BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLYMPUS

    MDR report key: 1642753 · Received March 23, 2010

    Report

    Report Number
    MW5015290
    Event Type
    Injury
    Date Received
    March 23, 2010
    Date of Event
    March 10, 2010
    Report Date
    March 23, 2010
    Manufacturer
    OLYMPUS AMERICA INC.
    Product Code
    GAA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE ISSUE OCCURRED INTRAPROCEDURE DURING AN ENDOBRONCHIAL ULTRASOUND. THE ISSUE WAS WITH THE VIZISHOT NEEDLES WE USE TO OBTAIN FINE NEEDLE ASPIRATION OF THE LYMPH TISSUE IN THE LUNG. THE PROBLEM THAT OCCURRED WAS OUTSIDE OF THE PT AFTER PASSING THE NEEDLE AND REMOVING THE SPECIMEN, THE STYLET GETS STUCK INSIDE THE SHEATH OF THE NEEDLE. WHEN THE STYLET GETS STUCK, YOU CAN NO LONGER USE THE NEEDLE TO OBTAIN SPECIMENS. IN THIS SPECIFIC CASE, THIS HAPPENED TWO DIFFERENT TIMES WITH THE SAME TYPE OF VIZISHOT NEEDLE. NO HARM WAS CAUSED TO THIS PT, AND THE EVENTS DID NOT INTERFERE WITH THE QUALITY OF THE SPECIMENS WE WERE OBTAINING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS ASPIRATION NEEDLE GAA OLYMPUS AMERICA INC. NA-201SX-4022 9ZK

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Disability