BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE

    MDR report key: 14199416 · Received April 26, 2022

    Report

    Report Number
    8010047-2022-07010
    Event Type
    Malfunction
    Date Received
    April 26, 2022
    Report Date
    June 27, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    ODG
    UDI-DI
    04953170356339
    PMA / PMN Number
    K093395
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE SERVICE EVALUATION FOUND THE ADHESIVE AT THE DISTAL END FORCEPS COVER WAS FOUND PEELING OFF. ADDITIONALLY, THE BENDING SECTION COVER GLUE IS CRACKED AND THE ELEVATOR CHANNEL INLET IS LOOSE. THE ASSET SCOPE PASSED THE AIR/WATER LEK TEST. THE ASSET SCOPE WAS REPAIRED AND RETURNED TO ASSET STOCK. THE ASSET WAS LAST SERVICED IN JANUARY 2022; NO PROBLEMS WERE FOUND, INSPECTION ONLY. THE INVESTIGATION IS ONGOING; THEREFORE, THE ROOT CAUSE OF THE REPORTED ISSUE CANNOT BE DETERMINED AT THIS TIME. HOWEVER, IF ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW UP MEDICAL DEVICE REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    CORRECTION TO THE INITIAL MEDWATCH. THE AWARE DATE SHOULD BE 11-JAN-2022. 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 COULD NOT BE IDENTIFIED. THE FOLLOWING IS INCLUDED IN THE DEVICE INSTRUCTIONS FOR USE (IFU) AND MAY HAVE HELPED PREVENT THE EVENT: "DO NOT APPLY EXCESSIVE FORCE TO THE DISTAL END OF THE ENDOSCOPE OR BEND IT. INSTRUMENT DAMAGE MAY OCCUR." "TO PREVENT A WATER LEAK, DO NOT APPLY EXCESSIVE FORCE WHEN CLEANING THE ENDOSCOPE." OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    OLYMPUS WAS INFORMED THAT THE ASSET/LOANER WAS RETURNED TO THE SERVICE CENTER WITH NO REPORTED DEFECT OR MALFUNCTION ASSOCIATED WITH THE DEVICE. HOWEVER, UPON INSPECTING AND TESTING, THE ADHESIVE AT THE DISTAL END FORCEPS COVER WAS FOUND PEELING OFF. NO DEATH, INJURY OR HARM WAS REPORTED TO OLYMPUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817641 EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE ULTRASOUND GASTROVIDEOSCOPE ODG OLYMPUS MEDICAL SYSTEMS CORP. GF-UCT180 04953170356339

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown