BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE

    MDR report key: 3040014 · Received April 3, 2013

    Report

    Report Number
    MW5029610
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 27, 2013
    Manufacturer
    ETHICON ENDO-SURGERY
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    HARMONIC ACE ACE 36E CONNECTED TO UNIT; UNIT UNABLE TO DETECT ACE36A. HARMONIC ACE 36A CONNECTED TO UNIT; UNIT WOULD NOT RESPOND TO ACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136563 HARMONIC ACE HARMONIC ACE LFL ETHICON ENDO-SURGERY J9309R

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention