BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE

    MDR report key: 1837346 · Received September 8, 2010

    Report

    Report Number
    1837346
    Event Type
    Malfunction
    Date Received
    September 8, 2010
    Date of Event
    September 8, 2010
    Report Date
    September 8, 2010
    Manufacturer
    COVIDIEN
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    THE SURGEON USING THE DEVICE NOTICED THE TRIGGER ON THE DEVICE WAS FROZEN, AND WAS UNABLE TO USE THE DEVICE FOR SURGERY. THE SURGEON OPENED A NEW ONE. THE NEW ONE WORKED PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE VESSEL SEALING DEVICE GEI COVIDIEN * 183402

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR NO OTHER THERAPIES