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 SURGEON ATTEMPTED TO START THE DEVICE, BUT THE ROBOT ARM WOULD TURN ON AUDIBLY AND THEN SHUTDOWN AS IT APPROACHED THE PATIENT. THE SURGERY WAS CANCELLED.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT MULTIPLE 3D RECONSTRUCTION PROBLEMS OCCURRED DURING THE PREPARATION OF THE SURGERY.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT MULTIPLE DEVICE SHUTDOWN AND A COLLISION OCCURED INTRA-OPERATIVELY. THE FIRST SHUTDOWN OCCURRED DURING REGISTRATION PHASE. THEN ONE TRAJECTORY WAS BEING DRIVED TO DESPITE THE FACT IT WAS APPARENT THAT THE TRAJECTORY WOULD BE INACCESSIBLE DUE TO THE STABILIZING ARM. SURGEON DECIDED TO ATTEMPT THE TRAJECTORY ANYWAY AND A COLLISION OCCURRED. FOLLOWING AN ATTEMPTED DEVICE RE-BOOT, THE ROBOT ARM WAS UNABLE TO CONNECT DUE TO THE COLLISION. AFTER MULTIPLE ATTEMPTS, A FULL DEVICE BREAK DOWN WAS REQUIRED AND POSTERIOR TRAJECTORIES WERE RE-PLANNED.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING SURGERY, IT WAS REPORTED THAT THE ROBOT HIT THE PATIENT'S FOREHEAD, WHEN THE ROBOT ARM WAS SENT ON TRAJECTORY WITH THE LASER TO MARK THE ENTRY POINT. THE PATIENT HAS A SMALL MARK WHERE THE ROBOT HIT HIM, THE SURGERY CONTINUED AS PLANNED.

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 THE ROBOTIC PORTION OF THE SURGERY, THE TIP-UP FENESTRATED GRASPER STOPPED WORKING AND WAS REMOVED FROM THE ABDOMEN BY DR. (B)(6). UPON VISUAL INSPECTION OF THE INSTRUMENT, ONE OF THE WIRES WAS NO LONGER INTACT. THE INSTRUMENT WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. WIRE THOUGHT TO HAVE SNAPPED IN HALF DURING CASE. PT RETURNED TO ED FOR BACK PAIN AND AN X-RAY WAS TAKEN FOR THAT CC. AT THAT TIME A SMALL (LESS THAN 9MM) PIECE OF FRAYED WIRE WAS SEEN IN PT - RFO.

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 TWO DAYS AFTER UNDERGOING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION, THE PATIENT WAS FOUND TO HAVE THREE UNSPECIFIED BOWEL INJURIES THAT WERE INITIALLY SUSPECTED TO BE DUE SOLELY DUE TO THE LARGE AMOUNT OF ADHESIONS INVOLVING THE BOWEL. DUE TO THE BOWEL INJURIES, THE PATIENT UNDERWENT AN OPEN SURGICAL PROCEDURE. ON 12/07/2017, AN INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) CONTACTED THE SURGEON AND OBTAINED ADDITIONAL INFORMATION REGARDING THE OPERATIVE COMPLICATIONS: THE SURGEON INDICATED THAT IS IT IMPOSSIBLE TO KNOW WITH CERTAINTY WHAT CAUSED THE BOWEL INJURIES. THE SURGEON EXPLAINED THAT THE PATIENT HAD SEVERAL PREVIOUS ABDOMINAL SURGERIES AND THERE WERE SO MANY ADHESIONS. THE SURGEON REPORTEDLY ADMITTED THAT HE ACCIDENTALLY PERFORATED THE PATIENT'S BOWEL IN THIS CASE WHICH REQUIRED REPAIR. THE SURGEON ALSO INDICATED THAT ANOTHER GYN SURGEON WAS CALLED INTO THE CASE TO FREE UP A RETAINED OVARY. ACCORDING TO THE CSR, THERE IS REALLY NO TELLING WHERE THE INJURIES CAME FROM. ON 12/13/2017, ISI CONTACTED THE CSR. THE CSR STATED THAT HE WAS PRESENT DURING THE SURGICAL PROCEDURE AND THE PATIENT HAD TREMENDOUS ADHESIONS. DURING THE FEW MINU

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING SURGICAL PROCEDURE USING THE MAZOR X SYSTEM AT (B)(6) HEALTHCARE (US) ON (B)(6) 2017 MEDIAL TRAJECTORY AT L4 DUE TO SOFT TISSUE PRESSURE FROM BILATERAL RETRACTOR RESULTED IN PROLONGATION OF MORE THAN AN HOUR DUE TO THE NEED TO REVISE THE TRAJECTORY. INVESTIGATION CONCLUDED THAT THE DEVICE DID NOT MALFUNCTION AND RELATED RISKS ARE WITHIN THE RISK ANALYSIS.

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 DR. (B)(6) AND PROF. (B)(6) EXPERIENCED AN ISSUE WITH THE LASER REGISTRATION. THE MEDTECH REPRESENTATIVE ARRIVED ON SITE TWO HOURS AFTER THE BEGINNING OF THE SURGERY, AND FOUND OUT THAT THE OPERATING LIGHTS WERE DISTURBING THE OPTICAL DISTANCE SENSOR. REGARDING THE CLINICAL IMPACT FOR THE PATIENT, NOTHING HAS BEEN OBSERVED OR REPORTED BY THE SURGEONS.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI-ASSISTED ¿ADHESIOLYSIS AND REDUCTION OF A SLIPPED NISSEN WITH COMPLETION LAPAROTOMY, REPAIR OF HIATAL HERNIA AND REDO OF NISSEN FUNDOPLICATION¿ PROCEDURE ON (B)(6) 2017. THE PLAINTIFFS¿ ATTORNEY ALLEGES THAT THE PATIENT ¿EXPERIENCED COMPLICATIONS DURING THE SURGERY, NAMELY ISSUES WITH THE PATIENT¿S BLOOD PRESSURE AND OXYGENATION WHEN HE INCREASED THE PRESSURE OF THE GAS INSUFFLATING THE PATIENT¿S ABDOMINAL WALL.¿ THE PLAINTIFFS¿ ATTORNEY NOTED THAT WHEN THE PRESSURE WAS DECREASED, THE SURGEON¿S ¿VISIBILITY ALSO DECREASED, LEADING HIM TO UNDOCK THE ROBOT AND CONVERT THE OPERATION TO AN OPEN SURGERY.¿ AT AN UNSPECIFIED TIME DURING THE SURGICAL PROCEDURE, THE PATIENT ALLEGEDLY SUSTAINED AN ¿ESOPHAGEAL PERFORATION RESULTING IN THE LEAKAGE OF STOMACH CONTENTS INTO HER MEDIASTINUM.¿ AS A RESULT, THE PATIENT EXPERIENCED ¿IMMEDIATE RESPIRATORY COMPLICATIONS INCLUDING ATELECTASIS, PLEURAL FLUID AND PNEUMONIA, AND EVENTUALLY TO SEPSIS.¿ THE PATIENT ALLEGEDLY EXPERIENCED ¿PAIN AND SUFFERING¿ FROM (B)(6) 2017. DURING THIS TIME, THE PATIENT REPORTEDLY HAD ¿THE INABILITY 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: THE CLIP FOR THE INTUITIVE DA VINCI CLIP APPLICATOR COULD NOT LOAD, SEVERAL CLIPS FAILED TO ADHERE. NO HARM TO THE PT.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A SURGERY THE ROBOT ARM COLLIDED WITH THE MAYFIELD HEAD HOLDER ADAPTOR AND THE DEVICE SHUTDOWN. FOLLOWING THE INCIDENT THE SURGEON WAS UNABLE TO UNSTUCK THE ROBOT ARM FROM THE MAYFIELD HEAD HOLDER ADAPTOR. SURGEON WAS FORCED TO SUPPORT MANUALLY THE PATIENT HEAD, UNLOCK THE TELESCOPIC ARM, PUSH BACK THE DEVICE AND THEN RECONNECT THE ROBOT AND FOLLOW THE RECOVERY PROCEDURE. THE CASE WAS COMPLETED SUCCESSFULLY BUT WITH A DELAY OF OVER 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 THAT IT WAS NOT POSSIBLE TO LOAD THE PATIENT FOLDER ONCE IMPORTED FROM THE PLANNING STATION TO THE DEVICE. SURGEON FINALLY IMPORTED ONLY THE CT, THEN REGISTERED THE FRAME AND FINALLY ENTERED THE LEKSELL COORDINATES FROM THE PLANNING. SURGEON AND WAS ABLE TO COMPLETE SUCCESSFULLY THE CASE.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2017 (REPORTED TO MAZOR ON (B)(4) 2017) THE MAZOR X SYSTEM WAS USED AT (B)(6) FOR A L4-S1 SURGERY. THE REPORTED EVENT: "WE HAD A SCREW BREACH MEDIAL DURING THE CASE AT SCRIPPS MEMORIAL ON (B)(6) WITH DR. (B)(6). AT THE TIME, DR. (B)(6) REMOVED THE SCREW AND REDIRECTED FREEHAND. THE NEW SCREW WAS CONFIRMED VIA FLURO AND NEUROMONITORING. ALL SIGNALS LEAVING THE CASE WERE OK. HOWEVER, DR. (B)(6) INFORMED ME LAST NIGHT THAT THE PATIENT WOKE UP WITH SOME LEFT SIDED SYMPTOMS AND FOOT DROP." UPDATE FROM (B)(6): PURSUANT TO DISCUSSION WITH THE SURGEON, HE HAS INFORMED THAT A COUPLE OF DAYS AFTER THE SURGERY THE PAIN HAS LESSENED BUT THE PATIENT STILL HAD PALSY.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2017, AT (B)(6) HOSPITAL (US), DR. (B)(6) PERFORMED AN L3-S1 FUSION SURGERY USING THE MAZOR X SYSTEM. INTRAOPERATIVELY THE SCREWS LOOKED ACCURATE, BUT POST-OPERATIVELY THE PATIENT SUFFERED FROM A DROP-FOOT. ON A POST-OP CT IT WAS NOTED THAT L3-L4 TRAJECTORIES WERE MEDIAL AND THESE WERE REVISED THE FOLLOWING DAY. THIS WAS REPORTED TO MAZOR ON (B)(4) 2017.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A SURGERY A COMMUNICATION FAILURE OCCURRED. FOLLOWING COMMUNICATION FAILURE AND RE-INITIALIZATION OF THE SYSTEM, ROSA COULD NOT CONNECT TO CONTROLLER. THE FIELD SERVICE ENGINEER TRIED SEVERAL TIME TO RESOLVE THE ISSUE AND FINALLY WHEN PERFORMED A MANUAL RELEASE OF THE ROBOT ARM FOLLOWED BY RE-INITIALISATION OF THE SYSTEM THE ISSUE WAS SOLVED. THE SURGERY WAS SUCCESSFUL BUT A DELAY OF 60 MINUTES OCCURRED

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 TOWARDS THE END OF A DA VINCI-ASSISTED RADICAL TONSILLECTOMY SURGICAL PROCEDURE, THE SURGEON NICKED THE BRANCHES OF THE CAROTID ARTERY. AS A RESULT, THE PATIENT EXPERIENCED A SIGNIFICANT AMOUNT OF BLEEDING AND THE SURGEON HAD TO CONVERT THE PROCEDURE TO A TRADITIONAL SURGICAL PROCEDURE TO CONTROL THE BLEEDING. THE PATIENT WAS IN THE INTENSIVE CARE UNIT WHEN THE EVENT WAS REPORTED TO INTUITIVE SURGICAL, INC. (ISI). HOWEVER, THERE IS NO ALLEGATION BY THE SITE OR THE SURGEON THAT AN ISI DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT OR THAT AN ISI DEVICE MALFUNCTIONED. ON OCTOBER 24 AND 26, 2017, ISI CONTACTED THE CLINICAL SALES REPRESENTATIVE (CSR) WHO WAS PRESENT DURING THE PROCEDURE AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: THE CSR STATED THAT THE SURGEON WAS USING THE MONOPOLAR CAUTERY AND THE SCHERTEL GRASPER INSTRUMENTS WHEN THE BLEEDING OCCURRED. THE CSR STATED THAT THE EXTERNAL CAROTID ARTERY BRANCH WAS NICKED AND SHE COULD NOT CONFIRM THE CAUSE. AS A RESULT, THERE WAS A SIGNIFICANT AMOUNT OF BLEEDING AND THE PROCEDURE WAS CONVERTED TO A TRADITIONAL SURGICAL PROCEDURE TO CONTROL THE BLEEDING. SINCE THE CSR LEFT THE ROOM AFTER

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 PLANNING OF THE SURGERY, SURGEON ATTEMPTED TO EXPORT PATIENT FOLDER FROM PLANNING STATION 5 TIMES FOLLOWING SHUTDOWNS, BEFORE IT 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: IT WAS REPORTED THAT WAS IMPOSSIBLE TO LOAD THE PATIENT FOLDER ON THE ROSA DEVICE AND ON THE PLANNING STATION AT THE BEGINNING OF THE SURGERY, THE PATIENT WAS PRESENT AND UNDER GENERAL ANESTHESIA. AFTER A MODIFICATION OF THE EXAM FILE THE SURGEON WAS ABLE TO LOAD THE PATIENT FOLDER AND PERFORM 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 REPORTED BY THE SURGEON THAT DURING A SURGICAL PROCEDURE OF "ROBOTIC-ASSISTED LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGECTOMY AND RIGHT OVARIAN BIOPSY": A WIRE BROKE IN "DA VINCI FENESTRATED BIPOLAR FORCEPS 8 MM." THE DEVICE WAS REPORTED TO HAVE SEVEN LIVES LEFT. THE DEVICE WAS SWITCHED OUT AND NO HARM WAS REPORTED TO THE PATIENT. THE SURGEON REPORTED NO OTHER COMPLICATIONS. NO OTHER DETAILS FOR THE DEVICE PROBLEM REPORTED.

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 REGISTRATION PERFORMED WITH THE OPTICAL DISTANCE SENSOR WAS NOT ACCURATE ENOUGH TO PROCEED WITH THE SURGERY, DESPITE THE THREE REGISTRATION ATTEMPTS. FINALLY, AFTER 2.5 HOURS DELAY, THE SURGEON DECIDED TO PERFORM REGISTRATION WITH BONE FIDUCIALS, REQUIRING TO PERFORM A NEW SCAN EXAM FOR THE PATIENT. THIS REGISTRATION METHOD WAS PERFORMED WITH NO PROBLEMS AND ENABLED TO PERFORM THE CASE.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A SURGERY THE SURGEON NOTICED THAT THE TIP OF THE OPTICAL DISTANCE SENSOR DEFLECTED. THE SURGEON HAD TO PLAN A SECOND TRAJECTORY TO REACH THE TARGET POINT, AND A NEW CT EXAM WAS ACQUIRED. THE SURGEON WAS ABLE TO SUCCESSFULLY ABLATE THE TUMOR USING THE SECOND TRAJECTORY. THE EVENT CAUSED A DELAY OF 30 MINUTES IN THE PROCEDURE.

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 POST-OPERATIVE CT SCAN SHOWED MULTIPLE INACCURATE ELECTRODE PLACEMENTS. DURING THE SURGERY AFTER THE LASER REGISTRATION AN AN ERROR MESSAGE AWARE OF INSUFFICIENT ACCURACY AND THE SURGEON HAD TO REPEAT THE REGISTRATION THREE TIMES. DESPITE THE LAST INSTANCE OF THE ERROR MESSAGE SURGEON WAS SATISFIED WITH VERIFICATION STAGE ACCURACY AND DECIDED TO PROCEED WITH THE SURGERY.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING THE REGISTRATION PHASE OF THE ANESTHETIZED PATIENT A COMMUNICATION ERROR SHUTDOWN OCCURRED. SUBSEQUENTLY, DESPITE THE SURGEON HAS RESTARTED THE DEVICE AND THE RE-INITIALIZED THE SYSTEM, BUT A SECOND COMMUNICATION ERROR AND SHUTDOWN OCCURRED. THEN THE SURGEON SHUT OFF THE DEVICE AND RELEASED THE EMERGENCY STOP BUTTON, BUT THE PROBLEM PERSISTED. THE FIELD SERVICE ENGINEER RELEASED MANUALLY THE ROBOT ARM AND RE-INITIALIZED SYSTEM, BUT THE PROBLEM PERSISTED. THE SURGERY WAS ABORTED AND RESCHEDULED FOR THE NEXT DAYS.

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)(6) 2017, FROM (B)(6) DESCRIBING A SITUATION IN WHICH A PROCEDURE (PERFORMED ON (B)(6) 2017) WENT WELL USING THE MAZOR X SYSTEM. THE SURGEON CONFIRMED THE ACCURACY OF PLACEMENT OF ALL THE PEDICLE SCREWS WHICH WERE PLACED WITH THE GUIDANCE OF THE MAZOR X SYSTEM WITH INTRAOPERATIVE FLUORO CONFIRMATION IMAGES. NEURO-MONITORING WAS ALSO EMPLOYED AND DID NOT INDICATE A BREACH OF THE PEDICLE. HOWEVER, THE NEXT DAY THE PATIENT COMPLAINED OF LEG/RADICULAR NERVE PAIN AND WAS TAKEN BACK TO THE HOSPITAL. THE SURGEON THEN INDICATED THAT SCREWS ON THE RIGHT SIDE WERE MEDIAL, WITH ONE OR MORE IN THE CANAL. THE SURGEON PERFORMED A REVISION AND REPOSITIONED THE SCREWS IN L3 AND L4 BY FREEHAND.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A SURGERY, THREE REGISTRATIONS WERE REQUIRED DUE TO INACCESSIBLE TRAJECTORIES AND INTERFERENCE OF THE MAYFIELD WITH THE PLANNED TRAJECTORIES. THE THIRD REGISTRATION WAS COMPLETED WITHOUT ISSUE AND ALL TRAJECTORIES WERE ACCESSIBLE

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 PRIOR TO THE START OF A DA VINCI-ASSISTED LOWER ANTERIOR RESECTION PROCEDURE, THE CUSTOMER EXPERIENCED A REPEATED 32053 ERROR. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) CONFIRMED THE ERROR AT SYSTEM START-UP. THE TSE ADVISED THE CUSTOMER TO CHECK IF THE POWER CORD WAS PROPERLY SEATED AND IT WAS. IT WAS ALSO CONFIRMED THAT THE POWER CORD WAS PROPERLY CONNECTED TO THE POWER STRIP AND THAT THE POWER SWITCH WAS ON. THE CUSTOMER POWER CYCLED THE SYSTEM; HOWEVER, THE ISSUE PERSISTED. THE INSTRUMENT CONTROL BOX (ICB) WOULD NOT POWER ON AND THE POWER LED WAS NOTED TO BE OFF. THE TSE ADVISED THE CUSTOMER TO HAVE THEIR BIOMED CHECK THE FUSES AND VOLTAGE PRESSURE AT THE POWER CORD. IT WAS REPORTED THAT THE CUSTOMER WOULD PROCEED WITH THE CASE WITHOUT USE OF THE VESSEL SEALER INSTRUMENT. ISI MADE MULTIPLE FOLLOW UP ATTEMPTS AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PATIENT WAS ADMINISTERED AN HOUR AND A HALF OF ADDITIONAL ANESTHESIA DUE TO THE TROUBLESHOOTING PERFORMED. THE SURGEON THEN DECIDED TO CONVERT THE PROCEDURE TO A TRADITIONAL LAPAROSCOPIC PROCEDURE DUE TO THE REPORTED ISSUE. HOWEVER, THE SURGEON WAS UNABLE TO SEE WITH THE LA

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 INGUINAL HERNIA REPAIR PROCEDURE, THE ROBOTIC ARMS ON THE PATIENT SIDE CART (PSC) COLLIDED AND AN UNSPECIFIED SYSTEM ERROR WAS GENERATED. WHEN THE EVENT OCCURRED, THE INITIAL REPORTER ALLEGED THAT AN UNSPECIFIED INSTRUMENT ADVANCED ABRUPTLY AND HIT THE MUCOSA OF THE BOWEL. THE SURGEON APPLIED A COUPLE OF STITCHES TO ADDRESS THE BOWEL MUCOSA. IT WAS ALSO REPORTED THAT AN INSTRUMENT GOT STUCK ON ONE OF THE ROBOTIC ARMS. ON 10/04/2017, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SITE'S ROBOTICS COORDINATOR (THE INITIAL REPORTER), AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE ROBOTICS COORDINATOR INDICATED THAT THE ROBOTIC ARM COLLIDED BEFORE A CADIERE FORCEPS INSTRUMENT GOT STUCK ON ONE OF THE ROBOTIC ARMS. THE ROBOTICS COORDINATOR CLARIFIED THAT THE CADIERE FORCEPS INSTRUMENT ADVANCED ABRUPTLY DURING ATTEMPTS BY THE SURGICAL STAFF TO REMOVE THE STUCK INSTRUMENT. AS A RESULT, THE PATIENT REPORTEDLY SUSTAINED A SLIGHT NICK ON THE BOWEL MUCOSA. THE PATIENT DID NOT EXPERIENCE ANY POST-OPERATIVE COMPLICATIONS AND WAS DISCHARGED HOME AT THE EXPECTED TIME. THE CADIERE FORCEPS INSTRUMENT WAS DISC

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 FOUR HOURS AFTER THE SURGERY A HEMORRHAGE WAS NOTICED IN A PATIENT. IT WAS REPORTED THAT THE SURGEON VERIFIED ALL ENTRY POINT AND TARGET POINT ERRORS WERE MINIMAL AND STATED THAT HE DID NOT BELIEVE THAT THE ROSA DEVICE CAUSED THE HEMORRHAGE.

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 FIRST LASER REGISTRATION FAILED WITH DEVICE DISPLAYING AN ERROR MESSAGE, THE SECOND ONE WAS ABORTED AFTER THE 6 INITIAL LANDMARK POINTS WERE ALL IN RED AND FINALLY THE THIRD PASSED. ONCE DRIVING TO TRAJECTORIES THE SURGEON NOTICED THAT THE ROBOT ARM POSITION WAS INACCURATE SO, FOLLOWING THE ADVICE OF THE FIELD SERVICE ENGINEER, THE SYSTEM WAS RE-INITIALIZED BUT THE PROBLEM PERSISTED. THE SURGEON DECIDED TO RE-START THE REGISTRATION FROM THE BEGINNING AND NO MORE ISSUES WERE OBSERVED. FOLLOWING THE SURGERY, THE RESIDENT MERGED THE POST-OPERATIVE CT EXAM TO PRE-OPERATIVE MRI EXAM AND FOUND INACCURATE PLACEMENT OF THE THREE LAST ELECTRODES. IT WAS REPORTED THAT THE RESIDENT SUSPECTS THAT THESE INACCURACIES MAY POSSIBLY HAVE BEEN DUE TO BRAIN SHIFT.

At 7:30 a.m. on September 18, 2017, an employee was touching up a part on a robot welder. The employee was unable to see the work area while standing on a stool. The employee shut the door to welding cage and climbed between the welding table and the robot platform. The employee was observing the welding sequence to make sure the machine was going to weld correctly. When the employee cycled the machine, the machine traveled to the home position at full speed. The employees legs were pinched between the welding table and the robot base. The employee was bruised and sustained lacerated on the back of both legs. The employee required several stiches on back of left leg. Employee was kept in the hospital for possible compartment syndrome.

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 POSITIONING OF THE GUIDE WIRES AN UNRECOVERABLE ERROR MESSAGE APPEARED AND THE DEVICE SHUTDOWN. THE DEVICE WAS WAS REBOOTED, BUT AFTER THIS THE PATIENT REFERENCE PIN WAS ACCIDENTALLY MOVED POSSIBLY BY THE ASSISTING SURGEON, LEADING TO ACCURACY LOSS. WIRES WERE ALREADY PLACED AT THIS STAGE AND THE ROSA ONE DEVICE WAS REMOVED. THE SURGERY WAS CONVERTED TO TRADITIONAL SURGERY. NO PATIENT HARM WAS REPORTED BUT A DELAY OF 45 MINUTES IN THE SURGERY WAS REPORTED.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A SURGERY AN ERROR MESSAGE POP UP AND THE ROBOT REFUSED TO MOVE. THE SURGEON HAD LATER TO STOP THE AUTOMATIC MOVEMENT BECAUSE THE ROBOT ARM WOULD HAVE TOUCHED PATIENT HEAD. THE SURGEON MODIFIED THE TRAJECTORY AND NO MORE ISSUES WERE NOTICED.

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 THROUGH A SOCIAL MEDIA BLOG THAT AFTER UNDERGOING A DA VINCI-ASSISTED HYSTERECTOMY WITH BILATERAL SALPINGECTOMY AND PELVIC FLOOR REPAIR PROCEDURE ON (B)(6) 2017, THE PATIENT WAS FOUND TO HAVE SUSTAINED A SMALL BOWEL PERFORATION. THE PATIENT REPORTEDLY DEVELOPED SEPSIS AND REQUIRED EMERGENCY SURGERY TO REPAIR THE BOWEL PERFORATION. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT THE SURGEON WANTED TO PERFORM AN OFF LABEL SURGERY. DURING REGISTRATION IT WAS REPORTED THAT A SAME ERROR OCCURRED TWICE AND FOR THEREFORE THE PATIENT REGISTRATION FAILED TWICE. THE SURGEON DECIDED TO ABORT THE SURGERY AND USE NAVIGATION.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ATTORNEYS HAVE ALLEGED THAT THEIR CLIENTS SUFFERED INJURIES ASSOCIATED WITH DA VINCI SURGICAL PROCEDURES. THESE CLAIMS DO NOT INVOLVED REPORTABLE DEATHS OR MALFUNCTIONS. THESE ALLEGATIONS WERE RECEIVED BY INTUITIVE SURGICAL, INC.(ISI) BETWEEN (B)(6) 2017. FOR THOSE CLAIMS WHERE PROCEDURE DATES ARE PROVIDED, THE DATES RANGE FROM (B)(6) 2014 - (B)(6) 2016.

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 PROCEDURE PRE-SURGERY IT WAS IMPOSSIBLE TO CONNECT THE ROBOT. THE SURGEON DECIDED TO ABORT THE COMPUTER-ASSISTED SURGERY AND PERFOM A NON ROBOTIC 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: 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: IT WAS REPORTED THAT DURING A SURGERY THE ROBOT ARM WAS UNABLE TO REACH THE TRAJECTORY TWICE DUE TO ONE COLLISION WITH THE ROBOT STAND AND ONE COLLISION WITH THE PATIENT. THE SURGEON DECIDED TO STOP USING THE ROSA DEVICE AND USED ANOTHER SURGERY TECHNIQUE TO PERFORM 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: DAVINCI ROBOT CUT MY JEJUNUM THROUGH AND THROUGH BURNED MY SIGMOID COLON DURING A ROBOTIC ASSISTED LAPAROSCOPIC HYSTERECTOMY AT (B)(6) CLINIC PERFORMED BY DR (B)(6). THERE WERE NO TROCARS INSERTED WHERE THERE WERE INJURIES. I BELIEVE THE FDA ERRED IN ALLOWING THIS DEVICE TO CONTINUE TO BE USED IN THE MEDICAL. I BELIEVE IT IS NOT SAFE AND THE PART ISSUES HAVE NOT BEEN REMEDIED. I BELIEVE THE FDA DID NOT AND DOES NOT CONTINUE TO MONITOR AND REGULATE INTUITIVE SURGICAL AS THERE CONTINUES TO BE INJURIES AND DEATHS SURROUNDING THE DAVINCI ROBOT. I ALSO BELIEVE THERE ARE VIOLATIONS AROUND ADVERSE EVENT REPORTING BASED ON THE FACT MY INJURIES WERE NOT REPORTED AS WELL AS A NUMBER OF INDIVIDUALS I HAVE TALKED TO WHO HAVE ALSO SUFFERED INJURIES FROM THE DAVINCI ROBOT. PER PREVIOUS COMMITMENTS FROM INTUITIVE SURGICAL TO FDA, PLEASE ADVISE ON THE FOLLOWING: INTUITIVE USES A (B)(4) AVIATION MFR TO MAKE SOME OF THEIR COMPONENTS IN THE DAVINCI ROBOT NAMED EASTON. DO THEY STILL CONTINUE TO USE THIS 3RD PARTY AND WHY THEY NEVER TESTED THE MATERIAL IN THE TUBES. ALSO, WHAT TYPE OF MATERIALS ARE USED AND HOW IS THIS MONITORED AND REGULATED. HISTORICALLY, INTUITIVE KNEW THE COMPOSITE MATERIAL WAS NOT

Around 2 p.m., the robot veered off its predetermined path and plunged into the fountain in the center of Washington Harbour.

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 MEDICAL STAFF OBSERVED TWICE POWER FAILURE DUE TO A DAMAGED CABLE AND THEY NEEDED TO RESTART THE DEVICE.

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 THE PATIENT UNDERWENT A SEEG PROCEDURE TO IMPLANT ELECTRODES. THE PROCEDURE WAS COMPLETED AND THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM. IT WAS STATED THAT WHILST IN THE RECOVERY ROOM THAT THE PATIENT SUFFERED AN ACUTE SUBDURAL HEMATOMA, LOST CONSCIOUSNESS AND WAS TRANSFERRED TO THE OPERATING ROOM FOR SUBDURAL HAEMATOMA EVACUATION. ADDITIONAL INFORMATION PROVIDED LATER BY THE OPERATING SURGEON INDICATES THAT THERE WERE NO APPARENT ISSUES NOTED INTRA-OPERATIVELY AND THAT THE ROSA DEVICE HAD NOT MALFUNCTIONED.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A SURGERY THE ROBOTIC ARM COLLIDED WITH THE DEVICE COVERS, GENERATING A COMMUNICATION ERROR IN THE SYSTEM AND A SHUTDOWN. WHEN THE DEVICE WAS RESTARTED THE REGISTRATION OF THE PATIENT POSITION WAS NOT ACCURATE ANYMORE. THIS EVENT OCCURRED RIGHT BEFORE IMPLANTING THE LAST ELECTRODE, FOR THAT REASON THE SURGEON DECIDED NOT TO IMPLANT IT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE ENDOWRIST STAPLER SHEATH (REF: (B)(4)) USED IN THE DA VINCI XI STAPLER 45 (REF: (B)(4)) TO COVER THE END SHAFT OF THE STAPLER HANDPIECE LOOKS LIKE AN ORIGINAL OEM PART THAT HAS ALWAYS BEEN A PART OF THE STAPLER. THERE WAS NO CLEAR WARNING OR BRIGHT NOTICE TO INSTRUCT USERS TO REMOVE THE SHEATH PRIOR TO SENDING TO STERILE PROCESSING DEPARTMENT (SPD) FOR REPROCESSING. THE BLACK PIECE OF THE SHEATH HAPPENED TO DISENGAGE FROM THE OTHER PART OF THE SHEATH AND WAS LEFT ON THE INSTRUMENT DURING THIS EVENT. THE SPD TEAM DID NOT NOTICE AND THE HANDPIECE WAS STERILIZED WITH THE PART OF THE SHEATH INTACT. THE INSTRUMENT WAS THEN USED ON A CASE. IT WAS DISCOVERED THE REMAINING PIECE WAS NOT PART OF THE STAPLER HANDPIECE WHEN ANOTHER SHEATH WAS INSERTED AND THAT THE STAPLER WOULD NOT FIT THE CANNULA. AT THIS POINT, THE INSTRUMENT BECOMES CONTAMINATED WITH BIOBURDEN (PART OF THE REMAINING SHEATH) AND THE WOUND CLASSIFICATION CHANGES FROM CLEAN TO CONTAMINATED. REQUEST THAT CHANGES TO THE SHEATH BE MADE TO WARN USERS THE SHEATH MUST BE REMOVED AFTER A CASE TO INCLUDE A RED WARNING "DISPOSE AFTER USE" OR CHANGING ENTIRE COLOR TO MAKE IT STAND OUT.

da Vinci Surgical System — Death 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 PROSTATECTOMY PROCEDURE, THE PATIENT EXPIRED ON AN UNSPECIFIED DATE. ACCORDING TO THE INITIAL REPORTER, THE SURGICAL PROCEDURE WAS LONG AND THERE WERE UNSPECIFIED COMPLICATIONS. THERE WERE NO REPORTED SYSTEM FAILURE ISSUES. ON 07/24/2017, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INITIAL REPORTER, AN ISI CLINICAL SALES REPRESENTATIVE (CSR), AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: THE CSR WAS NOT PRESENT DURING THE SURGICAL PROCEDURE WHICH WAS NOT RECORDED ON VIDEO. TO HER KNOWLEDGE, THE DA VINCI SURGICAL SYSTEM WAS IN THE OPERATING ROOM (OR) FOR APPROXIMATELY 13 HOURS. TO HER UNDERSTANDING, THE DA VINCI SURGICAL SYSTEM WAS USED FOR THE ENTIRE DURATION OF THE SURGICAL PROCEDURE AND THERE WERE NO REPORTS THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. THE CSR STATED THAT THE PATIENT REPORTEDLY HAD A TON OF ADHESIONS WHICH TOOK A WHILE TO CLEAR IN ORDER FOR THE SURGEON TO GAIN ACCESS TO THE PROSTATE. THE SURGICAL PROCEDURE WAS COMPLETED. HOWEVER, POST-OPERATIVELY THE PATIENT COMPLAINED OF SEVERE ABDOMINAL PAIN AND UNDERWENT SOME TYPE OF UNSPECIFIED SCAN. THE CSR WAS UN

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 SOCIAL MEDIA THAT AS A RESULT OF UNDERGOING AN UNSPECIFIED DA VINCI-ASSISTED SURGICAL PROCEDURE ON AN UNSPECIFIED DATE, THE PATIENT ALLEGED THAT HER INSIDES WERE BURNED AND HER BOWEL PROLAPSED. THE PATIENT ALSO STATED, MY PRIZED ORGAN IS FOREVER DESTROYED BY A FAULTY TIP AND NOT 93'S OF BONES IS WORTH (B)(6)? IT IS UNCLEAR WHAT SPECIFIC ORGAN THE PATIENT WAS REFERRING TO AND WHAT TYPE OF DAMAGE/INJURY WAS SUSTAINED. IT IS ALSO UNCLEAR WHAT SPECIFIC INSTRUMENT OR ACCESSORY WAS ALLEGEDLY FAULTY. NO FURTHER CLINICAL INFORMATION WAS PROVIDED.

At approximately 4:00 p.m. on June 23, 2017, an employee entered a robotic cell to make an adjustment to guide rails where half dive shafts were placed by a robot. The robot cycled while the employee was within the danger zone and was pinned between the robot and a conveyor, receiving a puncture wound to chest.

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 ROSA CRASHED AND WAS NOT POSSIBLE TO RESTART THE ROBOT. IN THIS SPECIFIC CASE WE HAVE NO INFORMATION ON THE OUTCOME OF THE SURGERY AND OF THE IMPACT ON PATIENT.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT, WHEN THE ROBOT ARM WAS IN POSITION TO START THE CONTACTLESS REGISTRATION, THERE WERE TWO COMMUNICATION ERRORS. THE THIRD TIME, THE SURGEON MANAGED TO PERFORM THE CONTACTLESS REGISTRATION AND THERE WERE NO OTHER COMMUNICATION ERRORS DURING THE REST OF THE SURGERY.

At approximately 7:00 a.m. on June 16, 2017, Employee #1 was watching a maintenance worker repair a sensor on an automatic robotic conveyor system located in Zone Number 2. He was in Zone Number 3 and standing in front of another robotic conveyor system when the robot struck him in his back. The robot caught and pinned him against the conveyor and fractured at least six of his ribs. Employee #1 was transported to a medical center, where he underwent treatment on the rib fractures and was then hospitalized.