BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE IMPACT

    MDR report key: 1981487 · Received January 25, 2011

    Report

    Report Number
    1981487
    Event Type
    Malfunction
    Date Received
    January 25, 2011
    Date of Event
    January 19, 2011
    Report Date
    January 25, 2011
    Manufacturer
    COVIDIEN VALLEYLAB
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US

    Narratives

    Description of Event or Problem · 1

    DURING SURGERY, TWO PHYSICIANS WERE USING THE LIGASURE IMPACT DEVICE. THE BLADE BECAME STUCK & PRODUCT WAS UNABLE TO BE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE IMPACT TISSUE FUSION SYSTEM GEI COVIDIEN VALLEYLAB * 196236L

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR