BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASOUND PROBE

    MDR report key: 8821447 · Received July 24, 2019

    Report

    Report Number
    8821447
    Event Type
    Malfunction
    Date Received
    July 24, 2019
    Date of Event
    July 19, 2019
    Report Date
    July 23, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FFK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DISPOSABLE PROBE BROKE 1/3 OF THE WAY DOWN FROM HANDLE (BOSTON SCIENTIFIC CORP 840-717 SWISS LITHOCLAST 3.8 MM 403 MM ULTRASOUND FLEXIBLE PROBE LATEX FREE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615442 ULTRASOUND PROBE LITHOTRIPTOR, ELECTRO-HYDRAULIC FFK BOSTON SCIENTIFIC CORPORATION M0068407170

    Patients

    Seq Age Sex Outcome Treatment
    1 22630 DA