BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC SCALP HND PIECE INTL

    MDR report key: 634064 · Received June 13, 2005

    Report

    Report Number
    1527736-2005-02506
    Event Type
    Malfunction
    Date Received
    June 13, 2005
    Report Date
    May 20, 2005
    Manufacturer
    ETHICON ENDO SURGERY, INC.
    Product Code
    LFL
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING AN UNKNOWN PROCEDURE, THE 4-40 STUD WAS FOUND TO BE BROKEN. IT IS UNKNOWN HOW THE CASE WAS COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.

    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. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN