BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE IMPACT

    MDR report key: 1163295 · Received September 9, 2008

    Report

    Report Number
    1717344-2008-00420
    Event Type
    Malfunction
    Date Received
    September 9, 2008
    Report Date
    August 5, 2008
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ENGINEERING EVALUATIONS HAVE BEEN ABLE TO DUPLICATE THIS FAILURE MODE BY CLAMPING ON LARGE, RIGID TISSUE. THE INSTRUCTIONS FOR USE FOR THIS DEVICE WARN AGAINST OVERFILLING THE JAWS OF THE INSTRUMENT BECAUSE IT MAY COMPROMISE THE CUTTING FUNCTION. THE IFU ALSO STATES TO CONFIRM THE JAWS HAVE REACHED THE CLOSED POSITION (TIPS OF THE JAWS NO MORE THAN 2 MM APART) BEFORE ACTIVATING THE CUTTER. OTHERWISE THE CUTTER MAY NOT SECURELY STAY WITHIN THE GUIDING TRACK OF THE JAWS. COVIDIEN LP HAS RECENTLY IMPLEMENTED A NEW JAW/BLADE ASSEMBLY DESIGN TO INCREASE THE BLADE RETENTION WITHIN THE JAWS OF THE HAND PIECE. THIS MAKES THE DESIGN MORE ROBUST TO VARIATIONS IN USER TECHNIQUE. THE RETURNED DEVICE WAS MANUFACTURED BEFORE THESE CHANGES WERE IMPLEMENTED.

    Description of Event or Problem · 1

    THE DEVICE LOCKED ON TISSUE DURING A PROCEDURE. THE SURGEON WAS ABLE TO SLIDE THE DEVICE OFF THE TISSUE WITHOUT INJURY TO THE PATIENT. THE INCIDENT DEVICE WAS RETURNED AND UPON EVALUATION ON 08/12/2008, A VISUAL INSPECTION REVEALED THAT THE KNIFE WAS PROTRUDING FROM THE JAWS OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE IMPACT LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP (VALLEYLAB) 142218

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK