BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS EXERA III BRONCHOFIBERVIDEOSCOPE

    MDR report key: 23066726 · Received September 16, 2025

    Report

    Report Number
    9610595-2025-20945
    Event Type
    Injury
    Date Received
    September 16, 2025
    Date of Event
    August 20, 2025
    Report Date
    January 4, 2026
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    EOQ
    PMA / PMN Number
    K172726
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1: (B)(6). THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE RESULTS OF THIRD-PARTY TESTING, THE DEVICE EVALUATION AND THE FINAL INVESTIGATION. UPDATED FIELDS: D9, H3, H6, H11 OLYMPUS PROVIDED THE FOLLOWING RESULT OF THE CULTURE TEST, PERFORMED AT THE THIRD-PARTY LABS: SAMPLING DATE: (B)(6) 2025 SAMPLING FROM: INSTRUMENT / BIOPSY / SUCTION CHANNEL CFU: 1 BACTERIAL IDENTIFICATION: ENTEROBACTER HORMAECHEI. SAMPLING DATE : (B)(6) 2025 SAMPLING FROM: ALL CHANNELS CFU: N/A BACTERIAL IDENTIFICATION: N/A. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION. THE INITIAL OLYMPUS HYGIENE MICROBIOLOGICAL INVESTIGATION (HMI) CONFIRMED CONTAMINATION, WITH 1 CFU OF ENTEROBACTER HORMAECHEI DETECTED. AFTER REPROCESSING BY OLYMPUS, THE SECOND HMI RESULT WAS NEGATIVE. DURING DEVICE EVALUATION, A LEAK IN THE BENDING SECTION COVER WAS IDENTIFIED. CUSTOMER HMI RESULTS AND DETAILED CLEANING, DISINFECTION, AND STERILIZATION (CDS) INFORMATION WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. BASED ON THE RESULTS OF THE INVESTIGATION, THERE COULD POTENTIALLY BE A CORRELATION BETWEEN THE ACTUAL PRODUCT/DEVICE STATUS AND CAUSE OF CONTAMINATION OR INFECTION. IN GENERAL, DEVICE DAMAGES COULD BE A SOURCE OF MICROORGANISMS, HOWEVER, THE INVESTIGATION FINDINGS DO NOT LEAD TO A CLEAR CONCLUSION ABOUT THE CAUSE OF THE REPORTED ADVERSE EVENT. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BRONCHOFIBERVIDEOSCOPE HAD A CROSS CONTAMINATION AND A PATIENT WAS SUSPECTED TO HAVE A VRE (VANCOMYCIN-RESISTANT ENTEROCOCCUS) INFECTION THAT WAS NOTED DURING REPROCESSING. THERE WERE NO REPORTS OF FURTHER PATIENT HARM.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2659610 EVIS EXERA III BRONCHOFIBERVIDEOSCOPE BRONCHOFIBERVIDEOSCOPE EOQ AIZU OLYMPUS CO., LTD. BF-MP190F

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown