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 XI HYSTERECTOMY PROCEDURE, THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT SPRING WAS BROKEN AFTER IT WAS HOOKED TO ROBOT. THE REPORT REVEALED THE GRASPS WOULD NOT OPEN OR CLOSE WITH THE SPRING PROTRUDED. NO PATIENT HARM WAS REPORTED. THE DEVICE WAS RETURNED TO THE MANUFACTURER.

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 XI HYSTERECTOMY PROCEDURE, THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT SPRING WAS BROKEN AFTER IT WAS HOOKED TO ROBOT. THE REPORT REVEALED THE GRASPS WOULD NOT OPEN OR CLOSE WITH THE SPRING PROTRUDED. NO PATIENT HARM WAS REPORTED. THE DEVICE WAS RETURNED TO THE MANUFACTURER.

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 FOLLOWING AN USER ERROR A DELAY OF 30 MINUTES WAS OBSERVED FOR THE IMPOSSIBILITY TO LOAD IMAGES TO ROSA.

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 AUTOMATIC SCAN COULD NOT BE PERFORMED TWICE DURING LASER REGISTRATION DUE TO PATIENT POSITIONING. IT WAS ALSO REPORTED THAT A COMMUNICATION FAILURE 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 NOTICED THAT SEVERAL TRAJECTORIES WERE INACCURATE. PATIENT WAS UN-DRAPED AND RE-DRAPED WITH CARE AND ROBOT ARM WITH INSTRUMENT HOLDER ATTACHED WAS DRIVEN TO ALL TRAJECTORIES SUCCESSFULLY. TOTAL TIME LOST WAS MORE THAN 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: DURING SURGERY THERE WERE THREE DEVICE SHUTDOWNS. AFTER EACH SHUTDOWN THE DEVICE WAS RESTARTED TO PURSUE 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: DR NOTICED FRAYED WIRE STICKING OUT AND THE INSTRUMENT WAS NOT WORKING PROPERLY. REMOVED THE INSTRUMENT FROM USE.

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 VENTRAL HERNIA REPAIR PROCEDURE, THE PATIENT WAS FOUND TO HAVE SUSTAINED A GASTRIC PERFORATION ON POST-OPERATIVE DAY 1. PRIOR TO UNDERGOING THE DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PATIENT HAD ALSO UNDERGONE A DIAGNOSTIC LAPAROSCOPY PROCEDURE WITH ADHESIOLYSIS. A SURGEON REPAIRED THE GASTRIC PERFORATION VIA OPEN SURGERY AND HAD TO REMOVE MESH. AFTER GOING HOME, THE PATIENT REPORTEDLY DEVELOPED AN UNSPECIFIED EMBOLISM AND GI BLEED. NO FURTHER CLINICAL INFORMATION WAS PROVIDED.

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, THE CT SCAN WAS LOADED ON THE DEVICE FROM AN USB DRIVE. ONCE OPENED ON THE DEVICE, THE IMAGES HAD AN INCORRECT APPEARANCE AND THE RESULT OF THE CT AND MRI AUTOMATIC MERGE WAS INCORRECT. TO BE ABLE TO PERFORM THE SURGERY, A NEW CT SCAN WAS ACQUIRED.

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 PULMONARY LOBECTOMY PROCEDURE, THE PATIENT EXPERIENCED BLEEDING FROM THE PULMONARY ARTERY. AT THE TIME THE BLEEDING WAS IDENTIFIED, THERE WAS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY HAD OCCURRED. WHEN THE EVENT OCCURRED, THE SURGEON WAS ABLE TO CONTROL THE BLEEDING BY USING TACHOSIL SPONGES. THE PULMONARY ARTERY WAS REPORTEDLY SEWN. NO BLOOD TRANSFUSIONS WERE ADMINISTERED. IT WAS NOTED THAT DUE TO THE COMPLEXITY AND LENGTH OF THE SURGICAL PROCEDURE, THE SURGEON MADE THE DECISION TO CONVERT THE SURGICAL PROCEDURE TO OPEN SURGERY. THE SURGEON REPORTEDLY FELT MORE SECURE COMPLETING THE SURGICAL PROCEDURE VIA OPEN SURGERY. ACCORDING TO THE INITIAL REPORTER, THE SURGEON WAS ABLE TO COMPLETE THE SURGICAL PROCEDURE 10-15 MINUTES AFTER THE CASE WAS CONVERTED TO OPEN SURGERY. IT IS UNCLEAR IF THE SURGEON REPAIRED THE PULMONARY ARTERY BEFORE OR AFTER THE SURGICAL PROCEDURE WAS CONVERTED TO OPEN SURGERY. THE PATIENT EXPERIENCED AN UNSPECIFIED RESPIRATION ISSUE POST-OPERATIVELY. HOWEVER, IT WAS REPORTED THAT THE RESPIRATION ISSUE WAS UNRELATED TO THE INTRA-OPERATIVELY BLEEDING EXPERIENCED BY THE P

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 PRE-OPERATIVE PLANNING PHASE OF THE SURGERY, THE PLANNING STATION WAS NOT WORKING ANYMORE. SURGEON COULD HAVE PERFORMED THIS PRE-OPERATING PLANNING DIRECTLY ON THE DEVICE BUT DECIDED TO ABORT SURGERY.

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, ROBOT ARM COLLIDED WITH THE MAYFIELD HEAD HOLDER ADAPTER. THE COLLISION WAS DETECTED BY THE SOFTWARE AND DEVICE SHUTDOWN. BECAUSE OF THE CONTACT OF THE ROBOT ARM AGAINST THE MAYFIELD HEAD HOLDER ADAPTER, ROBOT ARM HAD TO BE RELEASED MANUALLY.

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 SINGLE-SITE DA VINCI-ASSISTED CHOLECYSTECTOMY PROCEDURE PERFORMED ON (B)(6) 2017, THE SURGEON EXPERIENCED A LOT OF RESISTANCE WITH INSTRUMENT MOVEMENT. ON 02/07/2017, AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) PERFORMED A FIELD EVALUATION AT THE SITE. THE FSE WAS UNABLE TO REPLICATE THE CUSTOMER REPORTED FAILURE MODE. THE FSE TESTED THE DA VINCI SURGICAL SYSTEM AND VERIFIED THAT THE SYSTEM WAS READY FOR USE. DURING THE FIELD EVALUATION, THE FSE REPORTEDLY SPOKE TO THE SITE'S ROBOTICS COORDINATOR REGARDING THE REPORTED EVENT. THE ROBOTICS COORDINATOR CLAIMED THAT DUE TO RESISTANCE WITH THE UNIVERSAL SURGICAL MANIPULATOR (USM) AND RESTRICTED MOTION, THE SURGEON HAD TO TARGET BELOW THE ANATOMY. THE ROBOTICS COORDINATOR CLAIMED THAT THERE WAS LIMITED SPACING AND MOVEMENT. ON 02/09/2017, THE ISI CLINICAL SALES REPRESENTATIVE (CSR) INDICATED THAT THE PATIENT CAME BACK TO THE HOSPITAL WITH A POST-OPERATIVE BILE LEAK AND WAS GOING THROUGH UNSPECIFIED TESTING. THE CSR INDICATED THAT THE SURGEON PERFORMED TWO SUBSEQUENT DA VINCI-ASSISTED SURGICAL PROCEDURES THE DAY THE REPORTED EVENT OCCURRED AND THERE WERE NO REPORTED ISSUES DURING

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 INVOLVE REPORTABLE DEATHS OR MALFUNCTIONS. THESE ALLEGATIONS WERE RECEIVED BY INTUITIVE SURGICAL, INC.(ISI) BETWEEN (B)(6) 2016 - (B)(6) 2017. FOR THOSE CLAIMS WHERE PROCEDURE DATES ARE PROVIDED, THE DATES RANGE FROM (B)(6) 2008 - (B)(6) 2015.

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 HOSP USED A DA VINCI MACHINE AND IT TORE MY LEFT ROTATOR CUFF, STILL BEING TESTED TO SEE IF CANCER IS GONE ON MY RIGHT KIDNEY. 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: IT WAS INITIALLY REPORTED THAT DURING A DA VINCI-ASSISTED BILIARY PANCREATIC DIVERSION PROCEDURE, THE PATIENT HAD AN ARTERIO-VENOUS LESION, A CADIERE FORCEPS INSTRUMENT WAS USED AS A CLAMP, AND THE SURGICAL PROCEDURE WAS CONVERTED TO OPEN SURGERY. IN ORDER TO REMOVE THE CADIERE FORCEPS INSTRUMENT, THE SURGICAL STAFF USED AN INSTRUMENT RELEASE KIT (IRK). ON (B)(6) 2017, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: THE SURGEON INDICATED THAT THE PATIENT SUSTAINED AN UNSPECIFIED INJURY AND HE USED THE CADIERE FORCEPS INSTRUMENT TO CONTROL BLEEDING FROM THE CAVERNOMA PORTAL VEIN. THE SURGEON DID NOT PROVIDE DETAILS REGARDING THE INJURY SUSTAINED BY THE PATIENT OR THE CAUSE OF THE BLEEDING FROM THE BLOOD VESSEL. DUE TO THE UNSPECIFIED INJURY, THE SURGEON MADE THE DECISION TO CONVERT THE DA VINCI-ASSISTED SURGICAL PROCEDURE TO OPEN SURGERY. DURING THE CONVERSION TO OPEN SURGERY, THE SURGICAL STAFF WAS ABLE TO UNDOCK THREE OF FOUR ROBOTIC ARMS THAT WERE INSTALLED ON THE PATIENT SIDE CART (PSC). HOWEVER, THE SURGICAL STAFF HAD DIFFICULTY OPENING THE JAWS OF A CADIERE FORCEPS INSTRUMENT THAT WAS INSTALLED ON THE FO

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ABSTRACT: WE SOUGHT TO COMPARE INTRAOPERATIVE SURGICAL INSTRUMENTATION TECHNIQUES WITH IMAGE-GUIDANCE VERSUS ROBOTIC-GUIDED PROCEDURES FOR POSTERIOR SPINAL FUSION. METHODS: 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. RESULTS: BETWEEN JANUARY 2017 AND FEBRUARY 2019, 46 O-ARM CASES (MEAN AGE 59.6 YEARS ± 13.7 YEARS) AND 39 MAZOR X CASES (MEAN AGE 59.5 YEARS ± 12.4 YEARS) 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 (P = 0.124), ESTIMATED BLOOD LOSS (P = 0.212), WOUND REVISION RATES (P = 0.560), AND CLINICALLY ACCEPTABLE INSTRUMENTATION PLACEMENT (P = 0.076) DID NOT DEMONSTRATE SIGNIFICANCE BETWEEN THE 2 GROUPS. HOWEVER, SCREW PLACEMENT WAS SIGNIFICANTLY MORE A C

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: HYSTERECTOMY WITH DA VINCI ROBOT AT (B)(6) HOSPITAL FOR 3.75 HOURS. WOKE WITH GRADE 4 ANNULAR TEAR IN L5-S1 LUMBAR DISC, CAUSING IMMEDIATE SEVERE PAIN AND REQUIRING ARTIFICIAL DISC REPLACEMENT 7 MONTHS LATER.

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 COMPLETION OF A DA VINCI-ASSISTED THORACOTOMY PROCEDURE PERFORMED ON AN UNSPECIFIED DATE IN (B)(6) 2016, THE PATIENT WAS IDENTIFIED TO HAVE A HEMOTHORAX ON POST-OPERATIVE DAY 1. THE SURGEON INDICATED THAT THE INTERNAL MAMMARY ARTERY (IMA), WHICH WAS HARVESTED DURING THE DA VINCI-ASSISTED SURGICAL PROCEDURE, WAS FOUND TO BE BLEEDING. THE SURGEON HAD TO PLACE SUTURES ON THE IMA IN ORDER TO CONTROL THE BLEEDING. THE SURGEON COULD NOT CONFIRM A ROOT CAUSE FOR THE POST-OPERATIVE COMPLICATION. HOWEVER, THE SURGEON INITIALLY ATTRIBUTED THE POST-OPERATIVE COMPLICATION TO POSSIBLE SURGEON-ERROR. ACCORDING TO THE SURGEON, THE PATIENT HAS BEEN DOING VERY WELL SINCE THEN. THE SURGEON STATED THAT A POSSIBLE CAUSE OF THE POST-OPERATIVE COMPLICATION WAS DUE TO A SETTING ON THE ERBE GENERATOR WHICH IS INTEGRATED WITH THE DA VINCI XI SURGICAL SYSTEM. THE SURGEON EXPLAINED THAT THE INTEGRATED ERBE GENERATOR DOES NOT GIVE THE OPTION OF INCREASING THE SETTINGS IN SMALLER INCREMENTS WHICH WOULD HELP WITH PURE COAGULATION. DURING THE SURGICAL PROCEDURE, THE SURGEON STATED THAT HE HAD SET THE ERBE GENERATOR AT 2 BUT WOULD HAVE PREFERRED TO SET IT AT 1.5 WHICH IS NOT AN AVAILABL

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 SEVERAL DEVICE PC PERFORMANCES ISSUES DURING A 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 THAT DURING A DA VINCI-ASSISTED TOTAL BENIGN HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY PROCEDURE ENERGY WAS ALLEGEDLY CUTTING TOO MUCH TISSUE. THE INITIAL REPORTER CLAIMED THAT BIPOLAR AND MONOPOLAR ENERGY WAS NOT STOPPING AND WAS BURNING THROUGH TOO MUCH TISSUE. ON (B)(6) 2016, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SITE'S OR ASSISTANT DIRECTOR AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE OR ASSISTANT DIRECTOR STATED THAT THE ENERGY TRAVELED DURING THE PROCEDURE, WHICH RESULTED IN A THERMAL BURN ON A FALLOPIAN TUBE AND THE SIGMOID COLON ADJACENT TO IT. IT WAS CONFIRMED THAT THERE WAS NO ARCING SEEN BY THE SURGEON OR THE BEDSIDE ASSISTANTS; HOWEVER, WHEN THE FALLOPIAN TUBE WAS MOVED THE SURGEON SAW EVIDENCE OF A BURN ON IT AND ON THE SIGMOID COLON. AT THIS TIME THE SURGEON INSPECTED THE SIGMOID COLON AND FOUND IT HAD A LEAK, THE SURGEON APPLIED SUTURES TO STOP THE LEAK. PHOTOGRAPHIC IMAGES OF THE PATIENT'S INJURY WERE REVIEWED BY THE HOSPITAL STAFF AND IT WAS REPORTED THAT THERE WAS A LARGE DISTANCE BETWEEN THE INJURED TISSUE AND THE INSTRUMENTS USED. THE SITE REPORTED THAT THE INSTRUMENTS ARE ALWAYS EXAMINED PRIO

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: TWO ELECTRODES IMPLANTED DURING (B)(6) 2016 SURGERY WERE NOT POSITIONED AS PLANNED, AND COULD NOT BE USED FOR EPILEPSY DIAGNOSTICS. THOSE TWO ELECTRODES WERE EXPLANTED AND TWO NEW ELECTRODES WERE IMPLANTED ON PATIENT ON (B)(6) 2016 SURGERY.

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 DEVICE ROBOT ARM WAS GOING TO A PLANNED TRAJECTORY. THE OPERATOR NOTICED THAT THE ROBOT ARM WOULD HAVE COLLIDED WITH THE PATIENT'S HEAD DURING THIS MOVEMENT, SO HE RELEASED THE VIGILANCE DEVICE WHICH PREVENTED THE COLLISION.

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 CONTACTLESS REGISTRATION PART OF THE SURGERY, A COMMUNICATION ERROR APPEARED. THE ROBOT ARM WAS IN EXCESSIVE EXTENSION WHEN IT WAS MOVING TO TEMPORAL SIDE. THIS ISSUED APPEARED BECAUSE TELESCOPIC ARM WAS TOO MUCH EXTENDED AND SO, PATIENT¿S HEAD WAS LOCKED TOO FAR FROM THE ROBOT ARM. THE DEVICE WAS RESTARTED AND THE TELESCOPIC ARM LENGTH WAS REDUCED IN ORDER TO ENSURE ACCESSIBILITY OF ALL SIDE OF THE PATIENT¿S HEAD. AFTER THIS MODIFICATION THERE WAS NO MORE REPORTED ISSUES.

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 SURGERY WAS ABORTED DUE TO BAD PLACEMENT OF LASER FIBER.

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 10/18/2016, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF THE OPEN MEDICINE JOURNAL ARTICLE TITLED, MALFUNCTIONS OF ROBOTIC SYSTEM IN SURGERY: ROLE AND RESPONSIBILITY OF SURGEON IN LEGAL POINT OF VIEW (FERRARESE, ET AL., 2016). THE PURPOSE OF THE JOURNAL ARTICLE WAS TO ESTIMATE THE IMPACT OF DEVICE MALFUNCTIONS IN ROBOTIC SURGERY AND ITS CONSEQUENT LEGAL IMPLICATIONS. WITHIN THE ARTICLE, THE FOLLOWING IS STATED: FROM A RS MALFUNCTION, 16 CAUSED PATIENT DAMAGE, OF WHICH 13 WERE MILD AND RESOLVED WITHOUT SEQUELAE, AND 3 WERE COMPLEX, INCLUDING AN EXTERNAL ILIAC VEIN LESION, ILEAL PERFORATION, AND URETHRAL LESION. THE LATTER WERE TREATED INTRA-OPERATIVELY WITH DIRECT ILIAC VEIN AND ILEAL SUTURE AND REIMPLANTATION OF THE URETHRAL LESION. NO FURTHER INFORMATION WAS PROVIDED WITHIN THE ARTICLE REGARDING THE OPERATIVE COMPLICATIONS.

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 PARATHYROID GLAD SURGICAL PROCEDURE, THE PATIENT EXPERIENCED COMPLICATIONS. THE PATIENT'S SPOUSE CONTACTED AN INTUITIVE SURGICAL, INC. (ISI) REPRESENTATIVE AND STATED THAT HIS WIFE HAD NERVE DAMAGE AND ALMOST LOST HER VOICE. THE SPOUSE FURTHER STATED THAT NOT ALL THE PARATHYROID GLANDS WERE REMOVED. ON 4/4/2017, ISI RECEIVED ADDITIONAL INFORMATION CONFIRMING THE DATE OF THE PROCEDURE. ON 4/10/2017 ISI RECEIVED ADDITIONAL INFORMATION FROM THE SURGEON WHO STATED THAT THERE WERE NO MALFUNCTION OF THE ISI SYSTEM, INSTRUMENT, OR ACCESSORIES. NO FURTHER DETAILS HAVE BEEN OBTAINED AS OF DATE OF THIS REPORT.

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 CHOLECYSTECTOMY PROCEDURE, THE PATIENT SIDE MANIPULATOR (PSM) 2 ALLEGEDLY MOVED ON ITS OWN WITH A PERMANENT CAUTERY HOOK INSTRUMENT INSTALLED. THE PSM IS AN INSTRUMENT ARM LOCATED ON THE PATIENT SIDE CART (PSC) THAT PROVIDES STERILE INTERFACE FOR THE ENDOWRIST INSTRUMENT. THE EVENT REPORTEDLY OCCURRED WHILE THE SURGEON WAS WAITING FOR INSTRUMENT REMOVAL. AS A RESULT, THE INITIAL REPORTER INDICATED THAT THE INSTRUMENT INJURED THE PATIENT'S LIVER AND BLEEDING ENSUED. AFTER THE SURGEON CONTROLLED THE BLEEDING USING CAUTERY WITH THE SAME PERMANENT CAUTERY HOOK INSTRUMENT, THE SURGICAL STAFF PROCEEDED WITH THE SURGICAL PROCEDURE. WHEN THE EVENT OCCURRED, THE INITIAL REPORTER AND SURGICAL STAFF CONTACTED AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) FOR SUPPORT. THE TSE INFORMED THE INITIAL REPORTER OF THE POSSIBLE CAUSES OF THE PSM DRIFTING. THE INITIAL REPORTER WAS GOING TO FOLLOW UP WITH THE SURGEON TO ENSURE HE REMOVES HIS HEAD FROM THE HIGH RESOLUTION STEREO VIEWER (HRSV) BEFORE RELEASING HIS GRIPS ON THE MASTER TOOL MANIPULATORS (MTMS). ON 12/05/2016, ISI CONTACTED THE INITIAL REPORTER AND OBTAINED THE FOLLOWING I

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS INITIALLY REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY PROCEDURE, THE SURGICAL STAFF ENCOUNTERED A DOUBLE-VISION ISSUE. THERE WERE NO REPORTS OF ANY PATIENT HARM ACCORDING TO THE INITIAL REPORTER, A ROBOTICS COORDINATOR. ON 12/15/2016, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SITE'S RISK MANAGER AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT. IT WAS REPORTED THAT DURING THE SURGICAL PROCEDURE, THE SURGEON ENCOUNTERED A DOUBLE-VISION ISSUE WITH THE DA VINCI SI SURGICAL SYSTEM AND WAS EXPERIENCING MIGRAINE-LIKE SYMPTOMS. THE ISI CLINICAL SALES REPRESENTATIVE (CSR) USED A BACKUP CAMERA TO REPLACE THE CAMERA OF THE PATIENT SIDE CART (PSC). THE RISK MANAGER STATED THAT PATIENT HARM OCCURRED DURING THE SURGICAL PROCEDURE. HOWEVER, THE RISK MANAGER DID NOT HAVE ACCESS TO THE PATIENT'S RECORDS AND COULD NOT PROVIDE ADDITIONAL DETAILS REGARDING THE PATIENT HARM. ISI ALSO CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR). THE CSR INDICATED THAT HE WAS AT ANOTHER HOSPITAL AND IN THE MIDDLE OF ANOTHER DA VINCI-ASSISTED SURGICAL PROCEDURE WHEN THE ROBOTICS COORDINATOR CALLED HIM FOR ASSISTANCE WITH THE DOUBLE-VISION ISSUE. ACCORDING TO THE CSR, AT 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: ATTORNEYS HAVE ALLEGED THAT THEIR CLIENTS SUFFERED INJURIES ASSOCIATED WITH DA VINCI SURGICAL PROCEDURES. THESE CLAIMS DO NOT INVOLVE REPORTABLE DEATHS OR MALFUNCTIONS. THESE ALLEGATIONS WERE RECEIVED BY INTUITIVE SURGICAL, INC.(ISI) BETWEEN JULY 2, 2016 - OCTOBER 1, 2016. FOR THOSE CLAIMS WHERE PROCEDURE DATES ARE PROVIDED, THE DATES RANGE FROM FEBRUARY 2013 - APRIL 2015.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT HAS BEEN REPORTED THAT DURING A SURGERY, A SOFTWARE FAILURE HAS BEEN DETECTED. THE WRIST OF THE ROBOT ARM HIT THE MAYFIELD SCREW, CAUSING A COLLISION THAT MADE THE SYSTEM SHUT DOWN. BECAUSE THERE WAS STILL PRESSURE BEING PUT ON THE ROBOT ARM BY THE MAYFIELD SCREW, THE SURGEON COULDN'T POWER THE ARM AGAIN TO MOVE IT IN COOPERATIVE MODE AND RESUME SURGERY. A SURGERY DELAY HAS BEEN REPORTED BETWEEN 30 MINUTES AND 1 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: DURING ROBOTIC ASSISTED LAPAROSCOPIC RADICAL PROSTATECTOMY A 1.5 CM PIECE OF PLASTIC SHEATH FROM THE MONOPOLAR CURVED SCISSORS CAME OFF OF THE DEVICE AND COULD NOT BE LOCATED. THE SCISSORS WERE NOTED TO HAVE A CRACK IN THE PLASTIC HOUSING DURING THE CASE. THE INSTRUMENT AND PORT WERE REMOVED AND A PIECE OF THE PLASTIC HOUSING WAS NOTED TO BE MISSING. THE SURGICAL TEAM INSPECTED THE SURGICAL FIELD AND THE ABDOMEN THROUGH BOTH THE CAMERA AND AIRSEAL PORT. THEY ALSO EXTENDED THE PORT INCISION AND INSPECTED THE ABDOMINAL WALL. THEY WERE UNABLE TO LOCATE THE MISSING FRAGMENT.

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 HEAD HOLDER ADAPTOR WAS NON-FUNCTIONAL. A SECOND REGISTRATION WAS REQUIRED DUE TO MOVEMENT OF THE PATIENT'S HEAD. A DELAY OF 30 MINUTES WAS REPORTED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: PT UNDERWENT ROBOTIC PROSTATECTOMY WITH S1. AFTER ROBOT DOCKED, SURGEON NOTED HAD CONTROLS WERE NOT COINCIDING WITH THE INSTRUMENTS INSIDE THE PT. CALLED TO INTUITIVE TECHNICAL SUPPORT LINE WITH REAL TIME TROUBLE SHOOTING FOR 45 MINUTES. TECH REP UNABLE TO RESOLVE ISSUE. THE ROBOTIC PROSTATECTOMY WAS ABORTED, THE PROCEDURE CONVERTED TO AN OPEN PROSTATECTOMY FOR PT SAFETY. F/U INVESTIGATION FOUND A WIRE FROM AN ELECTRICAL BOARD ON THE CAMERA ARM AT THE UPPER JOINT HAD ACTUALLY BEEN CAUGHT IN THE JOINT. WHEN THE ARM WAS MOVED SIDE TO SIDE IT WOULD CAUSE TENSION EFFECT ON THE WIRE. THE WIRE HAD COMPLETELY SEVERED. THIS DID NOT SHOW UP ON THE IT DATA REPORT BUT WAS DISCOVERED UPON VISUAL EXAM OF THE ROBOTIC ARM.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT HAS BEEN REPORTED THAT DURING A SURGERY, THE PC WAS NON-FUNCTIONAL. NO PATIENT IMPACT WAS REPORTED. A SURGERY DELAY HAS BEEN REPORTED OF 40 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 HAS BEEN REPORTED THAT DURING A SURGERY, A SOFTWARE FAILURE WAS DETECTED. APPROX 9 OF 12 TRAJECTORIES WERE INACCESSIBLE WITH THE DISTANCE SENSOR. THE SYSTEM WAS RESTARTED AND THE SURGERY CONTINUED WITHOUT FURTHER ISSUE. A SURGERY DELAY OF 30-40 MINUTES WAS REPORTED.

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 APPROXIMATELY 2 WEEKS POST A SUCCESSFUL DA VINCI ASSISTED SINGLE-VESSEL SMALL THORACOTOMY PROCEDURE; THE PATIENT HAD DIMINISHED BRAIN FUNCTION. CURRENTLY THE PATIENT IS IN A COMA. ON 11/16/2016, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON WHO ASSISTED DURING THE PROCEDURE; HE STATED THAT APPROXIMATELY TWO WEEKS POST-OPERATIVELY, THE PATIENT WAS ADMITTED INTO THE EMERGENCY ROOM WITH DIMINISHED BRAIN FUNCTION. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL AFTER THE INTERNAL MAMMARY ARTERY THAT HAD BEEN HARVESTED ROBOTICALLY DURING THE PROCEDURE TWO WEEKS PREVIOUSLY WAS FOUND TO BE BLEEDING. THE SURGEON STATED HE COULD NOT CONFIRM ANY ROOT CAUSE FOR THE BLEEDING; HOWEVER, HE STATED THAT SINCE IT HAPPENED TWO WEEKS AFTER THE PROCEDURE HE BELIEVES THE COAGULUM COULD HAVE SLOUGHED OFF. AS PER THE HOSPITAL'S FOLLOW THE HEART PROGRAM, THE PATIENT WAS MONITORED AND WAS DOING WELL UNTIL THIS ACUTE EVENT HAPPENED. THE IMA HARVESTING WAS DONE ROBOTICALLY AND THE REST OF THE PROCEDURE WAS DONE AS A TRADITIONAL OPEN PROCEDURE. ON FURTHER FOLLOW UP WITH THE ISI CLINICAL SALES MANAGER IT WAS STATED THAT WHEN THE PATIENT CAME IN WITH A DIMINISHED BRAIN FUNCTION THE B

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 ROBOT STAND REFERENCE.

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 POST A SUCCESSFUL DA VINCI ASSISTED HYSTERECTOMY PROCEDURE ON AN UNSPECIFIED DATE, DURING THE PATIENT'S POST-OPERATIVE RECOVERY, THE PATIENT'S HEMOGLOBIN LEVELS HAD DROPPED. THE HOSPITAL STATED THEY WERE NOT ABLE TO LOCATE THE SOURCE AND THE PATIENT WAS ADMINISTERED 2 UNITS OF BLOOD AND THE POST-OPERATIVE BLEEDING WAS REPORTED TO HAVE RESOLVED ON ITS OWN. THE PATIENT WAS RELEASED FROM THE HOSPITAL THE FOLLOWING DAY. ON 10/12/2016, THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) WHO INITIALLY REPORTED THIS COMPLAINT PROVIDED ADDITIONAL INFORMATION, AFTER MEETING WITH THE APPLICABLE HOSPITAL STAFF, STATING THAT THE SURGEON DID NOT EXPERIENCE ANY MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING THE PLANNED PROCEDURE. THE SURGEON USED THE MARYLAND BIPOLAR FORCEPS INSTRUMENT TO SEAL VESSELS AND USED THE AUTO STOP FEATURE FOR THE BIPOLAR COAGULATION MODE ON THE ERBE VIO DV ELECTROSURGICAL (ESU) GENERATOR. THE SURGEON'S INTERPRETATION OF THIS FEATURE WAS THAT COMPLETION OF THE AUTO STOP TONE WAS AN INDICATION THAT A VESSEL WAS ADEQUATELY SEALED. ACCORDING TO THE CSR, AFTER COMPLETION OF THE AUTO STOP TONE, THE SURGE

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 POST A SUCCESSFUL DA VINCI ASSISTED HYSTERECTOMY PROCEDURE ON AN UNSPECIFIED DATE, THE PATIENT'S HEMOGLOBIN LEVELS HAD DROPPED. THE PATIENT UNDERWENT AN ADDITIONAL SURGICAL PROCEDURE; HOWEVER THE HOSPITAL STATED THEY WERE NOT ABLE TO LOCATE THE SOURCE. THE PATIENT WAS ADMINISTERED 2 UNITS OF BLOOD AND THE POST-OPERATIVE BLEEDING WAS REPORTED TO HAVE RESOLVED ON ITS OWN. THE PATIENT WAS RELEASED FROM THE HOSPITAL THE FOLLOWING DAY. ON 10/12/2016, THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) WHO INITIALLY REPORTED THIS COMPLAINT PROVIDED ADDITIONAL INFORMATION, AFTER MEETING WITH THE APPLICABLE HOSPITAL STAFF, STATING THAT THE SURGEON DID NOT EXPERIENCE ANY MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING THE PLANNED PROCEDURE. THE SURGEON USED THE MARYLAND BIPOLAR FORCEPS INSTRUMENT TO SEAL VESSELS AND USED THE AUTO STOP FEATURE FOR THE BIPOLAR COAGULATION MODE ON THE ERBE VIO DV ELECTROSURGICAL (ESU) GENERATOR. THE DATE OF THE REPORTED EVENT WAS NOT PROVIDED BY THE HOSPITAL AND THERE IS NO VIDEO RECORDING OF THE PLANNED SURGICAL 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 HAS BEEN REPORTED THAT DURING A SURGERY, A SOFTWARE FAILURE HAS BEEN DETECTED. INCORRECT AUTOMATIC IMAGE FUSION WITH STEREOTACTIC FRAME WAS REPORTED. A SURGERY DELAY OF 2 HOURS HAS BEEN REPORTED.

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 POST A SUCCESSFUL DA VINCI ASSISTED CHOLECYSTECTOMY PROCEDURE ON AN UNSPECIFIED DATE, DURING THE PATIENT'S POST-OPERATIVE RECOVERY, THE PATIENT'S HEMOGLOBIN LEVELS HAD DROPPED. THE PATIENT UNDERWENT AN ADDITIONAL SURGICAL PROCEDURE TO DETERMINE THE SOURCE OF THE BLEEDING; HOWEVER, THE HOSPITAL STATED THEY WERE NOT ABLE TO LOCATE THE SOURCE. THE PATIENT WAS ADMINISTERED 2 UNITS OF BLOOD AND THE POST-OPERATIVE BLEEDING WAS REPORTED TO HAVE RESOLVED ON ITS OWN. THE PATIENT WAS RELEASED FROM THE HOSPITAL THE FOLLOWING DAY. ON 10/12/2016, THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) WHO INITIALLY REPORTED THIS COMPLAINT PROVIDED ADDITIONAL INFORMATION, AFTER MEETING WITH THE APPLICABLE HOSPITAL STAFF, STATING THAT THE SURGEON DID NOT EXPERIENCE ANY MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING THE PLANNED PROCEDURE. THE SURGEON USED THE MARYLAND BIPOLAR FORCEPS INSTRUMENT TO SEAL VESSELS AND USED THE AUTO STOP FEATURE FOR THE BIPOLAR COAGULATION MODE ON THE ERBE VIO DV ELECTROSURGICAL (ESU) GENERATOR. THE SURGEON'S INTERPRETATION OF THIS FEATURE WAS THAT COMPLETION OF THE AUTO STOP TONE WAS AN INDICATION THA

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 CHOLECYSTECTOMY PROCEDURE, THE SURGEON GOT INTO BLEEDING AND THE CASE WAS CONVERTED TO OPEN SURGERY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT LOST 2700 CC OF BLOOD AND WAS ALSO GIVEN 4 UNITS OF BLOOD. IT WAS ALSO REPORTED THAT THE SURGEON TRANSECTED AND CLIPPED THE COMMON DUCT DURING THE SURGICAL PROCEDURE. ON (B)(6) 2016, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: THE CSR WAS IN THE OR ON THE DAY OF THE SURGERY BUT HAD ALREADY LEFT WHEN THE REPORTED EVENT OCCURRED. AT THE BEGINNING OF THE SURGERY, THE CSR NOTED THE PATIENT'S GALLBLADDER AS BEING THICK AND ABNORMAL. HE ALSO STATED THAT THE PATIENT'S CYSTIC DUCT WAS VERY SHORT. FIREFLY WAS USED DURING THE SURGICAL PROCEDURE. AFTER THE REPORTED EVENT OCCURRED, THE CSR SPOKE TO THE SURGEON AND THE SITE'S ROBOTICS COORDINATOR. ACCORDING TO THE CSR, THE SURGEON THOUGHT HE HAD CLIPPED AND TRANSECTED THE CYSTIC DUCT. HOWEVER, THE SURGEON HAD INADVERTENTLY CLIPPED AND TRANSECTED THE COMMON BILE DUCT INSTEAD. AFTER REPAIRING THE COMMON BILE DUCT, THE SURGEON PROCEEDED WITH THE S

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT HAS BEEN REPORTED THAT DURING A SURGERY, A SOFTWARE FAILURE WAS DETECTED. SEVERAL SOFTWARE COMMUNICATION ERRORS OCCURRED. THE PROCEDURE WAS COMPLETED WITH A TRADITIONAL SURGERY TECHNIQUE.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT HAS BEEN REPORTED THAT DURING A SURGERY, A SOFTWARE FAILURE HAS BEEN DETECTED. IT WAS REPORTED THAT WHEN THE STAFF WAS PERFORMING A REGISTRATION, THE ROBOTIC ARM COULD NOT MOVE IN COOPERATIVE MODE A COMMUNICATION FAILURE OCCURRED AND THE CONTROLLER BEGAN TO BEEP. THE SURGEON REPORTED THAT HE WAS ABLE TO PLAN THE POINTS ON THE FACE FOR CONTACTLESS REGISTRATION, BUT WHEN IT CAME TIME FOR HIM TO MOVE THE ARM IN COOPERATIVE MODE, REGARDLESS OF WHETHER OR NOT THE ARM WAS PUT IN FAST OR SLOW, THE ARM REFUSED TO MOVE. HE SAID THAT HIS STAFF HAD TRIED THIS ABOUT 10 TIMES AND THE ARM CONTINUED TO HAVE A COMMUNICATION FAILURE AND SHUT DOWN. IT HAS BEEN REPORTED THAT THE SURGERY HAS BEEN 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 HAS BEEN REPORTED THAT DURING A SURGERY, A SOFTWARE FAILURE HAS BEEN DETECTED. IT WAS IMPOSSIBLE TO PERFORM THE REGISTRATION STEP. REGISTRATION AND VERIFICATION ERRORS OCCURRED THREE TIMES WHEN ATTEMPTING TO REGISTER THE PATIENT USING THE LASER REGISTRATION IN THE HYBEX HEAD FRAME. THE FIRST TWO TIMES WERE ON THE SAME MRI, AND THE THIRD TIME WAS ON A DIFFERENT MRI. AFTER LOOKING AT THE VERIFICATION ON THE 4TH ATTEMPT, THE SURGEON DECIDED TO MOVE FORWARD WITH THE CASE. A SURGERY DELAY HAS BEEN REPORTED OF 3 HOURS.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT HAS BEEN REPORTED THAT DURING A SURGERY, A SOFTWARE FAILURE HAS BEEN DETECTED. IT WAS REPORTED THAT WHEN TRYING TO OPEN UP AN EXISTING PATIENT FOLDER, IT WAS SEEN THAT THE PATIENT FOLDER WAS NOT THERE. A SURGERY DELAY HAS BEEN REPORTED OF 1 HOUR.

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 BRAIN STEM BIOPSY, THE HEAD HOLDER ADAPTOR WAS NON-FUNCTIONAL. THE SURGEON PREPARED THE MAYFIELD ADAPTER AND LOOSENED THE SCREW TO BRING THE ADAPTER IN THE RIGHT POSITION. WHEN HE TRIED TO FIX IT AGAIN, HE WAS NOT ABLE TO FIX THE ADAPTER, BECAUSE THE SCREW WAS STUCK. IT WAS REPORTED THAT THE SURGERY WAS CANCELLED.

CyberKnife — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A SYSTEM TECHNICIAN RECEIVED AN ELECTRIC SHOCK WHILE MAKING ADJUSTMENTS IN THE EQUIPMENT ROOM.

ROSA Robotic Surgery — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT HAS BEEN REPORTED THAT DURING A SURGERY, A SOFTWARE FAILURE HAS BEEN DETECTED. THE SURGEON REPORTED 2 SOFTWARE CRASHES WHILE CHECKING THE ACCESSIBILITY TO THE TRAJECTORY. THE SURGEON REBOOTED THE SYSTEM AND CONTINUED WITH THE SURGERY. A DELAY OF 30 MINUTES TO SURGERY WAS REPORTED.