BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE IMPACT

    MDR report key: 1931509 · Received December 10, 2010

    Report

    Report Number
    1717344-2010-00878
    Event Type
    Malfunction
    Date Received
    December 10, 2010
    Date of Event
    December 31, 2009
    Report Date
    November 15, 2010
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED WITH TISSUE IN-BETWEEN THE JAWS AND WERE STUCK SHUT. THE KNIFE WAS PROTRUDING FROM THE JAWS AND THE KNIFE WEBBING WAS BENT. THIS FAILURE MODE HAS BEEN DUPLICATED IN ENGINEERING EVALUATIONS 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 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 HAS 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 THE DEVICE KNIFE BROKE DURING THE PROCEDURE BUT IT DID NOT FALL INTO THE PT CAVITY. A NEW DEVICE WAS OPENED AND USED TO COMPLETE THE PROCEDURE. THERE WAS NO PT INJURY. THE SAMPLE WAS RETURNED FOR EVALUATION WITH THE KNIFE PROTRUDING FROM THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE IMPACT LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP (VALLEYLAB) 168289

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK