BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE IMPACT

    MDR report key: 2111388 · Received May 27, 2011

    Report

    Report Number
    2111388
    Event Type
    Malfunction
    Date Received
    May 27, 2011
    Date of Event
    May 16, 2011
    Report Date
    May 27, 2011
    Manufacturer
    COVIDIEN VALLEYLAB
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OK, US

    Narratives

    Description of Event or Problem · 1

    THE JAWS OF THE LIGASURE IMPACT WOULD NOT OPEN. SURGEON HAD TO CUT TISSUE TO RELEASE EQUIPMENT.======================MANUFACTURER RESPONSE FOR TISSUE FUSION SYSTEM, LIGASURE IMPACT (PER SITE REPORTER)======================NONE AS OF YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE IMPACT TISSUE FUSION SYSTEM GEI COVIDIEN VALLEYLAB * 204746LX

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR