BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRWAY MOBILESCOPE

    MDR report key: 20398425 · Received October 8, 2024

    Report

    Report Number
    9610595-2024-20397
    Event Type
    Malfunction
    Date Received
    October 8, 2024
    Date of Event
    October 3, 2024
    Report Date
    November 26, 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

    UPDATED FIELDS: B3, H3, H6, AND H11. THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF 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. IT HAS BEEN OVER 2 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE FOR THE SUGGESTED REPORTED MALFUNCTION COULD NOT BE ESTABLISHED. THE EVENT CAN BE DETECTED/PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE WHICH STATE: ·LABELING IT WAS CONFIRMED THAT INSTRUCZTIONS FOR MAF-DM2, MAF-GM2, AND 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.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE AIRWAY MOBILESCOPE EXHIBITED THE COATING PEELING OFF THE CONNECTING TUBE BY 1 TO 2MM OR MORE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636598 AIRWAY MOBILESCOPE AIRWAY MOBILESCOPE EOQ AIZU OLYMPUS CO., LTD. MAF-DM2 04953170407260

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown