REMOVE THE INSTRUMENT. THE TSE INSTRUCTED THE CUSTOMER TO RESEAT THE STERILE ADAPTER AND TRY A TRAINING INSTRUMENT. THE CUSTOMER RESEATED THE INSTRUMENT ARM DRAPES, CONFIRMED THE DISCS WERE SPINNING, AND INSTALLED THE TRAINING INSTRUMENT. IT WAS NOTED THAT PSM 1 STILL HAD A YELLOW LIGHT EMITTING DIODE (LED), AND THE TRAINING INSTRUMENT WAS NOT RECOGNIZED. THE TSE HAD THE CUSTOMER REMOVE THE TRAINING INSTRUMENT AND STERILE ADAPTER, AND THE CUSTOMER REPORTED THAT ONE OF THE INSTRUMENT PRESENCE PINS ON PSM 1 WAS BROKEN/

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING AN UNSPECIFIED DA VINCI-ASSISTED SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT SHEARS BROKE. A FRAGMENT FELL INSIDE THE PATIENT AND WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED ROBOTICALLY.

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-ASSISTED BRONCHOSCOPY PROCEDURE THE PATIENT EXPERIENCED A PNEUMOTHORAX. THE LOCATION WAS RIGHT UPPER LOBE. THE LOCATION OF THE PNEUMOTHORAX WAS RIGHT SIDE. DURING THE PROCEDURE THE PATIENT WENT IN CARDIAC ARREST FROM A TENSION PNEUMOTHORAX. A NEEDLE DECOMPRESSION WAS USED, AND PATIENT REGAINED THEIR PULSE. A CHEST TUBE WAS PLACED IN THE PATIENT AND THE PATIENT WAS HOSPITALIZED. THE CHEST TUBE WAS REMOVED ON (B)(6) 2021. THE PATIENT WAS DISCHARGED ON (B)(6) 2021.

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IMMEDIATELY AFTER COMPLETING BONE PREPARATION, AND POSTERIOR BONE FRAGMENTS WERE REMOVED IT WAS OBSERVED THAT THE POPLITEAL TENDON WAS NICKED AND BLEEDING. BLEEDING WAS ABLE TO BE ISOLATED AND SUTURED WITH MINIMAL DELAY IN THE CASE. SURGEON WAS REQUESTING FURTHER INFORMATION ABOUT IF THERE HAVE BEEN OTHER REPORTED INCIDENTS OF SIMILAR OCCURRENCES TO HELP ESTABLISH WHICH CUT HE MAY HAVE CAUSED THE NICK ON.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: COMPANY REPRESENTATIVE (CR) WAS IN HOSPITAL TO SUPPORT A BILATERAL SEEG. SURGEON PLANED ALL 16 TRAJECTORIES FROM BRAINLAB BURNED IN ON ROSA. WHEN WE TRIED TO LOAD THE LATEST CT WITH FIDUCIALS ROSANNA CRASHED. AFTER LOADING PATIENT FOLDER 4 TRAJECTORIES WERE MISSING COMPLETELY. 1 WAS CHANGED. SURGEON REPLANNED THE 5 TRAJECTORIES AND CHECKED ALL OTHERS AS WELL. (65 MINUTES DELAY). 2 TRAJECTORIES WERE REALLY CLOSE TO MAYFIELD. CAMENBERT USED TO SOLVE ALMOST COLLISION. WHEN POSITIONED ON FIRST 3 LEFT TRAJECTORY, SURGEON USED AXIAL MODE TO POSITION. DURING THIS MONITOR WENT BLACK. 10 SECONDES. LATER MAIN MENU TO CREATE/LOAD FOLDER OR SHUT DOWN APPEARED. AFTER RELOADING FOLDER, SURGEON WANTED TO DOUBLE CHECK ACCURACY AND PLANED A TRAJECTORY ON A FIDUCIAL. ACCURACY WAS OK. REST OF PROCEDURE WENT WITHOUT ISSUES.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING AN SEEG CASE, THE ROSA DISCONNECTED FROM THE CONTROLLER. THIS OCCURRED AFTER REGISTRATION WAS COMPLETE AND THE ROSA WAS AT THE HOME POSITION. THERE WAS NO OBVIOUS CAUSE TO THE ERROR. THERE WAS NO PATIENT IMPACT. THERE WAS AN HOUR DELAY TO THE CASE WHILE THE PATIENT WAS UNDER ANESTHESIA. THE CONTROLLER WOULD NOT RECONNECT AFTER MULTIPLE SHUTDOWNS, WITH UPWARDS OF 3 MINUTES OF POWER DOWN BEFORE RESTART. THE SOLUTION WAS DELETING THE 'SFTY.DAT' AND 'PDRV.DAT' FILES IN FTP SURFER FOR THE CONTROLLER.

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: ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT THE CASE WAS MINIMALLY INVASIVE. THE CASE WAS STARTED SUCCESSFULLY, BUT AT THE SECOND SCREW, THE SCREWDRIVER WAS STUCK ON THE SCREW AND THE SURGEON PULLED OUT THE SCREW WITH TOO MUCH FORCE CAUSING A SHOULDER SHIFT. AT THIS POINT, S1 AND L5 RIGHT SIDE SCREWS WERE ALREADY PLACED. A NEW REGISTRATION WAS DONE, BUT THE SURGICAL ARM HAD PROBLEMS REACHING THE OTHER TRAJECTORIES DUE TO THE SCREW EXTENDERS. THE SURGEON WAS ALSO NOT HAPPY WITH THE RIGHT L5 SCREW SO THEY REMOVED THEY REMOVED BOTH L5 SCREWS AND DECIDED TO START FROM THE BEGINNING. THE RIGHT L5 WAS TOO MEDIAL AND THE LEFT L5 WAS TOO LATERAL AND SUPERIOR. THE S1 LEFT SCREW WAS DEVIATED SO THE PLANNING WAS CHANGED INTRAOPERATIVELY DUE TO THE PATIENT BEING OBESE AND THE COLLISION WITH THE EXTENDERS OF L5 AND PELVIS. THE PATIENT EXPERIENCED ISSUES TWO WEEKS AFTER SURGERY. NAVIGATION WAS CHECKED AND EVERYTHING WAS OKAY.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PARTIAL NEPHRECTOMY SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS TIP COVER ACCESSORY FELL INTO THE SITUS. THE TIP COVER ACCESSORY WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) ATTEMPTED TO FOLLOW-UP WITH THE CUSTOMER TO OBTAIN ADDITIONAL DETAILS RELATED TO THE EVENT. HOWEVER, AS OF THE DATE OF THIS REPORT, NO FURTHER 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: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY SURGICAL PROCEDURE THE SYNCHROSEAL INSTRUMENT JAW HINGE PIN, END PIECE, FELL OFF THE INSTRUMENT INTO THE PATIENT. THE SURGEON RETRIEVED THE PIECE WITH A BACKUP INSTRUMENT AND CONTINUED THE PROCEDURE. NO OTHER PIECES WERE OBSERVED TO BE MISSING FROM THE INSTRUMENT. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) ADVISED THE CALLER TO PROMPT THE CUSTOMER TO RETURN THE INSTRUMENT FOR FAILURE ANALYSIS. THE PROCEDURE WAS COMPLETED 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.

ROSA Robotic Surgery — 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 SURGEON WAS PERFORMING AN SEEG CASE. WHILE POSITIONED ON THE FIRST TRAJECTORY, LF1C-CB, THE ROSA SOFTWARE SHUTDOWN, RETURNED TO THE ROSA BRAIN HOME SCREEN AND DISCONNECTED THE CONTROLLER. BECAUSE OF AN EARLIER, ALREADY REPORTED ISSUE, THE PATIENT FOLDER WAS NOT ABLE TO BE REOPENED AND PATIENT REGISTRATION HAD TO BE PERFORMED AGAIN. THIS CAUSED AROUND A 45 MINUTE DELAY TO THE CASE, ADDITIONAL ANAESTHETIC WAS PROVIDED TO THE PATIENT. ONCE REGISTRATION WAS REDONE, CASE PROCEEDED AS EXPECTED.

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 BENIGN HYSTERECTOMY SURGICAL PROCEDURE, IT WAS NOTED THAT ONE OF THE PADS ON THE HARMONIC SCALPEL FELL OFF INTO THE PATIENT. THE CUSTOMER INFORMED THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) THE ISSUE HAD OCCURRED AND THE CUSTOMER RETRIEVED THE GREY INSTRUMENT TIP PAD WITH NO ISSUES TO THE PATIENT. IT WAS NOTED THE CUSTOMER DISCARDED THE INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CLINICIAN INFORMED THE INSTRUMENT WAS INSPECTED PRIOR TO USE. PRIOR TO THE FRAGMENT FALLING, THE INSTRUMENT HAD BEEN IN USE FOR ABOUT 45  60 MINUTES. AT THE TIME OF THE REPORTED ISSUE, THE CLINICIAN NOTED THAT THE SURGEON WAS PERFORMING AN EXCISION OF FIBROIDS AND STATED THE HARMONIC INSTRUMENT AND TENACULUM INSTRUMENT COLLIDED. THE SURGEON DID NOT NOTICE AN ISSUE WITH THE INSTRUMENT FUNCTIONALITY DURING THE CASE. IT WAS NOTED THE FRAGMENT FELL OFF INTO THE PATIENT IN THE MIDDLE OF THE CASE AND DID NOT OCCUR DURING AN INSTRUMENT COLLISION. THE WHITE TIP OF THE HARMONIC INSTRUMENT WAS RETRIEVED IN ONE PIECE WITH A G

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 BY THE PATIENT THAT THEIR LIFE WAS RUINED AND THEY EXPERIENCED A SIGNIFICANT LIFE CHANGING INJURY THROUGH USE OF THE GUIDANCE SYSTEM FOR SPINAL SURGERY. THE PATIENT REPORTED HAD TWO SEPARATE PROCEDURE USING THE GUIDANCE SYSTEM.

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 REPORTED THE PATIENT WAS UNABLE TO PROPERLY MOVE THEIR FOOT AND THEY WERE UNABLE TO VOID THEIR BLADDER AFTER THE PROCEDURE. THE PATIENT'S HOSPITAL STAY WAS EXTENDED.

Mazor Renaissance — 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 BY THE PATIENT THAT THEIR LIFE WAS RUINED AND THEY EXPERIENCED A SIGNIFICANT LIFE CHANGING INJURY THROUGH USE OF THE GUIDANCE SYSTEM FOR SPINAL SURGERY. THE PATIENT REPORTED HAD TWO SEPARATE PROCEDURE USING THE GUIDANCE SYSTEM.

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 MALIGNANT HYSTERECTOMY SURGICAL PROCEDURE, THE SYNCHROSEAL INSTRUMENT WAS FOUND TO HAVE THE BUTTON FELL OFF. THE BUTTON WAS IN A CUP. THE PROCEDURE WAS COMPLETED 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 BUTTON SIMPLY FELL OFF AND WAS DISCOVERED WITHIN THE PATIENT. THE INSTRUMENT WAS INSPECTED PRIOR TO USE. THE FRAGMENT WAS LIKELY RETRIEVED WITH A ROBOTIC/LAP INSTRUMENT DURING THE CASE. NO POST-OPERATIVE TESTS LIKE AN X-RAY OR ULTRASOUND WERE PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT NOR ANY OTHER DAMAGE TO THE INSTRUMENT AFTER THE EVENT OCCURRED. THE WRIST WAS NOT STRAIGHTENED PRIOR TO REMOVAL BUT WAS STRAIGHTENED UPON FINAL REMOVAL OF THE INSTRUMENT. NO PATIENT INJURY WAS IDENTIFIED. THE PART L90200818-0262 WAS USED ON (B)(6) 2021.

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 SPLENECTOMY PROCEDURE, BLEEDING OCCURRED. THE SURGEON REPORTED THAT HE THINKS HE GRABBED A VEIN WHICH CAUSED THE BLEEDING. THE SITE GAVE THE PATIENT A BLOOD TRANSFUSION AND CONVERTED TO OPEN SURGERY. THE SURGEON REPORTED TWO DAYS AFTER THE PROCEDURE THAT THE PATIENT WAS DOING FINE. THE SURGEON REPORTED THAT HE DOES NOT BELIEVE AN INTUITIVE SURGICAL INC. (ISI) PRODUCT CAUSED OR CONTRIBUTED TO THE REPORTED INJURY. FOLLOW-UP: ON 04/22/2021, INTUITIVE SURGICAL INC. (ISI) CONTACTED THE CONSOLE SURGEON OF THE PROCEDURE AND ADDITIONAL INFORMATION WAS OBTAINED ABOUT THE EVENT: THE BLEEDING EVENT OCCURRED WHILE TAKING THE SPLENIC MINOR ATTACHMENT WITH THE SYNCHROSEAL INSTRUMENT. THE SURGEON SAID WHILE HE WAS SEALING TISSUE BLOOD STARTED FLOWING FROM IT. THE SURGEON CLARIFIED THAT THE BLOOD APPEARED WHILE THE SYNCHROSEAL INSTRUMENT WAS SEALING WITH ENERGY. THE SURGEON GRASPED THE BLEEDING VESSEL AT THE INFLOW SIDE, BUT THE BLOOD VOLUME INCREASED; THE PROCEDURE WAS THEN CONVERTED TO OPEN TO CONTROL THE BLEEDING VESSEL WITH SUTURES. THE SURGEON SAID THE VESSEL WAS NOT LARGER THAN 5MM AND THAT THE SYNCHROSEAL WAS WORKING FINE DURING THE WHOLE PROC

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE PATIENT HAD A MILD HERNIA THAT NEEDED REPAIR. IT WAS DONE ROBOTICALLY USING THE DAVINCI SYSTEM. THE PATIENT HAD A PUNCTURED ARTERY AND A LACERATED BOWEL FROM SURGICAL ERRORS DURING THE PROCEDURE. THERE WAS EXTENSIVE INTERNAL BLEEDING. THE PATIENT BECAME SEPTIC AND WITHIN THREE DAYS WAS DEAD. THE PATIENT WAS HEALTHY WHEN HE WALKED IN EVEN THOUGH HE WAS AN OLDER PATIENT. THE PATIENT WENT TO THE HOSPITAL WITH UPPER ABDOMINAL PAIN. IT WAS DETERMINED HE HAD A HERNIA AND HE WAS SENT TO A DOCTOR TO HAVE IT REPAIRED. FDA SAFETY REPORT ID # (B)(4).

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 MASTER KNIFE WAS CUTTING THE LIVER, AND THE ULTRASONIC KNIFE HEAD SUDDENLY BROKE OFF WITHOUT ANY HINT. FORTUNATELY, THE BROKEN KNIFE HEAD WAS PICKED OUT. THE FRAGMENT WAS RETRIEVED DURING THE OPERATION. THE PROCEDURE WAS COMPLETED WITH A BACKUP DA VINCI INSTRUMENT OF THE SAME KIND, AND THERE WAS NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CUSTOMER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE. THE INSTRUMENT WAS USED FOR APPROXIMATELY ONE HOUR PRIOR TO THE BREAKAGE. THE SURGEON HAD NO ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE PROCEDURE. THE SURGEON HAD NO ISSUES WITH REMOVING THE INSTRUMENT FROM THE ARM PRIOR TO THE BREAKAGE. THERE WAS NO REPORT OF COLLISION WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIAL. ALL FRAGMENT(S) WERE RETRIEVED WITH THE ENDOSCOPIC INSTRUMENT DURING THE SAME PROCEDURE. NO SURGICAL PROCEDURES WERE REQUIRED TO REMOVE THE FRAGMENT. NO POST-OPERATIVE TESTS WERE PERFORMED TO CHECK FOR REMAINING FRAGMENTS. NO INFORMATION WAS PROVIDED PERTAINING TO IF THE PATIENT HAS RETURNED TO THE HOSPITAL DUE TO PO

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ABSTRACT: TO COMPARE THE PATIENT-REPORTED OUTCOMES (PROS) BETWEEN PATIENTS UNDERGOING MULTILEVEL LUMBAR FUSION WITH ROBOT-ASSISTED VS. FREEHAND TECHNIQUES. THIS WAS A SINGLE-INSTITUTION COHORT STUDY OF ADULT PATIENTS (=18 YEARS OLD) UNDERGOING ROBOT-ASSISTED SPINE SURGERY FROM 2016 TO 2018 WITH MINIMUM 2-YEAR FOLLOW-UP. A PROPENSITY-SCORE MATCHING (PSM) ALGORITHM ACCOUNTED FOR SEVERAL PERIOPERATIVE FACTORS. PROS WERE MEASURED USING THE OSWESTRY DISABILITY INDEX (ODI). THE MINIMUM CLINICALLY IMPORTANT DIFFERENCE (MCID) BETWEEN GROUPS WERE ASSESSED AT EACH FOLLOW-UP PERIOD (6-WEEKS/6-MONTHS/1-YEAR/2-YEARS). CHI-SQUARE/FISHER EXACT TEST AND T-TEST/ANOVA WERE USED FOR CATEGORICAL AND CONTINUOUS VARIABLES, RESPECTIVELY. AFTER PSM, A TOTAL OF 70 PATIENTS REMAINED. THE MEAN (STANDARD DEVIATION) CHARLSON COMORBIDITY INDEX WAS 1.4 (1.0) AND 57% OF PATIENTS WERE FEMALE. THE MOST COMMON DIAGNOSES INCLUDED DEGENERATIVE DISC DISEASE (37.1%), DEGENERATIVE SCOLIOSIS (27.1%), AND HIGH GRADE SPONDYLOLISTHESIS (GRADE > 2) (19%), AND THE MEAN NUMBER OF INSTRUMENTED LEVELS WAS 4.6 (4.4). RATES FOR INTRAOPERATIVE/POSTOPERATIVE COMPLICATIONS, AND ANY REOPERATION WITHIN 2 YEARS AFTER SURGERY WERE LOW AND