BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE IMPACT

    MDR report key: 4133637 · Received October 1, 2014

    Report

    Report Number
    1717344-2014-00855
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    July 10, 2014
    Report Date
    July 10, 2014
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ONE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION FOUND THE KNIFE WAS PROTRUDING FROM THE JAWS. THE JAWS WOULD NOT OPEN OR CLOSE DUE TO THE PROTRUDING KNIFE. THE CUSTOMER'S REPORTED CONDITION WAS CONFIRMED AND ATTRIBUTED TO USER ERROR. KNIFE TRAP HAPPENS WHEN THE BLADE IS EXTENDED AND THE JAWS ARE NOT COMPLETELY CLOSED. THIS ALLOWS THE KNIFE TRACK TO OPEN TOO WIDE AND THE BLADE MOVES OUT OF ITS TRACK. AS A SAFETY MEASURE, THE KNIFE MUST BE RETRACTED IN ORDER TO OPEN THE JAWS. THE TISSUE IN THE WEBBING MAY HAVE PREVENTED THE KNIFE FROM RETRACTING FAR ENOUGH TO ALLOW THE JAWS TO OPEN. MORE FREQUENT CLEANING COULD HAVE REDUCED THE DIFFICULTY IN ACTIVATING THE KNIFE. PER THE IFU, THE JAWS SHOULD BE CLOSED AND LOCKED BEFORE ACTIVATING THE CUTTER. A DEVICE HISTORY REVIEW WAS COMPLETED AND NO ENTRIES PERTINENT TO THE CUSTOMER'S REPORT WERE NOTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT DEVICE HAS BEEN RECEIVED AND IS UNDER EVALUATION. WHEN THE DEVICE EVALUATION IS COMPLETE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER HAD REPORTED THAT DURING A PROCEDURE, THE BLADE OF THE DEVICE CAME OUT OF ITS TRACK, THE JAWS WOULD NOT MOVE AND THE DEVICE COULD NOT BE USED. THERE WAS NO HARM TO THE PATIENT. UPON RECEIPT OF THE DEVICE FOR EVALUATION AT COVIDIEN, A PRELIMINARY INVESTIGATION FOUND THAT THE DEVICE WAS RECEIVED WITH THE KNIFE BLADE PROTRUDING FROM THE JAWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612441 LIGASURE IMPACT LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP LF4200 238541LX

    Patients

    Seq Age Sex Outcome Treatment
    1