BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ADVANCE PISTOL GRIP

    MDR report key: 3881772 · Received May 27, 2014

    Report

    Report Number
    1717344-2014-00453
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    April 23, 2014
    Report Date
    April 29, 2014
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 DEVICE WOULD NO LONGER OPEN DURING THE PROCEDURE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311537 LIGASURE ADVANCE PISTOL GRIP LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP 40100188X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK