BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III COLONOVIDEOSCOPE

    MDR report key: 21767728 · Received April 3, 2025

    Report

    Report Number
    9610595-2025-05222
    Event Type
    Malfunction
    Date Received
    April 3, 2025
    Date of Event
    March 14, 2025
    Report Date
    April 3, 2025
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDF
    UDI-DI
    04953170305115
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION. A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION: 1- AW-CYLINDER (TUBE) HAS FOREIGN OBJECTS. (WHITE FOREIGN MATERIAL). 2-AW-TUBE HAS FOREIGN OBJECTS. (WHITE FOREIGN MATERIAL). THE WHITE FOREIGN MATERIAL DETECTED BY INCOME INSPECTION HAS BEEN HANDLED BY OMSC CAPA-201632. ACCORDING TO PREVIOUS INVESTIGATIONS, THE USE OF PRODUCTS THAT CONTAIN SILICONE CAN CAUSE DEPOSITS OF WHITE FOREIGN MATERIAL. SILICONE IS FOR EXAMPLE INCLUDED IN SIMETHICONE, A DEFOAMING AGENT, LUBRICANTS AND SO ON. IF THE CUSTOMER USED THEM, THERE WAS RISK THAT FOREIGN MATERIAL WAS REMAINED IN THE CHANNEL EVEN IF THE REPROCESSING WAS CONDUCTED IN ACCORDANCE WITH IFU. SIMETHICONE AND PETROLEUM/OIL/SILICONE-BASED LUBRICANTS ARE NON-WATER SOLUBLE AND THUS NOT RECOMMENDED FOR USE BY OLYMPUS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE FLEX VIDEO SCOPE EXHIBITED A FOREING MATERIAL ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653985 EVIS EXERA III COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF AIZU OLYMPUS CO., LTD. CF-HQ190L 04953170305115

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown