BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III COLONOVIDEOSCOPE

    MDR report key: 23289190 · Received October 15, 2025

    Report

    Report Number
    9610595-2025-25708
    Event Type
    Malfunction
    Date Received
    October 15, 2025
    Date of Event
    September 11, 2025
    Report Date
    April 21, 2026
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDF
    UDI-DI
    04953170305177
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    117

    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.

    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. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. OLYMPUS PROVIDED THE FOLLOWING RESULT OF THE CULTURE TEST, PERFORMED AT THE THIRD-PARTY LABS: SAMPLING DATE: (B)(6) SAMPLING FROM: COLOSCOPE/OLYMPUS/CF-H190 I/2842693 CFU: NO GROWTH AFTER 7 DAYS INCUBATION BACTERIAL IDENTIFICATION: N/A BASED ON THE PROVIDED DATA, NO CORRELATION HAS BEEN OBSERVED BETWEEN ACTUAL PRODUCT DEVICE STATUS AND CAUSE OF CONTAMINATION. IN GENERAL, DEVICE DAMAGES (E.G. SCRATCHES, CRACKS, CREASES, KINKS) COULD BE A SOURCE OF MICROORGANISMS PARTICULARLY WHEN COMBINED WITH POOR REPROCESSING. WITHOUT THE CLEANING DISINFECTION AND STERILIZATION (CDS) INFORMATION FROM THE CUSTOMER, WE ARE NOT ABLE TO CORRELATE ANY POSSIBLE LAPSES IN REPROCESSING REGARDING THE VALIDATED PROCEDURE DESCRIBED IN THE INSTRUCTIONS FOR USE (IFU) WITH PRODUCT STATUS. AFTER REPROCESSING BY OLYMPUS, THE HYGIENE MICROBIOLOGICAL INVESTIGATION (HMI) RESULTS COULD NOT CONFIRM CUSTOMER FINDINGS AND SHOWN NO GROWTH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING REPROCESSING, THE COLONOVIDEOSCOPE TESTED POSITIVE FOR ESCHERICHIA COLI IN TWO TESTS. ALL CHANNELS WERE SAMPLED. 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

    NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2733148 EVIS EXERA III COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF AIZU OLYMPUS CO., LTD. CF-H190I 04953170305177

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown