BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC SCALP HND PIECE UNTL

    MDR report key: 616786 · Received June 7, 2005

    Report

    Report Number
    1527736-2005-02374
    Event Type
    Malfunction
    Date Received
    June 7, 2005
    Report Date
    May 12, 2005
    Manufacturer
    ETHICON ENDO-SURGERY, INC. (CINCINNATI)
    Product Code
    LFL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PRIOR TO AN UNKNOWN PROCEDURE, THE DEVICE HAD A BROKEN 4-40 STUD. THERE WAS NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC SCALP HND PIECE UNTL ULTRACISION SURGERY REUSABLE DEVICES, HANDPIECES LFL ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN