BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE

    MDR report key: 3911904 · Received June 18, 2014

    Report

    Report Number
    3911904
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    May 2, 2014
    Report Date
    May 9, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, INC
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    HARMONIC SCALPEL WOULD NOT WORK. IT WAS REMOVED AND REPLACED WITH ANOTHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357615 HARMONIC ACE INSTRUMENT, ULTRASONIC, SURGICAL LFL ETHICON ENDO-SURGERY, INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR THIS IS UNKNOWN.