BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET

    MDR report key: 1111634 · Received August 13, 2008

    Report

    Report Number
    3005099803-2008-02203
    Event Type
    Malfunction
    Date Received
    August 13, 2008
    Date of Event
    July 12, 2008
    Report Date
    July 18, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LQC
    PMA / PMN Number
    K040447
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE PREPARING FOR AN UNSPECIFIED ENDOSCOPIC PROCEDURE, THE TIP BROKE. A TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET HAD BEEN SELECTED FOR USE. WHILE PREPARING THE DEVICE, THE DEVICE WAS TESTED. WHEN "TOPMOST" PART OF THE DEVICE WAS BROKEN WHILE CLOSING THE BASKET. THE PROCEDURE WAS COMPLETED WITH ANOTHER TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET LQC BOSTON SCIENTIFIC M00510870 11669008

    Patients

    Seq Age Sex Outcome Treatment
    1