BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE, MODELS 6410, 6411, 6412

    MDR report key: 2002999 · Received February 28, 2011

    Report

    Report Number
    3005099803-2011-00490
    Event Type
    Malfunction
    Date Received
    February 28, 2011
    Date of Event
    January 12, 2011
    Report Date
    February 8, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    EOQ
    PMA / PMN Number
    K040018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4):ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED OF AND IS NOT AVAILABLE FOR RETURN. A DEVICE EVALUATION CANNOT BE PERFORMED. IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE DEVICE WAS USED DURING A BRONCHOSCOPY PROCEDURE IN THE TRACHEA TO OBTAIN A BIOPSY SAMPLE.ACCORDING TO THE COMPLAINANT, THE NEEDLE FAILED TO RETRACT WITHIN THE SHEATH DURING THE PROCEDURE. THIS WAS NOTED AFTER THE NEEDLE WAS REMOVED OUT OF THE BRONCHOSCOPE AND PATIENT. THE WORKING CHANNEL OF THE SCOPE WAS ALSO FOUND TO BE DAMAGED. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH ANOTHER OF THE SAME DEVICE.NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. AT THE CONCLUSION OF THE PROCEDURE, THE PATIENT'S CONDITION WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE, MODELS 6410, 6411, 6412 BRONCHOSCOPE (FLEXIBLE OR RIGID) EOQ BOSTON SCIENTIFIC - SPENCER M00564101 13945354

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR