BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTROHYDRAULIC LITHOTRIPTOR

    MDR report key: 3767222 · Received April 18, 2014

    Report

    Report Number
    3767222
    Event Type
    Malfunction
    Date Received
    April 18, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 18, 2014
    Manufacturer
    RICHARD WOLF MEDICAL INSTRUMENT CORP.
    Product Code
    FFK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    (B)(6) Y/O MALE IN THE OPERATING ROOM FOR LASER CYSTOLITHOLAPAXY. DURING USAGE, LITHOTRIPTOR USED AND DEVICE FUNCTION STOPPED. ANOTHER ONE USED AND SURGEON NOTED A METALLIC FOREIGN BODY IN BLADDER. FOREIGN BODY RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238597 ELECTROHYDRAULIC LITHOTRIPTOR NONE FFK RICHARD WOLF MEDICAL INSTRUMENT CORP. 2135.0905 9FR 529131

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR