BEUDAMED
    FDA Adverse Event Other Summary report: N

    ULTRASOUND LITHOTRIPSY PROBE

    MDR report key: 492109 · Received October 24, 2003

    Report

    Report Number
    1418479-2003-00037
    Event Type
    Other
    Date Received
    October 24, 2003
    Date of Event
    September 18, 2003
    Report Date
    September 24, 2003
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    FEO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A POST-ASSEMBLY PROBLEM WAS DISCOVERED BY THE MANUFACTURER OF AN ULTRASOUND LITHOTRIPSY PROBE. THE SHAFT TUBING WAS ATTACHED IN REVERSE TO THE HANDLE. THE SMALL DIAMETER OPENING OF THE TUBING IS NORMALLY AT THE DISTAL END, TO LIMIT THE SIZE OF STONE FRAGMENTS ENTERING THE SYSTEM. SINCE THE TUBE WAS ATTACHED IN REVERSE, THE SMALL OPENING WAS AT THE PROXIMAL END. LARGER FRAGMENTS OF STONE COULD BECOME LODGED AND CLOG THE TUBE AT THAT POINT, CAUSING OPERATIONAL PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRASOUND LITHOTRIPSY PROBE ULTRASOUND LITHOTRIPSY PROBE FEO RICHARD WOLF GMBH 8963.535 M000580

    Patients

    Seq Age Sex Outcome Treatment
    1 NA