BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEW LIGASURE 5MM

    MDR report key: 3002660 · Received February 13, 2013

    Report

    Report Number
    1717344-2013-00075
    Event Type
    Malfunction
    Date Received
    February 13, 2013
    Date of Event
    January 14, 2013
    Report Date
    January 22, 2013
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE KNIFE OF THE INCIDENT DEVICES WAS ACTIVATED ON A SILICONE TEST STRIP WITH ACCEPTABLE RESULTS. THE KNIFE WAS INSPECTED UNDER MAGNIFICATION AND NO DAMAGE TO THE LEADING EDGE OF THE BLADE WAS FOUND. THE DEVICE WAS TESTED FOR ACTIVATION AND SEALING FUNCTION ON SIMULATED TISSUE WITH ACCEPTABLE RESULTS. ADDITIONAL FUNCTIONAL TESTING WAS PERFORMED WITH THE RETURNED DEVICE ON PORCINE KIDNEY TISSUE. MULTIPLE SEALS ON VARIOUS SIZE VESSELS WERE MADE. ALL SEAL CYCLES WERE COMPLETED SATISFACTORILY AND NO RIPPING OR TEARING OF THE TISSUE WAS NOTICED. COVIDIEN COULD NOT CONFIRM THE CUSTOMER'S REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSTRUMENT WAS DAMAGING THE TISSUE. IT IS UNK HOW THE TISSUES WERE DAMAGED. BLEEDING WAS REPORTED BUT THE AMOUNT IS UNK AND NO TRANSFUSION WAS NECESSARY. THE CASE CONTINUED WITH A NEW DEVICE AND THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63795 NEW LIGASURE 5MM LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP 244274X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK