BEUDAMED
    FDA Adverse Event Death Summary report: N

    DA VINCI XI SURGICAL SYSTEM

    MDR report key: 6012159 · Received October 7, 2016

    Report

    Report Number
    2955842-2016-00717
    Event Type
    Death
    Date Received
    October 7, 2016
    Date of Event
    August 17, 2016
    Report Date
    September 10, 2016
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ON 10/09/2016, THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) PROVIDED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: THE SURGICAL PROCEDURE WAS NOT RECORDED ON VIDEO. AT THE TIME OF SURGERY, THE PATIENT WAS (B)(6). THE PATIENT'S MEDICAL HISTORY CONSISTED OF HYPERTENSION AND HYPERLIPIDEMIA. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. THE PATIENT DID NOT EXPERIENCE ANY INTRA-OPERATIVE COMPLICATIONS WHILE UNDERGOING THE DA VINCI-ASSISTED SURGICAL PROCEDURE WHICH WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2016. ON (B)(6) 2016, THE PATIENT WAS SEEN IN AN ER AT AN OUTSIDE HOSPITAL FOR URINARY RETENTION AND WAS DISCHARGED THE SAME DAY IN STABLE CONDITION WITH A FOLEY CATHETER. THE FOLLOWING DAY, THE PATIENT WENT TO (B)(6) HOSPITAL AFTER HAVING NO URINE OUTPUT AND WAS ADMITTED FOR URINARY RETENTION. UPON ADMISSION, A CT-SCAN REVEALED ONLY GASTRIC DISTENTION. DURING THE HOSPITALIZATION, THE PATIENT HAD A SYNCOPE EPISODE WHILE ON A COMMODE, IN ADDITION TO A RESPIRATORY EVENT. A NGT TUBE WAS PLACED AND 1000 CC WAS SUCTIONED. THE PATIENT WAS REPORTEDLY TRANSFERRED TO THE ICU AND UNDERWENT MULTIPLE SPECIALTY EVALUATIONS FOR RESPIRATORY FAILURE AND RENAL FAILURE. A GI EVALUATION REVEALED SIGNIFICANT ILEUS. THE PATIENT WAS INTUBATED AND REQUIRED FULL RESPIRATORY SUPPORT FOR PRESUMED ASPIRATION PNEUMONITIS. A SCROTAL ULTRASOUND REVEALED ONLY EXPECTED FLUID. A REPEAT CT-SCAN FAILED TO REVEAL ANY INTRA-ABDOMINAL ISSUES. THE PATIENT WAS STARTED ON CRRT (CONTINUOUS RENAL REPLACEMENT THERAPY) FOR RENAL FAILURE. ON AN UNSPECIFIED DATE, THE PATIENT WAS NOTED TO BE UNRESPONSIVE AND A HEAD CT REVEALED AN ACUTE STROKE IN THE PICA DISTRIBUTION (POSTERIOR INFERIOR CEREBELLAR ARTERY). THE PATIENT DEVELOPED ATRIAL FIBRILLATION THAT WAS MANAGED BY CARDIOLOGY. THE PATIENT WAS GIVEN VASOPRESSOR SUPPORT. THE PATIENT WAS SEEN BY PALLIATIVE CARE AND THE DECISION WAS MADE BY THE PATIENT'S FAMILY TO PLACE THE PATIENT ON DNR (DO NOT RESUSCITATE) CODE. THE PATIENT EXPIRED ON (B)(6) 2016. AN AUTOPSY REPORT FOUND 4 PERFORATIONS IN THE PROXIMAL JEJUNUM. HOWEVER, THE CAUSE OF THE BOWEL PERFORATIONS IS UNKNOWN. ACCORDING TO THE CSR, THE SOURCE OF THE PERFORATIONS WAS UNCLEAR SINCE THE PATIENT UNDERWENT TWO CT-SCANS DURING THE HOSPITALIZATION THAT FAILED TO SHOW ANY ACUTE INTRA-ABDOMINAL ISSUES. ALSO, NO EVIDENCE OF SPILLAGE WAS FOUND UPON EVALUATION AND INSPECTION OF PORT WITHDRAWAL AT THE CONCLUSION THE DA VINCI-ASSISTED SURGICAL PROCEDURE. BASED ON THE CURRENT INFORMATION PROVIDED, THIS COMPLAINT WILL REMAIN REPORTABLE DUE TO THE FOLLOWING CONCLUSION: AFTER COMPLETION OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PATIENT PASSED AWAY. IN ADDITION, AN AUTOPSY REVEALED THAT THE PATIENT HAD SUSTAINED 3-4 BOWEL PERFORATIONS. HOWEVER, THE ROOT CAUSES OF THE BOWEL INJURIES ARE STILL UNKNOWN.

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE FOR THE REPORTED OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT AND HIS SUBSEQUENT DEMISE. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE DA VINCI-ASSISTED SURGICAL PROCEDURE. ISI HAS ATTEMPTED TO CONTACT THE SURGEON TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT. IF ADDITIONAL INFORMATION IS OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED TO THE FDA. ISI HAS REVIEWED THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2016. NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AFTER COMPLETION OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PATIENT PASSED AWAY. IN ADDITION, AN AUTOPSY REVEALED THAT THE PATIENT HAD SUSTAINED 3 BOWEL INJURIES. HOWEVER, THE ROOT CAUSES OF THE BOWEL INJURIES AND THE PATIENT'S DEMISE ARE UNKNOWN.

    Description of Event or Problem · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662848 DA VINCI XI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS4000

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death| R