BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE

    MDR report key: 1920207 · Received November 12, 2010

    Report

    Report Number
    1920207
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    November 10, 2010
    Report Date
    November 12, 2010
    Manufacturer
    COVIDIEN VALLYELAB
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE DEVICE DID NOT WORK. A NEW ONE WAS OPENED AND IT WORKED FINE.====================== HEALTH PROFESSIONAL'S IMPRESSION======================THERE WAS NO ADVERSE ADVENT. THE INSTRUMENT HAD NO POWER GOING THROUGH IT. WE SIMPLY REPLACED THE INSTRUMENT WITH ANOTHER ONE AND IT WORKED FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE PISTOL GRIP TISSUE FUSSION SYSTEM GEI COVIDIEN VALLYELAB ADVANCE 185586

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR NO OTHER THERAPIES