BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III COLONOVIDEOSCOPE

    MDR report key: 22058064 · Received May 21, 2025

    Report

    Report Number
    9610595-2025-09122
    Event Type
    Malfunction
    Date Received
    May 21, 2025
    Date of Event
    May 9, 2025
    Report Date
    May 21, 2025
    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
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION. THE CUSTOMER COMPLAINT WAS CONFIRMED. A DEFINITIVE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE IDENTIFIED. HOWEVER, BASED ON THE RESULTS OF THE INVESTIGATION, IT IS PROBABLE 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 HAD 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. THE EVENT CAN BE PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE WHICH STATE: NOTHING OTHER THAN STERILE WATER SHOULD BE USED FOR AIR/WATER FEEDING. NO ADDITIVES SHOULD BE PUT INTO THE STERILE WATER. NON-STERILE WATER MAY CAUSE PATIENT CROSS-CONTAMINATION AND/OR INFECTION. 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 COLONOVIDEOSCOPE AIR/WATER-CYLINDER (TUBE) HAS FOREIGN OBJECTS; AIR/WATER-TUBE HAS FOREIGN OBJECTS; AND JET-TUBE HAS FOREIGN OBJECTS. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78496 EVIS EXERA III COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF AIZU OLYMPUS CO., LTD. CF-HQ190I 04953170305139

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown