BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC FOCUS

    MDR report key: 2063666 · Received April 12, 2011

    Report

    Report Number
    2063666
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    March 2, 2011
    Report Date
    April 12, 2011
    Manufacturer
    ASCENT HEALTHCARE SOLUTIONS
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    WHILE USING A REPROCESSED HARMONIC DEVICE, IT STOPPED WORKING DURING THE CASE. WE NEEDED TO SHUT THE MACHINE OFF AND TIGHTEN THE DEVICE AGAIN. LATER DURING THE CASE, WHILE IN THE DOCTOR'S HAND, IT BECAME ACTIVATED. THE DOCTOR WAS NOT PRESSING THE HANDLE. IT ALSO BECAME WARM IN HIS HAND. IT WAS REPLACED WITH A NEW ITEM USING THE SAME CORD AND MACHINE. MACHINE AND CORD WERE CHECKED AFTER CASE AND NO PROBLEMS WERE FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC FOCUS INSTRUMENT, ULTRASONIC SURGICAL, CURVED SHEARS LFL ASCENT HEALTHCARE SOLUTIONS FCS9 1323355

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR