BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET

    MDR report key: 1161556 · Received September 15, 2008

    Report

    Report Number
    3005099803-2008-04570
    Event Type
    Malfunction
    Date Received
    September 15, 2008
    Date of Event
    August 19, 2008
    Report Date
    August 21, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LQC
    PMA / PMN Number
    K040447
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LE
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING UNPACKING OF THE DEVICE, DAMAGE WAS DISCOVERED. AN RX LITHOTRIPTER BASKET HAD BEEN UNPACKED. FOR UNSPECIFIED REASONS, THE DEVICE WAS "CHECKED" TO SEE IF THE BASKET WOULD FUNCTION "PROPERLY". IT WAS DISCOVERED THAT THE "PLASTIC TIP AT THE HEAD OF THE BASKET IS BROKEN AND THE BASKET IS COMPLETELY DAMAGE." THE DEVICE DID NOT HAVE CONTACT WITH THE PT. THE PT'S CURRENT CONDITION IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET LQC BOSTON SCIENTIFIC M00510890 11125238

    Patients

    Seq Age Sex Outcome Treatment
    1