BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE

    MDR report key: 1140591 · Received August 28, 2008

    Report

    Report Number
    3005099803-2008-04185
    Event Type
    Malfunction
    Date Received
    August 28, 2008
    Report Date
    August 1, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EOQ
    PMA / PMN Number
    K040018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER OF THE SUSPECT DEVICE IS UNKNOWN; THEREFORE, THE MANUFACTURE AND EXPIRATION DATE CAN NOT BE DETERMINED. THE SUSPECT DEVICE HAS BEEN DISPOSED. A DEVICE EVALUATION WILL NOT BE PERFORMED; THEREFORE, THE CAUSE OF THE REPORTED EVENT IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC THAT DURING A BRONCHOSCOPY PROCEDURE, THE EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE WAS BENDING INTO A "J"SHAPE WHEN BEING ADVANCED. THE CASE WAS SUCCESSFULLY COMPLETED WITH THIS DEVICE. THE PATIENT IS "FINE".

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR