BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMANENT CAUTERY HOOK

    MDR report key: 2110067 · Received May 25, 2011

    Report

    Report Number
    2110067
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Date of Event
    May 9, 2011
    Report Date
    May 25, 2011
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERGOING ROBOTIC MYOMECTOMY. THE DA VINCI PERMANENT CAUTERY HOOK BROKE INTO THREE PIECES IN THE INTRA-ABDOMINAL CAVITY. A SCOPE WAS UTILIZED AND THE CAUTERY HOOK PIECES WERE RECOVERED. THIS WAS THE 7TH TIME THIS INSTRUMENT HAD BEEN USED - EXPECTED LIFE IS TEN USES.======================MANUFACTURER RESPONSE FOR ENDOWRIST MONOPOLAR CAUTERY INSTRUMENT, PERMANENT CAUTERY HOOK (PER SITE REPORTER)======================MANUFACTURER HAS NOT RESPONDED AS OF THE DATE OF THIS NOTICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERMANENT CAUTERY HOOK ENDOWRIST¿ MONOPOLAR CAUTERY INSTRUMENT NAY INTUITIVE SURGICAL, INC. 420183 M10100629

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR NO OTHER THERAPIES