BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC SCALP HND PIECE INTL

    MDR report key: 694545 · Received October 11, 2005

    Report

    Report Number
    1527736-2005-04637
    Event Type
    Malfunction
    Date Received
    October 11, 2005
    Report Date
    September 16, 2005
    Manufacturer
    ETHICON ENDO-SURGERY, INC. (CINCINNATI)
    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 BY THE CUSTOMER THAT THE DEVICE HAD A BROKEN STUD. 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. (CINCINNATI) NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN GENERATOR