BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SURGICAL SYSTEM

    MDR report key: 1915210 · Received December 6, 2010

    Report

    Report Number
    2955842-2010-00530
    Event Type
    Other
    Date Received
    December 6, 2010
    Date of Event
    November 8, 2010
    Report Date
    November 8, 2010
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K011002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN ISI REPRESENTATIVE ARRIVED ONSITE SHORTLY AFTER THE CASE WAS CONVERTED TO OPEN. WITH THE ASSISTANCE OF AN ISI TECHNICAL SUPPORT ENGINEER, THE SURGEON SIDE CONSOLE CABLES WERE INSPECTED AND RECONNECTED. THE SYSTEM WAS REBOOTED AND HOMED AND NO SYSTEM ERRORS OCCURRED. ADDITIONAL INVESTIGATION WAS CONDUCTED BY A FIELD SERVICE ENGINEER WHOM WAS UNABLE TO REPLICATE THE CUSTOMER REPORTED SYSTEM ERROR CODE 21003. IT WAS CONCLUDED THAT SYSTEM ERROR CODE 21003 WAS ASSOCIATED WITH PATIENT SIDE MANIPULATOR (PSM) ARM COLLISIONS. ON (B)(4), 2010, THE ISI REPRESENTATIVE CONFIRMED WITH THE SURGEON THAT THE CASE WOULD HAVE LIKELY BEEN CONVERTED DUE TO THE PATIENT'S ANATOMY. THE PATIENT HAD A LARGE UTERUS, 16 TO 18 WEEKS IN SIZE, AND THE SURGEON WAS HAVING DIFFICULTY COMPLETING THE CASE ROBOTICALLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI HYSTERECTOMY PROCEDURE, THE SITE EXPERIENCED MULTIPLE OCCURRENCES OF SYSTEM ERROR CODE 21003. THE PATIENT WAS UNDER ANESTHESIA FOR APPROXIMATELY 2 HOURS WHEN THE SURGEON DECIDED TO CONVERT TO TRADITIONAL OPEN SURGICAL TECHNIQUES TO COMPLETE THE PLANNED PROCEDURE. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DA VINCI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS1200 A4.3P9

    Patients

    Seq Age Sex Outcome Treatment
    1 Other DA VINCI SYSTEM INSTRUMENTS AND ACCESSORIES