BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHICON HARMONIC ACE

    MDR report key: 4250962 · Received November 7, 2014

    Report

    Report Number
    4250962
    Event Type
    Malfunction
    Date Received
    November 7, 2014
    Date of Event
    June 9, 2014
    Report Date
    November 7, 2014
    Manufacturer
    STERILMED, INC.
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US

    Narratives

    Description of Event or Problem · 1

    REPROCESSED DEVICE ETHICON ACE45E BROKE AT TIP WHILE IN THE PATIENT. THE TIP WAS RECOVERED AND THE INSTRUMENT WAS REMOVED FROM THE SURGICAL TABLE AND REPLACED WITH A NEW INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718636 ETHICON HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL LFL STERILMED, INC. * 1764507

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR