BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE

    MDR report key: 3042135 · Received April 3, 2013

    Report

    Report Number
    3042135
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    February 5, 2013
    Report Date
    March 12, 2013
    Manufacturer
    STERILMED, INC
    Product Code
    NLQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    HAND PIECE STOPPED WORKING. STAFF WENT THROUGH ALL STEPS INDICATED ON MACHINE. AFTER DOING ALL STEPS MACHINE SAID TO REPLACE.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?TOTAL LAPARACOPIC HYSTERECTOMY, MINI LAPAROTOMY ASSISTED, BILATERAL SALPINGO-OOPHORECTOMY AND LYSIS OF ADHESIONS.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136322 HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL NLQ STERILMED, INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR