Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A NEAR DEATH EXPERIENCE.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THERE WAS A DEVIATION DURING A L4-S1 CASE. THE SCREWS WERE PLACED ACCURATELY ON THE LEFT SIDE OF THE PATIENT. ON THE RIGHT SIDE, THERE WAS A SUSPECTED MEDIAL SKIVE AT L5. WHEN THE SURGEON WAS TAPPING AT L5, THE TAP WAS PLACED MEDIAL AND DEVIATED 10 MM MEDIALLY FROM PLAN. THE TAP WAS INSERTED INTO THE CANAL AND THERE WAS NOTICEABLE CEREBROSPINAL FLUID (CSF) COMING FROM FROM THE TRAJECTORY. THE SURGEON REPAIRED THE CSF LEAK AFTER REMOVING ABORTING THE USE OF THE GUIDANCE SYSTEM AND REMOVING IT FROM THE TABLE. THERE WAS NO PATIENT HARM AND THE PROCEDURE WAS DELAYED LESS THAN AN HOUR.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON 5-MAY-2021, INTUITIVE SURGICAL, INC. (ISI) RECEIVED MW5100203 STATING: ¿A (B)(6) Y/O FEMALE WITH A HISTORY OF 12DM. HTN. UTERINE ADENO CANCER S/P HYSTERECTOMY (2016), HX OF APPENDICEAL ADENOMA SEEN ON ENDOSCOPY THAT WAS SUSPICIOUS FOR MALIGNANCY UNDERWENT A ROBOTIC ASSISTED LAP RIGHT HEMICOLECTOMY ON (B)(6) 2021. ON (B)(6) 2021 THE PATIENT BECAME HYPOXIC AND CARDIAC ARRESTED. THE PATIENT UNDERWENT THREE ROUNDS OF CPR BEFORE OBTAINING ROSC. THE PATIENT WAS TRANSPORTED TO ICU, AND THREE UNITS OF EMERGENCY RELEASED PRSCS WERE TRANSFUSED, DUE TO A PROFOUND DROP IN HER HGB, THE PATIENT REMAINED HEMODYNAMICALLY UNSTABLE AND A DECISION WAS MADE TO RETURN TO THE OPERATING ROOM FOR AN EXPLORATORY LAPAROTOMY. IN THE OPERATING ROOM, THE ILEOCOLIC ARTERY WAS FOUND TO HAVE A PULSATILE BLEED AND WAS SUBSEQUENTLY LIGATED. ON RETURN TO THE ICU, PT. REMAINED HEMODYNAMICALLY UNSTABLE WITH WORSENING HYPOXIA. THE PATIENT REQUIRED INCREASED PRESSURE SUPPORT THROUGHOUT THE DAY. ON (B)(6) 2021 THE PATIENT¿S CONDITION CONTINUED TO WORSEN. ABDOMINAL COMPARTMENT SYNDROME WAS SUSPECTED AND THE DECISION WAS MADE BY THE ICU TEAM TO RE-OPEN THE ABDOMEN AT THE BEDSIDE. UPON ENTRY INTO THE ABDOMEN, 1000 CCS OF

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DR (B)(6) CONTACTED A FIELD SERVICE ENGINEER (FSE) BY PHONE FOLLOWING AN ISSUE ON HIS PATIENT FOLDER. THE PLANNING MADE FOR HIS CASE WAS NOT SEEN BY ROSA BRAIN ON THE PLANNING STATION AND ON ROSA DEVICE. THE PATIENT WAS ALREADY IN THE OPERATING ROOM AND THE CASE WITHOUT THE SURGERY WILL BE DONE IN ABOUT 3H (SEEG ¿ 15 ELECTRODS). BY CONSEQUENCE, THE FSE AND DR (B)(6) CONTACTED A SERVICING ENGINEER TO FIND A SOLUTION OR AT LEAST A WORKAROUND. AFTER TESTING MANY WAYS THROUGH THE MAINTENANCE SESSION: COPY OF THE FOLDER ON USB KEY AND TRANSFER THE PATIENT FOLDER TO THE DEVICE, OR UNENCRYPT THE PATIENT FOLDER, OPEN THE FOLDER SINCE THE MAINTENANCE SESSION, EVERYTHING FAILED. WITH HELP OF A SOFTWARE ENGINEER, IT WAS DISCOVERED THAT IT WAS AN ISSUE WITH THE .ROS FILE. THIS FILE MOVED FROM .ROS TO .DEL, AFTER REPLACING .DEL BY .ROS EVERYTHING WAS FIXED.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AT 10:45 AM, THE ROBOT ARM WAS DRIFTING WHEN IN AXIAL AND FREE AND FAST (WHERE THE ARM WAS MOVING ON ITS OWN WITHOUT TACTILE INTERACTION FROM THE USER). AFTER THE FIRST ELECTRODE, THE SURGEON CHECKED THE BONE FIDUCIAL PLACEMENT BY MAKING A TRAJECTORY AND DRIVING THERE, AND THE TRAJECTORY TO THE BONE FIDUCIAL APPEARED TO BE ABOUT 1 MM OFF SO THE ROBOT WAS UNDRAPED, THE PATIENT WAS RE-REGISTERED AND THE ROBOT WAS RE-DRAPED. AT THAT POINT, EVERYTHING WAS ACCURATE FOR THE REST OF THE CASE AND NO DRIFTING. THERE COULD HAVE BEEN A CALIBRATION ISSUE WHEN THE SURGEON CALIBRATED THE INSTRUMENT HOLDER THE FIRST TIME. INITIALLY THE USER USED INSTRUMENT HOLDER MT-02- 158 (B)(4) THEN AFTERWARDS WHEN WE RE-DRAPED THE USER USED MT-2-158 (B)(4). THIS CAUSED ABOUT A 30-MINUTE DELAY.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DR (B)(6) CONTACTED A FIELD SERVICE ENGINEER (FSE) BY PHONE FOLLOWING AN ISSUE ON HIS PATIENT FOLDER. THE PLANNING MADE FOR HIS CASE WAS NOT SEEN BY ROSA BRAIN ON THE PLANNING STATION AND ON ROSA DEVICE. THE PATIENT WAS ALREADY IN THE OPERATING ROOM AND THE CASE WITHOUT THE SURGERY WILL BE DONE IN ABOUT 3H (SEEG ¿ 15 ELECTRODS). BY CONSEQUENCE, THE FSE AND DR (B)(6) CONTACTED A SERVICING ENGINEER TO FIND A SOLUTION OR AT LEAST A WORKAROUND. AFTER TESTING MANY WAYS THROUGH THE MAINTENANCE SESSION: COPY OF THE FOLDER ON USB KEY AND TRANSFER THE PATIENT FOLDER TO THE DEVICE, OR UNENCRYPT THE PATIENT FOLDER, OPEN THE FOLDER SINCE THE MAINTENANCE SESSION, EVERYTHING FAILED. WITH HELP OF A SOFTWARE ENGINEER, IT WAS DISCOVERED THAT IT WAS AN ISSUE WITH THE .ROS FILE. THIS FILE MOVED FROM .ROS TO .DEL, AFTER REPLACING .DEL BY .ROS EVERYTHING WAS FIXED.

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS REPORTED: "I RECEIVED SOME INFORMATION REGARDING A SURGEON OUT OF (B)(6) WHO IS AN AVID MAKO SUPPORTER AND USER. HE EXPRESSED SOME CONCERNS OVER PRESS-FIT FEMORAL FIT" CASE 1: PATIENT COMPLAINED OF PAIN SO THEY THOUGHT IT WAS LOOSENING OF FEMUR BUT THEY DIDN¿T HAVE TO DO ANYTHING.

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS REPORTED: "I RECEIVED SOME INFORMATION REGARDING A SURGEON OUT OF KNOXVILLE, TN WHO IS AN AVID MAKO SUPPORTER AND USER. HE EXPRESSED SOME CONCERNS OVER PRESS-FIT FEMORAL FIT". CASE 2: FEMUR LOOSENING WAS OBSERVED.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2021, IT WAS REPORTED THAT DURING A MONARCH-ASSISTED BRONCHOSCOPY PROCEDURE THE PATIENT WAS OBSERVED TO HAVE A PNEUMOTHORAX. THE TARGET LOCATION WAS RIGHT UPPER LOBE. THERE WAS NO ALLEGATION OF DEVICE FAILURE. A CHEST TUBE WAS PLACED AND THE PATIENT WAS HOSPITALIZED. CHEST TUBE WAS REMOVED ON (B)(6) 2021. THE PNEUMOTHORAX WAS RESOLVED, AND THE PATIENT WAS DISCHARGED ON (B)(6) 2021.

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 (CRÀ WAS PRESENT FOR A BIOPSY AND ABLATION CASE. THE SURGEON POSITIONED THE PATIENT PRONE USING A REGULAR MAYFIELD AND ATTACHED TO THE ROSA. THE SURGEON THEN PLACED FIDUCIALS AND GOT AN O-ARM SPIN (FIRST GENERATION) OF THE FIDUCIALS FOR REGISTRATION. WHEN CR WENT TO LOAD THE SCAN INTO THE ROSA USING A USB, THE MERGE SCREEN SHOWED THAT SOME OF THE SLICES HAD BEEN CUT OUT, SO THAT THERE WAS A STRANGE JUMP IN BONE AT THE TOP OF THE HEAD. WHEN LOADING IN THE SCAN, THE CR HAD RECEIVED AN ERROR THAT THERE WERE GAPS BETWEEN SLICES. CR THOUGHT THAT THE SCAN HAD NOT COPIED CORRECTLY ONTO THE USB, AND SO PULLED THE SAME EXAM FROM PACS. CR CONFIRMED THAT 191 SLICES WERE PRESENT IN THE EXAM IN THE IQVIEW TEMPORARY FOLDER. HOWEVER, THE SAME PROBLEM OCCURRED ON THE MERGE SCREEN, BUT THE CR DID NOT RECEIVE ANY ERRORS THIS TIME FROM THE ROSA SOFTWARE. THE SURGEON NOTED THAT THE PATIENT HAD HARDWARE FROM A SHUNT LOCATED AT THE SAME LEVEL WHERE THE SLICES SEEMED TO JUMP. THE SURGEON DECIDED TO GET ANOTHER SCAN AND TILT THE GANTRY OF THE O-ARM SLIGHTLY TO ALLOW FOR CLEAR VISUALIZATION OF THE FIDUCIALS BELOW THE PROBLEM AREA. THE 2ND SCAN WAS TRANSFERRED BY USB TO THE ROBOT AND

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, AND REPORTED AT STARTING UP THE SYSTEM, ROSA SAYS THE ARM IS NOT FREE. BEFORE THAT HAPPENS THE SYSTEM WAS NORMALLY SHUT DOWN. THE SURGEON HAD PUSH EMERGENCY BUTTON AND IN MAINTENANCE MODE SHE WAS ABLE TO MOVE THE ROSA ARM. IN THEATRE/PATIENT UNDER ANESTHESIA/BEFORE SURGERY PROCEDURE AND INCISION DELAY IN MINUTES: 35, SYSTEM HAD RESTARTED MULTIPLE TIMES, TO START PROCEDURE.

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 SURGICAL PROCEDURE, THE CUSTOMER CONTACTED THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) REGARDING A MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY. THE CUSTOMER REACHED OUT WHEN AN MCS TIP COVER ACCESSORY CAME OFF OF A ROBOTIC INSTRUMENT THAT WAS BEING USED. THE CUSTOMER WAS ASKING IF IT WOULD SHOW UP ON AN X-RAY IF THEY COULD NOT FIND IT. THE CUSTOMER ALSO INDICATED THEY DID NOT USE ANY KIND OF LUBRICANT WITH THE MCS INSTRUMENT AND COULD NOT BELIEVE IT CAME OFF. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE MCS INSTRUMENT AND MCS TIP COVER ACCESSORY WERE INSPECTED PRIOR TO USE AND NO DAMAGE WAS NOTED ON EITHER. THE MCS TIP COVER ACCESSORY FELL INSIDE THE PATIENT, AND WAS RETRIEVED USING A LAPAROSCOPIC GRASPER. THE CUSTOMER WAS REMOVING THE INSTRUMENT FROM THE PATIENT WHEN THE TIP COVER FELL. SURGEON DID NOT NOTICE ANY ISSUE WITH INSTRUMENT FUNCTIONALITY AND THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENT. UPON REMOVAL OF THE MCS, THE TIP WAS STRAIGHTENED AND THERE WAS NO RESISTANCE. THERE WAS

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS NOTED THAT THE L1 SCREW WAS 4.5MM MEDIAL AND THE L2 SCREW WAS 1.5-2MM LATERAL. THE L2 SCREW WAS NOT REDIRECTED OR REVISED. NO PERMANENT HARM WAS DONE TO THE PATIENT DUE TO THE DEVIATIONS.

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 MULTIPLE ACCURATE CASES HAVE BEEN COMPLETED SINCE THE EVENT. THE REPRESENTATIVE HAD MADE SUGGESTIONS ABOUT THE SURGEONS TECHNIQUE, THE POSSIBILITY OF THE SPINE "TORQUING" WITH INSTRUMENTATION AND USING THE CLAMP VERSUS PELVIC FIXATION, BUT THE SURGEON DISAGREED WITH THESE AS THE CAUSE OF THE DEVIATIONS.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2020, IT WAS REPORTED THAT DURING A MONARCH-ASSISTED BRONCHOSCOPY PROCEDURE THE PATIENT WAS OBSERVED TO HAVE A PNEUMOTHORAX. THE TARGET LOCATION WAS RIGHT LOWER LOBE, BUT THE PNEUMOTHORAX WAS SEEN IN THE RIGHT UPPER LOBE, AND THE USER DID NOT DRIVE IN THE RIGHT UPPER LOBE. THE CAUSE OF THE PNEUMOTHORAX IS UNKNOWN. THE INSTRUMENTS USED WERE AN OLYMPUS NEEDLE AND AURIS FORCEPS. AN ENDOBRONCHIAL ULTRASOUND (EBUS) AND X-RAY WAS PERFORMED AFTER THE CASE. A CHEST TUBE WAS PLACED AND THE PATIENT WAS CHECKED INTO THE HOSPITAL. THE PNEUMOTHORAX WAS RESOLVED, AND THE PATIENT WAS DISCHARGED ON (B)(6) 2020.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

iRobot Clean Base for Roomba i7+ Robot Vacuum — Automatic dirt-disposal dock for certain Roomba i7+ models poses an electrical hazard: significant liquid ingestion by the vacuum can disperse onto the dock's internal circuit board and cause a short circuit. 11,971 units sold in Canada Jul 2018-Mar 2020. No incidents or injuries reported in Canada as of 2020-12-08. Free repair (fused cord) or replacement offered.

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 ON 25-NOV-2020 THAT AFTER A DA VINCI-ASSISTED GYNECOLOGY PROCEDURE IN 2018, THERE WAS A ¿SURGICAL SITE INFECTION¿. THE CUSTOMER (INFECTION CONTROL) SUBSEQUENTLY REQUESTED A MEETING WITH INTUITIVE SURGICAL, INC. (ISI) TO FOLLOW UP ON THE REPORT. AT THIS TIME, THE PROCEDURE TYPE, THE DATE OF THE PROCEDURE, THE SEVERITY OF THE INFECTION, AND THE STEPS TAKEN TO ADDRESS THE INFECTION REMAIN UNKNOWN. ISI HAS REACHED OUT TO THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION BUT HAS NOT YET RECEIVED A RESPONSE. ALL FOLLOW-UP ATTEMPTS HAVE BEEN EXHAUSTED.

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 ON 25-NOV-2020 THAT AFTER A DA VINCI-ASSISTED GYNECOLOGY PROCEDURE IN 2019, THERE WAS A ¿SURGICAL SITE INFECTION¿. THE CUSTOMER (INFECTION CONTROL) SUBSEQUENTLY REQUESTED A MEETING WITH INTUITIVE SURGICAL INC. (ISI) TO FOLLOW UP ON THE REPORT. AT THIS TIME, THE PROCEDURE TYPE, THE DATE OF THE PROCEDURE, THE SEVERITY OF THE INFECTION, AND THE STEPS TAKEN TO ADDRESS THE INFECTION REMAIN UNKNOWN. INTUITIVE SURGICAL, INC. (ISI) HAD REACHED OUT TO THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION BUT HAS NOT YET RECEIVED A RESPONSE. ALL FOLLOW-UP ATTEMPTS HAVE BEEN EXHAUSTED.

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 2 SCREWS WERE MISPLACED. UPON REMOVAL OF THE SECOND SCREW, THE INTERNAL ILIAC ARTERY WAS PERFORATED CAUSING BLOOD LOSS TO THE PATIENT. THIS WAS RESOLVED AND THE PATIENT IS RECOVERING. THIS EVENT OCCURRED IN BELGIUM.

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 TOTAL BENIGN HYSTERECTOMY SURGICAL PROCEDURE, A PLASTIC PART OF THE SYNCROSEAL JAW FELL OFF WHILE THE INSTRUMENT WAS IN THE SURGICAL FIELD. THE OPERATING ROOM (OR) STAFF WAS ABLE TO REMOVE THE PIECE FROM THE PATIENT WITHOUT ANY ISSUES AND THERE WAS NO REPORT OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) COMPLETED FOLLOW-UP AND OBTAINED THE FOLLOWING INFORMATION: PER THE REPORTER, ALL FRAGMENTS WERE RETRIEVED USING A LAPAROSCOPIC GRASPER. THERE WAS NO ADDITIONAL SURGICAL PROCEDURE REQUIRED TO REMOVE THE FRAGMENT NOR WERE THERE ANY POST-OPERATIVE TESTS PERFORMED. THE SURGEON WAS USING THE MONOPOLAR CURVED SCISSORS TO CLEAN TISSUE OFF THE SYNCHROSEAL WHEN THE REPORTED ISSUE OCCURRED. THE INSTRUMENT WAS REMOVED PROPERLY AND THERE WAS NO REPORT OF PATIENT INJURY, NOR HAS THE PATIENT RETURNED TO THE HOSPITAL DUE TO POST-OPERATIVE COMPLICATIONS.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED BY A REPRESENTATIVE FROM (B)(6) THAT 2 SCREWS WERE MISPLACED. UPON REMOVAL OF THE SECOND SCREW, THE INTERNAL ILIAC ARTERY WAS PERFORATED CAUSING BLOOD LOSS TO THE PATIENT. THIS WAS RESOLVED AND THE PATIENT IS RECOVERING.

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: DURING REVIEW OF A LITERATURE ARTICLE INVOLVING DA VINCI ASSISTED ROBOTIC PROCEDURES TITLED, ¿SINGLE PORT ROBOTIC RADICAL PROSTATECTOMY VERSUS MULTI-PORT ROBOTIC RADICAL PROSTATECTOMY: A HUMAN FACTOR ANALYSIS DURING THE INITIAL LEARNING CURVE¿ THE FOLLOWING EVENTS WERE REPORTED: FROM (B)(6) 2018 TO (B)(6) 2019, THE FIRST 20 CONSECUTIVE SINGLE PORT (SP) ROBOTIC ASSISTED LAPAROSCOPIC PROSTATECTOMIES (RALPS) PERFORMED BY A SINGLE EXPERIENCED ROBOTIC SURGEON WERE COMPARED AGAINST 20 MULTIPORT (MP) RALPS PERFORMED AT ANOTHER SITE IN ITALY. OF THE 20 CASES THAT WERE PERFORMED USING THE DA VINCI SINGLE PORT (SP), ONE INTRA-OPERATIVE COMPLICATION OF SEROSAL INJURY DUE TO EXTENSIVE LYSIS OF ADHESIONS WAS REPORTED. EIGHTEEN POST-OPERATIVE COMPLICATIONS WERE MENTIONED IN THE ARTICLE, WHICH INCLUDES CLAVIEN-DINDO GRADE I TO GRADE IVB. EIGHT PATIENTS DEVELOPED GRADE I POST-OPERATIVE COMPLICATIONS INVOLVING SHOULDER PAIN, ILEUS, ELECTROLYTE DERANGEMENT, NAUSEA, AND/OR VOMITING. SIX PATIENTS EXPERIENCED GRADE II COMPLICATIONS INVOLVING URINARY TRACT INFECTION (UTI), HEALTHCARE ACQUIRED PNEUMONIA (HCAP), EPIDIDYMOORCHITIS, AND/OR PELVIC HEMATOMA WHICH REQUIRED TRANSFUSION. TWO PATIENTS HAD GRADE I

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LIVER RESECTION PROCEDURE, THE CUSTOMER REPORTED THAT THE HARMONIC ACE INSTRUMENT TIP FROM THE JAWS FELL OFF INSIDE THE PATIENT AND WAS RETRIEVED IN THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH REPORTER AND OBTAINED THE FOLLOWING INFORMATION: THE ISSUE OCCURRED WITH THE THIRD "PASSING" OF THE INSTRUMENT. THE INSTRUMENT WAS INSPECTED BEFORE USE AND THERE WAS NO VISIBLE DAMAGE NOTED. THE INSTRUMENT TIP BROKE OFF DURING LIVER MOBILIZATION. THE SURGEON SAW THE TIP BREAK OFF IN ONE PIECE AND USED A LAPAROSCOPIC GRASPER DURING THE SAME SURGERY TO REMOVE THE FRAGMENT. NO POST-OPERATIVE INVESTIGATION WAS DONE AFTER THE PROCEDURE AS IT WAS DEEMED NOT NECESSARY. THERE WERE NO ISSUES WITH FUNCTIONALITY OF THE INSTRUMENT AND NO COLLISION OF THE INSTRUMENT WITH ANY HARD MATERIAL BEFORE THE TIP BROKE OFF. THE SURGEON BELIEVES THE INSTRUMENT TIP BROKE OFF DUE TO A DEFECTIVE INSTRUMENT. THE PATIENT WAS A (B)(6) YEAR-OLD FEMALE, WEIGHING (B)(6) KG. DATE OF BIRTH WAS (B)(6) 1960. RACE AND ETHNICITY WERE UNKNOWN. RELEVANT MEDICAL HISTORY AND INVESTIGATIONS WERE REQUESTED BUT NOT

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 THEATER MANAGER CALLED THE COMPANY REPRESENTATIVE TO INFORM THAT DURING THE SURGERY THE MONITOR TURNS OFF WHEN THE ROBOT WAS MOVING INTO TRAJECTORY. THE ISSUE OCCURRED TWO TIMES EVEN AFTER A REBOOT. THEY CHANGED ROSA FOR ANOTHER SURGERY TOOL.

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 ON (B)(6) 2020, THE PATIENT WAS OBSERVED TO HAVE A PNEUMOTHORAX DURING POST-OP CHECK-UP. A CHEST TUBE WAS PLACED, AND THE PATIENT WAS HOSPITALIZED. THE PATIENT HAS SINCE RECOVERED AND WAS RELEASED FROM THE HOSPITAL ON (B)(6) 2020. THERE WAS NO REPORT OF DEVICE FAILURE.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

Mazor Renaissance — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ADDITIONAL INFORMATION WAS RECEIVED STATING THAT SCREW WAS DEVIATED BETWEEN 3.5 TO 10MM. THERE WAS NO IMPACT TO THE PATIENT OUTCOME. THE SYSTEM HAS BEEN IN OTHER CASES SINCE AND HAS PASSED AN ACCURACY CHECK EACH TIME.

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 VENTRAL HERNIA REPAIR SURGICAL PROCEDURE, THE RIGHT EYE IN THE SURGEON SIDE CONSOLE (SSC) WAS BLUE. PRIOR TO CALL CUSTOMER TRIED ANOTHER SCOPE, NO CHANGE. TECHNICAL SUPPORT ENGINEER (TSE) RECOMMENDED PERFORMING A HARD POWER CYCLE OF THE VISION SIDE CART (VSC) AND RESEATING THE FIBER CABLES, NO CHANGE. TSE RECOMMENDED TRYING A THIRD SCOPE, NO CHANGE. TSE RECOMMENDED REMOVING SCOPE AND CHECK THE SSC RIGHT EYE, RIGHT EYE WAS STILL BLUE IN SSC. TSE RECOMMENDED HARD POWER CYCLING THE SSC, NO CHANGE. TSE RECOMMENDED ANOTHER HARD POWER CYCLE OF THE SSC AND RESEATING THE FIBER CABLE, NO CHANGE. TSE RECOMMENDED BRINGING IN ANOTHER DA VINCI SSC. THE SURGEON OPTED TO CONVERT TO OPEN AND NEEDS TO END THE CALL. CTA CALLED BACK TO INFORM THAT THEY WERE ABLE TO GET ANOTHER SURGEON CONSOLE IN THE OR AND COMPLETE THE CASE. THE PROCEDURE WAS CONVERTED TO ANOTHER DA VINCI SYSTEM WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: SURGEON PLACED PORTS. DOCKED THE X SYSTEM. SURGEON SAT DOWN AND NOTICED THE RIGHT EYE WAS SHOWING BLUE SCREEN. VISION TOWER TROUBLESHO

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THERE WERE TECHNICAL ISSUES DURING A RIGHT LEFT L4-L5 TLIF PROCEDURE. THE SURGEON DRILLED PILOT HOLES FOR ALL TRAJECTORIES USING A PERCUTANEOUS TECHNIQUE. SCREWS WERE THEN PLACED. A POST-OP SPIN WAS DONE AND THE SCREWS AT L4 WERE FOUND TO BE SUBOPTIMAL AND WAS SLIGHTLY OFF BY ABOUT 3.5 MM. THE SCREWS WERE SLIGHTLY LATERAL AND COULD HAVE AFFECTED THE RIGIDITY OF THE CONSTRUCT. TROUBLESHOOTING DURING THE INITIAL PROCEDURE INCLUDED CHECKING LANDMARKS. THE PATIENT EXPERIENCED RIGHT SIDE BACK PAIN. A REVISION PROCEDURE WAS DONE AND THE SCREWS WERE REPOSITION FREEHAND. THE SUSPECTED CAUSE OF THE DEVIATION WAS SKIVING AND NON-OPTIMAL ENTRY PLANNING. 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 VIA A REPLY TO A SOCIAL MEDIA POSTING ("WHAT'S THE NICEST THING YOU CAN SAY TO A DOCTOR?"): "DON'T WORRY, WE'RE NOT GOING TO SUE YOU." SAID BY MY HUSBAND TO THE SURGEON (WHO WAS CRYING) WHILE I WAS IN ICU ON A VENT, FOLLOWING A PROBLEM DURING SURGERY WITH THE DAVINCI ROBOT. WE LOVED THE SURGEON & MY HUSBAND WANTED TO ASSURE HIM THAT HE KNEW IT WASN'T THE SURGEON'S FAULT.¿ THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. NO FURTHER CLINICAL INFORMATION WAS PROVIDED.

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 SCREW WAS MISPLACED BY 1 CM.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE FOLLOWING EVENT OCCURRED AFTER A DBS CASE ON (B)(6) 2020 WITH THE CLINICAL REPRESENTATIVE (CR): THE POST-OPERATIVE CT SCAN WAS TAKEN AND MERGED TO THE PLAN. THE MERGE WAS ACCEPTED, AND WHILE LOOKING AT THE POST-OPERATIVE SCAN, THE LEFT LEAD WAS 4 MM DEEP, WHILE THE RIGHT LEAD HAD NO ISSUES. THE SURGEON DETERMINED THAT THE LEAD WOULD NEED TO BE 'PULLED BACK' 4 MM. A REVISION SURGERY WAS PERFORMED FOR RETRACT THE LEAD 4 MM, AND ANOTHER POST OPERATIVE SCAN WAS TAKEN. WHEN THIS SCAN WAS MERGED IT WAS DETERMINED THAT THE LEAD WAS IN THE RIGHT SPOT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT DURING A T8-T12 TRAUMA BURST FRACTURE, THE LEFT T8 SCREW WAS DEVIATED LATERAL BY ABOUT 5 MM. THE LEFT T8 SCREW WAS PLACED FIRST AND FOUND TO BE DEVIATED ON A POST-OP CT. THE REST OF THE SCREWS WERE PLACED ACCURATELY. THE CAUSE OF THE DEVIATION WAS UNKNOWN. A REVISION WAS SCHEDULED, BUT THE MANUFACTURER REPRESENTATIVE NOTED THAT IT MAY BE CANCELLED DUE TO UNRELATED COMPLICATIONS. THE PROCEDURE WAS DELAYED LESS THAN AN HOUR.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2020, IT WAS REPORTED THAT DURING A MONARCH-ASSISTED BRONCHOSCOPY PROCEDURE THE PATIENT WAS OBSERVED TO HAVE A PNEUMOTHORAX. A CHEST TUBE WAS PLACED ON (B)(6) 2020 AND WAS REMOVED ON (B)(6) 2020. THE PATIENT WAS HOSPITALIZED FOR OBSERVATION AND PAIN MANAGEMENT. THE PATIENT HAS SINCE RECOVERED AND WAS RELEASED FROM HOSPITAL ON (B)(6) 2020.

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 DURING A T4-S2 CASE WITH THREE SEGMENTS, RIGHT T4 - T9 SCREWS WERE MEDIAL TO PLAN. THIS OCCURRED DURING THE FINAL SEGMENT WITH THE CLAMP PLACED AT T10. THE MANUFACTURER REPRESENTATIVE BELIEVED THE DEVIATIONS WERE DUE TO SKIVING AS THE SURGEON WAS ON THE RIGHT SIDE AND MALLEATING VERY HARD. THE SCREWS WERE DEVIATED LESS THAN 3.5 MM. THE SURGEON WAS NOT WORRIED ABOUT MISPLACED SCREWS DURING THE PROCEDURE SINCE ALL INTRA-OP AP IMAGES APPEARED WITHIN NORMAL LIMITS. AFTER THE PROCEDURE IN POST-OPERATION, THE PATIENT COMPLAINT OF PAIN. A POST-OP CT REVEALED T4-T9 WAS DEVIATED ON THE RIGHT SIDE. THE PATIENT WAS TAKEN BACK TO THE OR TO REPOSITION THE SCREWS WITH NAVIGATION. THERE WERE NO FURTHER SYMPTOMS AFTER THE REVISION.

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 SURGEON NOTIFIED THE CLINICAL REPRESENTATIVE (CR) THAT ONE OF RNS LEADS IMPLANTED WAS TOO DEEP BY APPROXIMATELY 12 MM. A REVISION SURGERY WAS PERFORMED, AND SURGEON CONFIRMED THAT MEASUREMENT MARK ON ELECTRODE WAS IN CORRECT SPOT. NO KNOWN COMPLICATIONS FOR THE PATIENT.

Walmart Inc. has ended its contract with Bossa Nova Robotics Inc.

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.