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.

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 SHOULDER WILL NOT LOCK VIA PHYSICAL BUTTON OR SOFTWARE BUTTON. IT WAS NOTED THERE WAS NO PATIENT HARM BUT THE CASE WAS ABORTED. THERE WERE NO ADDITIONAL COMPLICATIONS REPORTED OR ANTICIPATED AS A RESULT OF THE EVENT.

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 THEY WERE DOING THE FIRST CASE WITH THE DEVICE ON THE DAY OF THE REPORT. THEY STARTED WITH L45 AND L3-4 INTRALIFS. THE L4-5 LEVEL WAS CONDUCTED AS A TRUE INTRALIF UTILIZING THE TRAJECTORY OF THE ROBOT ARM. THE HCP REMOVED THE INTERNAL DISSECTOR AND PLACED A 7.5 MM AND 6.5 MM DILATOR FROM JOIMAX AND PASSED A K-WIRE THROUGH IT. THEN, THEY TOOK OUT THE DILATORS AND PASSED THROUGH A GLOBUS 8/5 MM TUBE THAT WAS SURE-TRACKED. THE HCP USED THE ROBOT TO GUIDE TO BOTH DISC SPACES. IT WAS NOTED THAT THE ROBOT SYSTEM AND NAVIGATION PERFORMED AS PLANNED. THE DILATOR WAS ACCURATE ON THE NAVIGATION WHEN USED WITH THE INSTRUMENTS. THE PATIENT HAD A LEFT L3 NEUROPRAXIA. THE PSOAS BELLY WAS MORE POSTERIOR THAN THE HCP THOUGHT. IT WAS NOTED THAT THE INTRALIF MAY NEED NEUROMONITORING. THE LEFT L4-5 WENT SMOOTHLY BUT THE HCP DECIDED TO BE A LITTLE EXTRA FORAMINAL FOR L3-4. IT WAS NOTED THE HCP MAY HAVE CONVERTED THE INTRALIF ALMOST INTO A ROBOT-GUIDED ENDOSCOPIC XLIF. THERE WERE NO ADDITIONAL COMPLICATIONS REPORTE

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: THE ROBOT, (B)(4), WAS ROLLED OVER TO STANFORD FROM THE LUCILE PACKARD (STANFORD CHILDREN¿S) SIDE OF THE HOSPITAL. WHEN THE SURGEON WAS READY TO PERFORM REGISTRATION, THE FIELD SERVICE ENGINEERS SWITCHED TO THE REGISTRATION TAB AND BEGAN CALIBRATING THE FORCE SENSOR. THE FORCE SENSOR CALIBRATED CORRECTLY BY ITSELF, BUT WHEN THE POINTER (S18130) WAS ATTACHED, THE ROBOT PROVIDED THE MESSAGE OF A CALIBRATION ERROR. CALIBRATION WAS RETRIED MULTIPLE TIMES WITHOUT SUCCESS. THE FIELD SERVICE ENGINEERS ATTEMPTED TO CALIBRATE THE DISTANCE SENSOR (S18082) ON THE FORCE SENSOR, WHICH PROVIDED THE SAME CALIBRATION ERROR. RESTARTING THE ROBOT AND RELOADING THE POINTER CALIBRATION FILE DID NOT FIX THE ISSUE. THE FIELD SERVICE ENGINEERS THEN REMOVED AND RESEATED THE INTERFACE PLATE (MT- 02-249 S18182) ONTO THE FORCE SENSOR BLOCK. THIS FIXED THE PROBLEM AND THE SURGERY WAS ABLE TO CONTINUE. DELAY TO CASE ABOUT 1 HOUR, NO PATIENT IMPACT, PATIENT 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 A COMMUNICATION FAILURE OCCURRED DUE TO AN ISSUE WITH NI DAQ CARD CONNECTION DURING A SURGERY. THIS EVENT CAUSED A 30 MINUTES DELAY AND NO PATIENT IMPACT.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: TWO FIELD SERVICE ENGINEERS (FSE) WERE PRESENT FOR AN SEEG CASE AT (B)(6). SURGICAL PLAN INVOLVED 17 TOTAL TRAJECTORIES WITH BILATERAL PLACEMENT. PATIENT WAS PINNED FAIRLY CLOSE TO SOME TRAJECTORIES, AND FSES DISCUSSED THIS RISK WITH THE SURGEON BEFORE PINNING AND MOVING FORWARD WITH THE CASE. DURING THE 3RD TO LAST TRAJECTORY, ROBOT MOVED TO THE TRAJECTORY, BUT THE ARM COULD NOT BE PUSHED SO THAT THE ADAPTOR WOULD BE FLUSH WITH THE SKIN DUE TO THE MAYFIELD ADAPTOR BEING IN THE WAY. THE SURGEON REQUESTED TO SEND THE ARM IN FROM A MODIFIED ANGLE SO THAT IT COULD COME OVER THE TOP OF THE MAYFIELD ADAPTOR AND BE PUSHED CLOSER IN TO THE PATIENT¿S HEAD. THE FSE SENT THE ARM BACK TO THE INTERMEDIATE POSITION AND MODIFIED THE ANGLE OF APPROACH FOR THE ARM IN WHAT SHE THOUGHT WAS THE APPROPRIATE DIRECTION. HOWEVER, THE ANGLE CHOSEN TURNED OUT TO MODIFY THE TRAJECTORY IN THE WRONG DIRECTION, AND THE MAYFIELD ADAPTOR WAS STILL IN THE WAY OF THE ARM. AS THE ARM WAS STILL AUTOMATICALLY NAVIGATING TO ITS POSITION, IT COLLIDED WITH THE MAYFIELD HOLDER, CAUSING A COMMUNICATION FAILURE AND SHUTDOWN OF THE ROBOT. THE FSE ATTEMPTED A MANUAL RELEASE OF THE ROBOT, HOWEVER, THE ARM WOULD NOT MOVE AT AN

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, WHEN TRYING TO MERGE AN O-ARM SPIN FOR REGISTRATION PURPOSES, THE RESULTING AUTOMATIC MERGE WAS VERY POOR. SEVERAL ATTEMPTS TO MERGE WITH BOTH THE PRE-OP CT AND MRI WERE BAD. SEMI-AUTOMATIC MERGE DID NOT WORK WELL EITHER. PATIENT WENT DOWN TO CT TO GET A NEW SCAN, AND THE RESULTANT STUDY HAD THE SAME MERGE ISSUES. SURGEON ENDED UP PERFORMING CONTACTLESS REGISTRATION.

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 MULTIPLE COMMUNICATION FAILURES OCCURRED DURING A BIOPSY

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ROBOT WAS TURNED ON AND THE IMAGES WERE LOADED, THE ROBOT WAS CONNECTED TO THE PATIENT AND THE PLAN WAS CREATED BY THE SURGEON. THE O-ARM IMAGES WITH THE FIDUCIALS WERE MERGED. AS THE REGISTRATION WAS ABOUT TO BEGIN THE ROBOT FAILED TO CONNECT DISPLAYING THE MESSAGE "ROBOT FAILED TO CONNECT". THE ROBOT WAS OPENED AND CHECKED FOR ANY LOOSE CONNECTIONS WHICH THERE WEREN'T ANY, THE ARM WAS MANUALLY RELEASED IN AN ATTEMPT TO ESTABLISH COMMUNICATION. IT WAS SUSPECTED THAT DUE TO THE MOVE THE PCI CARD WAS DISPLACED THEREFORE THE PLACEMENT WAS CHECK WITH NO ERRORS FOUND. FINALLY, ROBOT COULD NOT CONNECT AND SURGERY WAS ABORTED.

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 TRAJECTORIES WERE LOW ON FIVE OF THE LAST 6 CASES. THE HCP PERFORMED AN MIS TLIF. THE ROBOT WAS SENT TO THE L5 AND S1 TRAJECTORIES ON THE LEFT AND RIGHT, THE SKIN WAS MARKED AND THEN INCISION WAS MADE. THE INNER AND OUTER DRILL GUIDE WAS PLACED AND THE PEDICLE WAS DRILLED. THE REDUCTION TUBE WAS INSERTED AND GUIDEWIRES PLACED THROUGH THE TUBES. THE C ARM WAS BROUGHT IN TO VERIFY GUIDEWIRE PLACEMENT. IT WAS NOTED THAT THE WIRES APPEARED LOW BUT SHOULD BE OK. A TLIF WAS PERFORMED AND THEN SCREWS INSERTED USING FLUOROSCOPY. ON SUNDAY (B)(6) 2019 THE PATIENT HAD TO BE BROUGHT BACK TO THE OR TO REMOVE THE L5 AND S1 SCREWS ON THE PATIENTS LEFT SIDE AS THEY WERE LOW AND THE L5 SCREW APPEARED TO BE IN THE FORAMEN. IT WAS DEEMED THAT THE SCREWS ON THE PATIENTS RIGHT SIDE WERE LOW BUT WERE STILL IN THE PEDICLE SO WERE LEFT IN. THERE WERE NO ADDITIONAL COMPLICATIONS REPORTED OR ANTICIPATED AS A RESULT OF THE 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: ON APRIL 10, 2019, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF THE FOLLOWING SOCIAL MEDIA POSTING: "I DONE FILED A COMPLAINT ON THE COLON SURGEON WHO USED THIS MACHINE ON MY COLON LAST JULY. I ENDED OFF AFTER A MONTH OF HAVING BLOATING AND GAS THIS LEAD TO A HOLE IN MY COLON AND NOW I GOT COLITIS CAUSE IF YOUR MESSED UP JUNK MACHINE. AND I AM SUING NO DOUBT ABOUT IT I COULD HAVE DIED 2 MONTHS AGO." ON 04/12/2019, ISI CONTACTED THE PATIENT AND THE FOLLOWING INFORMATION REGARDING THE ALLEGED EVENT WAS OBTAINED: THE PATIENT UNDERWENT COLON SURGERY ON AN UNSPECIFIED DATE IN 2018. A MONTH AFTER SURGERY, THE PATIENT STARTED HAVING "TUMMY PAINS AND A LOT OF PAIN." THE PATIENT ENDED UP HAVING DIAGNOSTIC LAPAROSCOPIC SURGERY ON (B)(6) 2019 AND A HOLE IN HER COLON WAS FOUND. SHE NOW HAS COLITIS. THE PATIENT BELIEVES THE DA VINCI SURGICAL SYSTEM CAUSED HER OPERATIVE COMPLICATIONS. THE PATIENT HAD HER SURGERIES PERFORMED IN (B)(6).

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING AN ASSISTED SURGERY, CONTACTLESS REGISTRATION WAS SELECTED, BUT THE FIELD SERVICE ENGINEER (FSE) NOTICED THAT THE INITIAL SCREEN SAYING TO 'PLEASE WAIT' WAS TAKING A LOT LONGER THAN USUAL (TRYING TO CONNECT TO CONTROLLER). AFTER WAITING A MINUTE, THE MESSAGE 'FAILURE CONNECTING TO THE ROBOT' WAS SHOWN, AND THEN A WINDOWS MESSAGE APPEARED SAYING THE 'ACCESSIBILITY ON-SCREEN KEYBOARD IS NOT RESPONDING'. THE FSE BACKED OUT OF THE SOFTWARE, AND SHUT THE ROBOT DOWN AS NORMALLY DONE. AFTER WAITING A FEW MINUTES, THE ROBOT WAS RESTARTED AND THIS TIME THERE WAS A SUCCESSFUL CONNECTION TO THE CONTROLLER, AND THE LASER REGISTRATION COULD BE STARTED. AFTER PERFORMING THE LASER REGISTRATION, THE VERIFICATION WAS PERFORMED. THE VERIFICATION FOR NASION, BONY TIP OF THE NOSE, OUTER CANTHI, AND FOREHEAD WERE ACCEPTABLE. SOME AREAS OF THE TEMPLES WERE ALSO ACCEPTABLE, BUT THERE WERE SOME AREAS THAT WERE SHOWING THE LASER BEING OFF THE SKIN ABOUT 3-4MM. AFTER SEEING THIS, THE SURGEON AND FSE DECIDED THIS WAS NOT AN ACCEPTABLE REGISTRATION TO USE. A SECOND REGISTRATION WAS PERFORMED, BUT SIMILAR RESULTS WERE OBTAINED. A CHANGE TO THE 3D MODEL CALCULATION WAS PERFORMED TO SEE IF THAT SOLVED THE

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: SURGEON HAD A DIFFICULT TIME MERGING SCANS DURING THIS CASE. THE FIELD SERVICE ENGINEER (FSE) LOADED IN MRI BEFORE THE CASE AND THE SURGEON PLANNED 1 TRAJECTORY FOR ABLATION AND BIOPSY. SURGEON PINNED PATIENT IN A PRONE POSITION WITH THE HEAD TURNED SLIGHT LATERAL. HE PLACED FIDUCIALS, THEN TOOK AN O-ARM SPIN FOR REGISTRATION. HOWEVER, WHEN THE FSE AUTOMATICALLY MERGED THE O-ARM SCAN TO THE MRI, THE AUTOMATIC MERGE DID NOT WORK AND THE TWO SCANS WERE VERY OBVIOUSLY NOT MATCHED. THE SURGEON SPENT A WHILE TRYING TO GET THE TWO SCANS TO OVERLAP PERFECTLY USING THE MANUAL CONTROLS. HOWEVER, AFTER PERFORMING REGISTRATION AND DRIVING TO THE TRAJECTORY, THE SURGEON FELT THAT THE TRAJECTORY DID NOT LINE UP ANATOMICALLY ON THE PATIENT WITH THE PLANNED ANATOMICAL LOCATION. FSE SUGGESTED TRYING SEMI-AUTOMATIC MERGE BECAUSE THE AUTOMATIC MERGE DID NOT WORK CORRECTLY AND WAS HARD TO MANUALLY FIX. HOWEVER, TWO TRIES WITH SEMI-AUTOMATIC ACTUALLY HAD WORSE RESULTS THAN THE AUTOMATIC MERGE DID. FINALLY, THE SURGEON HAD TO USE AUTOMATIC MERGE AND THEN MANUALLY ADJUST AGAIN, AND THEN REDO REGISTRATION. THE TRAJECTORY ENDED UP BEING IN THE EXACT SAME SPOT, WHICH WAS STILL SLIGHTLY OFF FROM THE SURGEON

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 THERE WERE 3 MISPLACED SCREWS WITH CANAL BREECHES AND DURAL TEARS. IT WAS NOTED THAT EXTREME SOFT TISSUE PRESSURE AND POOR TECHNIQUE LEAD TO THE EVENT. IT WAS NOTED THAT THE NAVIGATION DID NOT DEPICT THE DEVIATIONS TRUE AS THEY OVERLAID THE ARM TRAJECTORY AND GAVE A FALSE SENSE OF SECURITY. IT WAS NOTED THAT THE SURGERY WAS COMPLETED WITH FREE HAND NAVIGATION. ADDITIONAL INFORMATION RECEIVED FROM THE REP INDICATED THAT THE SCREW PLACEMENT WAS 10-11MM MIDLINE. CONTRIBUTING FACTORS TO THE TECHNIQUE ISSUES INCLUDED A DEEP BIG PATIENT AND LOTS OF TISSUE PRESSURE. MICROSCOPE AND SUTURE TO REPAIR TEARS WAS DONE TO RESOLVE THE DURAL TEARS. THERE WERE NO ADDITIONAL COMPLICATIONS REPORTED OR ANTICIPATED AS A RESULT OF THE EVENT.