BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE IMPACT

    MDR report key: 3240583 · Received July 16, 2013

    Report

    Report Number
    1717344-2013-00521
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Date of Event
    June 20, 2013
    Report Date
    June 26, 2013
    Manufacturer
    COVIDIEN LLC (SHANGHAI)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A VISUAL INSPECTION OF THE DEVICE FOUND THE KNIFE WAS PROTRUDING FORM THE JAWS. THIS FAILURE MODE IS ATTRIBUTED TO USER ERROR; IT HAS BEEN DUPLICATED IN ENGINEERING EVALUATION 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 LP IMPLEMENTED A 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A CORONARY BYPASS PROCEDURE, WITH THE DEVICE ON THICK TISSUE, THE KNIFE BLADE STARTED FROM ITS TRACKS AND THE JAWS WOULD NOT MOVE. THE DEVICE WAS REMOVED FROM THE TISSUE MANUALLY, WITH NO HARM TO THE PT. A NEW DEVICE WAS OPENED TO COMPLETE THE PROCEDURE. UPON RECEIPT AT COVIDIEN, A PRELIMINARY EVALUATION OF THE DEVICE FOUND THAT THE KNIFE BLADE WAS PROTRUDING FORM THE JAWS OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330235 LIGASURE IMPACT LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LLC (SHANGHAI) S2HF015X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK