BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE PRECISE+

    MDR report key: 3170833 · Received June 7, 2013

    Report

    Report Number
    1717344-2013-00410
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 14, 2013
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A VISUAL INSPECTION OF THE INCIDENT DEVICE FOUND THE TRIGGER HALVES DISENGAGED FROM THE DEVICE AND RETURNED IN THE PACKAGE. NO PARTS WERE MISSING. IT WAS DETERMINED THAT THE TRIGGER PRESS DID NOT FULLY ENGAGE THE TRIGGER HALVES DURING ASSEMBLY CAUSING THE PIECES TO COME APART DURING USE. IT IS POSSIBLE THAT THIS DEVICE PASSED FUNCTIONAL TESTING AND CAME LOOSE AFTER ACTIVATING SEVERAL TIMES DURING THE PROCEDURE.

    Description of Event or Problem · 1

    THE CUSTOMER INITIALLY REPORTED THAT DURING AN EXCISION OF A THIGH TUMOR, THE KNIFE TRIGGER BROKE AFTER APPROXIMATELY TEN SEAL CYCLES. THE DEVICE WAS EVALUATED UPON RECEIPT AND THE TRIGGER WAS DISENGAGED FROM THE DEVICE. ALL PIECES OF THE DEVICE WERE ACCOUNTED FOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254183 LIGASURE PRECISE+ LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP 242625X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK