BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 22298218 · Received June 20, 2025

    Report

    Report Number
    9610595-2025-11866
    Event Type
    Malfunction
    Date Received
    June 20, 2025
    Date of Event
    May 12, 2025
    Report Date
    August 11, 2025
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE. THIS REPORT IS RELATED TO 9610595-2025-10223-00 AND 9610595-2025-10217-00.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION AND THE REPORTED FAILURE WAS CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION: THE DEVICE WAS USED ON A PATIENT AFTER BEING WASHED WITH A WASHING AND DISINFECTION DEVICE WITH THE WASHING TUBE DETACHED. THERE IS A POSSIBILITY THAT THE USER UNDERSTANDING MAY HAVE DIFFERED FROM OLYMPUS RECOMMENDATION IN DEVICE HANDLING AND/OR REPROCESSING STEPS. THE EVENT 1. IS PREVENTABLE BY HANDLING DEVICE IN ACCORDANCE WITH THE FOLLOWING IFU. AN INSUFFICIENTLY REPROCESSED ENDOSCOPE AND/OR ACCESSORY MAY POSE AN INFECTION CONTROL RISK TO THE PATIENTS AND/OR OPERATORS WHO TOUCH THEM. 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 REPORTED THAT THE ENDOSCOPE REPROCESSOR WAS USED TO REPROCESS A GASTROINTESTINAL VIDEOSCOPE (GIF-XZ1200) WITHOUT THE CONNECTING TUBE ATTACHED TO THE VIDEOSCOPE AND THE VIDEOSCOPE WAS USED ON THE NEXT PATIENT AS IS. THE ISSUE WAS FOUND DURING REPROCESSING AND THERE WERE NO REPORTS OF DELAYS OR PATIENT HARM.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1362394 GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS AIZU OLYMPUS CO., LTD. GIF-XZ1200

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown MAJ-1500.| OER-3.