BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSCOPIC TRANSBRONCHIAL

    MDR report key: 1812490 · Received August 17, 2010

    Report

    Report Number
    MW5017174
    Event Type
    Malfunction
    Date Received
    August 17, 2010
    Date of Event
    August 12, 2010
    Report Date
    August 17, 2010
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FCG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    USED NEEDLE TO GET SPECIMEN AND ATTEMPTED TO PUT SPECIMEN IN CYTOLYTE. THE NEEDLE WOULD NOT COME OUT OF THE SHEATH. THE NEEDLE HAD TO BE CUT OFF TO GET THE SPECIMEN OUT AND SENT TO THE LAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOSCOPIC TRANSBRONCHIAL NONE FCG BOSTON SCIENTIFIC 13409832

    Patients

    Seq Age Sex Outcome Treatment
    1