BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ADVANCE PISTOL GRIP

    MDR report key: 3150302 · Received May 30, 2013

    Report

    Report Number
    1717344-2013-00392
    Event Type
    Malfunction
    Date Received
    May 30, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 9, 2013
    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 SAMPLE HAS BEEN REQUESTED BUT TO DATE, THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE JAWS COULD NOT BE OPENED OR CLOSED DURING A BARIATRIC PROCEDURE. THE USER NOTICED A PIECE OF WIRE PROTRUDING FROM THE AREA JUST BELOW THE JAWS. ANOTHER DEVICE WAS USED TO FINISH THE CASE AND THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237957 LIGASURE ADVANCE PISTOL GRIP LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP 250460X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK