BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ADVANCE PISTOL GRIP

    MDR report key: 3061763 · Received March 29, 2013

    Report

    Report Number
    1717344-2013-00240
    Event Type
    Malfunction
    Date Received
    March 29, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 8, 2013
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE KNIFE IS TRAPPED AND PROTRUDING FROM THE JAWS. THIS CAN OCCUR 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. MORE FREQUENT CLEANING COULD HAVE ALSO REDUCED THE DIFFICULTY ACTIVATING THE KNIFE. THE IFU CAUTIONS TO CONFIRM THAT THE JAWS HAVE REACHED THE CLOSED POSITION AND ARE LOCKED (THE HANDLE IS LATCHED) BEFORE ACTIVATING THE CUTTER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE BLADE WOULD NOT RETRACT. THERE WAS NO PT INJURY. THE DEVICE WAS RETURNED TO COVIDIEN AND VISUAL INSPECTION NOTED THAT THE KNIFE WAS PROTRUDING FROM THE JAWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129583 LIGASURE ADVANCE PISTOL GRIP LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP 246617X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK