ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IN PREPARATION OF THE SURGERY THE ROBOT WAS TURNED ON, AND IT WAS NOT POSSIBLE TO CONNECT TO THE ROBOT ARM DESPITE SEVERAL ATTEMPTS. THE PATIENT WAS ALREADY IN THE OR AND PREPARED FOR SURGERY. MULTIPLE RESOLUTIONS WERE ATTEMPTED UNSUCCESSFULLY. THE SURGERY WAS ABORTED AND POSTPONED TO ANOTHER DAY.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING A SURGERY THE ROBOT FAILED TO CONNECT. MULTIPLE ATTEMPTS WERE MADE BUT DID NOT RESOLVE THE ISSUE. THE SURGEON DID NOT FEEL THAT THE ROBOT WAS RELIABLE AND DECIDED TO POSTPONE THE CASE. THE PATIENT WAS WOKEN FROM ANESTHESIA. NO CUTS WERE MADE.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: FOLLOWING A SURGERY USING MAZOR X SYSTEM, AT (B)(6) INTERNATIONAL HOSPITAL (B)(6), ON (B)(6) 2019, IT WAS REPORTED THAT WHILE USING THE SYSTEM TO DIRECT DRILLING INTO A VERTEBRA FROM A POSTERIOR DIRECTION, THE VERTEBRAL BODY WAS BREACHED ANTERIORLY AND PERFORATED THE INFERIOR VENA CAVA (IVC). L3-L5 SCREW PLACEMENT WAS PLANNED INTRA-OPERATIVELY USING O-ARM IMAGING. DURING THE PROCEDURE, L3L AND L4L WERE DRILLED USING THE SHORT DRILL GUIDE AND SHORT DRILL BIT. AS SURGEON FELT K-WIRE WAS DEVIATED, INDICATED BY BLOODSTAIN AND BONE ON THE DRILL, FURTHER X-RAY AND 3D IMAGING CONFIRMED THE DRILLS PERFORATED THE FRONT VERTEBRAL BODY. MAZOR X PROCEDURE WAS ABORTED. PATIENT UNDERWENT CT SCAN AND FOUND TEAR VEIN AND BLOOD CONGESTION NEARBY INFERIOR VENA CAVA. THE CLINICAL INVESTIGATION HAD SHOWN THE TRAJECTORIES EXECUTED WERE ACCURATE WITHIN THE PEDICLE AND PER PLAN, IN BOTH AXIAL & SAGITTAL PLANES. AS THERE ARE NO ISSUES OF ABNORMAL ANATOMY OR PLATFORM MOUNTING OR EVIDENCE FOR MALFUNCTION, IT WAS CONCLUDED THAT THE ROOT CAUSE FOR THE ANTERIOR BREACHING DURING THE MAZOR X PROCEDURE IS INCORRECT HARDWARE USE. IT IS PROBABLE THAT THERE WAS DEVIATION FROM SURGICAL TECHNIQUE, MANIFESTED AS USING

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 RADICAL HYSTERECTOMY PROCEDURE, ELECTRICAL ENERGY BURNED THROUGH A MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY THAT WAS INSTALLED ON A MCS INSTRUMENT. AS A RESULT, THE PATIENT SUSTAINED AN INJURY THROUGH THE ILIAC ARTERY. THE CASE WAS REPORTEDLY CONVERTED TO OPEN SURGERY. ON (B)(4) 2019, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES ASSOCIATE (CSA) AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: THE CSA WAS NOT PRESENT DURING THE SURGICAL PROCEDURE. THE SITE¿S ROBOTICS COORDINATOR CLAIMED THAT ELECTRICAL ENERGY ¿ESCAPED¿ THROUGH THE MCS TIP COVER ACCESSORY. THE SURGICAL STAFF INITIALLY ATTEMPTED TO REPAIR THE VESSEL INJURY USING THE DA VINCI SURGICAL SYSTEM. HOWEVER, THE CASE WAS REPORTEDLY CONVERTED TO OPEN SURGERY TO REPAIR THE VESSEL. AFTER THE VESSEL WAS REPAIRED, THE HYSTERECTOMY WAS COMPLETED VIA OPEN SURGERY. NO POST-OPERATIVE COMPLICATIONS HAVE BEEN REPORTED. THE CSA INDICATED THAT THE LAST TIME HE HAD SPOKEN TO THE CUSTOMER, THE SITE¿S RISK MANAGEMENT DEPARTMENT HAD THE MCS INSTRUMENT AND/OR MCS TIP COVER ACCESSORY.

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) WAS ASSISTING THE SURGEON WITH AN RNS CASE USING ROBOT BR18054. BONE FIDUCIALS WERE USED FOR REGISTRATION, SO THE POINTER INSTRUMENT WAS BEING USED. AROUND 9:52AM EST, AFTER SUCCESSFUL REGISTRATION OF THE PATIENT, THE ROBOT EXPERIENCED A COMMUNICATION ERROR DURING THE VERIFICATION PORTION OF REGISTRATION. THE SURGEON MOVED THE ARM IN FREE/FAST MODE TO THE PATIENT'S SKIN ON THE SKULL TO VERIFY THE ACCURACY OF REGISTRATION. THE SURGEON FELT THE ARM LOCK WHEN REACHING THE PATIENT'S SKIN AND AN AUDIBLE CLICK NOISE WAS HEARD. THE MESSAGE COMMUNICATION FAILURE WITH THE ROBOT. THE SYSTEM WILL SHUT DOWN APPEARED ON THE SCREEN, AND THE ROBOT WAS FORCED TO RESTART. THE POINTER WAS TOUCHING THE PATIENT'S SKIN, BUT WAS NOT STUCK IN A POSITION THAT WOULD BE AN ISSUE FOR THE PATIENT. AROUND 9:55AM EST, AFTER RESTARTING THE ROBOT, THE SURGEON ATTEMPTED TO MOVE THE POINTER OUT OF THE WAY TO RESTART THE VERIFICATION. WHEN THE FSE SWITCHED TO VERIFICATION AND TO PUT THE ARM MOVEMENT AT FREE AND FAST, ANOTHER COMMUNICATION ERROR OCCURRED WITH THE SAME AUDIBLE CLICK AND MESSAGE ON SCREEN AS BEFORE. THERE WAS ALSO AN ADDITIONAL MESSAGE THAT SAID IMPOSSIBLE TO MODIFY COO

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) ASSISTED THE SURGEON WITH AN RNS CASE ON (B)(6) 2018 USING ROBOT BR18054. AFTER TWO COMMUNICATION ERROR SHUTDOWNS, THE SURGEON WANTED TO UPLOAD A SET OF IMAGES TO THE PLAN THAT WAS ON A CD. THE PATIENT WAS UNDER ANESTHESIA, NO INCISIONS WERE MADE. AROUND 10AM EST, THE CD WAS SELECTED FOR PULLING THE IMAGES OFF OF, BUT THE LOADING OF ALL THE SERIES WAS TAKING VERY LONG. THE PROGRESS FROM 0% TO 100% FOR UPLOADING THE SCAN WAS TAKING A VERY LONG TIME, AS IF THE PC WAS NOT PERFORMING AT IT'S BEST. THE FSE NOTICED THE LIGHT FOR THE EMERGENCY BUTTON WAS RED DURING THIS PROCESS, WHICH COULD HAVE BEEN AN INDICATION THAT SOMETHING WAS WRONG. AFTER WAITING AROUND 55 MINUTES FOR THE IMAGES TO UPLOAD, THE ROBOT EXPERIENCED A SHUTDOWN DUE TO THE PROGRAM NOT RESPONDING MESSAGE APPEARING AROUND 10:55AM EST. THIS CAUSED A SHUTDOWN OF THE ROBOT. THE FSE WAITED A FEW MINUTES TO TURN THE ROBOT BACK ON AFTER SHUTTING IT DOWN. AFTER THE RESTART, THE FSE WAS ABLE TO SELECT THE ONE SERIES OF IMAGES FROM THE DISC THAT THE SURGEON WAS INTERESTED IN BY ACCESSING THE DATA FROM THE DISC THROUGH THE PACS SELECTION. THE IMAGES WERE UPLOADED AND MERGED TO THE PLAN, AND EVERYTHING

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 AFTER UNDERGOING A DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE AND THE PATIENT WAS DISCHARGED, THE PATIENT¿S BOWEL WAS FOUND TO BE STUCK TO THE ABDOMINAL WALL. THE PATIENT UNDERWENT ANOTHER UNSPECIFIED SURGICAL PROCEDURE ON AN UNSPECIFIED DATE TO TAKE DOWN THE BOWEL USING BLUNT DISSECTION. THERE WAS NO REPORT OF A BOWEL PERFORATION. THE ROOT CAUSE OF THE POST-OPERATIVE COMPLICATION IS UNKNOWN. ON 12/13/2018, INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED FROM AN ISI CLINICAL TERRITORY ASSOCIATE (CTA): THE CTA WAS PRESENT DURING THE DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE WHICH WAS NOT RECORDED ON VIDEO. THERE WERE NO INTRA-OPERATIVE COMPLICATIONS OR REPORTS OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. THE CASE WAS COMPLETED ROBOTICALLY. ON AN UNSPECIFIED DATE POST-OPERATIVELY, THE PATIENT DEVELOPED UNSPECIFIED SYMPTOMS AND UNDERWENT AN UNSPECIFIED NON-ROBOTIC SURGICAL PROCEDURE TO TAKE DOWN THE BOWEL WHICH WAS FOUND TO BE STUCK TO THE PELVIC WALL BY THE CUFF CLOSURE. THE CTA SPOKE TO THE SURGEON ABOUT THE POST-OPERATIVE COMPLICATION. THE SURGEON DID NOT KNOW THE CAUSE OF THE POST-O

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE CONNECTOR OF FORCE SENSOR CABLE WAS BROKEN INSIDE, THIS RESULTED IN SEEG SURGERY ABORTION.

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 WAS AT THE REGISTRATION (MARKERS) PHASE OF HIS SECOND SURGERY OF THE DAY AND WAS EXPERIENCING DIFFICULTY MOVING THE ROBOTIC ARM IN COOPERATIVE MODE. HE CLAIMED THAT DURING HIS FIRST SURGERY THIS DAY THE ROBOTIC ARM WAS VERY HARD TO MOVE AND DID NOT MOVE THE WAY HE INTENDED WHEN USING COOPERATIVE MODE. HE MENTIONED THAT AT ONE POINT THE ROBOT ARM MOVED WHEN HE STEPPED ON THE PEDAL AND WAS NOT TOUCHING IT. WHILE ON THE PHONE, HE CLAIMED THAT THE ARM WAS NOT RESPONDING AND HE COULD NOT MOVE IT IN ANY DIRECTION. HE STATED THAT THE ARM WAS NOT IN A WEIRD POSITION (FULLY EXTENDED OR FOLDED ON ITSELF) AND THAT THE TELESCOPIC ARM WAS FULLY IN (AT POSITION 0). THE FIELD SERVICE ENGINEER (FSE) ASKED HIM TO DO THE FOLLOWING: - CHANGE THE SPEED BETWEEN FAST AND SLOW AND ATTEMPT TO MOVE - HE SAID THAT THIS DID NOT WORK AND THAT THE ARM WOULD ONLY MOVE IN VERY SMALL STEPS - LOOSEN THE KNURLED SCREWS HOLDING THE POINTER PROBE TO THE INTERFACE BLOCK AND TRY TO MOVE - NO DIFFERENCE - EXIT REGISTRATION AND PUT ROBOT IN FREE AND FAST - NO DIFFERENCE - CHECK THE FORCE SENSOR CABLE CONNECTION - CABLE IS SECURE AND DOES NOT APPEAR TO BE BROKEN AT THIS POINT, THE FSE ASKED THE SURGEON TO REST

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6). 2018 THE FIELD SERVICE ENGINEER (FSE) WAS ON SITE (APHM MARSEILLE) TO ASSIST A SURGERY CASE. WHEN THE SURGEON WANTED TO START MARKER REGISTRATION A MESSAGE APPEARED ON THE SCREEN "IMPOSSIBLE TO CONNECT TO THE ROBOT, THE DEVICE WILL SHUT DOWN". THE FSE DECIDED TO RESTART THE DEVICE AND AT THE SAME STEP, THE SAME MESSAGE APPEARED. THE FSE RESTART THE DEVICE AGAIN AND LOGGED INTO TECHNICAL SESSION. THE LOG FILES READING SHOWED THAT IT WAS IMPOSSIBLE FOR THE COMPUTER TO CONNECT TO THE CONTROLLER. THE FSE DECIDED TO REMOVE THE ROBOT FROM THE OPERATING ROOM AND REMOVE ALL COVER PANEL TO ACCESS TO THE CONTROLLER. BEFORE A TOO BIG LOST TIME, THE FSE DECIDED WITH THE SURGEON TO CANCEL THE SURGERY CASE WITH THE DEVICE. AFTER A COMPLETE CHECKING THE CONNECTION BETWEEN ROBOT ARM-CONTROLLER-COMPUTER SEEMS TO WORK WELL. THE FSE SUSPECTS THAT THE STARC CARD WAS UNPLUGGED (CONTROLLER LOG FILE WILL CONFIRM IT). A POSSIBLE EXPLANATION OF THIS HYPOTHESIS IS THAT THE FLOOR IS NOT PERFECTLY FLAT BETWEEN THE STORAGE SPACE AND THE OR. AFTER SEVERAL TEST, THE ROBOT WORKED WELL ON BOTH TECHNICAL AND MAINTENANCE SESSION.

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 COMPLETION OF A DA VINCI-ASSISTED PULMONARY LOBECTOMY PROCEDURE, A PULMONARY ARTERY WAS ¿HIT¿ AND AS A RESULT, THE PATIENT BLED OUT AND EXPIRED. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. ON (B)(6) 2018 AND (B)(6) 2019, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: THERE WAS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. THE CSR DID NOT KNOW WHAT SURGICAL TASK THE SURGEON WAS PERFORMING WHEN THE VESSEL WAS ALLEGEDLY ¿HIT.¿ ACCORDING TO THE CSR, THE GENERAL CONSENSUS SO FAR WAS THAT THE EVENT WAS RELATED TO ¿GENERAL SURGICAL TECHNIQUE AND AN UNEXPECTED VESSEL.¿ THE CSR SPOKE TO THE HEAD OF THE DEPARTMENT. ACCORDING TO THE CSR, THE HEAD OF THE DEPARTMENT BELIEVES THE VESSEL TORE DUE TO TENSION AND TRAUMA DURING DISSECTION BUT IT IS IMPOSSIBLE TO KNOW FOR CERTAIN WITHOUT VIDEO. THE SURGEON HIMSELF REITERATED THAT HE WAS NOT WORKING ON THE VESSEL AT THE TIME AND IT WAS THE RESULT OF TENSION ON A SMALL WEAK BRANCH. HOWEVER, THE ROOT CAUSE OF THE

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT THE PATIENT FOLDER COULD NOT BE USED FOR A SURGERY. THE CONTRAST VALUE WAS MODIFIED BUT AFTER THIS MODIFICATION THE PATIENT FOLDER DID NOT APPEAR ANYMORE ON THE DEVICE. THE SURGEON DECIDED TO ABORT THE SURGERY.

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 HYSTERECTOMY PROCEDURE, A CABLE ON A FENESTRATED BIPOLAR FORCEPS INSTRUMENT ALLEGEDLY ¿RUPTURED.¿ THERE WAS NO REPORTED HARM TO THE PATIENT ALTHOUGH IT WAS NOTED THAT THE CASE WAS CONVERTED TO OPEN SURGERY. THE INITIAL REPORTER INDICATED, HOWEVER, THAT THE CONVERSION TO OPEN SURGERY WAS NOT DUE TO THE ALLEGED INSTRUMENT ISSUE. ON (B)(4) 2018, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SITE¿S ROBOTICS COORDINATOR AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: AFTER THE DA VINCI-ASSISTED HYSTERECTOMY WAS COMPLETED, IT WAS ALLEGED THAT ¿ENDOSCOPICALLY INVISIBLE, SILENT BLEEDING¿ OCCURRED. AS A RESULT, THE CASE WAS CONVERTED TO OPEN SURGERY. THE ROBOTICS COORDINATOR INDICATED THAT THE PATIENT WAS ¿FINE¿ AND THERE HAVE BEEN NO REPORTED POST-OPERATIVE COMPLICATIONS. HOWEVER, AT THIS TIME, THE ROOT CAUSE OF THE INTRA-OPERATIVE COMPLICATION IS 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: ON 28-MAR-2023, INTUITIVE SURGICAL BECAME AWARE OF A JOURNAL OF BREAST CANCER ARTICLE TITLED, ¿DEVELOPMENT OF ROBOTIC MASTECTOMY USING A SINGLE-PORT SURGICAL ROBOT SYSTEM¿ (PARK, H.S., ET AL., 2020). WITHIN THE JOURNAL ARTICLE, IT WAS MENTIONED AFTER A BILATERAL DA-VINCI ASSISTED MASTECTOMY PERFORMED ON (B)(6) 2018 ON A PATIENT WITH DUCTAL CARCINOMA IN SITU (DCIS), THERE WAS A MINOR SKIN BURN FOUND ON THE RIGHT BREAST. THERE WAS NO MENTION OF MEDICAL TREATMENT TO ADDRESS THE MINOR SKIN BURN IN THE ARTICLE. THERE WERE NO OTHER IMMEDIATE POSTOPERATIVE COMPLICATIONS. THE PATIENT WAS DISCHARGED ON POSTOPERATIVE DAY 15 AND DRAIN WAS REMOVED ON DAY 24. PATIENT RE-VISITED THE CLINIC ON DAY 55 BECAUSE OF REDNESS AND HEATING SENSATION OF THE RIGHT BREAST. ANTIBIOTICS AND CONSERVATIVE TREATMENT INCLUDING DRESSING AND RE-INSERTION OF THE DRAIN WERE APPLIED. HER SYMPTOMS SUBSIDED AFTER 1 DAY OF TREATMENT AND NO MAJOR SURGICAL INTERVENTION WAS NEEDED. THERE WAS NO MENTION OF ANY MALFUNCTIONS OF ANY DV SYSTEMS, INSTRUMENTS OR ACCESSORIES. FENESTRATED BIPOLAR FOCEPS (FBF) INSTRUMENT, MARLAND FORCEPS INSTRUMENT AND MONOPOLAR CURVED SCISSORS (MCS) WERE INSTALLED ON UNIVERSAL SURGICAL MANIPULATOR(US

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 MULTIPLE DEVICE SHUTDOWNS DURING A SURGERY, WITHOUT A CONFIRMED NUMBER OF OCCURRENCES.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: WHILE TALKING TO THE ELECTROPHYSIOLOGY GROUP, THEY RELAYED AN EVENT THAT OCCURRED TO THE PATIENT FROM (B)(6) 2018. THEY STATED THAT THE PATIENT HAD A BLEED DUE TO AN ELECTRODE DEVIATING INSIDE OF THE SKULL AND ANOTHER ELECTRODE TEARING DURING THE REMOVAL PROCESS. THE RESIDENT TOLD TO THE FIELD SERVICE ENGINEER (FSE) THE FOLLOWING: - A SMALL EPIDURAL HEMATOMA OCCURRED POST-OPERATIVELY - CAUSE THOUGHT TO BE A DURAL PUNCTURE DUE TO DRILLING - IT WAS DETERMINED ON POST-OP THAT THE ELECTRODE (RSB) RELATED TO THE BLEED DEVIATED AND WAS EPIDURAL - THE PATIENT EXPERIENCED SOME TRANSIENT WEAKNESS ON THE LEFT SIDE (CONTRALATERAL TO RSB) BUT THE WEAKNESS RESOLVED BEFORE THE ELECTRODE WAS REMOVED - THE SEIZURE FOCUS WAS SUCCESSFULLY MAPPED AND THE EPILEPSY GROUP IS CURRENTLY DETERMINING NEXT STEPS FOR THE PATIENT. - THE RESIDENT ALSO MENTIONED THAT IT WAS DISCOVERED DURING REMOVAL THAT ONE ELECTRODE HAD BEEN TORN OR CUT AND THAT A CRANIOTOMY WAS NECESSARY TO FULLY REMOVE THE ELECTRODE FROM THE PATIENT. HE BELIEVES THAT THIS WAS DUE TO THE FACT THAT THE BROKEN ELECTRODE WAS CLOSE TO ANOTHER ELECTRODE AT IMPLANT AND THAT THE BROKEN ELECTRODE MAY HAVE BEEN CAUSED WHEN THE SECOND ELECTRODE WAS DRI

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2018 AT (B)(6) WITH DR. (B)(6) DURING SEEG SURGERY A 2 HOUR DELAY OCCURRED DUE TO MULTIPLE FAILED REGISTRATION ATTEMPTS. THE VERIFICATION OF THE REGISTRATION SHOWED SIGNIFICANT DISCREPANCY BETWEEN ROBOT POSITION AND EXPECTED POSITION ON THE CT SCAN. FIELD SERVICE ENGINEER (FSE) ON SITE SUGGESTED THAT ANOTHER IMAGE BE TAKEN WITH THE O-ARM. THE SURGERY WAS DELAYED WHILE THE SURGEON WAITED ON THE O-ARM TO ARRIVE, WHICH TOOK APPROXIMATELY AN HOUR, DURING WHICH THE FSE ATTEMPTED TO TROUBLESHOOT. AFTER THE NEW IMAGE SET WAS TAKEN REGISTRATION WAS COMPLETED IMMEDIATELY. COMPARISON OF THE ORIGINAL CT TO THE O-ARM SCANS SHOWED THAT THE FIDUCIALS APPEARED TO HAVE SHIFTED.

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 ENGINEER ASSISTED DR. (B)(6) AT SPECTRUM HEALTH WITH AN ABLATION CASE ON 16/NOV/2018, USING ROBOT BR18075. THE START OF THE CASE WAS DELAYED BY AROUND 3 HOURS. FIELD SERVICE ENGINEER OBTAINED THE CD WITH CT AND MR DATA FOR THE CASE AROUND 7:30AM, THE PLAN WAS NOT CREATED YET AT THIS POINT. THE CST NOTED THE CT SCAN WAS OVER 400 SLICES, AND THE MR SCAN WAS OVER 300 SLICES. THE SURGEON WAS NOTIFIED THAT IMAGE SETS WITH OVER 255 SLICES MAY CAUSE AN ISSUE WITH UPLOADING. FIELD SERVICE ENGINEER CONFIRMED THE HOSPITAL HAD THE IMAGE PROTOCOL FOR ROSA CASES.

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 ENDOSCOPY THE DEVICE SHUT DOWN WITH A SYSTEM ERROR. AFTER THE RESTART THE FORCE SENSOR WAS CALIBRATED WITH THE ENDOSCOPE ON TOP. THE CLEARANCE PROCEDURE WAS STARTED. THE SURGEON TRIED TO MOVE THE ROBOT USING FREE FAST, BUT WAS NOT ABLE TO. RESTARTING THE DEVICE SEVERAL TIMES DID NOT HELP. ATIDAQ SHOWED NO MOVEMENT ON THE FORCE WHEN FORCE WAS APPLIED TO THE SENSOR. THE SURGEON HAD TO FINISH THE CASE MANUALLY. THE FSE CONFIRMED THAT THE SURGEON HAD TO REVERT TO TRADITIONAL SURGERY AS HE COULD NOT MOVE THE ARM ANY MORE IN COOPERATIVE MODE. THE SURGEON DID NOT NOTICED ANY ADVERSE EFFECT DUE TO THE ISSUE, HOWEVER THE SURGERY WAS EXTENDED BY 30 MINUTES. THE FSE ADDED INFORMATION REGARDING THE EVENT : AFTER UNDRAPING THE FORCE SENSOR WAS WET. DURING THE SURGERY, THE SURGEON FLUSHED THROUGH THE ENDOSCOPE THE WHOLE TIME. THERE WAS A BIT WATER RUNNING DOWN INSIDE THE DRAPE

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 AFTER UNDERGOING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PATIENT WAS FOUND TO HAVE A PANCREATIC FISTULA/LEAK. NO FURTHER CLINICAL INFORMATION WAS PROVIDED. THERE IS NO INDICATION OR ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. ON (B)(4) 2018, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION FROM A SURGEON AT A DIFFERENT HOSPITAL POSSIBLY RELATED TO THE REPORTED EVENT. THE SURGEON INDICATED THAT THE PATIENT HAD POSSIBLY EXPIRED AFTER SURGERY. THE SURGEON WAS UNABLE TO PROVIDE ANY ADDITIONAL DETAILS.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: PHYSICIAN REPORTED A PNEUMOTHORAX 2 HOURS POST PROCEDURE AND REQUIRED CHEST TUBE PLACEMENT. THE PATIENT WAS ADMITTED FOR OBSERVATION AND RELEASED UPON THE PNEUMOTHORAX RESOLVING ITSELF WITH NO RESIDUAL EFFECTS.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING THE L3-L5 TLIF PROCEDURE, PERFORMED ON (B)(6) 2018, ALL TRAJECTORIES WERE CONFIRMED TO BE ACCURATE, AND NO SPECIAL ISSUES OCCURRED. HOWEVER, IN FOLLOW-UP EXAMINATION PERFORMED AFTER 2 MONTHS (COMPANY AWARENESS DATE (B)(6) 2019), THE SURGEON HAS NOTICED THAT SCREWS HAVE DEVIATED LATERALLY, REQUIRING ADDITIONAL REVISION SURGERY FOR THEIR CORRECTION. CLINICAL INVESTIGATION CONCLUDED THAT THERE IS NO MALFUNCTION EVIDENCE.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: WHILE DRILLING THE LAIN TRAJECTORY, THE 2 SURGEONS NOTED A BIT OF BLOOD ALONG WITH CSF DRIP FROM THE ANCHOR BOLT. AFTER DRILLING LPIN TRAJECTORY, ONE OF THE SURGEON ALSO OBSERVED BLOOD DRIPPING WITH CSF FROM THE BOLT AND WAS CONCERNED THAT A HEMORRHAGE HAD OCCURRED. THE SURGERY WAS FINISHED AND THE PATIENT WAS TAKEN TO CT. THE CT REVEALED A MINOR HEMORRHAGE OF THE DURAL VASCULATURE IN LAIN. ONE OF THE SURGEON OPTED FOR NO SURGICAL INTERVENTION AND WILL CONTINUE TO MONITOR THE PATIENT. THIS DOES NOT APPEAR TO BE DUE TO INACCURACY OF THE ROSA AND APPEARS TO BE DUE TO PLANNING CLOSE TO VESSELS IN THE DURA. THE SURGEON EXPLAINED THAT THESE VESSELS AREN'T AS HIGHLY SCRUTINIZED AS DEEP VESSELS WHEN PLANNING. THE FIELD SERVICE ENGINEER SPOKE WITH THE SURGEON AFTER THE CASE, THE BLEED SEEMED TO HAVE BEEN CAUSED BY DRILLING AND NOT THE OBTURATOR OR ELECTRODE.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A COMPLAINT WAS RECEIVED ON (B)96) 2018 FROM (B)(6). DESCRIBING A SITUATION IN WHICH A TRAJECTORY DEVIATION OCCURRED AND RESULTED IN PENETRATION OF CEMENT INTO THE CANAL. THE SURGERY CONTINUED AS PLANNED AND THE PATIENT WAS FINE.

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 SURGERY, THE SURGEON TRIED TO MOVE THE ROBOT ARM IN AXIAL COOPERATIVE MODE AND SUDDENLY THE ARM BEGAN TO MOVE ALONE BUT WAS STILL IN THE TRAJECTORY AXIS.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: POST-OPERATIVE EXAM SHOWED LARGE HEMORRHAGE IN THE BRAIN AND SMALLER, POSSIBLY-UNRELATED HEMORRHAGE ELSEWHERE IN THE BRAIN. THE PATIENT IS IN GOOD HEALTH AND ELECTRODE PLACEMENT WAS ¿SPOT ON SO SURGEON REMOVED ELECTRODES THE NEXT MORNING.

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 PRE-OPERATIVE PLANNING, FIELD SERVICE ENGINEER MADE MULTIPLE ATTEMPTS TO LOAD THE PATIENT FOLDER UNSUCCESSFULLY. FINALLY, THE PATIENT FOLDER WAS LOADED AFTER USING THE COMPUTER FOR PRE-OP PLANNING. THEN, A COMMUNICATION ERROR OCCURRED WHILE DRIVING ROBOT ARM TO PARKING POSITION. THIS EVENT CAUSED A DELAY GREATER THAN ONE 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: ON (B)(6) 2019, INTUITIVE SURGICAL, INC. (ISI) RECEIVED SUS VOLUNTARY EVENT REPORT #MW5084047 WITH THE FOLLOWING EVENT DESCRIPTION: ¿NEEDLE FROM DAVINCI ROBOT FELL INTO PT¿S SURGICAL WOUND DURING ROBOTIC HYSTERECTOMY. NEEDLE MAY HAVE FALLEN INTO SURGICAL WOUND AT SOME POINT DURING CASE. DID NOT DISCOVER UNTIL AFTER CLOSURE. NEEDLE TOO SMALL TO DETECT ON X-RAY. PT DOING WELL. SURGEON NOTIFIED. HOOK ON THE MONOPOLAR STOPPED WORKING.¿

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THREE SEPARATE COMMUNICATION FAILURE OCCURRED ON (B)(6) 2018 DURING SEEG SURGERY PERFORMED AT (B)(6) HOSPITAL, WITH DEVICE (B)(4). THE ROBOT ARM WOULD NOT CONNECT TO THE CONTROLLER WHEN THE START BUTTON WAS PRESSED DURING THE REGISTRATION PHASE. THE ROBOT WAS DETACHED FROM THE PATIENT AND MANUALLY RELEASED 3 OF THE ARM JOINTS. THERE WAS NO DAMAGE TO THE ARM. THE STAFF WAS ASKED IF ANY IMPACT HAD OCCURRED AND "NON" WAS REPORTED. THE SURGERY WAS DELAYED APPROXIMATELY 45 MINUTES AS THE COMPUTER WAS REBOOTED SEVERAL TIMES AND THE ARM RELEASE PROCEDURE WAS COMPLETED. THE SURGERY WAS COMPLETED WITHOUT ISSUE.

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 AFTER UNDERGOING AN UNSPECIFIED DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PATIENT DEVELOPED A "CONTAGIOUS DISEASE WITH FEVER." THE PATIENT WAS REPORTEDLY HOSPITALIZED FOR AN EXTENDED PERIOD OF TIME. HOWEVER, AT THIS TIME, THE ROOT CAUSE OF THE PATIENT'S POST-OPERATIVE COMPLICATION IS UNKNOWN. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. ON 12/10/2018 AND 12/11/2018, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: THE PATIENT UNDERWENT A DA VINCI-ASSISTED PARTIAL NEPHRECTOMY PROCEDURE ON (B)(6) 2018. THERE WAS NO REPORT THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. THERE WERE NO REPORTED INTRA-OPERATIVE COMPLICATIONS. ON (B)(6) 2018, THE PATIENT REPORTEDLY DEVELOPED AN UNSPECIFIED ¿CONTAGIOUS DISEASE WITH FEVER.¿ AS OF (B)(6) 2018, THE CAUSE OF THE DISEASE WAS UNKNOWN AND THE SITE WAS INSPECTING THE CASE. IN ADDITION, AS A RESULT OF THE ALLEGED COMPLICATIONS, THE PATIENT WAS ADMINISTERED UNSPECIFIED ¿TRANSFUSION AND ANTIBIOTICS.¿ THE PATIENT WAS STILL 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: IT WAS INITIALLY REPORTED THAT AFTER UNDERGOING A DA VINCI-ASSISTED SLEEVE GASTRECTOMY PROCEDURE, THE PATIENT CAME BACK SEVERAL WEEKS LATER WITH A HEMATOMA AND BLEEDING. THE SURGEON PERFORMED AN OPEN SURGICAL PROCEDURE AND CLEANED THE AREA AROUND THE HEMATOMA. ACCORDING TO THE INITIAL REPORTER, THE SURGEON INDICATED THAT EVERYTHING LOOKED SEALED FROM WHAT HE COULD SEE AND THERE WAS NO EXTRA BLEEDING. IT WAS ASSUMED THAT THE STAPLES WERE INTACT. THE PATIENT WAS REPORTEDLY STABLE. ON (B)(4) 2018, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE CSR WAS PRESENT DURING THE DA VINCI-ASSISTED SURGICAL PROCEDURE WHICH WAS NOT RECORDED ON VIDEO. THERE WAS NO REPORT THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. THERE WERE ALSO NO REPORTED INTRA-OPERATIVE COMPLICATIONS. THE SURGEON WAS NOT SURE WHAT CAUSED THE POST-OPERATIVE HEMATOMA AND BLEEDING. ACCORDING TO THE CSR, THE HEMATOMA APPEARED TO BE NEAR THE STAPLE LINE. HOWEVER, THERE WERE NO ISSUES IDENTIFIED WITH THE STAPLE LINE INTRA-OPERATIVELY OR POST-OPERATIVEL

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 A LETTER SEEKING COMPENSATION DIRECTLY FROM INTUITIVE SURGICAL, INC. (ISI), THE PATIENT¿S WIFE REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY PROCEDURE PERFORMED ON (B)(6) 2018, THE PATIENT ALLEGEDLY SUSTAINED A BURN INJURY WHICH DAMAGED THE PATIENT'S LYMPH SYSTEM. IN (B)(6) 2013, THE PATIENT HAD AN IVC FILTER IMPLANTED FOR BLOOD CLOTS AT A LOCAL HOSPITAL. IT WAS NOT A COOK FILTER, BUT A RETRIEVABLE FILTER WHICH WAS SUPPOSED TO HAVE BEEN REMOVED IN 6 MONTHS. THE PATIENT ALLEGES HE WAS NOT INFORMED OF THAT, AND THE HOSPITAL DID NOT FOLLOW-UP EITHER. IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT A DA VINCI-ASSISTED PROSTATECTOMY PROCEDURE AT A DIFFERENT HOSPITAL IN A DIFFERENT TOWN. IMMEDIATELY AFTER SURGERY, FLUID WAS LEAKING FROM THE CENTRAL INCISION AND WAS TREATED WITH A PRESSURE WRAP. AFTER THE PATIENT WAS RELEASED, FLUID CONTINUED TO LEAK FROM THE INCISION BUT THE SURGEON DETERMINED IT WAS NOT FROM THE SURGERY. IN (B)(6) 2018, THE PATIENT HAD ABDOMINAL DISCOMFORT AND WENT TO A LOCAL UROLOGIST. AN ULTRASOUND WAS PERFORMED, AND A LOT OF FLUID WAS IDENTIFIED. THE PATIENT CONTACTED THE ROBOTIC SURGEON; HOWEVER, THE SURGEON¿S RESIDENT RECOMMENDED 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: THE FIELD SERVICE ENGINEER (FSE) WAS CALLED ON THURSDAY (B)(6) 2018 BY THE HEAD NEURO NURSE TO INFORM ME THAT THE PATIENT FROM TUESDAY¿S ((B)(6) 2018) SEEG CASE HAD EXPERIENCED A BLEED AND THAT ALL OF THE ELECTRODES HAD BEEN TAKEN OUT. THIS CASE WAS COVERED BY AN FSE, BUT HAD BEEN A SMOOTH CASE WITH NO ISSUES WITH THE DEVICE. THE SURGEON INFORMED THAT HE NOTICED THAT THERE WAS MORE BLEEDING THAN NORMAL WHEN THE ANCHOR BOLT WAS PLACED FOR TRAJECTORY 7, BUT THEY HAD USED ¿FLOSEAL¿ TO STOP THE BLEEDING AND WAITED ABOUT 10 MINUTES BEFORE PUTTING THE ELECTRODE THROUGH THE BOLT. THEY THEN FINISHED UP THE CASE (6 MORE TRAJECTORIES), BUT ANESTHESIST STARTED TO NOTICE CHANGES IN THE PATIENT¿S VITAL SIGNS. THE PATIENT WAS DETACHED FROM ROSA AND BROUGHT DOWN TO GET A CT SCAN WHILE STILL ASLEEP. THE SCAN SHOWED A SUPERFICIAL BLEED AND THE PATIENT WAS AUTOMATICALLY BROUGHT BACK TO THE OR TO ADDRESS THE PROBLEM. AT THIS TIME ALL OF THE ELECTRODES WERE REMOVED AND THE BLEED WAS CLEARED. THE PATIENT IS NOW 2 DAYS POST-OPERATIVE AND THE SURGEON SAID THAT THE PATIENT IS MAKING DRASTIC IMPROVEMENTS,BUT IS NOT BACK TO BASELINE YET. THE SURGEON SAID THAT HE HAD NOT MERGED THE POST-OP CT TO THE ROSA PLA

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 WAS NOTIFIED THAT ROSA SEEG SURGERY WAS POSTPONED AFTER 5 ELECTRODES WERE ALREADY IMPLANTED DUE TO A CORTICAL BLEED. THE FIELD SERVICE ENGINEER WAS NOT PRESENT FOR THIS CASE. SURGEON INDICATED THAT THE PATIENT IS DOING WELL ENOUGH TO PROCEED WITH SECOND ROUND OF ELECTRODE IMPLANTATION ON (B)(6) 2018.

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 REPORTED THAT IT WAS IMPOSSIBLE TO LOAD THE PATIENT FOLDER. FINALLY, THE SURGEON WAS ABLE TO LOAD THE PATIENT FOLDER AFTER IMPORTING THE IMAGES AGAIN. THIS EVENT CAUSED A DELAY OF 45 TO 60 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 REGISTERED THE PATIENT FIRST WITH THE LASER REGISTRATION. THE SURGEON ONLY CHECKED ONE POINT WITH THE LASER. THEN HE DECIDED TO CHANGE TO ANOTHER FORM OF REGISTRATION, AND USED THE POINTER AND CHECKED THE SKIN FIDUCIALS AS LANDMARKS. THE SKIN FIDUCIALS DID NOT FIT WITH THE PLANNING. THE SURGEON REGISTERED THE SKIN FIDUCIALS. THE SKIN FIDUCIAL REGISTRATION WAS NOT ADEQUATE (> 3MM RMS). THE SURGEON THEN PERFORMED ANOTHER LASER REGISTRATION. THE ROBOT DISPLAYED A WARNING MESSAGE. THE FIELD SERVICE TECHNICIAN LATER CHECKED THE DATA LOGS AND CONFIRMED THAT THE RMS WAS TOO HIGH. THE SURGEON CHECKED 3 POINTS AND THE THIRD POINT DID NOT MATCH. HE REGISTERED AGAIN WITH THE SKIN FIDUCIALS AND CHECKED THE REGISTRATION, BUT WAS NOT SATISFIED WITH THE REGISTRATION. HE REGISTERED THE SKIN FIDUCIALS AND CHECKED THE REGISTRATION AND DECIDED TO PROCEED WITH THE SURGERY. WHEN HE TOOK THE SECOND PROBE, BLOOD CAME OUT OF THE NEEDLE. HE WAS ABLE TO STOP THE BLEEDING BY FLUSHING THROUGH THE BIOPSY NEEDLE. THE POST-OPERATIVE CT SHOWED SOME BLOOD STILL. ON THE CT, IT WAS NOT POSSIBLE TO CHECK THE ACCURACY OF THE TRAJECTORY.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS THE LASER WAS BEING MOVED FROM THE MEDIAL CANTHUS TO THE NOSE DURING REGISTRATION, THE LASER LIGHT TURNED OFF WITHOUT PRESSING ANY SWITCH OR DISCONNECTING THE CABLE. AFTER MOVING THE ARM AND DISTANCE SENSOR WIRE AROUND, THE LIGHT CAME BACK ON. HOWEVER, WHEN TRYING TO RECORD A POINT AFTER THE LIGHT WENT OFF AND CAME BACK ON, THERE WAS A DISTANCE CALIBRATION ERROR. THE LASER HAS BEEN COLLECTED FORM THE HOSPITAL AND WILL BE SHIPPED BACK. A NEW LASER IS BEING ORDERED FOR THE HOSPITAL. THE PATIENT WAS ASLEEP AND 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: THE ROBOT WAS PUT IN AXIAL SLOW, THEN FREE AND FAST TO CLEAR THE ARM AWAY FROM THE PATIENT. THE SURGEON STARTED MANEUVERING THE ARM AND SPINNING IT. AS THE SURGEON WAS MOVING IT, THE FORCE SENSOR CABLE GOT CAUGHT IN THE JOINT CAUSING IT TO RIP OUT OF THE FORCE SENSOR BLOCK. IN THE PROCESS, IT BENT A COUPLE OF PINS. THE PINS WERE STRAIGHTENED AND THE CABLE PLACED BACK, BUT EVERY TIME THE ARM WAS SET TO AUTOMATIC MODE, IT DETECTED A COLLISION. THE PATIENT WAS ASLEEP AND INCISION HAD ALREADY BEEN MADE. THREE OUT OF 10 ELECTRODES WERE PLACED BEFORE THE SURGERY HAD TO BE ABORTED.

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 SENT TO THE FIELD SERVICE ENGINEER 2 PICTURES OF THE SCREEN OF THE ROBOT SHOWING THE ERROR VALUES OF THE INITIAL POINTS AND THE ERROR MESSAGE: "THE REGISTRATION COULD NOT BE COMPUTED. DO YOU WANT TO PERFORM AGAIN THE REGISTRATION OR RETRY BY MODIFYING THE INITIAL POINTS? ". THE INITALS POINTS WERE ALL RATED GREEN (CORRECT) ON THE RECOLLECTION OF INITIAL POINTS. THE SURGEON ASKED WHY EVERYTHING IS GREEN WHEREAS THE REGISTRATION IS NOT POSSIBLE. THE FSE ADVISED TO RETRY FIRST SETTING THE INITIAL POINTS AGAIN AND HAVE THE ERROR BELOW 2MM FOR EACH POINT. LATER, THE SURGEON INFORMED THE FSE THAT THE REGISTRATION WAS SUCCESSFUL.

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 WAS INFORMED THAT A PATIENT FROM THE WEEK BEFORE HAD EXPERIENCED A HEMORRHAGE DURING THE ROSA ASSISTED SEEG CASE. THE HOSPITAL WAS INDEPENDENT FOR THIS CASE SO THERE WERE NO ROSA REPRESENTATIVES IN THE CASE. THE DOCTOR MENTIONED THAT THE TRAJECTORY THAT HE THINKS CAUSED THE HEMORRHAGE WAS ONE THAT WAS PLANNED AT THE LAST MINUTE. THE PATIENT WAS BROUGHT BACK TO THE OPERATING ROOM ON THE DAY OF SURGERY AND AN ADDITIONAL SURGERY WAS PERFORMED TO CLEAR THE HEMORRHAGE. ONLY ONE OF THE SEEG ELECTRODES WAS REMOVED IN THIS PROCESS. THE PATIENT IS DOING WELL AND THE NEUROLOGY TEAM IS CURRENTLY MONITORING THE REMAINING ELECTRODES.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT A 3DEFINE SCAN WAS COMPLETED AND REGISTRATION WAS ACHIEVED WITH AN O-ARM. LEFT AND RIGHT L2 WERE MEDIAL DUE TO SOFT TISSUE PRESSURE. THE RIGHT L2 TRAJECTORY PENETRATED THE DURA AND THE NERVE ROOT. THE CASE WAS ABORTED AFTER CONFIRMATION OF RIGHT L2 DEVIATION.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON 2ND OCTOBER, DR (B)(6) (NEUROLOGIST) CALLED MEDTECH CUSTOMER SERVICE TO INFORM THAT DURING LAST SURGERY ON THE (B)(6) 2018, A BLEEDING APPEARED AT THE POST-OP CONTROL. THE SURGERY CASE WAS A SEEG AND WAS DONE BY DR (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: THE SURGEON CALLED THE FIELD SERVICE ENGINEER ON 20 SEP 2018 TO INFORM THAT SHE NOTICED SOME ELECTRODES IMPLANTED ON (B)(6) 2018 WERE MISPLACED. THE SURGEON STATED THAT THE TEMPORAL ELECTRODES WERE SHIFTED 4-5MM ON CORONAL PLAN. SHE ALSO STATED THE SURGERY WENT FINE: LASER REGISTRATION PASSED ON THE FIRST TIME, NO CORRECTIONS, VERIFICATION PASSED AND PATIENT INSTALLATION CHECKED. A FIELD SERVICE ENGINEER WAS ON SITE ON (B)(6)2018 TO PERFORM KINEVERIF TESTS (LASER, POINTER) AS WELL AS APPLICATIVE TEST, WHICH BOTH PASSED. THE SURGEON CONFIRMED THE PATIENT WAS DOING FINE.

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 THE START OF A DA VINCI-ASSISTED MINIMALLY INVASIVE DIRECT CORONARY ARTERY BYPASS (MID CAB) PROCEDURE, A PATIENT EXPERIENCED DANGEROUS HEART RHYTHMS. THE OPERATIVE COMPLICATION REPORTEDLY OCCURRED UPON INITIAL ENTRY/INSERTION OF A TROCAR AND WHILE CONNECTING TO AN ERBE GENERATOR. AS A RESULT OF THE OPERATIVE COMPLICATION, THE PATIENT HAD TO BE SHOCKED TWICE IN ORDER TO GET BACK TO A REGULAR HEART RHYTHM. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: DURING THE START OF THE DA VINCI-ASSISTED MID CAB PROCEDURE, THE PATIENT EXPERIENCED DANGEROUS HEART RHYTHMS WHEN THE SURGEON APPLIED ENERGY THROUGH A BOVIE PEN (A 3RD PARTY MANUFACTURER PRODUCT) WHICH IS CONNECTED TO THE INTEGRATED ELECTROSURGICAL UNIT (IESU) OF THE DA VINCI XI SURGICAL SYSTEM. AT THE TIME THE EVENT OCCURRED, THE SURGEON WAS ATTEMPTING TO USE THE BOVIE PEN TO CREATE THE FIRST INCISION PORT. THE SURGICAL STAFF SHOCKED THE PATIENT IN ORDER TO ACHIEVE A REGULAR HEART RHYTHM. AT THE TIME THE EVENT OCCURRED, THE ROBOT WAS NOT DOCKED TO THE PATIENT YET. THE SURGICAL PROC

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 THE START OF A DA VINCI-ASSISTED MINIMALLY INVASIVE DIRECT CORONARY ARTERY BYPASS (MID CAB) PROCEDURE, THE PATIENT EXPERIENCED DANGEROUS HEART RHYTHMS. THE OPERATIVE COMPLICATION REPORTEDLY OCCURRED UPON INITIAL ENTRY/INSERTION OF A TROCAR AND WHILE CONNECTING TO AN ERBE GENERATOR. AS A RESULT OF THE OPERATIVE COMPLICATION, THE PATIENT HAD TO BE SHOCKED TWICE IN ORDER TO GET BACK TO A REGULAR HEART RHYTHM. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: DURING THE START OF THE DA VINCI-ASSISTED MID CAB PROCEDURE, THE PATIENT EXPERIENCED DANGEROUS HEART RHYTHMS WHEN THE SURGEON APPLIED ENERGY THROUGH A BOVIE PEN (A 3RD PARTY MANUFACTURER PRODUCT) WHICH IS CONNECTED TO THE INTEGRATED ELECTROSURGICAL UNIT (IESU) OF THE DA VINCI XI SURGICAL SYSTEM. AT THE TIME THE EVENT OCCURRED, THE SURGEON WAS ATTEMPTING TO USE THE BOVIE PEN TO CREATE THE FIRST INCISION PORT. THE SURGICAL STAFF SHOCKED THE PATIENT IN ORDER TO ACHIEVE A REGULAR HEART RHYTHM. AT THE TIME THE EVENT OCCURRED, THE ROBOT WAS NOT DOCKED TO THE PATIENT YET. THE SURGICAL PR

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 PLANNED DA VINCI-ASSISTED MINIMALLY INVASIVE DIRECT CORONARY ARTERY BYPASS (MID CAB) PROCEDURE, A PATIENT EXPERIENCED DANGEROUS HEART RHYTHMS. THE OPERATIVE COMPLICATION REPORTEDLY OCCURRED UPON INITIAL ENTRY/INSERTION OF A TROCAR AND WHILE CONNECTING TO AN ERBE GENERATOR. AS A RESULT OF THE OPERATIVE COMPLICATION, THE PATIENT HAD TO BE SHOCKED TWICE IN ORDER TO GET BACK TO A REGULAR HEART RHYTHM. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: DURING THE START OF THE DA VINCI-ASSISTED MID CAB PROCEDURE, THE PATIENT EXPERIENCED DANGEROUS HEART RHYTHMS WHEN THE SURGEON APPLIED ENERGY THROUGH A BOVIE PEN (A 3RD-PARTY MANUFACTURER PRODUCT) WHICH IS CONNECTED TO THE INTEGRATED ELECTROSURGICAL UNIT (IESU) OF THE DA VINCI XI SURGICAL SYSTEM. AT THE TIME THE EVENT OCCURRED, THE SURGEON WAS ATTEMPTING TO USE THE BOVIE PEN TO CREATE THE FIRST INCISION PORT. THE SURGICAL STAFF SHOCKED THE PATIENT IN ORDER TO ACHIEVE A REGULAR HEART RHYTHM. AFTER THE EVENT OCCURRED, THE SURGEON MADE THE DECISION TO CONVERT THE PLANNED SURGICAL PROCEDURE T

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 THE DA VINCI-ASSISTED RIGHT HEMICOLECTOMY PROCEDURE, A VESSEL SEALER INSTRUMENT WAS ALLEGEDLY NOT SEALING. AT THE TIME THE INITIAL REPORTER CONTACTED AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) FOR ASSISTANCE, THE SURGICAL STAFF HAD ALREADY CONVERTED THE SURGICAL PROCEDURE TO OPEN SURGERY. ACCORDING TO THE INITIAL REPORTER, THE SURGICAL STAFF PULLED THE VESSEL SEALER INSTRUMENT OUT AND CLAIMED THAT THE INSTRUMENT WOULD HEAT UP ON A CLOTH. HOWEVER, WHEN THE VESSEL SEALER INSTRUMENT WAS REINSERTED BACK INTO THE PATIENT, IT WAS ALLEGED THAT THE INSTRUMENT WOULD NOT SEAL A VESSEL. THE INITIAL REPORTER INDICATED THAT THE VESSEL IN QUESTION SEEMED TO BE NORMAL IN SIZE. THE INITIAL REPORTER ALSO CLAIMED THAT WHEN THE EVENT OCCURRED, THE AUDIBLE TONES INDICATING THAT THE SEALING CYCLE WAS COMPLETE WERE HEARD. THE TSE CHECKED THE SYSTEM LOGS AND DID NOT FIND ANY RELATED SYSTEM ERRORS. ON (B)(6) 2018, ISI CONTACTED THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE SURGEON HAD REPORTEDLY TESTED THE VESSEL SEALER INSTRUMENT ON FAT TISSUE TO CONFIRM ENERGY DELIVERY PRIOR TO ATTEMPTING TO SE

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A ROSA TECHNICIAN WORKING FOR THE (B)(6) DISTRIBUTOR INFORMED A FIELD SERVICE ENGINEER BY EMAIL ON SEPTEMBER 10TH 2018 THAT THE SURGICAL TEAM HAD A COUPLE OF REBOOTS DURING THE LAST MONTHS. LOG FILES WERE SENT FOR THE PERIOD (B)(6) TO (B)(6) 2018 AND WERE ANALYZED. ONE OCCURENCE HAS BEEN FOUND ON (B)(6). LOG FILES SHOW THAT 3 SOFTWARE CRASHES AND ONE COMMUNICATION ERROR OCCURRED DURING A SURGERY.

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 END OF THE CASE WHEN THE SURGEON WAS TRYING TO MOVE THE ARM CLEAR IN FREE/ FAST MODE, THE FORCE SENSOR CABLE GOT STUCK AND BENT. A COMMUNICATION ERROR THEN OCCURRED AND THE ROBOT SHUT DOWN. SINCE THIS WAS THE END OF THE CASE AND THE ROBOT WAS NOT ATTACHED TO THE PATIENT (PATIENT¿S HEAD HOLDER WAS ONLY ATTACHED TO THE BED), THE LASERS WERE PLACED BEFORE RESTARTING THE ROBOT AND ROLLING IT AWAY FROM THE PATIENT. A MEDTECH REPRESENTATIVE WAS PRESENT AT THE TIME OF THE EVENT AND ATTEMPTED TO RESOLVE THE ISSUE, HOWEVER THE DAMAGE SUSTAINED BY THE CABLE CAUSED FURTHER COLLISION ERRORS. AS THIS ISSUE OCCURRED AFTER THE ROSA PORTION OF THE SURGERY WAS FINISHED, THERE WAS NO DELAY AND THE PATIENT WAS NOT AFFECTED. HOWEVER, DUE TO THE DAMAGE, THE NEXT SCHEDULED SURGERY WITH ROSA WAS CANCELLED. THE SURGEON HAD ANOTHER NAVIGATION SYSTEM THAT HE USED INSTEAD.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THREE DAYS AFTER SURGERY, THE NEUROSURGERY FELLOW NOTIFIED A REPRESENTATIVE OF MEDTECH, THE CST, THAT THE PATIENT HAD A HEMORRHAGE AND WAS IN THE INTENSIVE CARE UNIT. THE FELLOW BELIEVED HIGH BLOOD PRESSURE DURING SURGERY MAY HAVE PLAYED A ROLE AND INDICATED THAT BLOOD WAS PRESENT ON LEFT SIDE, WHERE ONLY THREE ELECTRODES WERE PLACED, DESPITE THE HIGHER CONCENTRATION OF ELECTRODES ON THE RIGHT SIDE. ELECTRODES FOR TRAJECTORIES ¿LA¿ AND ¿LPH¿ APPEAR BENT BUT ACCURATE, AND TRAJECTORY ¿LAH¿ APPEARS 2 MILLIMETERS DEEP. INACCURATE ELECTRODE PLACEMENTS ON THE RIGHT SIDE LIKELY DID NOT CONTRIBUTE TO THIS ISSUE. INFORMATION WAS ALSO RECEIVED FROM THE SURGEON THAT THE PATIENT'S PRIOR CONDITION (CARDIOVASCULAR DISEASE) WAS LIKELY A CONTRIBUTORY FACTOR.