BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE BLUNT TIP LAP SEALER/DIVIDER

    MDR report key: 3192569 · Received June 19, 2013

    Report

    Report Number
    1717344-2013-00432
    Event Type
    Malfunction
    Date Received
    June 19, 2013
    Date of Event
    May 21, 2013
    Report Date
    May 22, 2013
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 AND MULTIPLE SEALS ON VARIOUS SIZE VESSELS WERE MADE. THE DEVICE WAS ACTIVATED WHILE PRESSING THE BUTTON IN VARIOUS LOCATIONS TO DETECT ANY PROBLEMATIC ACTIVATION ISSUES. ALL SEAL CYCLES WERE COMPLETED SATISFACTORILY AND END TONES WERE HEARD INDICATING COMPLETED ACTIVATION CYCLES. AT NO TIME DURING TESTING DID THE DEVICE ACTIVATE ON ITS OWN. COVIDIEN COULD NOT CONFIRM THE CUSTOMER'S REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE WAS ACTIVATING ON ITS OWN WHILE OUTSIDE OF THE PT. THERE WAS NO PT INJURY. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279381 LIGASURE BLUNT TIP LAP SEALER/DIVIDER LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP 251584X

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR