BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA DUODENOVIDEOSCOPE

    MDR report key: 12317250 · Received August 13, 2021

    Report

    Report Number
    8010047-2021-10204
    Event Type
    Malfunction
    Date Received
    August 13, 2021
    Report Date
    September 17, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDT
    PMA / PMN Number
    K024033
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. OLYMPUS NOTICED THE DATE OF G3 FOR THE INITIAL REPORT WAS NOT JULY 22, 2021 BUT JUNE 18, 2021. SO G3 IS CORRECTED TO JUNE 18, 2021. THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) BUT WAS RETURNED TO OLYMPUS EUROPA K.G (OEKG). OEKG SENT THE DEVICE TO A THIRD PARTY LABORATORY FOR MICROBIOLOGICAL TESTING. AS A RESULT OF THE TESTING, NO MICROBE WAS DETECTED FROM THE SAMPLE COLLECTED FROM THE ALL CHANNELS AND THE DISTAL END OF THE SUBJECT DEVICE. THE TESTING RESULT CLEARED THE GERMAN GUIDELINE. BASED ON THE EVALUATION, LEAKAGE FROM UNIVERSAL CORD AND DIRT FROM MULTIPLE AREA (HOLD RING, A/W CYLINDER, SUCTION CYLINDER) WERE CONFIRMED FROM THE DEVICE. DEVICE HISTORY RECORD REVIEW INDICATES THAT THE PRODUCT WAS MANUFACTURED AND TESTED IN ACCORDANCE WITH ALL APPLICABLE PROCEDURES AND MET ALL FINAL PRODUCT RELEASE CRITERIA. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) BUT WAS RETURNED TO OLYMPUS (B)(4). THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT AS A RESULT OF MULTIPLE MICROBIOLOGICAL TESTING BY THE USER FACILITY, UNSPECIFIED MICROBES WERE DETECTED FROM THE SAMPLE COLLECTED FROM THE SUBJECT DEVICE. (B)(6) 2021. INSTRUMENT CHANNEL; TOTAL MICROBES (2 UFC/CHANNEL). SUCTION CHANNEL; TOTAL MICROBES (500 UFC / CHANNEL). AIR/WATER CHANNEL; TOTAL MICROBES (<2 UFC /CHANNEL). ELEVATOR CHANNEL; TOTAL MICROBES (2 UFC /CHANNEL). (B)(6) 2021. INSTRUMENT CHANNEL; TOTAL MICROBES (<2 UFC/CHANNEL). SUCTION CHANNEL; TOTAL MICROBES (>500 UFC / CHANNEL). AIR/WATER CHANNEL; TOTAL MICROBES (2 UFC /CHANNEL). ELEVATOR CHANNEL; TOTAL MICROBES (<2 UFC /CHANNEL). THE DEVICE HAD BEEN REPROCESSED WITH AN OLYMPUS AUTOMATED ENDOSCOPE REPROCESSOR MODEL ETD DOUBLE, USING PERACETIC ACID. THERE WAS NO REPORT OF INFECTION ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1217809 EVIS EXERA DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT OLYMPUS MEDICAL SYSTEMS CORP. TJF-160VR

    Patients

    Seq Age Sex Outcome Treatment
    1