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 FIVE DAYS AFTER COMPLETION OF AN UNSPECIFIED DA VINCI-ASSISTED SURGICAL PROCEDURE PERFORMED IN (B)(6) 2016, THE PATIENT EXPERIENCED POST-OPERATIVE HEMORRHAGING IN HER ROOM. THE CAUSE AND SOURCE OF THE HEMORRHAGING IS CURRENTLY UNKNOWN. CARDIAC MASSAGES WERE ADMINISTERED TO THE PATIENT A LITTLE OVER FOUR HOURS IN HER ROOM. ONCE THE PATIENT WAS STABLE, THE PATIENT WAS TAKEN TO THE OR. HOWEVER, THE SURGICAL STAFF WAS UNABLE TO SAVE THE PATIENT. THE PATIENT REPORTEDLY EXPIRED FIVE DAYS AFTER UNDERGOING THE DA VINCI-ASSISTED SURGICAL PROCEDURE. NO FURTHER CLINICAL INFORMATION WAS PROVIDED. THE FOLLOWING INFORMATION IS UNKNOWN: THE ACTUAL DATE THAT THE DA VINCI-ASSISTED SURGICAL PROCEDURE WAS PERFORMED, WHAT SPECIFIC TYPE OF SURGICAL PROCEDURE WAS PERFORMED, WHAT DATE THE HEMORRHAGE WAS IDENTIFIED, AND WHAT DATE THE PATIENT EXPIRED.

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 — 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 COMPLETION OF A DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE, THE PATIENT WAS FOUND TO HAVE SUSTAINED A BOWEL INJURY THAT WAS NOT IDENTIFIED INTRA-OPERATIVELY. THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) WAS INFORMED ABOUT THE REPORTED EVENT FROM THE SURGEON'S 1ST ASSIST. THE CSR WAS NOT PRESENT DURING THE DA VINCI-ASSISTED SURGICAL PROCEDURE. THERE WERE NO REPORTS OF ANY INTRA-OPERATIVE COMPLICATIONS. THERE WAS ALSO NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. AFTER THE SURGICAL PROCEDURE WAS COMPLETED, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON AN UNKNOWN DATE. ON (B)(6) 2016, THE PATIENT RETURNED TO THE HOSPITAL AND WAS SEPTIC. AN EXPLORATORY LAPAROTOMY WAS PERFORMED ON THE PATIENT AND A HOLE WAS FOND ON THE TRANSVERSE COLON. PER THE CSR, THE SURGEON INFORMED HIM THAT DURING THE DA VINCI-ASSISTED SURGICAL PROCEDURE, HE WAS NOWHERE NEAR WHERE THE BOWEL INJURY WAS LOCATED. ACCORDING TO THE CSR, THE SITE DOES NOT KNOW WHAT CAUSED THE BOWEL INJURY. HOWEVER, THE CSR INDICATED THAT THE SITE IS SUSPECTING THAT THE BOWEL INJURY OCCURRED DURING INSERTION OF AN

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.

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. THIS ISSUE HAS BEEN IDENTIFIED DURING THE PATIENT DATA FILE CREATION. THERE WAS ONE HOUR DELAY ON 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 HAS WAS REPORTED THAT DURING A SURGERY THERE WAS A LASER INACCURACY OBSERVED DURING THE REGISTRATION PROCESS. THE REGISTRATION WAS REPEATED TWICE AND THE SURGEON DECIDED TO PROCEED WITH SURGERY. 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: IT WAS REPORTED THAT APPROXIMATELY A FEW DAYS AFTER COMPLETION OF A DA VINCI-ASSISTED CHOLECYSTECTOMY PROCEDURE, A SMALL HOLE THAT WAS DESCRIBED AS BEING PIN POINT IN SIZE WAS FOUND IN THE BOWEL. AS A RESULT THE PATIENT CAME BACK WITH UNSPECIFIED SIGNS OF INFECTION AND UNDERWENT AN EXPLORATORY LAPAROTOMY PROCEDURE ON AN UNSPECIFIED DATE TO REPAIR THE HOLE IN THE BOWEL. ON 09/30/2016, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: THE CSR STATED THAT HE WAS NOT PRESENT DURING THE SURGICAL PROCEDURE AND THAT THE PROCEDURE WAS NOT RECORDED. APPROXIMATELY A FEW DAYS AFTER THE PROCEDURE THE CSR BELIEVES THE PATIENT CAME BACK TO THE HOSPITAL WITH SIGNS OF INFECTION. TO HIS KNOWLEDGE, THE PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY PROCEDURE ON AN UNSPECIFIED DATE TO REPAIR THE HOLE. THE CSR MENTIONED THAT OTHER LAPAROSCOPIC INSTRUMENTS WERE USED DURING THE INITIAL CHOLECYSTECTOMY SURGICAL PROCEDURE. WHEN THE CSR FOLLOWED UP WITH THE SURGEON, THE SURGEON STATED ROBOTICALLY THE SURGERY WENT VERY WELL. THERE WERE NO REPORTS OF ANY INTRA-OPERATIVE COMPLICATIONS. ACCORDING TO THE CSR, TH

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) 2017, INTUITIVE SURGICAL, INC. (ISI) RECEIVED FDA VOLUNTARY REPORT MW5066629 WITH THE FOLLOWING EVENT DESCRIPTION: ON (B)(6) 2016 MY SON, (B)(6) HAD HIS GALL BLADDER REMOVED AT (B)(6) HOSPITAL BY ROBOTIC SURGERY. TWO DAYS LATER I TOOK HIM TO THE ER WHERE IT WAS DISCOVERED THAT HIS SMALL INTESTINES HAD BEEN PUNCTURED DURING SURGERY. ULTIMATELY, HE HAD TO HAVE SMALL BOWEL RESECTION, HE HAD PERITONITIS, ETC. LIST ALL CURRENT PRESCRIPTION MEDICATIONS AND MEDICAL DEVICES BEING USE: NONE, JUST FINISHED A 2-PACK, AS HE WAS JUST DIAGNOSED WITH PNEUMONIA. LIST ALL OVER-THE-COUNTER MEDICATIONS: NONE (ADVIL FOR PAIN) OCCASIONALLY, WHEN HE CANNOT STAND IT. ON (B)(6) 2017, ISI CONTACTED THE INITIAL REPORTER. HOWEVER, THE INITIAL REPORTER WAS UNWILLING TO PROVIDE ANY ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE FOLLOWING INFORMATION IS UNKNOWN AT THIS TIME: HOSPITAL NAME WHERE THE DA VINCI-ASSISTED SURGICAL PROCEDURE WAS PERFORMED AND THE NAME OF THE SURGEON WHO PERFORMED THE SURGICAL PROCEDURE.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ADDITIONAL INFORMATION RECEIVED FROM REPORTER ON 03/01/2017 FOR MW5066629: I SUBMITTED A MEDICAL DEVICE REPORT AFTER MY SON WAS INJURED FOLLOWING SURGERY WITH A DA VINCI ROBOTIC SYSTEM. (MW5066629) AFTER I SUBMITTED MY REPORT TO YOUR AGENCY, I RECEIVED A CALL FROM SOMEONE IN THE REGULATORY COMPLAINTS DEPARTMENT AT INTUITIVE SURGICAL (MAKERS OF THE DA VINCI ROBOTIC SYSTEM). HE SAID HE HAD RECEIVED A COPY OF MY SON'S INJURY REPORT FROM THE FDA AND HE WANTED TO KNOW THE NAME OF THE SURGEON AND THE HOSPITAL WHERE THE INJURY HAPPENED. HE HAD THE DATE OF THE SURGERY, KNEW FROM MY AREA CODE THAT I WAS FROM THE (B)(6) AREA AND SAID HE DID HAVE ONE REPORT OF AN INJURY BEING REPORTED IN (B)(6) ON OR AROUND THAT DATE. ((B)(6) 2016 WAS THE DATE OF THE INITIAL SURGERY, (B)(6) 2016 WAS THE DATE OF THE EMERGENCY SURGERY AFTER THE INJURY WAS DISCOVERED). I RESPONDED, "OH GOOD, SO THE SURGEON OR THE HOSPITAL DID REPORT THE INJURY PROCEEDING THE DA VINCI SURGERY TO YOUR COMPANY." THE MAN IN THE REGULATORY DEPARTMENT THEN SAID, "WELL NOT EXACTLY, THE SURGEON REPORTED THE INJURY TO OUR DA VINCI SALES PERSON, AND I FILED MY REPORT TO THE FDA BASED UPON WHAT OUR SALES PERSON REPORTED TO ME." (I FOUND 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: IT WAS REPORTED THAT POST A DA VINCI ASSISTED HYSTERECTOMY PROCEDURE, IT WAS DISCOVERED THAT THE PATIENT'S URETER WAS CUT. THE PATIENT UNDERWENT 2 SUBSEQUENT SURGICAL PROCEDURES AND IS GOING TO UNDERGO A 3RD PROCEDURE TO REPAIR THE DAMAGE TO HER URETER. IT WAS ALSO REPORTED THAT THE PATIENT HAS A BAG. ON (B)(6) 2016 INTUITIVE SURGICAL, INC. (ISI) OBTAINED ADDITIONAL INFORMATION FROM THE PATIENT REGARDING THE REPORTED EVENT. ACCORDING TO THE PATIENT, SHE UNDERWENT THE PLANNED SURGICAL PROCEDURE ON (B)(6) 2016 AND WAS RELEASED FROM THE HOSPITAL THE FOLLOWING DAY. ON POST-OP DAY 3 SHE PRESENTED TO THE HOSPITAL'S EMERGENCY ROOM DEPARTMENT AND IT WAS DISCOVERED THAT HER URETER WAS CUT. ACCORDING TO THE PATIENT, THE DAMAGE TO HER URETER PREVENTED HER KIDNEY FROM DRAINING. IN ADDITION TO UNDERGOING TWO SUBSEQUENT LAPAROSCOPIC PROCEDURES TO RESOLVE THE DRAINAGE ISSUE SHE CURRENTLY HAS A TEMPORARY UROSTOMY BAG. SHE IS EXPECTED TO UNDERGO THE 3RD SURGICAL PROCEDURE TO REPAIR HER URETER IN APPROXIMATELY 1 MONTH. ACCORDING TO THE PATIENT, THERE WAS NO REPORT TO HER BY THE HOSPITAL THAT ANY MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM AND/OR INSTRUMENTS OCCURRED DURING THE SURGICAL PROCEDURE. TH

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 SOFTWARE FAILURE WAS DETECTED. A COMMUNICATION ERROR WAS IDENTIFIED. A SURGICAL DELAY BETWEEN 30 MINUTES AND 1 HOUR 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 HAS BEEN REPORTED THAT THERE WAS AN INACCURACY IN THE TRAJECTORY OF THE INSTRUMENT ADAPTOR DURING SURGERY. THE PROCEDURE WAS COMPLETED WITH A TRADITIONAL METHOD OF SURGERY.

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 COMPLETION OF A DA VINCI-ASSISTED INGUINAL HERNIA REPAIR PROCEDURE, THE PATIENT WAS READMITTED TO THE HOSPITAL TWO TIMES. THE DATES OF THE READMISSIONS ARE UNKNOWN. IN ADDITION, THE REASONS FOR THE READMISSIONS ARE UNKNOWN. ON AN UNSPECIFIED DATE POST-OPERATIVELY, THE PATIENT PASSED AWAY. 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 NOT PRESENT DURING THE UNRECORDED DA VINCI-ASSISTED SURGICAL PROCEDURE. THERE WERE NO REPORTS OF ANY INTRA-OPERATIVE COMPLICATIONS. AFTER THE PATIENT PASSED AWAY ON AN UNSPECIFIED DATE, AN AUTOPSY WAS PERFORMED AND 3 SEPARATE PUNCTURE HOLES WERE FOUND ON THE PATIENT'S BOWEL. THE CSR DID NOT KNOW THE CAUSE OF THE BOWEL DEFECTS OR THE PATIENT'S DEATH.

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 APRIL 1, 2016 - JULY 1, 2016. FOR THOSE CLAIMS WHERE PROCEDURE DATES ARE PROVIDED, THE DATES RANGE FROM (B)(6) 2012 - (B)(6) 2014.

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 PATIENT WOKE UP, WHICH REQUIRED THE SURGEON TO PERFORM A NEW REGISTRATION. PRIOR TO THE PATIENT WAKING UP, 2 REGISTRATIONS WERE PERFORMED. AFTER THE PATIENT WOKE UP, A FURTHER 3 REGISTRATIONS WERE PERFORMED.

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 PHARYNGECTOMY PROCEDURE, THE PATIENT ALLEGEDLY SUFFOCATED BY ASPIRATION FROM LIGHT BLEEDING. ON 09/21/2017 AND 10/02/2017, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION FROM THE SITE REGARDING THE REPORTED EVENT: THERE WAS NO REPORT OR ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. THE PATIENT ALSO DID NOT EXPERIENCE ANY INTRA-OPERATIVE COMPLICATIONS. POST-OPERATIVELY, ON AN UNSPECIFIED DATE, THE PATIENT DEVELOPED EDEMA IN THE THROAT AND EXPERIENCED DYSPHAGIA. IN ADDITION, THE PATIENT ALLEGEDLY EXPERIENCED SUFFOCATION AFTER ASPIRATING BLOOD. AS A RESULT, THE PATIENT WAS ADMINISTERED ARTIFICIAL RESPIRATION AND WAS TAKEN TO THE ICU. NO ADDITIONAL MEDICAL INTERVENTION WAS ADMINISTERED IN THE ICU. THE SITE ALSO INDICATED THAT NO MEDICAL INTERVENTION WAS ADMINISTERED SPECIFICALLY FOR THE POST-OPERATIVE LIGHT BLEEDING. ON 10/02/2017, ISI RECEIVED INFORMATION INDICATING THAT THE PATIENT WAS CURRENTLY IN GOOD CONDITION AND HAS SINCE BEEN DISCHARGED FROM THE HOSPITAL.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: PT WAS MY SISTER (B)(6), DOB (B)(6) 1957, WHO HAD ELECTIVE SURGERY ON (B)(6) 2016 FOR A PARTIAL HYSTERECTOMY. THE SURGERY WAS PERFORMED AT (B)(6) HOSPITAL IN (B)(6), WITH A DA VINCI ROBOT. DURING THE PROCEDURE, HER BOWEL WAS PERFORATED THREE TIMES. THIS WAS UNDETECTED BY THE SURGEON OR THE MEDICAL STAFF. SHE WAS KEPT OVERNIGHT FOR OBSERVATION DUE TO PAIN ON (B)(6) 2016 AND DISCHARGED ON (B)(6) 2016. SHE LIVED ALONE AND WAS IN TOUCH FOR A WHILE WITH DISTANT RELATIVES. WHEN NOT HEARD FROM ON (B)(6) 2014 A FRIEND WAS CALLED TO DO A WELFARE CHECK ON HER. SHE WAS FOUND UNCONSCIOUS, BLUE IN COLOR, DELIRIOUS AND IN SEVERE RESPIRATORY DISTRESS FROM SEPTIC SHOCK. SHE WAS TRANSPORTED VIA AMBULANCE TO (B)(6) HOSPITAL IN (B)(6) WHERE SHE WAS DIAGNOSED WITH SEPTIC SHOCK AND PLACED INTO EMERGENCY SURGERY. SHE DIED AT APPROX 9:45PM ON SUNDAY (B)(6) 2016. THE (B)(6) MEDICAL EXAMINER REPORT STATES THE CAUSE OF DEATH WAS SEPTIC SHOCK FROM THREE PERFORATIONS OF THE BOWEL. THIS PROBLEM FROM MY RESEARCH HAPPENS IN LESS THAN 1/2 OF ONE PERCENT OF CASES THAT ARE DONE WITH NORMAL LAPAROSCOPIC SURGERY WITH NO ROBOT. IT IS MY UNDERSTANDING THAT IT HAPPENS A LOT MORE OFTEN WITH THE DA VINCI ROBOT AND IS UNDE

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2016, INTUITIVE SURGICAL, INC. (ISI) RECEIVED FDA VOLUNTARY REPORT MW5064171 WITH THE FOLLOWING EVENT DESCRIPTION: PT WAS MY SISTER (B)(6), DOB (B)(6) 1957, WHO HAD ELECTIVE SURGERY ON (B)(6) 2016 FOR A PARTIAL HYSTERECTOMY. THE SURGERY PERFORMED AT (B)(6) HOSPITAL IN (B)(6), WITH A DA VINCI ROBOT. DURING THE PROCEDURE, HER BOWEL WAS PERFORATED THREE TIMES. THIS WAS UNDETECTED BY THE SURGEON OR THE MEDICAL STAFF. SHE WAS KEPT OVERNIGHT FOR OBSERVATION DUE TO PAIN ON (B)(6) 2016 AND DISCHARGED ON (B)(6) AND DISCHARGED ON (B)(6) 2016. SHE LIVED ALONE AND WAS IN TOUCH FOR A WHILE WITH DISTANT RELATIVES. WHEN NOT HEARD FROM ON (B)(6) 2014 A FRIEND WAS CALLED TO DO A WELFARE CHECK ON HER. SHE WAS FOUND UNCONSCIOUS, BLUE IN COLOR, DELIRIOUS AND IN SEVERE RESPIRATORY DISTRESS FROM SEPTIC SHOCK. SHE WAS TRANSPORTED VIA AMBULANCE TO (B)(6) HOSPITAL IN (B)(6) WHERE SHE WAS DIAGNOSED WITH SEPTIC SHOCK AND PLACED INTO EMERGENCY SURGERY. SHE DIED AT APPROX. 9:45 PM ON SUNDAY (B)(6) 2016. THE (B)(6) MEDICAL EXAMINER REPORT STATES THE CAUSE OF DEATH WAS SEPTIC SHOCK FROM THREE PERFORATIONS OF THE BOWEL. THIS PROBLEM FROM MY RESEARCH HAPPENS IN LESS THAN 1/2 OF ONE PERCENT OF CASES THAT