BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ADVANCE PISTOL GRIP

    MDR report key: 3061793 · Received March 29, 2013

    Report

    Report Number
    1717344-2013-00234
    Event Type
    Malfunction
    Date Received
    March 29, 2013
    Date of Event
    February 21, 2013
    Report Date
    February 28, 2013
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT DEVICE HAS BEEN RECEIVED 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 JAWS LOCKED SHUT WHILE THEY WERE NOT ON TISSUE. THIS HAPPENED TOWARDS THE BEGINNING OF THE CASE. ANOTHER LIGASURE WAS USED TO COMPLETE THE CASE AND THERE WAS NO PT INJURY. THE DEVICE WAS RETURNED TO COVIDIEN AND VISUAL INSPECTION DISCOVERED THAT THE WEBBING WAS PROTRUDING FROM THE HINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129582 LIGASURE ADVANCE PISTOL GRIP LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP 247692X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK