BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE IMPACT

    MDR report key: 3240568 · Received July 16, 2013

    Report

    Report Number
    1717344-2013-00520
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 24, 2013
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A VISUAL INSPECTION OF THE DEVICE FOUND THE KNIFE WAS PROTRUDING FROM THE JAWS. THE JAWS WOULD NOT OPEN OR CLOSE DUE TO THE PROTRUDING KNIFE. 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 THE BLADE OF THE DEVICE WOULD NOT RETRACT DURING A CASE. IT IS UNK IF THE DEVICE WAS ON TISSUE AT THE TIME, AND IF SO, HOW IT WAS REMOVED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE, AND THERE WAS NO PT INJURY. UPON RECEIPT AT COVIDIEN, THE KNIFE BLADE WAS FOUND TO BE PROTRUDING FROM THE JAWS OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330180 LIGASURE IMPACT LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK