BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHICON HARMONIC ACE

    MDR report key: 1884258 · Received October 22, 2010

    Report

    Report Number
    1884258
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    October 20, 2010
    Report Date
    October 22, 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

    OR STAFF REPORT, PRIOR TO PROCEDURE, THIS REPROCESSED ETHICON HARMONIC ACE SHEARS PASSED THE TEST FOR USE. HOWEVER WHEN FIRST ATTEMPTING TO USE IT FOR LAPAROSCOPIC MYOTOMY IT WOULD NOT FIRE APPROPRIATELY, SO WAS REMOVED FROM SERVICE BEFORE COMING INTO CONTACT WITH THE PATIENT. NO INJURY TO THE PATIENT. THE DEVICE WAS REMOVED FROM FIELD AND WAS REPLACED WITH A NEW ETHICON HARMONIC ACE SHEAR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *