BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE CURVED SHEARS

    MDR report key: 1010508 · Received February 7, 2008

    Report

    Report Number
    1010508
    Event Type
    Malfunction
    Date Received
    February 7, 2008
    Date of Event
    November 12, 2007
    Report Date
    February 7, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    HARMONIC SCALPEL DID NOT PASS TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE CURVED SHEARS HARMONIC SCALPEL, CURVED SHEARS LFL ETHICON ENDO-SURGERY, INC. * D4HG18

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR