BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE IMPACT

    MDR report key: 2841804 · Received October 12, 2012

    Report

    Report Number
    2841804
    Event Type
    Malfunction
    Date Received
    October 12, 2012
    Date of Event
    August 2, 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

    DURING THE PROCEDURE, THE DEVICE HANDLE FAILED TO RELEASE. DEVICE WAS REMOVED FROM THE FIELD WITHOUT INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE IMPACT ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN * 234540LX

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR