BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE

    MDR report key: 24939870 · Received April 21, 2026

    Report

    Report Number
    3002808148-2026-12321
    Event Type
    Malfunction
    Date Received
    April 21, 2026
    Date of Event
    April 8, 2026
    Report Date
    April 21, 2026
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    PSV
    UDI-DI
    04953170356360
    PMA / PMN Number
    K070983
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THE BRONCHOFIBERVIDEOSCOPE DID NOT FEEL CLEAN ENOUGH AFTER REPEATED WASHING AND REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467220 EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE ULTRASONIC BRONCHOFIBERVIDEOSCOPE PSV SHIRAKAWA OLYMPUS CO., LTD. BF-UC180F 04953170356360

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown