BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE

    MDR report key: 1884285 · Received October 18, 2010

    Report

    Report Number
    1884285
    Event Type
    Malfunction
    Date Received
    October 18, 2010
    Date of Event
    September 22, 2010
    Report Date
    October 18, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    THE HARMONIC SHEARS WERE BEING TEMPERAMENTAL. EVERY FEW SECONDS IT HAD TO BE REMOVED DUE TO THE ERROR MESSAGE #5 SHOWING UP ON THE MACHINE. IT SAID THAT HANDPIECE NEEDED TO BE TIGHTENED AND TIPS CLEANED. THE SCRUB TECH WASHED THE TIPS EACH TIME WITH ROOM TEMPERATURE SALINE. SHE TIGHTENED THE TIPS WITH THE ACCOMPANYING WRENCH. THESE THINGS ONLY SOLVED THE PROBLEM FOR A FEW MINUTES. I CALLED THE ETHICON REPRESENTATIVE TO TALK TO HIM ABOUT THE ISSUE WITH THE HARMONIC. HE SAID HE IS AWARE OF THE ISSUE. HE OFFERED A COUPLE OF SUGGESTIONS TO PHYSICIAN. ALSO, HE SAID TO SEND THE HANDPIECE TO BIOMED AND THEY WOULD RETURN IT TO FOR A REPLACEMENT. I OPENED ANOTHER HANDPIECE FOR THE DOCTOR AND HE USED THAT WITH NO ISSUES FOR THE REST OF THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL, CURVED SHEARS LFL ETHICON ENDO-SURGERY, INC. * G9KK52

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR