BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OES BRONCHOFIBERSCOPE

    MDR report key: 12047316 · Received June 23, 2021

    Report

    Report Number
    8010047-2021-07868
    Event Type
    Malfunction
    Date Received
    June 23, 2021
    Report Date
    August 23, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    EOQ
    UDI-DI
    04953170308123
    PMA / PMN Number
    K023984
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    LOCAL SERVICE DEPARTMENT CHECKED THE SUBJECT DEVICE AND FOUND THAT THE PHENOMENON OCCURRED DUE TO DETERIORATION. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 0

    THIS IS A SUPPLEMENTAL REPORT TO PROVIDE ADDITIONAL INFORMATION. THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THEREFORE, THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. THE MANUFACTURING RECORD WAS REVIEWED AND FOUND NO IRREGULARITIES. OMSC PRESUMED THAT THE PHENOMENON OCCURRED DUE TO FOLLOWING POSSIBLE CAUSES. A) PHYSICAL STRESS. B) CHEMICAL STRESS . C) POOR STORING ENVIRONMENT, SUCH AS IN DIRECT SUNLIGHT, AT HIGH TEMPERATURES, IN HIGH HUMIDITY OR EXPOSED TO X-RAYS AND ULTRAVIOLET-RAYS.

    Description of Event or Problem · 0

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT DURING THE INCOMING INSPECTION FOR REPAIR AT LOCAL SERVICE DEPARTMENT OF OLYMPUS, IT WAS FOUND THAT THE COATING ON THE CONNECTING TUBE WAS PEELING OFF. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    948556 OES BRONCHOFIBERSCOPE BRONCHOFIBERSCOPE EOQ OLYMPUS MEDICAL SYSTEMS CORP. BF-P60 04953170308123

    Patients

    Seq Age Sex Outcome Treatment
    1