BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC 5MM CURVED SHEARS

    MDR report key: 2192652 · Received August 2, 2011

    Report

    Report Number
    MW5021587
    Event Type
    Injury
    Date Received
    August 2, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 22, 2011
    Manufacturer
    ETHICON
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    HARMONIC HAND PIECES X2 MALFUNCTIONED; A SECOND HARMONICS CABLE WAS USED WITH SAME RESULT. THIRD HAND PIECE WORKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC 5MM CURVED SHEARS CURVED SHEARS LFL ETHICON

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention