BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FUJIFILM BRONCHOSCOPE EB-580S

    MDR report key: 12216839 · Received July 23, 2021

    Report

    Report Number
    1000513161-2021-00004
    Event Type
    Injury
    Date Received
    July 23, 2021
    Date of Event
    May 25, 2021
    Report Date
    July 23, 2021
    Manufacturer
    FUJIFILM CORPORATION
    Product Code
    EOQ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    ON JUNE 17, 2021, FUJIFILM MEDICAL SYSTEMS U.S.A., INC. WAS INFORMED OF AN INCIDENT INVOLVING THE EB-580S BRONCHOSCOPE. BRONCHOALVEOLAR LAVAGE (BAL) WAS PERFORMED ON A PATIENT, AND THE COLLECTED SAMPLE TESTED POSITIVE FOR PSEUDOMONAS AERUGINOSA. THE PATIENT WAS TREATED WITH MEDICATION. THERE WAS NO DEATH OR OTHER SERIOUS INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1116291 FUJIFILM BRONCHOSCOPE EB-580S BRONCHOSCOPE EOQ FUJIFILM CORPORATION EB-580S N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention