BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE IMPACT

    MDR report key: 1082463 · Received July 22, 2008

    Report

    Report Number
    1717344-2008-00315
    Event Type
    Malfunction
    Date Received
    July 22, 2008
    Date of Event
    June 1, 2008
    Report Date
    June 13, 2008
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4). 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.

    Description of Event or Problem · 1

    THE REPORT STATED THAT THE SURGEON WAS USING THE DEVICE FOR AN OPEN COLON PROCEDURE. HE COMPLETED THE SEAL BUT WHEN HE FIRED THE KNIFE IT JAMMED UP. HE WAS ABLE TO SLOWLY SLIDE THE LOCKED JAWS OFF THE TISSUE. ON 06/23/2008 VISUAL INSPECTION FOUND THAT THE KNIFE WAS PROTRUDING FROM THE JAWS WHICH HAS THE POTENTIAL TO CAUSE AN INJURY

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE IMPACT LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP (VALLEYLAB) 140281

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK