BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE

    MDR report key: 8538334 · Received April 22, 2019

    Report

    Report Number
    8010047-2019-01757
    Event Type
    Malfunction
    Date Received
    April 22, 2019
    Date of Event
    March 18, 2019
    Report Date
    May 15, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    ODG
    UDI-DI
    04953170287879
    PMA / PMN Number
    K093395
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) BUT WAS RETURNED TO OLYMPUS FRANCE (OFR). OFR SENT THE DEVICE TO A THIRD PARTY LABORATORY FOR MICROBIOLOGICAL TESTING. THE ADDITIONAL MICROBIOLOGICAL TESTING INDICATED NO MICROBIAL GROWTH FOR THE ALL CHANNEL OF THE DEVICE. THEREFORE, THE TESTING RESULT CLEARED THE FRENCH GUIDELINE. OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) REVIEWED THE MANUFACTURING HISTORY (DHR) OF THE DEVICE AND CONFIRMED NO IRREGULARITY. IN ADDITION, "DEVICE MANUFACTURER DATE" OF THE DEVICE WAS AUGUST 21, 2014. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO OMSC FOR EVALUATION.THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT AS A RESULT OF MICROBIOLOGICAL TESTING BY THE USER FACILITY, THE SAMPLE COLLECTED FROM THE SUBJECT DEVICE TESTED POSITIVE FOR KLEBSIELLA OVARIICOLA (>100 CFU/100ML), ENTEROBACTER CLOACAE (>100 CFU/100ML) AND STENOTROPHOMONAS MALTOPHILIA (>100 CFU/100ML). THE DEVICE HAD BEEN REPROCESSED USING A NON-OLYMPUS AUTOMATED ENDOSCOPE REPROCESSOR MODEL SOLUSCOPE S4 WITH PERACETIC ACID. THERE WAS NO REPORT OF INFECTION ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331392 EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE ULTRASOUND GASTROVIDEOSCOPE ODG OLYMPUS MEDICAL SYSTEMS CORP. GF-UCT180 04953170287879

    Patients

    Seq Age Sex Outcome Treatment
    1