BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE IMPACT

    MDR report key: 1821383 · Received August 20, 2010

    Report

    Report Number
    1717344-2010-00575
    Event Type
    Malfunction
    Date Received
    August 20, 2010
    Date of Event
    July 15, 2010
    Report Date
    July 23, 2010
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A VISUAL INSPECTION OF THE INCIDENT SAMPLE SHOWED TISSUE IN-BETWEEN THE JAWS. THE KNIFE WAS PROTRUDING FROM THE JAWS AND THE JAWS 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 INSTRUCTIONS 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 HAND PIECE. THIS MAKES THE DESIGN MORE ROBUST TO VARIATIONS IN USER TECHNIQUE. THESE CORRECTIVE ACTIONS HAVE SIGNIFICANTLY REDUCED REPORTS OF THIS NATURE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE CUTTING THICK TISSUE UNDER TENSION DURING A COLECTOMY, THE DEVICE WOULD NO LONGER OPEN. THE DEVICE WAS CUT FROM TISSUE AND A NEW IMPACT WAS INTRODUCED INTO THE SURGICAL FIELD. LATER IN THE PROCEDURE AND UNDER THE SAME CIRCUMSTANCES, THE SECOND DEVICE LOCKED AND WAS ALSO CUT FROM TISSUE. AT THIS POINT IN THE PROCEDURE, IT WAS NOT NECESSARY TO INTRODUCE A THIRD DEVICE INTO THE FIELD. THE CASE ENDED WITHOUT INCIDENT. THERE WAS NO PATIENT INJURY. THE ADDITIONAL DEVICE IN THIS PROCEDURE CAN BE FOUND ON MFR. REPORT# 1717344-2010-00576.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE IMPACT LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP (VALLEYLAB) 184521L

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK