da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: INSTRUMENT NOT GRABBING SUTURE. FDA SAFETY REPORT ID# (B)(4).

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON 10-FEBRUARY-2020, INTUITIVE SURGICAL, INC. (ISI) RECEIVED FDA VOLUNTARY REPORT # MW5092558 WITH THE FOLLOWING EVENT DESCRIPTION, "THE PATIENT SUFFERED VAGINAL DEHISCENCE 12 WEEKS AFTER RECEIVING A DA VINCI ROBOTIC HYSTERECTOMY. REQUIRED EMERGENCY SURGERY TO PREVENT BOWEL EVISCERATION AND DEATH." HOWEVER, THERE IS NO ADDITIONAL INFORMATION PROVIDED REGARDING THE DA VINCI SURGICAL SYSTEM, HOSPITAL SITE NAME, OR PATIENT. AS A RESULT, ISI COULD NOT PERFORM FOLLOW-UP INVESTIGATION TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED 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: REFER TO FOR FOLLOW-UP INFORMATION.

Mako Robotic-Arm — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MAKO ROBOTIC EQUIPMENT MADE INCORRECT POSTERIOR CHAMBER CUT DURING SURGERY. 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: EVENT REPORTED BY THE FIELD SERVICE ENGINEER : THE ROBOT BS18962, WOULDN¿T CONNECT. THE PATIENT WAS ATTACHED TO THE ROBOT, AS WE WANTED TO START THE REGISTRATION PROCESS THE ROBOT DISPLAYED 'UNRECOVERABLE ERROR OCCURRED' WHICH RESULTED IN A SHUTDOWN. WHEN THE ISSUE OCCURRED WE DISCONNECTED THE PATIENT WITHIN 15-20 MINUTES AND THE SURGERY WAS PERFORMED USING A DIFFERENT METHOD.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THE LEFT LS SCREW WAS PLACED LOW TO PLAN. THE SCREW WAS REPOSITIONED INTRA-OPERATIVELY TO A NEW TRAJECTORY USING FLUOROSCOPIC IMAGING. IMMEDIATELY POST-OPERATIVE THE PATIENT HAD LIMITED MOVEMENT TO THE LOWER LEG AND FOOT. 28 DAYS LATER, THE SURGEON REPORTED THAT THE PATIENT HAD STARTED TO RECOVER MOVEMENT AND BELIEVED THIS IMPROVEMENT WOULD CONTINUE.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: SURGEON PERFORMING MARKER REGISTRATION, NOTED THAT MOVEMENT IS MARKEDLY DIFFERENT POST-UPGRADE. SURGEONS BOTH NOTED THE INCREASED DIFFICULTY WITH MOVEMENT USING POINTER TO PERFORM REGISTRATION. SURGEON FINDS IT "ALMOST UNUSABLE". SURGEONS EXPRESSED CONCERN FOR FUTURE SCHEDULED CASES; ADDITIONALLY NOTED THAT MAYBE WILL NOT PURCHASE SECOND SYSTEM IF CONTINUES TO BE DIFFICULT TO USE. DELAY OF 30 MINUTES. PATIENT UNDER ANESTHESIA, PINNED, BUT AWAKE; DBS PROCEDURE.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MARKERS REGISTRATION FLIPPED ANTERIOR AND POSTERIOR UPON VERIFICATION. MARKERS WERE RECORDED IN CORRECT ORDER. REGISTRATION WAS PERFORMED AGAIN, AND AN ADDITIONAL MARKER WAS DEFINED ON THE LEKSELL FRAME TO ORIENT AN ADDITIONAL MARKER IN NON-SYMMETRICAL PLACEMENT. RMS WAS ACCEPTABLE. DELAY OF 25 MINUTES. PATIENT UNDER ANESTHESIA, BUT AWAKE, DBS PROCEDURE, PATIENT PINNED. NO INCISION.

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, PATIENT EXPERIENCED A PNEUMOTHORAX DURING THE POST PROCEDURE CHEST FLUOROSCOPY USING THE MONARCH SYSTEM. PATIENT WAS REQUIRED TO BE HOSPITALIZED. CHEST TUBE WAS PLACED ON (B)(6) 2020. PNEUMOTHORAX WAS RESOLVED AND PATIENT WAS RELEASED. ELEVEN SUCCESSFUL BIOPSIES WERE COMPLETED USING FIVE NON-AURIS NEEDLES, THREE NON-AURIS BRUSHES, AND THREE AURIS FORCEPS.

At 4:30 a.m. on January 9, 2020, an employee and Coworker #1 were performing maintenance work drilling out and replacing bolts for an access panel on the pusher table of an auto depalletizing robot (Robot #2) within a robot cell. At the same time, coworker #2 was preparing to test the operational functions of the dunnage robot (Robot #1). Coworker #2 completed maintenance work on Robot #1 while the employee and Coworker #1 remained inside the robot cell. Coworker #2 exited the robot cell to reset the light curtains. The employee and Coworker #1 had entered the robot cell through the light curtains and that neither had isolated the electrical and pneumatic energy sources at the controls on Robot #2 or affixed lockout devices before performing maintenance work. Coworker #2 reset the robot cell perimeter light curtains for Robot #1 and Robot # 2 in preparation for a test run on Robot #1. The Robot #2 pusher table and robot arm turned on after the perimeter light curtains were reset and the run cycle was initiated in automatic mode on the operator control panel. The employee and Coworker #1 were both sitting on the Robot #2 pusher table while repairing damaged bolts on the table, so the pusher arm sensor for the Robot #2 pusher arm detected something on the table that needed to be pushed off. Coworker #1 managed to get off the pusher table without injury, but the employee was unable to move in time. The employee's feet had dropped down into the recessed area where they had removed an access plate from the table. His feet were repeatedly struck by the pusher arm as the robot tried to complete the normal programmed action of clearing materials from the table outgoing conveyors. His coworkers hit the emergency stop buttons on the outside of the robot cell and helped the employ

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING GUIDANCE OF THIRD TRAJECTORY, THE ROBOT ARM COLLIDED WITH AN ANCHOR BOLT, AND THE RESULTING IMPACT KNOCKED IT OUT OF THE PATIENT¿S HEAD. THE CASE WAS THEN ABORTED. BECAUSE A FIELD SERVICE ENGINEER (FSE) WAS NOT PRESENT AT THE TIME OF THE EVENT, WE ARE STILL MISSING A LOT OF THE DETAILS. A FSE PERFORMED ACCURACY CHECKS ON FRIDAY, 10-JAN-2020, AND VERIFIED THAT THE SYSTEM PASSED THOSE CHECKS SUCCESSFULLY.

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 2 ELECTRODES IMPLANTED, ABORTED PROCEDURE AFTER THIRD TRAJECTORY. POST-OP SCAN INDICATED BOTH ELECTRODES WERE DEEP ROUGHLY 3-5MM.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AT THE BEGINNING OF REGISTRATION SURGEON ASKED FOR HIS SPEED TO BE SWITCHED FROM SLOW TO FAST. WHEN USING THE TOUCH SCREEN TO DO THIS TASK, THE SCREEN FROZE AND THE ROBOT SHUTDOWN. WE THEN CONTINUED TO COMPLETE REGISTRATION. AFTER REGISTRATION, THE SURGEON REQUESTED THAT WE USE THE DISTANCE SENSOR TO MARK THE ENTRY POINTS ON THE HEAD. WHILE DRIVING TO TRAJECTORY 13, JOINT NUMBER 6 COLLIDED WITH THE TELESCOPIC ARM. THIS RESULTED IN A SHUTDOWN. AFTER REBOOTING, IT WAS NOT POSSIBLE TO MOVE THE ARM AWAY FROM THE TELESCOPIC ARM BECAUSE THE ROBOT WOULD SHUTDOWN JUST BEFORE SHOWING THE 'CLEARING THE PATIENT' SCREEN. THERE WERE MULTIPLE SHUTDOWNS BEFORE THE FIELD SERVICE ENGINEER (FSE) DECIDED TO MANUALLY RELEASE THE ARM. THE FSE REMOVED THE SIDE PANEL AND MANUALLY RELEASED THE ARM BY MOVING JOINT NUMBER 3. THE FSE REBOOTED THE ROBOT AND CONTINUED ON WITH THE SURGERY. THERE WAS NO HARM TO THE PATIENT. THIS PROCESS DELAYED THE CASE ABOUT 30 MINUTES.

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 DURING A ROSA BRAIN PROCEDURE, AN RNS NEUROSTIMULATOR KIT (COMPETITOR PRODUCT) WAS PLACED INTO THE WRONG SPOT IN THE OPTICAL NERVE. THE PATIENT HAS EXPERIENCED PAIN SINCE THE PROCEDURE. DURING FOLLOW-UP EVALUATION, THE FREQUENCY WAS INCREASED ON THE RNS DEVICE WHICH CAUSED A SEIZURE. IT WAS CONFIRMED AT THAT TIME THAT THE RNS WAS PLACED IN THE WRONG LOCATION. THE DEVICE WAS REMOVED AND REPLACED APPROXIMATELY 4 (FOUR) YEARS LATER. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

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 ON (B)(6) 2019, A PATIENT HAD A PNEUMOTHORAX THAT WAS DISCOVERED AFTER A PROCEDURE. THE LOCATION OF THE LESION IS IN THE LEFT UPPER LOBE, AND A NEEDLE BIOPSY WAS PERFORMED USING A SUPER D ARCPOINT NEEDLE. THE LOCATION OF THE PNEUMOTHORAX IS IN THE LINGULAR OF THE LEFT LUNG. THERE WERE TWO PATHWAYS TAKEN TO ACCESS THE LESION, ONE FROM THE LEFT LOWER LOBE, AND ANOTHER FROM THE LEFT UPPER LOBE. A CHEST TUBE WAS PLACED IN THE PATIENT AND WAS ADMITTED TO THE HOSPITAL OVERNIGHT. 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: IT WAS REPORTED THAT AFTER UNDERGOING A DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE, DISSECTION OF THE VAGINAL STUMP WAS PERFORMED, AND TISSUE WAS DAMAGED. ON (B)(6) 2020, INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CUSTOMER AND OBTAINED THE FOLLOWING INFORMATION: IT WAS REPORTED THAT THE STUMP OF THE VAGINA WAS INJURED DURING THE PROCEDURE. THE CAUSE OF THE INJURY WAS ATTRIBUTED TO THE SURGEON¿S MISJUDGMENT. THE SURGEON CONFIRMED THAT ANOTHER STITCH SHOULD HAVE BEEN PLACED. IT IS UNKNOWN WHAT MEDICAL INTERVENTION WAS REQUIRED TO REPAIR THE VAGINAL STUMP. ADDITIONALLY, THE SURGEON STATED THAT THE EVENT DID NOT OCCUR AS A RESULT OF THE DA VINCI SURGICAL SYSTEM MALFUNCTION. THE SURGERY WAS COMPLETED AS PLANNED AND THE PATIENT HAS PROGRESSED WELL WITHOUT ANY PROBLEMS.

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 GENERAL PHYSICIAN INQUIRY THAT AFTER A COMPLETED DA VINCI-ASSISTED GYNECOLOGY PROCEDURE, POSSIBLY ON (B)(6) 2019, PATIENT INJURY WAS REPORTED. THE PATIENT RETURNED TO THE HOSPITAL SIX TO SEVEN DAYS POST DA VINCI PROCEDURE, POSSIBLY ON (B)(6)2019, FOR WHAT WAS DESCRIBED AS ¿REPAIR¿ AS THERE WAS AN OBSERVED ¿TROCAR INJURY¿ AND ¿BOWEL NECROSIS¿. FURTHER DETAIL WAS UNKNOWN. THE PATIENT¿S CURRENT STATUS IS ALSO UNKNOWN.

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 CUSTOMER NOTED A METAL SHAVING AFTER PASSING A NEEDLE THROUGH THE CANNULA. THE CUSTOMER REPORTEDLY ATTEMPTED TO GRAB THE SHAVING WITH A LAPAROSCOPIC INSTRUMENT BUT WAS NOT ABLE TO LOCATE IT. IT WAS REPORTED THAT THE CUSTOMER WAS NOT ABLE TO SEE THE SHAVING ON AN X-RAY AND WAS NOT SURE OF THE SOURCE OF THE SHAVING. THE SIZE AND SHAPE OF THE METAL SHAVING ARE UNKNOWN SINCE THE CUSTOMER DID NOT PROVIDE ANY DETAILS ON THEM. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER NOTICED THE SHAVING DURING INSTALLATION OF THE ENDOSCOPE. THE CUSTOMER WAS NOT ABLE TO IDENTIFY THE SOURCE OF THE SHAVING. THE CANNULA AND ENDOSCOPE WERE INSPECTED AFTER THE PROCEDURE AND NO VISIBLE DAMAGE WAS OBSERVED ON EITHER OF THEM. THE INSTRUMENTS USED AT THE TIME OF THE REPORTED EVENT DID NOT MAKE CONTACT WITH ANY OTHER INSTRUMENT OR OTHER HARD MATERIAL DURING THE SURGICAL PROCEDURE. THE INSTRUMENTS USED AT THE TIME OF THE REPORTED EVENT WERE NOT INSPECTED PRIOR TO USE. NO ADDITIONAL POST-OPERATIVE TESTS OR PROCEDURES WERE PERFORMED TO

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, ¿EXTRAPERITONEAL VERSUS TRANSPERITONEAL SINGLE-PORT ROBOTIC RADICAL PROSTATECTOMY: A COMPARATIVE ANALYSIS OF PERIOPERATIVE OUTCOMES", THE FOLLOWING EVENTS WERE REPORTED. 98 PATIENTS UNDERWENT SINGLE-PORT ROBOTIC PROSTATECTOMY USING THE DA VINCI SP ROBOTIC SYSTEM WITH EXTRAPERITONEAL (GROUP I (N=52)) VERSUS TRANSPERITONEAL (GROUP II (N=46)) APPROACH FROM SEPTEMBER 2018 TO JUNE 2019 WERE INCLUDED IN THE STUDY. THE MEAN OPERATIVE TIME WAS SIGNIFICANTLY SHORTER WITH THE EXTRAPERITONEAL APPROACH COMPARED TO THE TRANSPERITONEAL APPROACH (201± 37.5 VERSUS 248.2 ± 42.3 MIN). NO PATIENTS RECEIVED PERIOPERATIVE BLOOD TRANSFUSION AND THE ESTIMATED BLOOD LOSS WERE SIMILAR AS 145.7± 87.7 VERSUS 117.6± 93.7ML RESPECTIVELY. POSTOPERATIVE COMPLICATIONS WERE COMPARABLE BETWEEN THE TWO GROUPS (TABLE 1). THERE WAS A TOTAL OF 6 CASES THAT DEVELOPED GRADE II CLAVIEN-DINDO COMPLICATIONS WHICH INCLUDES URINARY TRACT INFECTION, ACUTE KIDNEY INJURY, PULMONARY EMBOLISM. THERE WERE A TOTAL OF 7 CASES THAT DEVELOPED GRADE IIIA CLAVIEN-DINDO COMPLICATIONS, WHICH INCLUDES LYMPHOCELE, PELVIC ABSCESS, PELVIC HEMATOMA, URI

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: TIP COVER WAS MISSING FROM ROBOTIC SCISSOR WHEN REMOVED FROM PT TROCAR DURING ROBOTIC SURGERY. EFFORTS MADE TO LOCATE WITH NO AVAIL. PT WAS BROUGHT BACK TO SURGERY ON (B)(6) 2019 TO REMOVE RETAINED TOP COVER. FDA SAFETY REPORT ID# (B)(4).

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: WHILE USING THE MAZOR NAVIGATION / ROBOTIC SYSTEM LEFT SIDE SCREWS OF A SPINAL FUSION WERE IN PLACE. THE RIGHT SIDED SCREWS WERE MEDIAL DISPLACED AND REQUIRED RE POSITIONING. FDA SAFETY REPORT ID# (B)(4).

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: 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: DR. (B)(6) CALLED THE FIELD SERVICE ENGINEER ON (B)(6) 2019 TO INFORM THAT THE ROBOT TURNED ON BUT NOTHING DISPLAYED ON THE SCREEN. ANOTHER FSE CALLED AND SUGGEST TO DR. (B)(6) AND HIS TEAM TO CHECK IF THE ELECTRICAL TRANSFORMER OF THE SCREEN WAS WELL PLUGGED. THEY DID IT AND THE SCREEN WORKED AGAIN. IT SEEMS THAT THERE WAS A DISCONNECTION DURING THE TRANSPORTATION OF THE ROBOT. THE SURGEON HAS DECIDED TO POSTPONE THE CASE TO AVOID ANY RISK BEFORE THE TECHNICAL INTERVENTION.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: SURGEON PERFORMED DBS PROCEDURE TARGETING BILATERAL VIM WITHOUT THE FIELD SERVICE ENGINEER. SURGEON AND STAFF STRUGGLED WITH OBTAINING ADEQUATE VALUE FOR FIDUCIAL RMS. REACHED OUT FOR PHONE SUPPORT TO FSE. CASE PROCEEDED NORMALLY. IT WAS NOTED DURING POST OPERATIVE IMAGING THAT DBS ELECTRODES APPEAR TO BE DEEP BY NEARLY 8 MM ON LEFT AND ON TARGET ON RIGHT.

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 A MORNING SEEG/ABLATION CASE AT (B)(6) HOSPITAL IN (B)(6). AT 9 AM, AFTER THE FIRST REGISTRATION, THE DEVICE SHUT DOWN. IT SAID "DEVICE SHUTTING DOWN" AND IT ASKED IF WE WANTED TO SAVE THE PATIENT FOLDER. THEY DID NOT CLICK ANY BUTTONS TO INITIATE THE SHUT DOWN AND THERE WAS NO COMMUNICATION ERROR WHICH WAS STRANGE. AT 9:32 AM, THERE WAS A COMMUNICATION FAILURE BETWEEN ROSA AND THE COMPUTER; ROSA SHUTDOWN DURING THE NEXT REGISTRATION ATTEMPT WHILE WE WERE ON THE PAGE TO MAKE EACH POINT MORE ACCURATE.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE SURGEON CALL THE COMPANY FIELD SERVICE ENGINEER ON 15-NOV-2019. SHE TOLD, THAT THE ROBOT HAD AN UNDISCOVERABLE ERROR. SHE TOLD THEY TRIED SEVERAL TIMES TO RESTART, BUT THE ROBOT DIDN´T START AGAIN. FINALLY THE SURGERY WAS CANCELLED. THE SURGEON ASKED FOR A CHECK, WHAT HAPPENED.

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 RECEIVED A CALL FROM THE SURGEON. HE TOLD THAT THE LED NEEDS TO BE FIXED. IN THE SAME TIME, THE DISPLAY OF THE ROBOT SEEMS TO BE NOT THE MAIN DISPLAY. THE CAMERA DISPLAY SHOWS MORE INFORMATION ON THE START UP (BIOS MESSAGE). THIS SHOULD BE CHANGED TO HAVE TO ROBOT DISPLAY SHOWING THIS. THIS WILL ALSO HELP ON THE ISSUE WITH THE LED.

At 8:30 p.m. on November 14, 2019, an employee was working for a firm that made medical and surgical instruments. She supervised mechanics and repair technicians. She was working in the facility's HA department, where the HA1 and HA2 robotic work cells were located. She was changing out a plasma spray gun from the HA2 robot. The robot was still energized. It had not been locked out. As she was loosening a bolt to detach the plasma spray gun from the robot, the wrench she was using contacted a metal fitting on the spray gun water line. An arc flash ensued. The employee received second-degree burns on two fingers on her left hand and on her right wrist. She was treated without hospitalization. The employee had not been trained on lockout or the use of padlocks. The interlocked access doors to the cell were equipped with a limit switch that did not deenergize the robot or the spray gun. The employee entered the cell two to three times daily. A risk assessment had not been performed. The employer was not enforcing energy control procedures.

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 (FSE) TOLD THE SURGEON THAT THE CTA MAY NOT BE USABLE FOR LASER REGISTRATION. THE FSE NOTICED THAT THE PATIENT'S FACE WAS NOT KEPT CLEAR FOR THE SCAN. THERE WAS A BELT HOLDING THE PATIENT DOWN ON THEIR FOREHEAD, AND WHAT APPEARED TO BE BLANKETS AROUND THEIR HEAD, POSSIBLY COMPRESSING THE HEAD AROUND THE TEMPLES AND OTHER AREAS. THE SURGEON WANTED TO TRY AND USE THE SCAN FOR LASER REGISTRATION. AROUND 10:10AM EST, THE FIRST LASER REGISTRATION WAS ATTEMPTED, BUT AN ERROR MESSAGE WAS EXPERIENCED. AFTER PERFORMING THE VERIFICATION, IT WAS DETERMINED THAT THE REGISTRATION WAS NOT ACCURATE. AFTER PERFORMING A SECOND AND THIRD LASER REGISTRATION, IT WAS DETERMINED THAT THE CURRENT SCAN WAS NOT WORKING, AND THAT A NEW SCAN WAS TO BE OBTAINED WITH BONE FIDUCIALS. AFTER THE NEW SCAN WAS OBTAINED AND UPLOADED/MERGED, THE BONE FIDUCIAL REGISTRATION WAS PERFORMED, AND THE SURGEON ACCEPTED THE RMS OF 0.99MM AND APPROVED OF THE VERIFICATION OF THE REGISTRATION. THERE WERE NO OTHER ISSUES EXPERIENCED DURING THE CASE. PATIENT WAS UNDER ANESTHESIA AND NO INCISIONS WERE MADE. TOTAL DELAY WAS OVER AN HOUR DUE TO THE NUMEROUS LASER REGISTRATIONS AND OBTAINING A NEW PATIENT SC

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 A DA VINCI-ASSISTED SINGLE-PORT (SP) EXTRAPERITONEAL PROSTATECTOMY PROCEDURE, THE PATIENT PRESENTED WITH A PNEUMOTHORAX. THIS WAS ONE OF THE SURGEON'S FIRST DA VINCI-ASSISTED SP CASES, AND THE DA VINCI AXIS PORT WAS NOT AVAILABLE BACK THEN. AS SUCH, THE SURGEON USED A MODIFIED 3RD PARTY GELPORT THAT THEY LEFT SLIGHTLY UNRAVELED IN ORDER TO ALLOW SOME ADDITIONAL ACCESS/WORKING SPACE. HOWEVER, THIS DID NOT CREATE A GREAT SEAL. HE BELIEVES THE CO2 TRAVELED UP THE RECTUS SHEATH TO THE MEDIASTINUM, AND THEN CAUSED THE PNEUMOTHORAX. FROM HIS RECOLLECTION, THE PATIENT PRESENTED WITH POST-OPERATIVE RESPIRATORY CONCERNS, LIKELY DYSPNEA, AND A CHEST X-RAY CONFIRMED THE PNEUMOTHORAX. THEY PUT IN A CHEST TUBE AND INVOLVED A PULMONOLOGIST, WHO MANAGED THAT ASPECT OF THE PATIENT'S CARE. THERE MAY HAVE BEEN SOME EXTRA HOSPITALIZATION, BUT THE PATIENT RECOVERED WELL, WITH NO SEQUELAE. THE SURGEON BELIEVED THE EXTRAPERITONEAL APPROACH MAY HAVE ALSO CONTRIBUTED TO THIS COMPLICATION, AS SOME PATIENTS CAN DEVELOP SUBCUTANEOUS EMPHYSEMA FROM CO2 WITH THIS KIND OF APPROACH. HE THOUGHT THAT THE PRESSURE THAT THEY WERE USING COULD HAVE ALSO BEEN TOO HIGH, WHICH MAY HAVE CONTRIBU

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IN (B)(6) 2019, IQ, A (B)(6) Y/O MARRIED, MOTHER OF A THREE Y/O CHILD, UNDERWENT A MINIMALLY INVASIVE ROBOTIC HYSTERECTOMY FOR TREATMENT OF SYMPTOMATIC UTERINE TUMORS ASSUMED TO BE BENIGN FIBROID DISEASE OF (B)(6). THE OPERATING SURGEON WAS (B)(6) FROM "(B)(6) OB/GYN". THE DIAGNOSIS OF UTERINE LEIOMYOSARCOMA WAS PRE-OPERATIVELY MISSED IN THIS PT. ACCORDING TO THE PT, HER SURGEON EXPLAINED THAT HER MALIGNANT UTERINE TUMOR WAS MORCELLATED IN ORDER TO ACCOMPLISH THE SMALL INCISION ROBOTIC HYSTERECTOMY OPERATION. SHE REPORTS THAT SHE WAS NO PRE-OPERATIVELY INFORMED OF THE NEED FOR MORCELLATION AND THAT NO DISCUSSION TOOK PLACE REGARDING THE POSSIBILITY THAT A MISSED / OCCULT CANCER COULD MASQUERADE AS A FIBROID TUMOR AND BE SPREAD OR UPSTAGED BY MORCELLATION. IT IS UNCLEAR WHETHER THE SURGEON USED THE ROBOTIC EQUIPMENT AS A MORCELLATOR TO DISINTEGRATE THE UTERINE TISSUES / TUMORS OR IF A LAPAROSCOPIC POWER MORCELLATOR DEVICE WAS USED IN THE OPERATION - AND IF SO, WHETHER A CONTAINMENT BAG WAS USED. IRRESPECTIVE, THE PT UNDERWENT MORCELLATION OF HER CANCER DESPITE CONCERNING PRE-OPERATIVE CLINICAL CRITERIA AND WITHOUT HAVING BEEN INFORMED OF THE POTENTIALLY DEADLY RISK OF CANCER UPSTAGI

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 THAT WAS USED FOR AM XLIF (EXTREME LATERAL INTERBODY FUSION) L3-S1, INCLUDING POSTERIOR INTERTRANSVERSE ARTHRODESIS L5-S1, AND PLACEMENT OF POSTERIOR SEGMENTAL SPINAL FIXATION L3-L4, L4-L5, AND L5-S1 PROCEDURE. DURING THIS SURGERY, THE SURGEON CUT NERVES TO THE PATIENT'S LEGS. THE PATIENT SUFFERED SERIOUS AND PERMANENT INJURIES AND DEBILITATING CONDITIONS, INCLUDING BUT NOT LIMITED TO PERMANENT NERVE DAMAGES TO LEGS, GREAT PAIN OF MIND AND BODY, MENTAL AND EMOTIONAL DISTRESS, AND DECREASES LIFE EXPECTANCY, AND ALSO REQUIRED EXTENSIVE MEDICAL TREATMENT.

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 SCOLIOSIS CORRECTION AND POSTEROLATERAL FUSION FROM T10-L4. THE GUIDANCE SYSTEM WAS INACCURATE AND A SUSPECTED BREACH AT RIGHT L4 WAS FOUND SEVERAL DAYS AFTER THE PROCEDURE. THE AMOUNT OF INACCURACY WAS UNKNOWN. NO TROUBLESHOOTING WAS DONE DURING THE INITIAL PROCEDURE AS THE INACCURACY OCCURRED ON THE LAST LEVEL AND THE SURGEON DECIDED TO NOT READJUST THE SCREW. THE REPRESENTATIVE SUSPECTED POSSIBLE SOFT TISSUE PULLING AS THE INACCURACY OCCURRED DURING THE LAST LEVEL. THE PATIENT EXPERIENCED CHRONIC NEUROPATHIC LEG PAIN. NOTHING WAS NOTICED ON THE POST-OP SPIN, BUT A CT SCAN FOUND THE SCREWS WERE PLACED TOO CLOSE TO THE NERVES. A BALL STIMULATING PROBE WAS USED TO CHECK EMB CHANGES AT L4. THERE WERE NO CHANGES, EVEN AT THE HIGHEST STIMULATION. A REVISION PROCEDURE WAS DONE TO REMOVE THE SCREWS AND PLACE NEW ONES. 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: IT WAS REPORTED THAT ON (B)(6) 2019, A PATIENT HAD A PNEUMOTHORAX THAT WAS DISCOVERED THREE HOURS AFTER THE PROCEDURE WAS COMPLETED. THE PNEUMOTHORAX WAS LOCATED IN THE LEFT UPPER LOBE ALONG THE PLEURA SPACE. THERE WERE TWELVE NEEDLE PASSES PERFORMED, AND EIGHT TO TEN FORCEPS BITES WERE PERFORMED. A BRONCHOALVEOLAR LAVAGE (BAL) AND AN ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE WERE ALSO PERFORMED, THESE TARGETED TWO LEFT SIDED LYMPH NODES, THE MEDIASTINUM STATION 7 LYMPH NODE AND ONE RIGHT SIDED LYMPH NODE. PATIENT WAS HIGHLY EMPHYSEMIC AND HAD HIGH RISK POTENTIAL FOR COMPLICATIONS. A PIGTAIL TUBE WAS PLACED IN THE PATIENT AND PATIENT WAS ADMITTED TO THE HOSPITAL OVERNIGHT. THERE WAS NO REPORT OF DEVICE FAILURE.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ABSTRACT: TO COMPARE INTRAOPERATIVE SURGICAL INSTRUMENTATION TECHNIQUES WITH IMAGE-GUIDANCE VERSUS ROBOTIC-GUIDED PROCEDURES FOR POSTERIOR SPINAL FUSION. A RETROSPECTIVE REVIEW OF INSTITUTIONAL DATA COLLECTED FROM A SINGLE SURGEON WAS USED TO COMPARE SURGICAL OUTCOMES BETWEEN O-ARM NEURONAVIGATION AND THE MAZOR X ROBOTIC-ASSISTANCE SYSTEM FOR PLACEMENT OF POSTERIOR SPINAL INSTRUMENTATION IN A CONSECUTIVE SERIES OF PATIENTS. UNIVARIATE STATISTICAL SIGNIFICANCE TESTING COMPARED TIME SPENT IN THE OPERATING ROOM, BLOOD LOSS, SCREW ACCURACY, AND WOUND HEALING. BETWEEN JANUARY 2017 AND FEBRUARY 2019, 46 O-ARM CASES AND 39 MAZOR X CASES WERE CONDUCTED. CASES WERE CLASSIFIED AS DEGENERATIVE, INFECTIOUS, ONCOLOGIC, AND TRAUMA WITH A MEAN OF 4.57 AND 5.43 LEVELS OPERATED ON USING O-ARM NEURONAVIGATION AND MAZOR X, RESPECTIVELY. MEAN OPERATIVE TIMES, ESTIMATED BLOOD LOSS, WOUND REVISION RATES, AND CLINICALLY ACCEPTABLE INSTRUMENTATION PLACEMENT DID NOT DEMONSTRATE SIGNIFICANCE BETWEEN THE 2 GROUPS. HOWEVER, SCREW PLACEMENT WAS SIGNIFICANTLY MORE ACCURATE AND PRECISE WITH ROBOTIC ASSISTANCE. ALTHOUGH A TREND TOWARD GREATER ACCURACY WAS NOTICED WITH ROBOTIC TECHNOLOGY WHEN DETERMINING CLINICALL

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 THE AUTOMATIC PORTION OF LASER REGISTRATION, WE RECEIVED THE ERROR ROBOT COULD NOT PERFORM AUTOMATIC TRAJECTORY IN ORDER TO SCAN PATIENT¿S HEAD. THIS CAUSED A 20-30-MINUTE DELAY AS THE PATIENT WAS RE-POSITIONED AND RE-REGISTERED. THEN, AT 6:40 PM, THERE WAS A ROBOT SHUT DOWN. COMMUNICATION FAILURE WITH THE ROBOT. THIS WAS DURING REGISTRATION. THIS CAUSED A 20-MINUTE DELAY AS THEY HAD TO RE-REGISTER. AT 7:40 PM, THERE WAS A ROBOT SHUT DOWN. COMMUNICATION FAILURE WITH THE ROBOT. THIS WAS AFTER REGISTRATION AND VERIFICATION, BUT BEFORE GUIDANCE AFTER DRAPING. THE ARM WAS IN THE HOME POSITION. THE ROBOT SHUT DOWN FOR NO APPARENT REASON. THIS CAUSED A 5-MINUTE DELAY. FINALLY, THERE WAS A ROBOT SHUT OFF AT 9:52 PM. COMMUNICATION FAILURE WITH THE ROBOT. THE SYSTEM WILL SHUT DOWN. WHEN TRYING TO TURN THE ROBOT BACK ON, IT DID NOT GO ON. IT WAS DISCOVERED THAT THE OUTLET WASN¿T WORKING, AND THE ROBOT TURNED BACK ON ONCE PLUGGED INTO A NEW OUTLET IN THE OR. THIS CAUSED A 5-10 MINUTE DELAY AS WE TROUBLE-SHOOTED AND GOT THE ROBOT UP AND RUNNING AGAIN.

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) 2019, THE CUSTOMER REPORTED THAT A PATIENT HAD A PNEUMOTHORAX. THE PNEUMOTHORAX WAS FOUND AND REPORTED AFTER THE PROCEDURE WHILE THE PATIENT WAS IN POST ANESTHESIA CARE FOLLOW-UP. THE PLAN HAD TWO TARGETS, ONE IN RIGHT UPPER LUNG (RUL) AND ONE IN LEFT LOWER LUNG (LLL). THE LOCATION OF THE PNEUMOTHORAX WAS IN THE RUL. THE PHYSICIAN USED AN AURIS CYTOLOGY BRUSH, AN AURIS BIOPSY FORCEPS, AND A COOK EUS 22GAUGE NEEDLE (AKA ECHO TIP). AT THIS TIME, THE PHYSICIAN DOES NOT ATTRIBUTE THE PNEUMOTHORAX WAS CAUSED BY ANY AURIS INSTRUMENT OR DEVICE. A FOLLOW-UP WITH THE ACCOUNT MANAGER FOR THE SITE CONFIRMED THAT A CHEST TUBE WAS PLACED IN THE PATIENT WHO RECOVERED AND WAS RELEASED ON THE FOLLOWING DAY. BASED ON THE INFORMATION PROVIDED BY THE PHYSICIAN, 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: AT ROUGHLY 10:12 AM, COMMUNICATION ERROR OCCURRED. ROBOT HAD BEEN IN AXIAL SLOW COOPERATIVE MODE, ON 'HIPPO HEAD' TRAJECTORY. SURGEON HAD MOVED TOWARDS TRAJECTORY, BUT COLLIDED WITH MAYFIELD. PATIENT WAS POSITIONED HEAD FACING TOWARDS LEFT, ALL TRAJECTORIES FACING UPWARD. MAYFIELD WAS POSITIONED WITH ATTACHMENT ANTERIOR TO PATIENT. COMPANY FIELD SERVICE ENGINEER (FSE) ATTEMPTED TO RESTART ROBOT THREE TIMES WITH FULL SHUTDOWN PROCEDURE. ON FOURTH ATTEMPT, SURGEON APPLIED SLIGHT FORCE TO MAYFIELD TO MOVE AWAY FROM POINT OF COLLISION. ROBOT WAS ABLE TO CONNECT. FSE EXPLAINED IMPORTANCE OF ACCURACY AND REGISTRATION VERIFICATION. SURGEON PROCEEDED WITH VERIFICATION OF ARM POSITION WITH INCISION PREVIOUSLY MADE ON TRAJECTORY. POST-OPERATIVE CT WAS UNAVAILABLE TO FSE, BUT SURGEON SENT EMAIL CONFIRMING CORRECT AND ACCURATE PLACEMENT ON CT FOLLOWING PROCEDURE. DELAY OF 30 MINUTES. SEEG PROCEDURE, ERROR OCCURRED ON 5TH OF 6 TRAJECTORIES.

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 BY THE PATIENT'S HUSBAND THAT AFTER UNDERGOING AN UNSPECIFIED DA VINCI-ASSISTED SURGICAL PROCEDURE, HE WAS INFORMED BY THE HOSPITAL THAT HIS WIFE¿S BOWEL HAD BEEN ¿NICKED¿ OR ¿CUT.¿ PER THE PATIENT¿S HUSBAND, HE ALSO CLAIMED THAT THE HOSPITAL INDICATED THAT THE INJURY WAS PART OF NORMAL SURGICAL COMPLICATIONS. THE PATIENT¿S HUSBAND REPORTEDLY DID NOT UNDERSTAND WHY THE PATIENT WAS SENT HOME AFTER THE OPERATION FOR TWO HOURS, ONLY TO RETURN TO THE EMERGENCY ROOM (ER). ACCORDING TO THE PATIENT¿S HUSBAND, AS A RESULT OF THE BOWEL INJURY, HIS WIFE STAYED IN THE ICU FOR 10 DAYS AND RECEIVED A BLOOD TRANSFUSION. IN ADDITION, HE ALLEGED THAT THE PATIENT EXPERIENCED A HEART ATTACK BECAUSE OF BLOOD LOSS. ON 11/04/2019, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE PATIENT¿S HUSBAND AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: HE DID NOT KNOW IF THE PATIENT HAD UNDERGONE ANY PREVIOUS SURGICAL PROCEDURES PRIOR TO UNDERGOING A DA VINCI-ASSISTED VENTRAL HERNIA REPAIR PROCEDURE. ACCORDING THE PATIENT¿S HUSBAND, THE PATIENT WAS TO UNDERGO A ROBOTIC HERNIA PAIR PROCEDURE TO FIX ONE DEFECT. HOWEVER, 4 SEPARATE DEFECTS WERE IDENTIFIED AND R

At 8:35 p.m. on October 22, 2019, an employee working for a plastics plumbing fixtures manufacturer was receiving parts from a robot press machine. The robot press struck the employee in the head. The employee lacerated his head and sustained a concussion, requiring hospitalization.

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 COMPANY FIELD SERVICE ENGINEER (FSE) AND TOLD HIM, HE TRIED 5-6 TIMES TO START THE ROBOT. THE FSE TOLD THE SURGEON TO CHECK THE EMERGENCY STOPP BUTTON: THE BUTTON WAS LIGHTED. THE FSE ASKED TO PRESS AND RELEASE THE BUTTON. RESTART THE SYSTEM AND LEAVE IT OFF THE POWER FOR MINIMUM 1 MINUTE. THHE SURGEON DR. FREIMAN DID SO. DIRECTLY WHEN HE TURNED THE POWER ON, THE RED LIGHT OF THE EMERGENCY STOP BUTTON LIGHTS UP. CASE WAS CANCELLED. PATIENT WAS ALREADY IN GENERAL ANESTHESIA AND WAS PINNED IN THE MAYFIELD.

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 WITH SURGEONS. DURING THE CASE, THE ROBOT SHUT DOWN TWICE DUE TO THE ARM BEING FULLY EXTENDED. THE FIRST TIME IT HAPPENED WAS AT 3:23 PM DURING REGISTRATION. BEFORE SHUTTING DOWN WE SAW AN ERROR 'IMPOSSIBLE TO RECORD POINT' WITH THE DISTANCE SENSOR AS THE TOOL ON THE ROBOT ARM. THIS CAUSED A 20 TO 30-MINUTE DELAY AS WE NEEDED TO START REGISTRATION AGAIN. THE SECOND TIME THE ROBOT SHUT DOWN DUE TO THE ARM BEING FULLY EXTENDED WAS DURING THE GUIDANCE PORTION OF THE SURGERY WHEN WE WERE GOING TO A TRAJECTORY ON THE PATIENT¿S RIGHT SIDE. THIS OCCURRED AT 5:57 PM. THERE WAS AN ERROR 'COMMUNICATION FAILURE WITH THE ROBOT.' THIS CAUSED A 5-10 MINUTE DELAY.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: STAPLE LINE FAILED DURING BRONCHIAL REINFLATION.

At 8:00 a.m. on October 16, 2019, an employee was working on the paint line in Section 1200 and entered into an area that was chained off with LOTO signs to free a jammed pallet. The employee was struck by a fiber concrete board that was rejected by a Guidel Gantry Systems Robot and crushed between it and a stack of other rejected boards, killing him.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON 10/10/2019, IT WAS REPORTED THAT DURING A MONARCH-ASSISTED BIOPSY PROCEDURE, THE PATIENT EXPERIENCED A PNEUMOTHORAX. THE TARGET WAS IN LEFT UPPER LOBE (LUL) APICAL POSTERIOR SEGMENT NEAR THE PLEURA. THE INSTRUMENTS USED WERE AURIS BRONCHOSCOPE, REBUS PROBE AND SUPERD ARC POINT NEEDLE. THE PHYSICIAN TOOK BIOPSIES USING SUPERD ARC POINT NEEDLE. IT WAS REPORTED THAT AFTER SUCCESSFUL FIRST AND SECOND PASSES, THE PHYSICIAN OBSERVED PNEUMOTHORAX ON THE THIRD PASS. AFTER COMPLETING THE PROCEDURE, A CHEST TUBE WAS PLACED IN THE PATIENT. THE CUSTOMER CONFIRMED ON (B)(6) 2019 THAT PNEUMOTHORAX WAS RESOLVED AFTER CHEST TUBE PLACEMENT AND THE PATIENT WAS DISCHARGED.

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 (FSE) REPORT A COMPLAINT THAT OCCURRED ON (B)(6) 2019 DURING AN SEEG SURGERY AT THE UNIVERSITY OF WISCONSIN (B)(4) AFTER REGISTRATION WAS PERFORMED, AN ERROR MESSAGE APPEARED THAT STATED THAT THE REGISTRATION COULD NOT BE COMPUTED. THE INITIAL POINTS WERE REDEFINED, BUT THE REGISTRATION STILL COULD NOT BE COMPUTED. THE REGISTRATION WAS THEREFORE CANCELLED AND RESTARTED. THE 3D RECONSTRUCTION WAS ADJUSTED PRIOR TO THE SECOND REGISTRATION AND THE SURGEON SPENT EXTRA ATTENTION ENSURING THE LASER DID NOT CROSS ANY HAIR AND WAS ORTHOGONAL TO THE SKIN. THIS CAUSE ABOUT A 35 MINUTE DELAY IN SURGERY. THERE WERE NO KNOWN ADVERSE EFFECTS TO THE PATIENT, AND THIS DID NOT INCLUDE A LONG TERM IMPLANT. SURGICAL PROTOCOL WAS FOLLOWED.

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 AND THE SURGEON WERE TRYING TO UPLOAD A CT TAKEN JUST MINUTES BEFORE AND MERGE THE SCAN WITH THE MRI THAT WAS USED TO PLAN THE SEEG SURGERY. THEY HAD DIFFICULTY MERGING THE TWO SCANS TOGETHER. AS A WORKAROUND, THEY UPLOADED ANOTHER MRI SCAN THAT HAD A DIFFERENT RESOLUTION. THEY WERE ABLE TO MERGE MRI 2 WITH MRI 1, HOWEVER WHEN THEY TRIED THE SAME FOR THE CT SCAN THEY WERE UNABLE TO DO SO. THE SYSTEM HAD AN ERROR MESSAGE "IMPOSSIBLE TO LOAD EXAM". IT WAS DECIDED TO DELETE MRI 2 OFF THE ROBOT AND THAT IS WHEN THE SOFTWARE BECAME UNRESPONSIVE SO THEY HAD TO RESTART THE ROBOT/COMPUTER. THIS REBOOT TOOK ABOUT 8 MINUTES. THEY THEN UPLOADED A NEW CT SCAN TO TRY TO MERGE THAT SCAN WITH MRI 1. IT WAS SUCCESSFUL, HOWEVER WHEN THEY SELECTED THE CT HAS THE 3D MODEL IN THE EXAM MANAGER THE ROBOT BECAME UNRESPONSIVE AND THERE HAD TO BE A MANUAL RESTART. THIS REBOOT TOOK ABOUT 8 MINUTES. AFTER THE MANUAL RESTART, THEY UPLOADED AND SUCCESSFULLY MERGED A SECOND CT SCAN. THEY PROCEEDED WITH THE CASE AFTER THE MERGE. THEY PERFORMED A SUCCESSFUL MARKER REGISTRATION AND PERFORMED ALL 10 PLANNED SEEG TRAJECTORIES. THE PATIENT WAS UNDER ANESTHESIA DURING THIS TIME, HOWEVER THE

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) 2019, IT WAS REPORTED THAT DURING A MONARCH-ASSISTED BIOPSY PROCEDURE, THE PATIENT HAD A PNEUMOTHORAX. THE PHYSICIAN PERFORMED SEVERAL BIOPSIES IN THE LOWER UPPER LUNG (LUL) AND SEVERAL BIOPSIES IN THE RIGHT UPPER LUNG (RUL). THE PHYSICIAN THEN PERFORMED AN ENDOBRONCHIAL ULTRASOUND (EBUS) ON THE RIGHT SIDE OF THE PATIENT'S LUNG AND COMPLETED THE PROCEDURE. THE PNEUMOTHORAX WAS THEN DISCOVERED ABOUT AN HOUR AFTER THE CASE DURING A POST-PROCEDURE X-RAY. THE PATIENT WAS THEN GIVEN A CHEST TUBE AND WAS HELD AT THE HOSPITAL. THE PATIENT RECOVERED AND WAS RELEASED FROM THE HOSPITAL ON THE FOLLOWING DAY. BASED ON THE INFORMATION PROVIDED BY THE PHYSICIAN, THERE WAS NO DEVICE FAILURE.