BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 21975115 · Received May 7, 2025

    Report

    Report Number
    9610595-2025-07917
    Event Type
    Malfunction
    Date Received
    May 7, 2025
    Date of Event
    April 30, 2025
    Report Date
    May 7, 2025
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDS
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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: FOREIGN OBJECTS IN THE AW-CYLINDER (TUBE), AW-TUBE, ADHESIVE ON A-RUBBER, AND CONNECTING TUBE. 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. 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 FLEX VIDEO SCOPE EXHIBITED FOREIGN OBJECTS DETECTED IN THE AIR/WATER-CYLINDER, AIR/WATER-TUBE, ADHESIVE ON A-RUBBER, AND CONNECTING TUBE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423239 EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS AIZU OLYMPUS CO., LTD. GIF-H190

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown