BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE

    MDR report key: 3904393 · Received June 16, 2014

    Report

    Report Number
    3904393
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Date of Event
    May 2, 2014
    Report Date
    May 9, 2014
    Manufacturer
    STERILMED, INC
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    DURING A ROUTINE GASTRIC BYPASS THE HARMONIC SCALPEL WAS BEING TESTED AND THE BLADE OF THE SCISSOR BROKE OFF. IT WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353443 HARMONIC ACE INSTRUMENT, ULTRASONIC, SURGICAL LFL STERILMED, INC ACE45E *

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR