BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE IMPACT

    MDR report key: 1894131 · Received November 4, 2010

    Report

    Report Number
    1717344-2010-00700
    Event Type
    Malfunction
    Date Received
    November 4, 2010
    Date of Event
    July 29, 2010
    Report Date
    August 10, 2010
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A VISUAL INSPECTION SHOWED TISSUE IN-BETWEEN THE JAWS. 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 (B)(4) RECENTLY IMPLEMENTED A NEW 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. THESE CORRECTIVE ACTIONS HAVE GREATLY REDUCED REPORTS OF THIS TYPE.

    Description of Event or Problem · 1

    THE CUSTOMER ORIGINALLY REPORTED THAT DURING AN ONCOLOGICAL PROCEDURE THE KNIFE OF THE DEVICE BECAME STUCK. THE DEVICE SAMPLE WAS REC'D FOR EVAL WITH THE KNIFE PROTRUDING FROM THE JAWS. THERE WAS NO PT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE IMPACT LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP (VALLEYLAB) 184490

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK