BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIRWAY MOBILESCOPE

    MDR report key: 20417695 · Received October 10, 2024

    Report

    Report Number
    9610595-2024-20616
    Event Type
    Injury
    Date Received
    October 10, 2024
    Date of Event
    September 26, 2024
    Report Date
    February 24, 2025
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    EOQ
    UDI-DI
    04953170407208
    PMA / PMN Number
    K201300
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION AND DEVICE EVALUATION. ADDITIONALLY, TO PROVIDE CORRECTION TO THE INITIAL WITH INFORMATION INADVERTENTLY LEFT OUT (D9) AND TO PROVIDE AN UPDATE TO FIELDS (H3 AND H4). THE DEVICE WAS EVALUATED BY OLYMPUS, AND THE LIQUID CRYSTAL DISPLAY (LCD) PANEL REQUIRED FLUID INVASION. 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, IT IS LIKELY THAT THE REPORTED EVENT OCCURRED DUE TO THE INTERNAL CIRCUIT OF THE LIQUID CRYSTAL DISPLAY (LCD) PANEL SHORTED-OUT WITH WATER INVASION. ALTHOUGH THE OBSERVED DEVICE DEFECT IS A NON-REPORTABLE MALFUNCTION, THE COMPONENT FAILURE LIKELY CAUSED AND/OR CONTRIBUTED TO THE REPORTED ADVERSE EVENT (PROCEDURE WAS DELAYED). HOWEVER, THE SPECIFIC ROOT CAUSE COULD NOT BE SPECIFIED. THE EVENT CAN BE DETECTED/PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE WHICH STATE: "REPROCESSING THE ENDOSCOPE (AND RELATED REPROCESSING ACCESSORIES)", "LEAKAGE TESTING OF THE ENDOSCOPE", " PERFORM THE LEAKAGE TEST". OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN SUBMITTED BY THE IMPORTER UNDER THIS MDR REPORT NUMBER 2429304-2024-0000436. THE EVALUATION OF THE EVENT IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A THERAPEUTIC LUNG RESECTION PROCEDURE, USING AIRWAY MOBILESCOPE, THERE WAS NO MOVING IMAGE ON THE SCREEN AND BAD QUALITY IMAGE WAS PRODUCED. NO ERROR MESSAGE WAS PRODUCED. THE PROCEDURE WAS REPORTED TO BE EXTENDED FOR 1 HOUR WHILE THE PATIENT WAS SEDATED, AND THE PROCEDURE TRIED ON A BACKUP OLYMPUS SCOPE WITH A (DIFFERENT MODEL WAS USED) THAT GAVE A PIXELATED IMAGE. THE PROCEDURE WAS COMPLETED WITHOUT ANY IMPACT TO THE PATIENT. THE PATIENT IS REPORTED TO BE DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2005892 AIRWAY MOBILESCOPE AIRWAY MOBILESCOPE EOQ AIZU OLYMPUS CO., LTD. MAF-GM2 04953170407208

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other