BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ATLAS HANDSWITCHING 37CM

    MDR report key: 1193089 · Received October 6, 2008

    Report

    Report Number
    1717344-2008-00458
    Event Type
    Malfunction
    Date Received
    October 6, 2008
    Date of Event
    September 5, 2008
    Report Date
    September 16, 2008
    Manufacturer
    COVIDIEN LP (US SURGICAL)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF INITIAL REPORT: 10/06/2008. 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 INFO PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE REPORT STATES THAT AFTER SIX TIMES OF FIRING THE DEVICE, IT STUCK TO PATIENT TISSUE AND COULD NOT BE OPENED. THE SURGEON CUT THE DEVICE OUT OF THE TISSUE, AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO BLEEDING OR PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE ATLAS HANDSWITCHING 37CM LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP (US SURGICAL) N8E127

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK