BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 22153177 · Received June 5, 2025

    Report

    Report Number
    9610595-2025-10447
    Event Type
    Malfunction
    Date Received
    June 5, 2025
    Date of Event
    February 11, 2025
    Report Date
    June 5, 2025
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION AND THE REPORTED FAILURE WAS CONFIRMED. IN ADDITION, THE FOLLOWING REPORTABLE MALFUNCTIONS WERE IDENTIFIED DURING THE DEVICE EVALUATION: AW-CYLINDER (TUBE) HAS FOREIGN OBJECTS AND AW-TUBE HAS FOREIGN OBJECTS. A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION: THE MOST PROBABLE CAUSE OF THE COMPLAINT IS CAUSE NOT ESTABLISHED, WHICH INDICATES THAT THE INVESTIGATION FINDINGS DO NOT LEAD TO A CLEAR CONCLUSION ABOUT THE CAUSE OF THE REPORTED ADVERSE EVENT. THE MOST PROBABLE CAUSE OF THE FAILURES "AW-CYLINDER (TUBE) HAS FOREIGN OBJECTS." AND "AW-TUBE HAS FOREIGN OBJECTS." IS CAUSE TRACED TO FAILURE TO FOLLOW INSTRUCTIONS. NO FURTHER ESCALATION IS REQUIRED. A CAPA HISTORY REVIEW WAS PERFORMED AND CAPA-201609 WAS IDENTIFIED TO BE RELATED TO THE FAILURE "DUE TO WEAR OF S-COVER, WATER TIGHTNESS IS LOST." A CAPA HISTORY REVIEW WAS PERFORMED AND CAPA-201632 WAS IDENTIFIED TO BE RELATED TO THE FAILURES "AW-CYLINDER (TUBE) HAS FOREIGN OBJECTS." AND "AW-TUBE HAS FOREIGN OBJECTS.". 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 GASTROINTESTINAL VIDEOSCOPE EXHIBITED FOREIGN MATERIAL INT THE AIR/WATER (A/W) CYLINDER AND THE AIR/WATER TUBE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1320418 GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS AIZU OLYMPUS CO., LTD. GIF-EZ1500

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown