BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III COLONOVIDEOSCOPE

    MDR report key: 23949724 · Received January 2, 2026

    Report

    Report Number
    9610595-2026-00535
    Event Type
    Malfunction
    Date Received
    January 2, 2026
    Date of Event
    November 21, 2025
    Report Date
    January 22, 2026
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDF
    UDI-DI
    04953170305139
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    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 COMPLAINT INVESTIGATION. 9610595-2026-00506 (2/9), 9610595-2026-00535 (3/9), 9610595-2026-00530 (4/9), 9610595-2026-00547 (5/9), 9610595-2026-00546 (6/9), 9610595-2026-00227 (7/9), 9610595-2026-00545 (8/9), 9610595-2026-00485 (9/9). ADDITIONALLY, THE FOLLOWING FIELDS HAVE BEEN CORRECTED: B5, H6. ADDITIONAL INFORMATION FIELDS: D8, H3, H4. OLYMPUS PROVIDED THE FOLLOWING RESULT OF THE CULTURE TEST, PERFORMED AT THE THIRD-PARTY LABS: SAMPLING DATE: (B)(6) 2025, SAMPLING FROM: AIR/WATER CHANNEL, AUXILIARY CHANNEL, CFU: <1CFU, BACTERIAL IDENTIFICATION: N/A. SAMPLING FROM: SUCTION CHANNEL, CFU: 1CFU, BACTERIAL IDENTIFICATION: MICROCOCCUS LUTEUS/LYLAE. SAMPLING FROM: INSTRUMENT CHANNEL, CFU: 1CFU, BACTERIAL IDENTIFICATION: ROSSELLOMOREA SP. THE DEVICE WAS EVALUATED WHERE AN ADDITIONAL POTENTIAL ADVERSE EVENT WAS CONFIRMED WHERE FOREIGN MATERIAL WAS FOUND IN THE AUXILIARY WATER CHANNEL. BASED ON THE RESULTS OF THE INVESTIGATION, OLYMPUS CONFIRMED FOREIGN MATERIAL WAS PRESENT WITHIN THE DEVICE, BUT THE TYPE OF THE MATERIAL CANNOT BE IDENTIFIED HOWEVER, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION: THE FOREIGN MATERIAL WAS POSSIBLY NOT REMOVED COMPLETELY IF THE REPROCESSING STEPS WERE NOT CONDUCTED PROPERLY. REGARDING THE POSITIVE CULTURE ALLEGATION: BASED ON THE RESULTS OF THE INVESTIGATION AND BECAUSE THE USER CULTURE RESULTS WERE NOT SHARED, THE REPORTED EVENT COULD NOT BE CONFIRMED, AND A ROOT CAUSE COULD NOT BE DETERMINED. GROWTH OF MICROORGANISMS WERE REPORTED THROUGH CULTURE TESTING BY THE USER AFTER REPROCESSING. HOWEVER, WHEN OLYMPUS CULTURE TESTED AFTER REPROCESSING IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) BEFORE REPAIR, THE RESULTS CONFORMED TO THE REGULATION'S RECOMMENDATION. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    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

    THE CUSTOMER REPORTED HAVING USED THE COLONOVIDEOSCOPE ON A PATIENT WHILE AWAITING THE RESULTS FOR ROUTINE CULTURE TESTING. POSITIVE CULTURE TEST RESULTS WERE SUBSEQUENTLY RECEIVED. THE USER DID NOT REPORT ANY CONTAMINATION OR ANY OTHER SERIOUS DETERIORATION IN STATE OF HEALTH OF ANY PERSON, TO WHICH THE SCOPE COULD HAVE BEEN A CONTRIBUTORY CAUSE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE COLONOVIDEOSCOPE TESTED POSITIVE FOR AN UNEXPECTED CONTAMINATION. THE ISSUE WAS FOUND DURING A ROUTINE CULTURE OF THE SCOPE. THE USER DID NOT REPORT ANY CONTAMINATION OR ANY OTHER SERIOUS DETERIORATION IN STATE OF HEALTH OF ANY PERSON, TO WHICH THE SCOPE COULD HAVE BEEN A CONTRIBUTORY CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143189 EVIS EXERA III COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF AIZU OLYMPUS CO., LTD. CF-HQ190I 04953170305139

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown