BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYBERWAND

    MDR report key: 3021378 · Received March 11, 2013

    Report

    Report Number
    3021378
    Event Type
    Malfunction
    Date Received
    March 11, 2013
    Date of Event
    February 25, 2013
    Report Date
    March 11, 2013
    Manufacturer
    CYBERSONICS, INC.
    Product Code
    FEO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    PATIENT BROUGHT TO THE OR FOR A CYTOLITHOTOMY AND STONE REMOVAL USING THE CYBERWAND. THE SURGEONS WERE ABLE TO COMPLETE THE CYSTOSCOPY AND WERE PREPARING TO USE THE CYBERWAND TO BREAK UP STONES WHEN IT WAS NOTED THAT THE CYBERWAND WAS NOT WORKING CORRECTLY. TWO DISPOSABLE PORTIONS OF THE HANDPIECE WERE TRIED AND NEITHER ONE WOULD WORK. THE REP WAS IN THE ROOM AND BELIEVED THAT IT WAS EITHER THE HANDPIECE OR THE CONSOLE THAT WASN'T WORKING CORRECTLY. BOTH THE HANDPIECE AND THE CONSOLE ARE LOANERS AND WE WERE UNABLE TO LOCATE ANOTHER HANDPIECE AND CONSOLE. DR WAS UNABLE TO REMOVE THE STONES WITHOUT THE CYBERWAND. HE SPOKE WITH THE FAMILY AND HAS PLANS TO RESCHEDULE THE PATIENT FOR SURGERY WHEN THE EQUIPMENT NEEDED IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102719 CYBERWAND LITHOTRIPTOR, ULTRASONIC FEO CYBERSONICS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR