BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE

    MDR report key: 1010488 · Received February 7, 2008

    Report

    Report Number
    1010488
    Event Type
    Malfunction
    Date Received
    February 7, 2008
    Date of Event
    January 15, 2008
    Report Date
    February 7, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    THE TIP OF THE REUSEABLE HARMONIC HANDPIECE BROKE OFF WHILE USING THE ACE36P.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE HARMONIC SCALPEL, CURVED SHEARS GAG ETHICON ENDO-SURGERY, INC. ACE36P *

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR