BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE

    MDR report key: 3033389 · Received February 28, 2013

    Report

    Report Number
    3033389
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    February 21, 2013
    Report Date
    February 28, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, INC
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    LAPAROSCOPIC CASE WAS BEING PERFORMED WITH HARMONIC SCALPEL USED DURING CASE. HARMONIC SCALPEL WAS INTACT AND USEABLE AT BEGINNING OF CASE, BUT WAS LATER FOUND TO HAVE ONE PART BROKEN OFF. PROLONGED SEARCH OF ABDOMEN WITH X-RAY AND LAPAROSCOPE WAS NOT ABLE TO FIND PIECE. DRAPES AND ROOM SEARCHED AT END OF CASE, NOT ABLE TO FIND PIECE.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88958 HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR