BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ADVANCE PISTOL GRIP

    MDR report key: 3061795 · Received March 29, 2013

    Report

    Report Number
    1717344-2013-00236
    Event Type
    Malfunction
    Date Received
    March 29, 2013
    Date of Event
    February 25, 2013
    Report Date
    March 7, 2013
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ONE LF5544 DEVICE WAS RETURNED FOR EVAL. THE SILICONE BOOT WAS DAMAGED. THE INSTRUCTIONS FOR USE (IFU) STATES CAREFULLY INSERT AND WITHDRAW THE INSTRUMENT FROM CANNULAE TO AVOID POSSIBLE DAMAGE TO THE DEVICES AND/OR INJURY TO THE PT. USE THE APPROPRIATELY SIZED TROCAR TO ALLOW FOR EASY INSERTION AND EXTRACTION OF THE INSTRUMENT. FAILURE TO DO SO MAY IMPACT THE INTEGRITY OF THE FLEXIBLE INSULATION. TROCAR CANNULAE WITH HARD, NON-BEVELED OPENINGS MAY CAUSE THE FLEXIBLE INSULATION TO RETRACT, WHICH MAY COMPROMISE THE INSULATION. IF RETRACTION OCCURS, THE INSTRUMENT MUSH BE DISCARDED. INJURY HAS RARELY BEEN REPORTED WITH THESE COMPLAINTS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE CLEAR INSULATION BECAME DAMAGED AND DETACHED DURING THE CASE. NOTHING FELL INTO THE PT CAVITY AND THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131062 LIGASURE ADVANCE PISTOL GRIP LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP 242394X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK