BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYBERWAND PROBE

    MDR report key: 7154367 · Received December 28, 2017

    Report

    Report Number
    MW5074284
    Event Type
    Malfunction
    Date Received
    December 28, 2017
    Date of Event
    November 29, 2017
    Report Date
    December 26, 2017
    Manufacturer
    CYBERSONICS INC.
    Product Code
    FFK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AFTER THE COMPLETION OF THE CYBERWAND LITHOTRIPSY, CMTEE DAVENPORT ST WAS DISASSEMBLING CYBERWAND AND NOTICED A SCREEN WAS BROKEN. NO HARM TO PATIENT. DR. (B)(6). DATES OF USE: (B)(6) 2017 1510-17:15. DIAGNOSIS OR REASON FOR USE: LEFT KIDNEY STONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    929880 CYBERWAND PROBE CYBERWAND PROBE FFK CYBERSONICS INC. CW-RBP

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR