BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE IMPACT

    MDR report key: 2123823 · Received May 31, 2011

    Report

    Report Number
    2123823
    Event Type
    Malfunction
    Date Received
    May 31, 2011
    Date of Event
    April 11, 2011
    Report Date
    May 31, 2011
    Manufacturer
    COVIDIEN VALLEYLAB
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OK, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AFTER USING THE DEVICE FOR ABOUT 45 MINUTES (OFF AND ON), THE DEVICE FAILED TO OPEN. WHEN THE SCRUB TECH TRIED TO OPEN THE DEVICE AFTER CLEANING, THE BLADE CAME OUT SIDEWAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE IMPACT TISSUE FUSION SYSTEM GEI COVIDIEN VALLEYLAB * 196232L

    Patients

    Seq Age Sex Outcome Treatment
    1 *