BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ADVANCE PISTOL GRIP

    MDR report key: 3823634 · Received February 28, 2014

    Report

    Report Number
    1717344-2014-00163
    Event Type
    Malfunction
    Date Received
    February 28, 2014
    Date of Event
    January 20, 2014
    Report Date
    February 20, 2014
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 KNIFE TRIGGER OF THE INSTRUMENT WAS NOT FUNCTION DURING A SLEEVE GASTRECTOMY. A NEW DEVICE WAS OPENED TO COMPLETE THE PROCEDURE AND THERE WAS NO INJURY TO THE PT. THE DEVICE WAS RETURNED TO COVIDIEN AND VISUAL INSPECTION DISCOVERED THAT THE CLEAR INSULATION WAS DAMAGED. FURTHER EVALUATION DISCOVERED THAT THE DEVICE FAILED HIPOT TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123772 LIGASURE ADVANCE PISTOL GRIP LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP 32410058X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK