BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE

    MDR report key: 1081989 · Received July 22, 2008

    Report

    Report Number
    3005099803-2008-01252
    Event Type
    Malfunction
    Date Received
    July 22, 2008
    Report Date
    June 24, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EOQ
    PMA / PMN Number
    K040018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED; THE EVALUATION HAS NOT BEEN COMPLETED. THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION IN 2008, THE AN EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE DEVICE WAS USED IN A CARINA PUNCTURE PROCEDURE ON THE DAY BEFORE. ACCORDING TO THE COMPLAINANT, THE DEVICE COULD NOT PUNCTURE THE LYMPH NODE. THE PROCEDURE WAS COMPLETED WITH A SECOND EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE EOQ BOSTON SCIENTIFIC CORPORATION M00564101 11386252

    Patients

    Seq Age Sex Outcome Treatment
    1