BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRONCHOFIBERSCOPE

    MDR report key: 24616634 · Received March 17, 2026

    Report

    Report Number
    9610595-2026-21735
    Event Type
    Malfunction
    Date Received
    March 17, 2026
    Report Date
    March 17, 2026
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    EOQ
    UDI-DI
    04953170339998
    PMA / PMN Number
    K023984
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE AFFECTED DEVICE WAS RETURNED TO OLYMPUS AMERICA INC. AND UNDERWENT PHYSICAL INSPECTION BY QUALIFIED PERSONNEL. BASED ON THE FINDINGS OF THE COMPLETED INVESTIGATION, PROBABLE CAUSES WERE ASSESSED, INCLUDING DAMAGE OR DETERIORATION OF COMPONENTS, ELECTRICAL ISSUES, ENVIRONMENTAL TEMPERATURE FACTORS, AND MAINTENANCE-RELATED CONCERNS. THE MOST PROBABLE CAUSE OF THE REPORTED COMPLAINT IS EXPECTED OR RANDOM COMPONENT FAILURE, WITH NO DESIGN DEFICIENCY OR MANUFACTURING NON-CONFORMANCE IDENTIFIED AS A CONTRIBUTING FACTOR TO THE REPORTED EVENT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    DURING THE DEVICE EVALUATION, IT WAS FOUND THAT THE RETURNED BRONCHOFIBERSCOPE EXHIBITED FORCEPS CHANNEL PORT STICKY AND SHAVED, AND THE CONTROL UNIT DISPLAYED CORROSION DUE TO WATER LEAKAGE. NO PATIENTS WERE INVOLVED IN ASSOCIATION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677474 BRONCHOFIBERSCOPE BRONCHOFIBERSCOPE EOQ AIZU OLYMPUS CO., LTD. BF-TE2 04953170339998

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown