BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC SCALP HND PIECE INTL

    MDR report key: 650316 · Received December 5, 2005

    Report

    Report Number
    1527736-2005-05873
    Event Type
    Malfunction
    Date Received
    December 5, 2005
    Report Date
    September 23, 2005
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    LFL
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE HAS LOOSE ACOUSTIC MOUNT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC SCALP HND PIECE INTL ULTRACISION SURGERY REUSABLE DEVICES, HANDPIECE LFL ETHICON ENDO-SURGERY, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN