BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGASURE IMPACT

    MDR report key: 1063361 · Received June 19, 2008

    Report

    Report Number
    1717344-2008-00280
    Event Type
    Injury
    Date Received
    June 19, 2008
    Date of Event
    April 10, 2008
    Report Date
    May 21, 2008
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. COVIDIEN LP (FORMERLY VALLEYLAB) HAS CHANGED THE MATERIAL OF THE CUTTER TO A MORE DUCTILE MATERIAL TO PREVENT ANY FURTHER OCCURRENCES OF THE CUTTER BREAKING. THIS DEVICE WAS MFG PRIOR TO THIS CORRECTIVE AND PREVENTIVE ACTION.

    Description of Event or Problem · 1

    THE REPORT STATED THAT THE LIGASURE IMPACT WAS IN USE DURING A SIGMOIDECTOMY. AFTER SEVERAL SEALING CYCLES THE INSTRUMENT WOULD NOT TRANSECT THE PT TISSUE. A VISUAL EXAMINATION OF THE DEVICE ON 05/21/08 FOUND THAT THE CUTTING BLADE IS MISSING FROM THE END OF THE INTEGRATED CUTTER. THE SITE WAS NOTIFIED AND ARRANGED FOR X-RAYS. RESULTS ARE NOT YET KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE IMPACT LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP (VALLEYLAB) 127062

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other