BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ADVANCE PISTOL GRIP

    MDR report key: 3150306 · Received May 30, 2013

    Report

    Report Number
    1717344-2013-00391
    Event Type
    Malfunction
    Date Received
    May 30, 2013
    Report Date
    May 7, 2013
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT DEVICE HAS BEEN RECEIVED AND IS UNDER EVALUATION. WHEN THE DEVICE EVALUATION IS COMPLETE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE WAS DEFECTIVE. NO ADDITIONAL INFORMATION IS AVAILABLE FROM THE SITE. THE DEVICE WAS RETURNED FOR EVALUATION AND VISUAL INSPECTION DISCOVERED THAT THE WEBBING IS PROTRUDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237996 LIGASURE ADVANCE PISTOL GRIP LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP 250957X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK