BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE

    MDR report key: 1191143 · Received September 26, 2008

    Report

    Report Number
    3005099803-2008-04874
    Event Type
    Malfunction
    Date Received
    September 26, 2008
    Date of Event
    August 21, 2008
    Report Date
    August 27, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EOQ
    PMA / PMN Number
    K040018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC THAT DURING A LIVER BIOPSY PROCEDURE, USING AN EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE, THE NEEDLE WOULD NOT RETRACT BACK INTO THE SYSTEM. THE CASE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PT IS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE EOQ BOSTON SCIENTIFIC CORPORATION M00564101 11827292

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR