BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III BRONCHOVIDEOSCOPE

    MDR report key: 25191166 · Received May 15, 2026

    Report

    Report Number
    9610595-2026-39842
    Event Type
    Malfunction
    Date Received
    May 15, 2026
    Date of Event
    April 11, 2026
    Report Date
    May 15, 2026
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    EOQ
    PMA / PMN Number
    K250862
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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 BRONCHOVIDEOSCOPE HAD A SCOPE COMMUNICATION ERROR DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132723 EVIS EXERA III BRONCHOVIDEOSCOPE BRONCHOVIDEOSCOPE EOQ AIZU OLYMPUS CO., LTD. BF-P190 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown