BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III COLONOVIDEOSCOPE

    MDR report key: 22487169 · Received July 11, 2025

    Report

    Report Number
    9610595-2025-13719
    Event Type
    Malfunction
    Date Received
    July 11, 2025
    Date of Event
    June 9, 2025
    Report Date
    November 11, 2025
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDF
    PMA / PMN Number
    K192793
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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

    CORRECTION: H6 - MEDICAL DEVICE PROBLEM CODE OF THE INITIAL REPORT, FROM A180105 - MICROBIAL CONTAMINATION OF DEVICE TO A180301 - FAILURE TO CLEAN ADEQUATELY THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE COMPLAINT INVESTIGATION. THE DEVICE WAS RETURNED AND EVALUATED ON RELATED MFR 12193 WHERE A DEVIATION FROM THE INSTRUCTIONS FOR USE (IFU) WAS CONFIRMED; THEREFORE, REPROCESSING MAY HAVE BEEN CONDUCTED INSUFFICIENTLY. THE INSTRUCTIONS FOR USE (IFU) WARNS OF INSUFFICIENT REPROCESSING BY STATING, ¿AN INSUFFICIENTLY REPROCESSED ENDOSCOPE AND/OR ACCESSORY MAY POSE AN INFECTION CONTROL RISK TO THE PATIENTS AND/OR OPERATORS WHO TOUCH THEM.¿ OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING REPROCESSING, THE FLEX VIDEO SCOPE TESTED POSITIVE FOR 10-100 COLONY FORMING UNITS (CFUS) OF E-COLI. THE DEVICE WAS RETESTED ON JUNE 12, 2025, AND RESULTS SHOWED GREATER THAN 100 CFUS OF E-COLI. 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
    873369 EVIS EXERA III COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF AIZU OLYMPUS CO., LTD. PCF-HQ190L

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown