BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRWAY MOBILESCOPE

    MDR report key: 20313858 · Received September 26, 2024

    Report

    Report Number
    9610595-2024-19350
    Event Type
    Malfunction
    Date Received
    September 26, 2024
    Report Date
    October 7, 2024
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    EOQ
    UDI-DI
    04953170407260
    PMA / PMN Number
    K201300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE EVALUATION IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, THE ROOT CAUSE OF THE REPORTED EVENT IS UNABLE TO BE DETERMINED. HOWEVER, THE LIKELY CAUSE OF THE REPORTED EVENT IS DUE TO STRESS OF REPEATED USE, EXTERNAL FACTORS, OR HANDLING OF THE DEVICE. THE EVENT CAN BE DETECTED BY FOLLOWING THE INSTRUCTIONS FOR USE (IFU) SECTION: NSTRUCTIONS FOR MAF-DM2, MAF-GM2, MAF-TM2 OPERATION MANUAL CHAPTER 3, ¿PREPARATION AND INSPECTION¿ SECTION 3.6, ¿INSPECTION OF THE ENDOSCOPE¿ DESCRIBES HOW TO INSPECT FOR THE EVENT. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE SUBJECT DEVICE EXHIBITED PEELING OF THE COATING OF THE IMAGE GUIDE HOSE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1372279 AIRWAY MOBILESCOPE AIRWAY MOBILESCOPE EOQ AIZU OLYMPUS CO., LTD. MAF-DM2 04953170407260

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown