BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ADVANCE PISTOL GRIP

    MDR report key: 4120847 · Received July 28, 2014

    Report

    Report Number
    1717344-2014-00641
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    June 12, 2014
    Report Date
    July 9, 2014
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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 ORIGINALLY REPORTED THAT IT WAS FOUND THAT THE DEVICE WOULD NOT ACTIVATE PRIOR TO THE INTENDED PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND ANOTHER DEVICE WAS OPENED AND USED FOR THE CASE. THE DEVICE WAS RETURNED FOR EVALUATION AND IT WAS FOUND THE CLEAR INSULATION WAS DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439886 LIGASURE ADVANCE PISTOL GRIP LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP 40930027X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK