BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA ELITE COLONOVIDEOSCOPE

    MDR report key: 22320159 · Received June 24, 2025

    Report

    Report Number
    9610595-2025-12154
    Event Type
    Malfunction
    Date Received
    June 24, 2025
    Date of Event
    May 28, 2025
    Report Date
    June 24, 2025
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDF
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION AND THE FOLLOWING REPORTABLE MALFUNCTION WAS IDENTIFIED DURING THE DEVICE EVALUATION: FOREIGN MATERIAL IN THE AIR/WATER CYLINDER AND TUBE. THIS COMPLAINT ALLEGATION HAS BEEN PREVIOUSLY INVESTIGATED THROUGH THE PRODUCT TECHNICAL INVESTIGATION (PTI) PROCESS. 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 REMAINED IN THE CHANNEL EVEN IF THE REPROCESSING WAS CONDUCTED IN ACCORDANCE WITH INSTRUCTIONS FOR USE - IFU. SIMETHICONE AND PETROLEUM/OIL/SILICONE-BASED LUBRICANTS ARE NON-WATER SOLUBLE AND THUS NOT RECOMMENDED FOR USE BY OLYMPUS. THE MOST PROBABLE CAUSE OF THE ADDITIONAL FAILURES "AW-CYLINDER (TUBE) HAS FOREIGN OBJECTS." AND "AW-TUBE HAS FOREIGN OBJECTS." IS KNOWN INHERENT RISK OF DEVICE. THE EVENT CAN BE DETECTED/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 SUBJECT DEVICE EXHIBITED FOREIGN MATERIAL IN THE AIR /WATER-CYLINDER (TUBE) AND JET-TUBE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1971423 EVIS LUCERA ELITE COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF AIZU OLYMPUS CO., LTD. CF-HQ290L

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown