BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE

    MDR report key: 1873179 · Received October 8, 2010

    Report

    Report Number
    1873179
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    October 7, 2010
    Report Date
    October 8, 2010
    Manufacturer
    ASCENT HEALTHCARE SOLUTIONS
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US

    Narratives

    Description of Event or Problem · 1

    A PATIENT WAS UNDERGOING A NISSEN FUNDOPLICATION LAPAROSCOPIC PROCEDURE WHEN THE RE-PROCESSED ACE36E HARMONIC SCALPEL WOULD NOT FUNCTION APPROPRIATELY. THE DEVICE WOULD WORK IN THE MAXIMUM SETTING BUT NOT IN THE MINIMUM SETTING. NO INJURY TO PATIENT, JUST INCONVENIENCE OF HAVING TO OBTAIN AN ALTERNATE DEVICE TO COMPLETE THE CASE. PATIENT TOLERATED THE REMAINDER OF THE PROCEDURE WELL AND WAS SENT TO PACU FOR RECOVERY.====================== HEALTH PROFESSIONAL'S IMPRESSION======================WOULD NOT WORK APPROPRIATELY====================== MANUFACTURER RESPONSE FOR ACE 36E HARMONIC SCALPEL, ETHICON======================REPROCESSOR'S REP IS AWARE OF SITUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL, CURVED SHEARS LFL ASCENT HEALTHCARE SOLUTIONS ACE36E 1231571

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR