BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE V

    MDR report key: 2111953 · Received May 29, 2011

    Report

    Report Number
    2111953
    Event Type
    Malfunction
    Date Received
    May 29, 2011
    Date of Event
    March 23, 2011
    Report Date
    May 29, 2011
    Manufacturer
    COVIDIEN VALLEYLAB
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SURGEONS WERE USING A LAPAROSCOPIC LIGASURE AND THEY STATED THAT IT WAS NOT FUNCTIONING PROPERLY. THEY SAID THAT IT WOULD NOT CUT PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE V TISSUE FUSION SYSTEM GEI COVIDIEN VALLEYLAB * 201840

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR