BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHICON HARMONIC ACE CURVED SHEARS

    MDR report key: 2032613 · Received March 23, 2011

    Report

    Report Number
    MW5019944
    Event Type
    Malfunction
    Date Received
    March 23, 2011
    Date of Event
    March 23, 2011
    Report Date
    March 23, 2011
    Manufacturer
    ETHICON ENDO-SURGERY
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SURGEON WAS USING THE HARMONIC ACE 14S CURVED SHEARS WITH SCISSOR HANDLES WHEN THE BLADE FROM THE SHEAR BROKE IN HALF. THERE WAS NOTHING UNUSUAL WITH ANATOMY OR USE OF THE PRODUCT. DIAGNOSIS OR REASON FOR USE: THYROIDECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON HARMONIC ACE CURVED SHEARS ACE 14S LFL ETHICON ENDO-SURGERY ACE 14S G4UF4U

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR