BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ADVANCE PISTOL GRIP

    MDR report key: 3170470 · Received May 24, 2013

    Report

    Report Number
    1717344-2013-00380
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Report Date
    April 30, 2013
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE HAS BEEN REQUESTED, BUT TO DATE, THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE CLEAR INSULATION CAME OFF OF THE DEVICE. AT THIS TIME, IT IS UNKNOWN EXACTLY WHEN IT CAME OFF AND IF IT FELL INTO THE PATIENT CAVITY. AFTER THE CASE, ALL OF THE CLEAR INSULATION WAS ACCOUNTED FOR AND NOTHING WAS MISSING. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232238 LIGASURE ADVANCE PISTOL GRIP LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP 204489X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK