BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ADVANCE PISTOL GRIP

    MDR report key: 3823626 · Received February 28, 2014

    Report

    Report Number
    1717344-2014-00167
    Event Type
    Malfunction
    Date Received
    February 28, 2014
    Report Date
    February 25, 2014
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT DEVICE HAS BEEN REC'D AND IS UNDER EVAL. WHEN THE DEVICE EVAL IS COMPLETE, A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE KNIFE BECAME DIFFICULT TO ACTIVATE IN ORDER TO CUT TISSUE DURING A LAPAROSCOPIC COLECTOMY. THERE WAS NO PT INJURY. THE DEVICE WAS RETURNED TO COVIDIEN AND VISUAL INSPECTION DISCOVERED THE WEBBING WAS PROTRUDING FROM THE HINGE. THIS CAUSED DAMAGE TO THE CLEAR INSULATION. FURTHER EVAL DISCOVERED THE DEVICE TO FAIL HIPOT TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124026 LIGASURE ADVANCE PISTOL GRIP LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP 32700030X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK