BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE, MODELS 6410, 6411, 6412

    MDR report key: 2071783 · Received April 28, 2011

    Report

    Report Number
    3005099803-2011-01379
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    March 30, 2011
    Report Date
    April 6, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    EOQ
    PMA / PMN Number
    K040018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE DEVICE EXPIRATION AND MANUFACTURE DATES ARE UNKNOWN.(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

    NOTE: THIS MFR REPORT PERTAINS TO ONE OF TWO DEVICES THAT WERE USED DURING THE SAME PROCEDURE. REFER TO ASSOCIATED MFR REPORT #3005099803-2011-01378 FOR A DESCRIPTION OF THE OTHER DEVICE. THIS REPORT IS FOR THE SECOND DEVICE.IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE DEVICE WAS USED DURING A BRONCHOSCOPY PROCEDURE.ACCORDING TO THE COMPLAINANT, DURING THE BRONCHOSCOPY PROCEDURE, THE CHARGE NURSE REPORTED THAT THE FIRST NEEDLE WOULD NOT FULLY RETRACT. A SECOND NEEDLE WAS USED, AND THE SAME ISSUE OCCURRED. FOR BOTH DEVICES, THEY FELT THAT THE TRIGGER WAS STUCK. THE SCOPE WAS IN A TORTUOUS POSITION. THEY WERE ABLE TO GET GREAT BIOPSIES. THE ACCOUNT REPORTED THAT THE NEEDLES DAMAGED THERE SCOPE. ALTHOUGH THE CONDITION OF THE PATIENT IS UNKNOWN, 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, MODELS 6410, 6411, 6412 BRONCHOSCOPE (FLEXIBLE OR RIGID) EOQ BOSTON SCIENTIFIC - SPENCER M00564101

    Patients

    Seq Age Sex Outcome Treatment
    1