BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE IMPACT

    MDR report key: 1970700 · Received January 3, 2011

    Report

    Report Number
    1970700
    Event Type
    Malfunction
    Date Received
    January 3, 2011
    Date of Event
    August 2, 2010
    Report Date
    December 20, 2010
    Manufacturer
    COVIDIEN VALLEYLAB
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL, US

    Narratives

    Description of Event or Problem · 1

    LIGASURE WORKED ONCE, WAS THEN REMOVED AND THE SURGEON REPLACED THE BITE. THE SURGEON NOTICED A METAL PIECE OF THE HANDPIECE WAS OUT OF PLACE. OPENED ANOTHER LIGASURE - IT DID NOT WORK AT ALL. SURGEON REGRASPED AND TRIED A SECOND TIME AND STILL DIDN'T WORK. SURGEON OPENED A THIRD HANDPIECE AND IT WORKED FINE. NO ISSUE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE IMPACT TISSUE FUSION SYSTEM GEI COVIDIEN VALLEYLAB * 184921L
    2 LIGASURE IMPACT TISSUE FUSION SYSTEM GEI COVIDIEN VALLEYLAB * 186825

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR