BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASOUND PROBE

    MDR report key: 1926250 · Received November 10, 2010

    Report

    Report Number
    1926250
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    October 19, 2010
    Report Date
    November 1, 2010
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FFK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US

    Narratives

    Description of Event or Problem · 1

    THE SHAFT OF THE INSTRUMENT SHEARED IN HALF DURING USE. THE DOCTOR WAS USNG BOTH THE PNEUMATIC AND ULTRASOUND INSTRUMENTS DURING THE CASE. THE INSTRUMENT WAS IN USE APPROXIMATELY TWO HOURS. THE PROBE WAS TAKEN OFF AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRASOUND PROBE PROBE, ULTRASONIC LITHOTRIPSY FFK BOSTON SCIENTIFIC 840-717 *

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR