BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE IMPACT

    MDR report key: 3190779 · Received June 14, 2013

    Report

    Report Number
    1717344-2013-00421
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Report Date
    June 5, 2013
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A VISUAL INSPECTION SHOWED TISSUE IN-BETWEEN THE JAWS AND THE JAWS WERE STUCK SHUT. THE KNIFE WAS PROTRUDING FROM THE JAWS AND THE JAWS HAD TO BE PRIED OPEN. THE KNIFE WEBBING WAS BENT. THIS FAILURE MODE HAS BEEN DUPLICATED IN ENGINEERING EVALS BY CLAMPING ON LARGE, RIGID TISSUE. THE IFU FOR THIS DEVICE WARNS AGAINST OVERFILLING THE INSTRUMENT JAWS SO AS NOT TO COMPROMISE THE CUTTING FUNCTION. THE IFU STATES TO CONFIRM THE JAWS HAVE REACHED THE CLOSED POSITION BEFORE ACTIVATING THE CUTTER OR THE CUTTER MAY NOT SECURELY STAY WITHIN THE GUIDING TRACK OF THE JAWS. THE IFU STATES TO ELIMINATE TENSION ON THE TISSUE WHILE SEALING AND CUTTING TO ENSURE PROPER FUNCTION. COVIDIEN LP IMPLEMENTED A JAW/BLADE DESIGN TO INCREASE THE BLADE RETENTION WITHIN THE JAWS OF THE HANDPIECE. THIS MAKES THE DESIGN MORE ROBUST TO VARIATIONS IN USER TECHNIQUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE WAS DEFECTIVE BUT PROVIDED NO DETAILS. WHEN THE DEVICE WAS RECEIVED AT COVIDIEN FOR EVAL, IT WAS FOUND THAT THE KNIFE BLADE WAS PROTRUDING FROM THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272292 LIGASURE IMPACT LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK