BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC SCALP HND PIECE INTL

    MDR report key: 589300 · Received April 5, 2005

    Report

    Report Number
    1527736-2005-01551
    Event Type
    Malfunction
    Date Received
    April 5, 2005
    Report Date
    April 1, 2005
    Manufacturer
    ETHICON ENDO-SURGERY, INC. (CINCINNATI)
    Product Code
    LFL
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS HANDPIECE WAS BEING USED AS A SAMPLE. THE TESTS SHOWED THAT THE WATERTIGHT CAP WAS DAMAGED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN