BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE

    MDR report key: 3852975 · Received May 15, 2014

    Report

    Report Number
    3852975
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 15, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT, US

    Narratives

    Description of Event or Problem · 1

    A FEMALE PATIENT WAS PRESENTED WITH ABDOMINAL PAIN TO THE OPERATING ROOM (OR) FOR AN EXPLORATORY LAPAROSCOPY WITH AN ENTEROLYSIS. THIS ENTEROLYSIS CREATED A SIDE-TO-SIDE JEJUNOJEJUNOSTOMY AND THERE WAS ALSO A PARTIAL SMALL BOWEL OBSTRUCTION. THE READOUT OF THE HARMONIC SCALPEL AFTER MULTIPLE USES WOULD NO LONGER WORK, AFTER THE GENERATOR INSTRUCTED CLEANING AND TIGHTENING. HARMONIC GENERATOR DIRECTED THE USE OF ANOTHER HAND PIECE. READOUT KEPT READING "RELEASE JAW", "CLEAN" "TIGHTEN ASSEMBLY"; ALL OF THESE STEPS WERE TAKEN BY THE OR STAFF WITHOUT YIELDING BETTER RESULTS. THEREFORE WE OPENED A NEW HARMONIC HANDPIECE TO COMPLETE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292649 HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC ACE LAPAROSCOPIC SHEARS 5 MM/36CM L90M7R

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR