BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE IMPACT

    MDR report key: 1220779 · Received October 31, 2008

    Report

    Report Number
    1717344-2008-00498
    Event Type
    Malfunction
    Date Received
    October 31, 2008
    Date of Event
    August 12, 2008
    Report Date
    October 6, 2008
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL INSPECTION OF THE INCIDENT SAMPLE SHOWED TISSUE IN-BETWEEN THE JAWS. THE KNIFE WAS PROTRUDING FROM THE JAWS AND HAD TO BE PRIED OPEN. THE KNIFE WAS INSPECTED AND REVEALED THE WEBBING WAS BENT. ENGINEERING EVALUATIONS HAVE BEEN ABLE TO DUPLICATE THIS FAILURE MODE BY CLAMPING ON LARGE RIGID TISSUE. THE INSTRUCTION FOR USE FOR THIS DEVICE WARN AGAINST OVERFILLING THE JAWS OF THE INSTRUMENT, SO AS NOT TO COMPROMISE THE CUTTING FUNCTION. THE IFU ALSO 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. COVIDIEN LP HAS RECENTLY IMPLEMENTED A NEW JAW/BLADE ASSEMBLY DESIGN TO INCREASE THE BLADE RETENTION WITHIN THE JAWS OF THE HANDPIECE. 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 REPORT STATED THAT DURING A VAGINAL UTERUS EXTIRPATION, THE KNIFE WAS BLOCKED AFTER SEVERAL USES. THERE WAS NO PT INJURY. THE INCIDENT DEVICE WAS RETURNED AND UPON EVALUATION ON 10/06/2008, 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) 139953

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK COVIDIEN FORCETRIAD ELECTROSURGICAL GENERATOR| SN UNK