ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS THE VERIFICATION STAGE WAS OVER, THE FIELD SERVICE ENGINEER COMMUNICATED CLEARING THE ARM ON 'FREE AND FAST'. THE ARM WASN'T CLEARED ALL THE DUE TO THE RESIDENT WANTING TO CHECK ANOTHER POINT NEAR THE TEMPLE, THAT IN TURN RESULTED IN A COLLISION AS THE ARM WASN'T CLEARED. THE ROSA DETECTED A COLLISION AND SHUT DOWN, THE FIELD SERVICE ENGINEER ENGAGED THE EMERGENCY BUTTON AND A MANUAL CLEARING OF THE POINTER PROBE 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: WHEN REMOVING THE MONOPOLAR SCISSOR FROM THE ROBOTIC PORT, IT WAS NOTED THAT THE (DISPOSABLE) COVER TIP WAS MISSING. UPON LOOKING IT WAS STILL IN THE TROCAR AND TORN. IT WAS THEN REMOVED AND A NEW ONE WAS PLACED ON THE SCISSORS. NO HARM TO PT. FDA SAFETY REPORT ID# (B)(4).

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE COMPANY FIELD SERVICE ENGINEER WAS PRESENT FOR A SEEG CASE. THE FIRST COMPLAINT OCCURRED IN THE MORNING CASE AT 9:18 AM WHEN THE ROBOT SHUT DOWN IN FREE AND FAST WHILE BACKING OUT AFTER REGISTRATION WAS COMPLETE. THE SECOND COMPLAINT OCCURRED IN THE MORNING CASE AT 10:14 AM WHEN THE ROBOT SHUT DOWN IN AXIAL FAST WHILE IN GUIDANCE MODE. THERE WAS A VIGILANCE DEVICE FAILURE AND THE ROBOT SHUT DOWN. THE ROBOT ARM WAS COMING BACK TO HOME AFTER THE SURGERY AND THE RESIDENT/MED STUDENT WAS STEPPING ON AND OFF THE PEDAL WHEN THE VIGILANCE DEVICE FAILED AND SHUT DOWN.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON 9/23/2019, IT WAS REPORTED THAT DURING A MONARCH-ASSISTED BIOPSY PROCEDURE, THE PATIENT EXPERIENCED A PNEUMOTHORAX. THE PNEUMOTHORAX WAS NOTED TO BE IN THE SAME AREA AS THE TARGET LESION. THE CUSTOMER CONFIRMED THAT THE CUSTOMER RECEIVED A CHEST TUBE AND SHORTLY RECOVERED AND WAS RELEASED. BASED ON THE INFORMATION PROVIDED BY THE PHYSICIAN, THERE WAS NO DEVICE FAILURE. IT WAS THE CUSTOMER'S BELIEF THAT THE PNEUMOTHORAX COULD BE ATTRIBUTED TO THE BIOPSY THAT WAS PERFORMED WITH NON-AURIS INSTRUMENTS.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE SYSTEM PLACED SCREWS AT LL AND L4 ACCURATELY, BUT L2 AND L3 WERE WAY OFF. ACCORDING TO THE LOCAL TEAM, THE SURVEILLANCE WAS FINE AND THE MERGE WAS ACCEPTABLE. THE PATIENT IS DOING WELL BUT HAD A SMALL DURAL SCRATCH WHICH WAS REPAIRED INTRA-OPERATIVELY WITH NO SERIOUS LONG-TERM EFFECT 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: ON 9/20/2019, IT WAS REPORTED THAT AFTER A MONARCH- ASSISTED BIOPSY PROCEDURE, THE PATIENT EXPERIENCED A PNEUMOTHORAX. THE LOCATION OF THE PNEUMOTHORAX WAS UNKNOWN. THE LESION WAS LOCATED IN THE RIGHT UPPER LOBE. THE PHYSICIAN DROVE TO THE LESION AND COLLECTED A BIOPSY USING A SUPERD ARCPOINT NEEDLE, SUPERD TRIPLE NEEDLE BRUSH AND AURIS FORCEPS. THE PNEUMOTHORAX WAS UNKNOWN UNTIL AFTER THE CASE WAS COMPLETED. ON (B)(6) 2019,FOLLOW UP WITH THE CUSTOMER CONFIRMED THAT THE PATIENT RECEIVED A CHEST TUBE, THE PATIENT RECOVERED FROM THE PNEUMOTHORAX, AND WAS RELEASED.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON 9/19/19, IT WAS REPORTED THAT DURING A MONARCH-ASSISTED BIOPSY PROCEDURE, THE PATIENT EXPERIENCED A PNEUMOTHORAX. THE CASE INVOLVED TWO TARGETS, ONE IN THE RIGHT LOWER LOBE AND ONE IN THE RIGHT UPPER LOBE. THE PHYSICIAN FIRST NAVIGATED THE BRONCHOSCOPE TO THE FIRST TARGET, WHICH WAS IN THE RIGHT LOWER LOBE AND COLLECTED BIOPSIES USING AN OLYMPUS PERRY FLEX NEEDLE AND AURIS BIOPSY FORCEPS. AFTER ACQUIRING THE SAMPLE FROM THE TARGET IN THE RIGHT LOWER LOBE, THE PHYSICIAN THEN PROCEEDED TO NAVIGATE THE BRONCHOSCOPE TO THE TARGET IN THE RIGHT UPPER LOBE. WHILE NAVIGATING IN THE RIGHT UPPER LOBE, THE PHYSICIAN OBSERVED THE PNEUMOTHORAX IN THE APEX OF THE LUNG. ON (B)(6) 2019, FOLLOW UP WITH THE CUSTOMER CONFIRMED THAT THE PATIENT RECEIVED A CHEST TUBE, RECOVERED FROM THE PNEUMOTHORAX, AND WAS RELEASED TWO DAYS AFTER. BASED ON FOLLOW-UP WITH THE CUSTOMER , THAT THERE WAS NO DEVICE FAILURE.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE SURGEON CALLED THE FIELD SERVICE ENGINEER TO NOTICE THAT THE ROBOT IS NOT USABLE DUE TO UNRECOVERABLE ERROR MESSAGE AND SHUT DOWN. THE MESSAGE APPEAR WHEN THE SYSTEM SHOULD START THE CONNECTION WITH THE ROBOTIC ARM, IN ORDER TO MOVE BETWEEN PARKING TO HOME POSITION. THE SURGERY IS CANCELLED.

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 AFTER UNDERGOING A DA VINCI-ASSISTED NEPHRECTOMY PROCEDURE, THE PATIENT EXPERIENCED POST-OPERATIVE BLEEDING. AS A RESULT, THE PATIENT UNDERWENT A SPLENECTOMY VIA OPEN SURGERY ON AN UNSPECIFIED DATE. HOWEVER, AT THIS TIME, THE ROOT CAUSE OF THE POST-OPERATIVE BLEEDING IS UNKNOWN. ON 10/18/2019, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES ASSOCIATE (CSA), AND THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT WAS OBTAINED: THE CSA WAS NOT PRESENT DURING THE DA VINCI-ASSISTED NEPHRECTOMY. ACCORDING TO THE CSA, SHE OVERHEARD A CONVERSATION IN THE HOSPITAL REGARDING THIS PATIENT. THE PATIENT REPORTEDLY EXPERIENCED A POST-OPERATIVE BLEED THAT RESULTED WITH A SPLENECTOMY. ON 10/18/2019, ISI ALSO CONTACTED THE ISI CLINICAL TERRITORY ASSOCIATE (CTA) WHO WAS PRESENT DURING THE DA VINCI-ASSISTED NEPHRECTOMY PROCEDURE WHICH WAS NOT RECORDED ON VIDEO. ACCORDING TO THE CTA, THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO REPORTED MALFUNCTIONS OF THE DA VINCI SURGICAL SYSTEM. THERE WERE ALSO NO INTRA-OPERATIVE COMPLICATIONS.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING THE FIRST REGISTRATION FOR THE SEEG THE ROBOT CRASHED. THE 2., 3. AND 4. REGISTRATION SHOWED A INSUFFICIENT ACCURACY WARNING MESSAGE. DR. (B)(6) CHECKED THE ACCURACY ON THE VERIFICATION AND WITH THE LAST ONE, HE WAS OK TO DO SURGERY.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE FIELD SERVICE ENGINEER SENT AN EMAIL ON 27-AUG-2019 WITH THE FOLLOWING INFORMATION: PLEASE RECORD A NEW COMPLAINT - ROBOT CRASHING AFTER REGISTRATION OF THE PATIENT WITH LASER REGISTRATION, WHEN ACCEPTING THE MERGE OF THE AUTOMATIC SCAN WITH THE 3D-MASH. SO BEFORE STARTING THE VERIFICATION. SURGEON TRIED THIS 2 TIMES WITH THE LASER. SAME ERROR OCCURRED WITH LANDMARK REGISTRATION WITH THE POINTER. ROBOT AGAIN CRASHED WHEN STARTING VERIFICATION STEP. ENDOSCOPY CASE CANCELLED. BIOPSY WHICH WAS PLANNED AFTER WITH THE ROBOT SWITCHED TO VARIOGUIDE. THE FIELD SERVICE ENGINEER SENT AN EMAIL ON 02-SEP-2019 WITH THE FOLLOWING INFORMATION: FOR FURTHER EXPLANATION: HE WAS THERE ON FRIDAY ((B)(6) 2019) AND COLLECTED THE LOG-FILES AND DID SOME TESTS. HE CHECKED, THAT THE ERROR OCCURRED ONLY ON THIS PATIENT FOLDER. THE MAINTENANCE PATIENT FOLDER IS WORKING PERFECTLY. HE ALSO REIMPORTED THE PATIENT FOLDER AGAIN FROM THE LAPTOP. THE ERROR WAS THE SAME. EVERYTIME, WHEN ENTERING VERIFICATION, THE SYSTEM CRASHED. THE WINDOWS ERROR MESSAGE WAS (B)(4) HAS STOPPED WORKING. THE (B)(4) LOGS SHOW AN UNKNOWN ERROR/EXCEPTION.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING A SURGERY WHERE THE FIELD SERVICE ENGINEER (FSE) WAS PRESENT THE SURGEON TOLD HIM THAT ON TUESDAY (B)(6) 2019 THE CONTACTLESS REGISTRATION COULD NOT BE COMPLETED, DESPITE HAVING BEEN TRIED SEVERAL TIMES (7 ATTEMPTS MADE), AND THAT THEREFORE THE SURGERY WAS CANCELLED. AFTER LOGS AND ROBOT CHECKS THE FSE NOTICED THAT THE OPTICAL DISTANCE SENSOR CONNECTOR WAS LOOSE. HE SCREWED THE CONNECTOR AND IT WAS POSSIBLE TO PERFORM THE CONTACTLESS REGISTRATION (E.G. THE MEASUREMENT WAS NOT INTERRUPTED ANYMORE).

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE SURGEON HAD A (B)(4) TRAJECTORIES SEEG CASE. THE PATIENT WAS ANESTHETIZED, PINNED, AND REGISTERED WITH BONE FIDUCIALS. VERIFICATION WAS COMPLETED AND REGISTRATION WAS VALIDATED. THE FIRST (B)(4) TRAJECTORIES WERE IMPLANTED. ON THE 5H TRAJECTORY, THE SURGEON HAD SOME TROUBLE PUNCTURING THE DURA, BUT WAS ABLE TO GET IT PLACED. THE SURGEON THEN MOVED ONTO THE NEXT TRAJECTORY (TRAJECTORY1) AND DRILLED THE 2.45MM DRILL HOLE. THERE WAS BLOOD COMING BACK AS SOON AS THE DRILL WAS REMOVED, SO THE SURGEON FLUSHED IT WITH SALINE FOR A FEW MINUTES. ONCE THE BLEEDING SLOWED, THE SURGEON DECIDED TO NOT IMPLANT THAT TRAJECTORY AND MOVED ONTO THE NEXT (TRAJECTORY (B)(4) ). THIS ONE WAS DRILLED AND THE SAME THING HAPPENED, WHEN THE BONE WAS DRILLED, BLOOD AUTOMATICALLY CAME BACK. AT THIS POINT, THE PATIENT WAS TAKEN OUT OF PINS AND TRANSFERRED TO A CT. THE SCAN SHOWED THAT THERE WAS AN EPIDURAL HEMATOMA. ROSA WAS REMOVED FROM THE ROOM AND THE PATIENT WAS BROUGHT BACK TO THE OR, ALL OF THE ELECTRODES THAT HAD BEEN PLACED WERE ALL REMOVED. A BONE FLAP WAS THEN REMOVED AND THE HEMATOMA WAS EVACUATED. THE CT SCAN WAS LOADED INTO ROSA AND IT WAS CONFIRMED THAT ALL OF THE BOLTS WERE ON TRAJECTORY, SO

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: FIELD SERVICE ENGINEERS (FSE) WERE PRESENT TO ASSIST A SURGERY. THE FIRST EVENT OCCURRED UNDER THE ROSA GUIDANCE TAB. SURGEONS PLACED THE SKULL CLAMP IN A POSITION WHERE THE STRUCTURE OF THE SKULL CLAMP DOES NOT INTERFERE WITH THE TRAJECTORIES PLANNED. HOWEVER, THE SKULL CLAMP POSITION DID MAKE IT DIFFICULT TO APPROACH WITH THE ROSA ARM ON THE LEFT SIDE OF THE PATIENT¿S HEAD. ONCE THE ROSA ARM WAS DRIVEN TO THE FIRST TRAJECTORY, IT WAS CLEAR THAT THERE WAS A HIGH RISK OF COLLISION. THE ROSA ARM¿S MOVEMENTS WERE STOPPED. THE PLAN WAS THEN TO CHANGE THE INSTRUMENT LENGTH OF THE FIRST TRAJECTORY TO A BIGGER VALUE SO THAT HE ROSA ARM CAN APPROACH THE ENTRY POINT AT A FURTHER DISTANCE AWAY. THE FSE SELECTED THE OPTIONS 'AXIAL' AND 'SLOW' FOR THE SURGERON TO BEGAN CLEARING THE ROSA ARM FROM THE PATIENT¿S HEAD. THE FSE THEN CHANGED THE SELECTION TO 'FREE' AND 'FAST' IN COOPERATIVE MODE ONCE THE ROSA ARM WAS BACKED AWAY AT A REASONABLE DISTANCE FROM THE SKULL CLAMP. HOWEVER, THE SURGEON STRUGGLED WITH THE CONTROL OF THE ROSA ARM. HE ACCIDENTALLY DROVE IT BACK TOWARDS THE SKULL CLAMP AND COLLIDED WITH IT. THE ROSA ROBOT DETECTED A COLLISION AND SHUTDOWN AS A RESULT. DUE TO THE POSITION OF T

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE SURGEON FOUND THAT THE PATIENT EXPERIENCED A HEMORRHAGE AFTER THE SEEG PROCEDURE. THE SURGEON STATED THAT THE IMMEDIATE POST-OP CT LOOKED NORMAL. LATER IN THE DAY THE PATIENT BECAME LETHARGIC AND A SECOND CT SCAN WAS TAKEN. THIS SECOND CT INDICATED THAT THERE WAS AN EDEMA. THE SEEG ELECTRODES WERE IMMEDIATELY REMOVED. THE SURGEON STATED THAT IT IS UNKNOWN WHAT COULD HAVE CAUSED THIS TO OCCUR AND THAT IT WAS NOT NOTICEABLE IMMEDIATELY AFTER SURGERY.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE SURGEON DID 2 TIMES THE REGISTRATION, BUT THE ROBOT COULD NOT REACH THE REQUESTED TRAJECTORY WITH THE ENDOSCOPE. THEN, HE TRIED WITH THE OPTICAL DISTANCE SENSOR AND THIS WORKED FINE.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON JULY 31, THE ROBOTIC ARM FAILED TO CONNECT. AFTER INSPECTION, WE CAN'T SOLVE THIS PROBLEM. THE FINAL SITUATION AS BELOW: - WHEN ENTERING THE ROSA APPLICATION INTERFACE, IT IS IMPOSSIBLE TO CONNECT ROBOTIC ARM. - WHEN ENTERING MAINTENANCE INTERFACE, FIRST OPEN ROSARIO SOFTWARE, THEN OPEN ROSANNA SOFTWARE, THE ROBOTIC ARM WORK WELL, OTHERWISE IT CAN'T. IT WAS REPORTED THAT DUE TO THIS EVENT THE SURGERY WAS POSTPONED FOR ONE DAY, WITHOUT REPORTED IMPACT ON THE PATIENT.

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 ALL OF THE SCREWS WERE NOT TO PLAN. ALL OF THE LEFT SIDE SCREWS WERE IN THE SPINAL CANAL AND THE RIGHT HAND SCREWS WERE LATERAL TO PLAN. PRIOR TO THE PROCEDURE, A 10 POINT ACCURACY CHECK WAS DONE AND THE GUIDANCE SYSTEM WAS ACCURATE ON ALL TRAJECTORIES. A SURGICAL ARM AND SHOULDER CHECK WERE ALSO DONE AND BOTH PASSED. THE TRAJECTORIES WERE PLANNED BY THE SURGEON AND THE C-ARM WAS CALIBRATED. THE GUIDANCE SYSTEM WAS PLACED ON THE BED AND DRAPED AS NORMAL. DURING THE PROCEDURE, EXPOSURE AND MARKING FILMS WERE DONE BEFORE THE SURGICAL SYSTEM WAS ATTACHED TO THE PATIENT. EXPOSE WAS GENEROUS AND THERE WERE NO ISSUE WITH SOFT TISSUE PRESSURE. A DUAL CLAMP WAS USED AT T4 AND T5. THE CONSTRUCT WAS RIGID BEFORE THE GUIDANCE SYSTEM WAS PLACED TO ATTACH TO THE CLAMP. A 3DEFINE SCAN AND DRAW SPINE WERE THEN COMPLETED. REGISTRATION WAS COMPLETED WITH TWO AP AND TWO OBLIQUE SHOTS. DURING IMAGING, RESPIRATION WAS SUSPENDED TO AVOID AN CROSS VIEW ERRORS. SEGMENTATION WAS ACHIEVED ON FIRST ATTEMPT AT LABELING AND ALL TRAJECTORIES WERE GREEN. REGISTRATION WAS APPROVED BY THE SURGEONS

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING THE VERIFICATION STEP, A COMMUNICATION ERROR OCCURRED WHILE MOVING TO ONE OF THE VERIFICATION POINTS. THE ROBOT WAS RESTARTED AND THE VERIFICATION SCREEN WAS OPENED TO RE-CHECK THE POINTS. WHILE THE POINTS LOOKED GOOD ORIGINALLY, OPEN RESTARTING THE DEVICE, THEY LOOKED FURTHER AWAY FROM THE SKIN. THE VERIFICATION STEP WAS STARTED AGAIN, BUT THE RED CIRCLE WAS MISSING. IT WAS NOTED THAT THE WRONG CT WAS USED TO CHECK THE VERIFICATION AND THAT WAS LIKELY WHY THE POINTS WERE OFF. THE ROBOT WAS RESTARTED AND VERIFICATION WAS ATTEMPTED AGAIN WITH THE CORRECT CONTRAST ON THE CT, BUT THE CIRCLE WAS MISSING AGAIN. THE ROBOT WAS RESTARTED A FINAL TIME AND REGISTRATION WAS RE-PERFORMED.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: STARTING AROUND 9AM EST, THE FIRST OF THREE LASER REGISTRATIONS WERE PERFORMED. EACH VERIFICATION SHOWED THE REGISTRATION TO BE UNSATISFACTORY AT POINTS NEAR THE OUTER CANTHI AND THE SKIN LATERAL TO THE OUTER CANTHI. ALL OTHER POINTS ON THE SKIN SURFACE (FOREHEAD, NASION, TEMPLES, ETC.) SHOWED SATISFACTORY RESULTS, BUT SINCE SOME TRAJECTORIES WERE PLANNED NEAR THE UNSATISFACTORY AREA, THE SURGEON DID NOT FEEL COMFORTABLE WITH MOVING FORWARD WITH ANY OF THE REGISTRATIONS. THE CT SCAN BEING USED WAS RECENT, AND THE 3D SEGMENTED MODEL APPEARED TO BE CLEAR AND CORRECT. THE MANUAL SCANS LOOKED GOOD FOR EACH REGISTRATION. WHEN PICKING THE INITIAL POINTS ON THE FACE AND TRYING TO MATCH THE POINTS WITH THE LASER, THE POINTS AT THE OUTER CANTHI ALWAYS SHOWED TO BE INSIDE THE 3D MODEL (INSIDE THE SKIN BY ABOUT 2MM). SINCE THIS WAS LESS THAN 2.9MM, THE RESULTS WOULD BE GREEN AND THE REGISTRATION WOULD BE MOVED FORWARD. NO MATTER HOW MANY TIMES THE OUTER CANTHI POINTS WERE ATTEMPTED WITH THE LASER, IT ALWAYS SHOWED TO BE INSIDE THE SKIN. AFTER THE THREE ATTEMPTS, SURGEON SWITCHED TO BONE FIDUCIALS, AND AN RMS OF 0.78MM WAS ACQUIRED. AFTER VERIFICATION, SURGEON WAS OKAY WITH MOVING FORWARD. AFT

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE FIELD SERVICE ENGINEER WAS MADE AWARE OF DEPTH ELECTRODES BEING PLACED INACCURATELY ON (B)(6) 2019. EPILEPSY TEAM MEMBER INFORMED THAT THE 9 OUT 10 ELECTRODES WERE PLACED DEEPER THAN INTENDED BY MARGIN OF AT LEAST 3 OR 4 MM AND IN CERTAIN CASES 9 OR 10MM. HE SHOWED ME THE POST-OPERATIVE CT SCAN AND MERGED IT WITH THE PRE-OP MRI SCAN THAT WAS USED TO PLAN THE ROSA SEEG CASE. NOT ONLY WERE THE ELECTRODES PLACED DEEP BUT THEY WERE ALSO INACCURATE IN TERMS OF BOLT PLACEMENT. THE SURGEON ADJUSTED AND PULLED A FEW OF THE MORE DEEP ELECTRODES BACK FOR BETTER PLACEMENT.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: LASER REGISTRATION WAS PERFORMED THREE TIMES, BECAUSE THE FIRST TWO REGISTRATIONS DID NOT SHOW GOOD ACCURACY IN THE VERIFICATION STEP. DURING THE FIRST REGISTRATION, THE SURGEON ACCIDENTALLY PLACED HIS FINGER IN FRONT OF THE LASER DURING THE RIGHT SIDE OF THE NOSE SCAN. THERE WAS NO ERROR MESSAGE AFTER THE REGISTRATION WAS PERFORMED; HOWEVER, THE CROSS-HAIR WITHIN THE CIRCLE ON THE NASEON AND OUTER CANTHUS POINTS LOOKED SLIGHTLY DEEP WHILE IT LOOKED SHALLOW ON THE TEMPLES. THE REGISTRATION WAS CANCELLED AND THE 3D MODEL WAS RESTRUCTURED BEFORE TRYING AGAIN. THE SECOND REGISTRATION AGAIN DID NOT SHOW ANY ERROR MESSAGE; HOWEVER, THE VERIFICATION WAS THE SAME. REGISTRATION WAS ATTEMPTED A THIRD TIME. THE 3D MODEL WAS RECONSTRUCTED AGAIN AND THE FOREHEAD POINTS WERE REDEFINED TO AVOID ANY DEFORMATION OF THE SKIN FROM THE LEKSELL PINS. THE NOSE AND TEMPLE SCANS WERE PERFORMED ON THE BONY PARTS OF THE ANATOMY. VERIFICATION OF THIS FINAL REGISTRATION LOOKED GOOD. THE DELAY WAS AN HOUR AND 20 MINUTES.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE SURGEON INFORMED THE FIELD SERVICE ENGINEER BY PHONE, THAT HE HAD SOME ISSUES DURING THE ENDOSCOPY CASE. HE DID THE REGISTRATION AND WANTED TO SENT ROSA ON TRAJECTORY. THE TRAJECTORY WAS NOT REACHABLE FOR THE ROBOT. THE SURGEON SWITCHED TO POSITION FOR NAVIGATION. HE THEN PUSHED THE ARM DOWN ALONG TRAJECTORY AND HAD A COMMUNICATION ERROR OCCURRED. AFTER RESTARTING THE SYSTEM, THE PATIENT FOLDER WAS NOT READ/LOADABLE ANY MORE. THE SURGEON DID NOT WANT TO REREGISTER THE PATIENT AND DECIDED TO DO THE SURGERY WITHOUT THE ROBOT.

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 A SURGERY THE CT IMAGE FROM O-ARM DID NOT MERGE CORRECTLY WITH THE CT SCAN LOADED ON THE PATIENT FOLDER WITH THE AUTOMATIC MERGE FUNCTION. SCAN WAS RE-MERGED TO THE MRI SCAN AND MERGED WELL.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT IS REPORTED THAT DURING KNEE ARTHROPLASTY WHEN THE SURGEON WAS VALIDATING THE TIBIAL CUTS, THE SYSTEM WAS STATING THAT NOT ENOUGH WAS CUT PER THE PLAN AND THE ROD SHOWED BAD ALIGNMENT. THE SURGEON MADE ADDITIONAL CUTS TO BRING THE TIBIA INTO NEUTRAL ALIGNMENT WHEN HE SWITCHED TO CONVENTIONAL INSTRUMENTATION.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: CONTACTLESS LASER REGISTRATION WAS UTILIZED WITH THE PATIENT. THE EVENT OCCURRED DURING THE GUIDANCE PORTION OF SURGERY. THE ROSA ARM WAS SENT TO THE FIRST TRAJECTORY. THE ROSA COMPLETE ITS MOVEMENT FURTHER AWAY FROM THE PATIENT THAN NORMALLY OBSERVED. THE SURGEON PROCEEDED TO DO THE USUAL SURGICAL TECHNIQUE TO PLACE IN THE ANCHOR BOLT. WHEN THE SURGEON WAS READY FOR THE DISTANCE TO TARGET MEASUREMENT TO BE TAKEN, THE FIELD SERVICE ENGINEER (FSE) HIT THE DISTANCE TO TARGET BUTTON ON THE ROSA MONITOR BUT NO MEASUREMENT APPEARED ON THE SCREEN. THE FSE ASKED THE SURGEON TO MOVE THE ROSA ARM BACKWARDS AXIALLY AND APPROACH THE ANCHOR BOLT AGAIN SO HE COULD RETRY THE DISTANCE TO TARGET MEASUREMENT. AFTER THE PREVIOUS STEP, STILL NO MEASUREMENT SHOWED UP ON THE SCREEN. THE FSE DECIDED TO HAVE THE ROSA ARM CLEARED AWAY FROM THE PATIENT¿S HEAD, MOVED TO HOME AND THEN HAVE THE ROSA ARM BE DRIVEN BACK ON THE SAME TRAJECTORY AS LAST TIME. THE ROSA ARM ONCE AGAIN STOPPED FROM A FURTHER DISTANCE AWAY FROM THE PATIENT¿S HEAD THAN COMMONLY OBSERVED. THE FSE PUT THE COOPERATIVE MODE TO AXIAL AND SLOW. THE VIGILANCE DEVICE PEDAL WAS PRESSED AND THE SURGEON PUT PRESSURE ON THE DRILL ADAPTOR TO DRIVE

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING THE FIFTH ATTEMPT TO REGISTER THE PATIENT, AN UNEXPECTED ROBOT SHUTDOWN OCCURRED. NO ERROR WAS SHOW ON SCREEN, SCREEN WENT BLACK, WHILE THE LASER STAYED ON. THE SYSTEM REMAINED PLUGGED IN, NO CONTACT HAD BEEN MADE WITH THE ROSA POWER CORD OR POWER OUTLET. A BRAINLAB SYSTEM WAS PLUGGED INTO SAME OUTLET AND WAS NOT AFFECTED. AT THIS POINT, THE USE OF ROSA FOR THE CASE WAS ABORTED BECAUSE OF LAST REGISTRATION ISSUE. SEEG WITH GRIDS AND STRIPS PROCEDURE. NO INCISION MADE.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REGISTRATION COMPLETED THREE TIMES BUT UNABLE TO ACHIEVE SUFFICIENT ACCURACY UPON VERIFICATION. SURGEON CHOSE TO ABORT PROCEDURE USING ROSA AND USED BRAINLAB INSTEAD. THE FIRST REGISTRATION WAS COMPLETED WITH SIGNIFICANT DIFFERENCES BETWEEN THE REFERENCE POINTS ON THE IMAGES AND THE POINTS COLLECTED DURING THE REGISTRATION. DURING VERIFICATION, IT WAS NOTED THAT THE MATCHING WAS NOT SATISFACTORY. SUFFICIENT ACCURACY ACCORDING TO THE SOFTWARE OCCURRED DURING THE SECOND ATTEMPT, AND THE SURFACE MATCHING SEEMED OK, BUT WHEN ATTEMPTING TO VERIFY THE INSULA TRAJECTORY, THE DISTANCE SENSOR WAS > 2 MM FROM SURFACE OF SCALP. REGISTRATION WAS THEN REPEATED FOR A THIRD TIME. FOR THIS ATTEMPT, THE 3D RECONSTRUCTION WAS ADJUSTED ALONG WITH THE CONTRAST, AND THE SURGEON MADE SURE TO BE MORE ORTHOGONAL TOWARDS SURFACE OF SKIN. AGAIN, THIS WAS INSUFFICIENT, AND ANOTHER ATTEMPT WAS MADE TO REGISTER THE PATIENT WITH ADDITIONAL 3D RECONSTRUCTION MODIFICATIONS MADE TO REMOVE ANY ARTIFACT OR HAIR ON THE RECONSTRUCTION. 2 HOUR DELAY OCCURRED DUE TO THE REPEATED REGISTRATION ATTEMPTS. SURGERY WAS TO BE SEEG WITH GRIDS AND STRIPS. FULL ACCURACY, APPLICATIVE AND PREVENTATIVE MAINTENANCE WERE PERFORMED.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE SURGEON CALLED HE FIELD SERVICE ENGINEER (FSE) TO ASK FOR A SOLUTION, HOW HE CAN GET THE ROBOT TO MOVE AGAIN, AFTER THE ROBOT HIT THE SUSTAINING ARM THE ROBOT SHOWED AN UNRECOVERABLE ERROR. THE ERROR APPEARED DIRECTLY AFTER RECONNECTING TO THE ROBOT, EVEN AFTER A COMPLETE COLD START (HARDWARE SWITCH OFF, WAITING UNTIL THE LIGHT ON THE RESET BUTTON IS OFF). FINALLY THE SURGEON REMOVED THE PATIENT, REMOVED THESUSTAINING ARM BY PULLING IT OUT, LEAVING A BIG SCRATCH ON THE SUSTAINING ARM. LIKE THIS THE REGISTRATION HAD TO BE DONE AGAIN. THE FSE ASSUMES A DELAY OF MORE THAN 30 MINUTES INCLUDING REGISTRATION.

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 GLASS PANE ON THE OPTICAL TIP OF THE 0 DEGREE 8MM ENDOSCOPE LED LIGHTS ALLEGEDLY "DISSOLVED." IT WAS UNKNOWN IF THE "DISSOLVED" PARTICLES OR SHARDS WERE INTRODUCED INTO THE PATIENT'S ANATOMY. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

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 AFTER PERFORMING AN UNSPECIFIED DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SURGEON IDENTIFIED A URETER THAT WAS UNINTENTIONALLY DISSECTED. THE SURGEON REPORTEDLY HAD TO REPAIR THE URETER. HOWEVER, AT THIS TIME, THE ROOT CAUSE OF THE OPERATIVE COMPLICATION IS UNKNOWN. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A FIELD SERVICE ENGINEER ASSISTED AT SPECTRUM HEALTH WITH AN SEEG CASE ON (B)(6) 2019 USING (B)(4). BONE FIDUCIALS WERE PLACED INTO PATIENT'S HEAD AND THE PATIENT WAS TAKEN TO GET A CT SO THE SCAN COULD BE USED FOR REGISTRATION. AFTER OBTAINING THE CT (AROUND 4:43PM EST), THE IMAGE SET WAS MERGED TO THE PRE-OP CTA SCAN USING THE AUTOMATIC FEATURE. THE SURGEON DID NOT APPROVE OF THE AUTOMATIC MERGE BETWEEN THE SCANS. THE CT WAS ALSO MERGED TO THE NEWEST MR SCAN THAT WAS UPLOADED, WHICH APPEARED TO MERGE CORRECTLY. WHEN COMPARING THE NEW CT FROM THIS MERGE WITH THE PRE-OP CTA, THERE WAS A VERY NOTICEABLE DIFFERENCE BETWEEN THE TWO SCANS. THE SURGEON WOULD LIKE TO KNOW WHY THE AUTOMATIC MERGE DID NOT WORK. TWO DIFFERENT BONE FIDUCIAL SCANS WERE UPLOADED AND ATTEMPTED TO BE MERGED, BUT NEITHER WORKED (ONE SET WAS AROUND 330 SLICES BUT WAS CUT DOWN BELOW 255 SLICES, AND THE OTHER SET WAS AROUND 210 SLICES). THE SURGEON DECIDED TO CANCEL THE CASE AND RESCHEDULE FOR (B)(6) 2019. THE PATIENT WAS UNDER ANESTHESIA AND INCISIONS WERE MADE FOR BONE FIDUCIALS. THE BONE FIDUCIALS WILL BE LEFT IN THE PATIENT'S HEAD UNTIL THE RESCHEDULED SURGERY DATE.

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 FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A GUIDANCE DEVICE BEING USED IN A SPINAL PROCEDURE. IT WAS REPORTED THAT THE STEALTH EDITION CAMERA UPGRADE WAS PERFORMED THIS PAST FRIDAY. THE 4.2 SOFTWARE HAD BEEN INSTALLED FOR A FEW MONTHS. STEALTH EDITION WAS NOT USED FOR THIS CASE. THE PATIENT WAS PLACED IN THE LATERAL POSITION FOR LATERAL PROCEDURE WITH THE LEFT SIDE UP. A SCHANZ PIN WAS PLACED IN LEFT PSIS AND 3DEFINE ATTEMPT WAS SUCCESSFUL. THE ARM WAS THEN SENT TO DRAPE FOR DRAW SPINE, BUT AN ERROR MESSAGE INDICATED THAT DRAPE POSITION WAS UNREACHABLE. THE 3D WORKING VOLUME WAS THOUGHT TO HAVE BEEN THE REASON FOR THIS. THE ARM WAS REMOUNTED WITH THE ELBOW JOINT ANGLE ADJUSTED SLIGHTLY. THE SECOND 3DEFINE WAS SUCCESSFUL AND THE ARM WAS SUCCESSFULLY SENT TO DRAPE MODE. DRAW SPINE WAS SUCCESSFUL. 3D MARKER SENT TO AP. THE 3D MARKER WAS ADJUSTED ANTERIOR TO BETTER CAPTURE THE AP. ERROR 295 APPEARED WHEN ATTEMPTING TO SEND THE ARM TO TAKE OBL IMAGE: ¿OBL POSITION IS UNREACHABLE. CONSIDER RE-DRAWING SPINE USING A DIFFERENT VERTEBRAL BODY.¿ THE ARM WAS MANIPULATED POSTERIOR AND THEN SUCCESSFULLY SENT TO THE OBL I

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 BIOPSY PROCEDURE, THE IRRIGATION PUMP WOULD NOT RESPOND TO COMMANDS FROM THE CONTROLLER AFTER THE CONTROLLER HAD BEEN DROPPED. THE SYSTEM WAS SHUT DOWN TO STOP THE IRRIGATION PUMP. APPROXIMATELY 500 ML OF SALINE WAS IRRIGATED INTO THE LUNG. THE PHYSICIAN USED A NON-AURIS MANUAL SCOPE TO REMOVE THE EXTRA FLUID. THE PHYSICIAN REPORTED THAT THE PATIENT CLEARED A SHORT OBSERVATION AND RECOVERED WITHOUT ANY PROBLEMS. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

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 INITIAL KNEE SURGERY, METAL SHAVINGS WERE NOTICED WHEN DRILLING A TROCHAR PIN THROUGH ONE OF THE HOLES OF THE CUT GUIDE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AN AIRO CT WAS TAKEN OF THE PATIENT IN THE PRONE POSITION. THE CT WAS TRANSFERRED ONTO A USB AND LOADED ONTO THE ROBOT. AN AUTOMATIC MERGE WAS PERFORMED; HOWEVER, THE MERGE WAS UNSUCCESSFUL. IT APPEARED THAT THE CT WAS FULLY ROTATED ON THE AXIS AND OVER 45 DEGREES OFF FROM THE MRI. THE MERGE WAS PERFORMED TWICE MORE WITH CUTTING EXTRA SLICES ON THE TOP AND BOTTOM OF THE SET; HOWEVER, THIS DID NOT WORK. A SEMI-AUTOMATIC MERGE WAS ATTEMPTED WITH 5 POINTS, BUT THIS MADE THE IMAGE WORSE. IT WAS CONFIRMED THAT THE AIRO OPTIONS FOR PRONE AND AXIAL CT HAD BEEN SELECTED. ANOTHER MRI WAS LOADED ONTO THE PATIENT (THIS ONE OF A SAGITTAL VIEW) AND MERGED TO THE ORIGINAL MRI ON THE PLAN.THE CT WAS THEN MERGED TO THIS SECOND MRI AND WAS ABLE TO MERGE SUCCESSFULLY. THE SURGEON WAS UPSET THAT THE SOFTWARE COULD NOT PERFORM THE AUTOMATIC MERGE ITSELF AND THAT THERE WAS NO OPTION TO ALIGN THE TWO IMAGES PARTIALLY AND ALLOW THE SOFTWARE TO DO THE AUTOMATIC MERGE FROM THAT POINT. A DELAY OF OVER AN HOUR OCCURRED DURING THIS TIME WHILE THE PATIENT WAS UNDER ANESTHESIA. THIS WAS AN RNS CASE.

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 TWO COLLISIONS BETWEEN THE ROBOT ARM AND THE MAYFIELD HEAD HOLDER OCCURRED DURING THE SURGERY.

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 THERE WERE TWO COMMUNICATION FAILURES DURING THE SURGERY. ONE UNEXPECTED COMMUNICATION FAILURE WHEN THE ROBOT ARM HAD NAVIGATED TO 13TH TRAJECTORY. IMAGES TAKEN OF ARM IN POSITION. 12 OTHER ELECTRODE TRAJECTORIES HAD BEEN COMPLETED WITHOUT ISSUE. DELAY OF 3 MINUTES. LATER ON, ROBOT ARM SENT TO HOME TO ADJUST ANGLE OF APPROACH TO AVOID MAYFIELD. UPON CHANGE OF TRAJECTORY, ROBOT ARM WAS IN HOME POSITION. UNEXPECTEDLY SHUTDOWN WITH ERROR 'COMMUNICATION FAILURE'. ADJUSTED ANGLE OF TRAJECTORY. ROUGHLY 10 MINUTE DELAY. NAVIGATED TO PREVIOUS BOLT TO CONFIRM CORRECT POSITION OF PATIENT AND MAINTENANCE OF REGISTRATION.

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 REPORTED.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A GUIDANCE DEVICE BEING USED IN A SPINAL PROCEDURE. IT WAS REPORTED THAT THE SURGEON PERFORMED AN L3-5 LATERAL MAZOR X CASE. PREPLANNING WAS DONE WITH THE SURGEON PRIOR TO THE PROCEDURE. SPECIAL ATTENTION WAS PAID TO AXIAL ANGLES AND SKIVE POTENTIALS. L3-5 OLIF WAS PERFORMED PRIOR TO USING THE MAZOR X. THE PATIENT WAS POSITIONED FOR A LATERAL PROCEDURE. THE SCHANZ PIN WAS PLACED IN LEFT PSIS. AND THE SCHANZ ARM WAS ATTACHED. 3DEFINE AND DRAW SPINE WERE SUCCESSFUL. REGISTRATION WAS SUCCESSFUL USING AUTO REGISTRATION AND THE BASIC ALGORITHM. ALL 6 WIRES WERE PLACED STARTING WITH RIGHT L3. ALL RIGHT SIDE TRAJECTORIES WERE INSTRUMENTED PRIOR TO LEFT SIDE TRAJECTORIES. LATERAL CONFIRMATION FLOURO IMAGES WERE TAKEN FOR EACH TRAJECTORY AND APPEARED ACCURATE. A FINAL AP CONFIRMATION SHOWED RIGHT L3 WAS LATERAL. RIGHT L3 WAS ADJUSTED IN THE PLAN AND DRILLED AGAIN. FINAL AP AND LATERAL FLOURO IMAGES WERE TAKEN AND ALL 6 SCREWS APPEARED TO BE PLACED ACCURATELY. THE POST-OP CT SHOWED LEFT SIDE SCREWS MISPLACED MEDIALLY AND RIGHT SIDE SCREWS MISPLACED LATERALLY. UPON CASE COMPLE

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 INITIALLY REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION (LAR) PROCEDURE, THE EXTERNAL ILIAC ARTERY WAS DAMAGED AND BLEEDING OCCURRED. THE CASE WAS CONVERTED TO OPEN SURGERY. THE SURGEON DID NOT KNOW WHEN THE VESSEL WAS DAMAGED. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. ON 06/18/2019, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE SURGICAL PROCEDURE WAS RECORDED ON VIDEO. HOWEVER, THE VIDEO IS NOT AVAILABLE FOR ISI TO REVIEW. NO MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY WAS REPORTED. THE EXTERNAL ILIAC ARTERY APPEARED TO HAVE BEEN ¿PRICKED.¿ HOWEVER, IT IS UNKNOWN WHEN THE VESSEL INJURY ACTUALLY OCCURRED DURING THE SURGICAL PROCEDURE. THE ESTIMATED BLOOD LOSS FROM THE VESSEL INJURY IS ALSO UNKNOWN. THE SURGEON ELECTED TO CONVERT THE SURGICAL PROCEDURE TO OPEN SURGERY DUE TO THE VESSEL INJURY, BLEEDING, AND SINCE THE PATIENT HAD A ¿WEAK HEART,¿ WAS HYPERTENSIVE, AND OBESE. THE PATIENT REPORTEDLY RECEIVED A BLOOD TRANSFUSION. THE PLANNED LOW ANTERIOR RESECTION PROCEDU

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: CUSTOMER WAS IN THE PROCESS OF DOING THE VERIFICATION PROCESS OF THE REGISTRATION, UPON DRIVING TO A FIDUCIAL, CUSTOMER STATED THEY WERE ROTATING THE ARM WHEN IT SHUT DOWN. RECEIVED ERROR OF FAILURE TO COMMUNICATE. THE FIELD SERVICE ENGINEER ARRIVED ON SITE, REBOOTED ROBOT AFTER DOING A THOROUGH SHUTDOWN. FAILURE TO CONNECT TO ROBOT. ATTEMPTED TO CONNECT THROUGH KINEVERIF, OBTAINED ERROR MESSAGE "FAILED TO TURN SERVOS ON" FOLLOWED BY "FAILED TO GET MARIO VERSION". ATTEMPTED TO MANUALLY RELEASE ROBOT ARM, REBOOTED ROBOT. FAILURE TO CONNECT TO ROBOT MESSAGE OBTAINED AGAIN. CONNECTED TO CONTROLLER, DELETED "CONFIG" AND "TEMP" FILES. REBOOTED SYSTEM. FAILED TO CONNECT, AT WHICH POINT CST WAS NO LONGER ABLE TO CONNECT TO THE CONTROLLER. FINALLY, ANOTHER ROBOT WAS USED TO PERFORM THE SURGERY, FROM THE NEIGHBORING HOSPITAL. THIS EVENT CAUSED A DELAY GREATER TO 2 HOURS.

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 FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A GUIDANCE DEVICE BEING USED IN A SPINAL PROCEDURE. IT WAS REPORTED THAT THE PLAN FOR THE CASE WAS TO PERFORM A SCAN AND PLAN AND EXECUTE SCREWS AT T11, T12, L2, AND L3. THIS WAS TO BACK UP A L1 BURST FRACTURE. ONCE THE SURGEON EXPOSED THE REGION OF INTEREST, THE REP SUGGESTED USING THE DUAL CLAMP AND CLAMPING AT T12 AND L2 SPINOUS PROCESSES. THIS WAS TO AVOID THE INSTABILITY OF L1. THE DUAL CLAMP WAS PLACED, 3DEFINE PERFORMED, SNAPSHOT TAKEN AND THEN STAR MARKER PLACED. DUE TO THE SIZE OF THE PATIENT AND HEIGHT OF THE DUAL CLAMP, IT TOOK THREE SPINS OF THE O-ARM TO ACHIEVE REGISTRATION. SCREWS WERE THEN PLANNED AND REVIEWED WITH THE SURGEON. THORACIC SCREWS WERE PLANNED BETWEEN 8-10 DEGREES OFF MIDLINE TO ACCOUNT FOR ANY SOFT TISSUE PROBLEMS, WITH LUMBAR SCREWS PLANNED SLIGHTLY MORE LATERAL. THE REP NOTED THE SMALL PEDICLES TO THE SURGEON AND ASKED IF THEY WOULD LIKE TO ADJUST TO 4.5MM SCREWS AND THEY OPTED TO KEEP THEM AT 5.5MM. THE SCREWS WERE THEN EXECUTED STARTING WITH T11 ON THE RIGHT AND WORKING DOWN, FOLLOWED BY T11 ON THE LEFT AND WORKING DOWN. NAVIGATION S

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE PROCEDURE WAS A SHUNT CASE AND ONE TRAJECTORY. SURGEON AND FIELD SERVICE ENGINEER WERE JUST MAKING SURE THAT THE FOOT PEDAL WOULD WORK, SINCE THIS HAS BEEN A REOCCURRING ISSUE, SO THE PATIENT HADN'T YET BEEN PINNED OR ATTACHED TO THE ROBOT. THE SURGEON PLANNED ON DOING CONTACTLESS REGISTRATION SO HE SELECTED THAT OPTION. THE "BOOM, CLICK" SOUND OF THE ROBOT CONNECTING TO THE CONTROLLER WAS HEARD. SURGEON AND FIELD SERVICE ENGINEER WERE THEN GIVEN THE PROMPT ON THE SCREEN TO STEP ON THE FOOT PEDAL SO THE ARM WOULD GO TO THE HOME POSITION. WHEN THE SURGEON STEPPED ON THE FOOT PEDAL/VIGILANCE DEVICE THE PROMPT CAME UP THAT HE HAD TAKEN OUR FOOT OFF THE PEDAL (NOT TRUE) AND THEN HE CYCLED THROUGH THE STEPS TO TRY TO MOVE THE ARM. SURGEON AND FIELD SERVICE ENGINEER COULDN'T RESOLVE THIS ISSUE. SO THEY RESTARTED THE ROBOT. THEY REPEATED THESE EXACT STEPS, PLUS ADDITIONALLY UNPLUGGING/REPLUGGING THE VIGILANCE DEVICE INTO THE ROBOT 4 TIMES. NONE OF THE ATTEMPTS WORKED. SURGEON AND FIELD SERVICE ENGINEER CAME TO THE COLLECTIVE DECISION TO NOT TRY AGAIN AND PROCEED TO THE CASE WITHOUT USING ROSA (POSSIBLE IN THIS SITUATION). THERE WAS NO MEDICAL INTERVENTION AND THERE WAS NO DELAY TO THE

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: SEEG PROCEDURE WITH ROSA COMPLETED SUCCESSFULLY WITH 16 TRAJECTORIES, BILATERAL. UPON POST-OPERATIVE CT IMAGING, IT WAS NOTED THAT THERE WAS A SIGNIFICANT BLEED. THE SURGEON DETERMINED THAT THE BLEED WAS LIKELY VENOUS, AND DID NOT APPEAR TO CAUSE MASS DISPLACEMENT. DURING ONE OF THE TRAJECTORIES, THE SURGEON DID NOT PASS AN OBTURATOR OR CANNULA PRIOR TO PASSING THE ELECTRODE. THE SURGEON BELIEVED THAT THE ELECTRODE MAY HAVE SKIVED DUE TO THE BLEED. THE SURGEON DECLINED A POST-OPERATIVE IMAGE FUSION TO THE ORIGINAL ROSA PLAN. HE STATED THAT THE ELECTRODES WERE PLACED ACCURATELY BUT THE ISSUE REGARDING THE BLEED WAS RELATED TO THE OBTURATOR.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A FIELD SERVICE ENGINEER ASSISTED AN SEEG CASE ON (B)(6) 2019. THE CASE WAS A CONTINUATION OF A PREVIOUS SEEG CASE THAT WAS PERFORMED ON (B)(6) 2019. THE SURGEON WANTED TO ADD FOUR MORE ELECTRODES TO THE PREVIOUS PLAN. AFTER THE SURGEON OBTAINED A CT THE MORNING OF SURGERY AND MERGED IT TO THE MR FROM THE ORIGINAL PLAN, IT WAS NOTICED THAT A LOT OF ELECTRODES WERE NOT ACCURATELY PLACED FROM THE ORIGINAL SURGERY (THE BOLT BEING A FEW MM'S OFF FROM THE PROJECTED ENTRY POINT). THE MERGE SEEMED TO BE ADEQUATE, AND THERE WERE SOME ELECTRODES THAT APPEARED TO BE ACCURATELY PLACED. AFTER DISCUSSING WITH THE SURGEON, THE ELECTRODES THAT WERE ACCURATELY PLACED WERE THE FIRST ELECTRODES THAT WERE INSERTED DURING THE PREVIOUS SURGERY, AND THE INACCURATE ONES WERE PLACED AFTER THOSE. IT WAS ALSO DISCUSSED THAT SINCE THE MERGE LOOKED ACCURATE AND THE FIRST ELECTRODES THAT WERE PLACED WERE ACCURATE, A HEAD SHIFT DURING THE SURGERY COULD HAVE POSSIBLY CAUSED THE INACCURACY FOR THE REMAINING ELECTRODES. THE DISCUSSION DELAYED SURGERY ABOUT 10 MINUTES, AND THEN IT WAS DECIDED TO MOVE FORWARD WITH ADDING THE ADDITIONAL ELECTRODES. THERE WERE NO OTHER ISSUES EXPERIENCED DURING THE CASE.

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: TRIATHLON TRITANIUM IMPLANTED AT INITIAL SX. INSTABILITY LED TO FEMORAL AND INSERT EXCHANGE.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE FOLLOWING INFORMATION WAS RECEIVED DURING A PHONE CALL WITH THE PHYSICIAN ON 10/30/2019: ON (B)(6) 2019, THE PATIENT UNDERWENT A MONARCH-ASSISTED BIOPSY PROCEDURE. A FEW DAYS AFTER THE PROCEDURE, ON (B)(6) 2019, THE PATIENT INFORMED THE PHYSICIAN THAT THEY WERE EXPERIENCING CHEST PAINS. A CHEST X-RAY WAS TAKEN, AND A PNEUMOTHORAX WAS IDENTIFIED. THE HOSPITAL PLACED A CHEST TUBE IN THE PATIENT AND THE PATIENT WAS HELD OVERNIGHT. THE PATIENT RECOVERED AND WAS RELEASED THE NEXT DAY. THERE WAS NO ALLEGATION OF DEVICE FAILURE.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: SURGEON CREATED AND PLANNED 13 TRAJECTORIES FOR CASE. THE PATIENT WAS PUT UNDER ANESTHESIA, BONE FIDUCIALS WERE PLACED, AND PATIENT WAS SENT DOWN TO CT. WHEN CT WAS COMPLETED, SURGEON ATTEMPTED TO LOAD CT INTO ROSA PLANNING STATION. THE SERIES CONTAINED MORE THAN 255 SLICES. THE ROSA PLANNING SOFTWARE SHUT DOWN. WHEN THE SURGEON ATTEMPTED TO RESTART, THE PATIENT FOLDER WAS NO LONGER VISIBLE. SURGEON WAS DELAYED IN STARTING SEEG BY 1 HOUR, WITH PATIENT UNDER ANESTHESIA. SURGEON CONTACTED A FIELD SERVICE ENGINEER FOR PHONE SUPPORT DURING ISSUE.