BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ATLAS

    MDR report key: 2841748 · Received October 12, 2012

    Report

    Report Number
    2841748
    Event Type
    Malfunction
    Date Received
    October 12, 2012
    Date of Event
    August 21, 2012
    Report Date
    October 12, 2012
    Manufacturer
    COVIDIEN
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    THE JAW PLATE BECAME DISENGAGED CAUSING THE DEVICE TO BECOME INOPERABLE. NO PIECES OF THE DEVICE WERE MISSING FROM THE DEVICE. THERE WAS NO INJURY NOTED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE ATLAS ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN * S2A0003X

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR