BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWISS LITHOCLAST

    MDR report key: 3123862 · Received March 11, 2013

    Report

    Report Number
    3123862
    Event Type
    Malfunction
    Date Received
    March 11, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 11, 2013
    Manufacturer
    BOSTON SCIENTIFIC, CORP
    Product Code
    FFK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US

    Narratives

    Description of Event or Problem · 1

    DURING A PERCUTANEOUS NEPHROLITHOTOMY, IT WAS NOTED THAT THERE WERE FLECKS FROM THE ULTRASOUND LITHOTRIPSY PROBE IN THE TISSUE OF THE KIDNEY ON THE MONITOR. THE PROBE WAS ISOLATED ALONG WITH THE PACKAGING. THE VENDOR WAS TO BE NOTIFIED TO VERIFY IF THIS IS AN EXPECTED OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102744 SWISS LITHOCLAST LITHOTRIPTER, ELECTRO-HYDRAULIC FFK BOSTON SCIENTIFIC, CORP M0068407170 15736459

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR