BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASONIC TRANSDUCER

    MDR report key: 262394 · Received February 11, 2000

    Report

    Report Number
    262394
    Event Type
    Malfunction
    Date Received
    February 11, 2000
    Date of Event
    November 19, 1999
    Report Date
    January 14, 2000
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    JOP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A STONE LITHOTRIPSY PROCEDURE, THE ULTRASOUND LITHOTRIPTOR TRANSDUCER STOPPED WORKING. ANOTHER TYPE OF LITHOTRIPSY SYSTEM WAS THEN USED TO COMPLETE THE CASE. NO PT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRASONIC TRANSDUCER ULTRASONIC TRANSDUCER JOP RICHARD WOLF GMBH 2168.50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Other