BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ATLAS

    MDR report key: 2132511 · Received June 6, 2011

    Report

    Report Number
    2132511
    Event Type
    Malfunction
    Date Received
    June 6, 2011
    Date of Event
    May 26, 2011
    Report Date
    May 27, 2011
    Manufacturer
    COVIDIEN VALLEYLAB
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US

    Narratives

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC HYSTERECTOMY, THE VALLEYLAB LIGASURE HANDPIECE MALFUNCTIONED. WHILE PHYSICIAN WAS ENGAGING THE HANDPIECE, AN ERROR CODE AND A SUPERVISOR ALERT APPEARED ON THE VALLEYLAB MACHINE. ACCORDING TO STAFF PRESENT, THE ERROR APPEARED AS "NUMBERS... SUPERVISOR ... MORE NUMBERS." THE PATIENT WASN'T HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE ATLAS TISSUE FUSION SYSTEM GEI COVIDIEN VALLEYLAB * S0K0002

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR