BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRWAY MOBILESCOPE

    MDR report key: 23132629 · Received September 24, 2025

    Report

    Report Number
    9610595-2025-22075
    Event Type
    Malfunction
    Date Received
    September 24, 2025
    Date of Event
    August 30, 2025
    Report Date
    September 24, 2025
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    EOQ
    PMA / PMN Number
    K201300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION. BASED ON THE RESULTS OF THE INVESTIGATION, A PROBABLE ROOT CAUSE COULD NOT BE IDENTIFIED. THE EVENT CAN BE DETECTED/PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE WHICH STATE: "INSTRUCTIONS AIRWAY MOBILESCOPE OLYMPUS MAF-DM2, MAF-GM2, MAF-TM2 CHAPTER 3 PREPARATION AND INSPECTION 3.5 INSPECT THE STILL IMAGES AND VIDEOS, 3.6 INSPECTION OF THE ENDOSCOPE, 3.11 INSPECTION OF THE ENDOSCOPIC SYSTEM IMPORTANT INFORMATION ¿ PLEASE READ BEFORE USE". 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 AIRWAY MOBILESCOPE EXHIBITED A DIRTY CAMERA SECTION DUE TO A WATER LEAKAGE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2492874 AIRWAY MOBILESCOPE AIRWAY MOBILESCOPE EOQ AIZU OLYMPUS CO., LTD. MAF-GM2

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown