BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE

    MDR report key: 1427857 · Received July 22, 2009

    Report

    Report Number
    1427857
    Event Type
    Malfunction
    Date Received
    July 22, 2009
    Date of Event
    May 4, 2009
    Report Date
    July 22, 2009
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA, US

    Narratives

    Description of Event or Problem · 1

    HANDPIECE REPEATEDLY FAILED TESTING.MANUFACTURER RESPONSE (AS PER REPORTER) FOR HARMONIC CURVED SHEARS, HARMONIC ACE:THEY WILL SEND RETURN KIT, REPLACE PRODUCT AND ADVISE OF FINDINGS WHEN QA IS DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE HARMONIC CURVED SHEARS LFL ETHICON ENDO-SURGERY, INC. * F4NE9G

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR