BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASONIC GASTROVIDEOSCOPE

    MDR report key: 9804103 · Received March 9, 2020

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    Report

    Report Number
    8010047-2020-01695
    Event Type
    Malfunction
    Date Received
    March 9, 2020
    Report Date
    May 14, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    ODG
    PMA / PMN Number
    K051541
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OMSC BUT WAS RETURNED TO OLYMPUS FRANCE.(OFR). OFR SENT THE DEVICE TO A THIRD PARTY LABORATORY FOR MICROBIOLOGICAL TESTING. AS A RESULT OF THE TESTING, THE SAMPLE COLLECTED FROM THE ALL CHANNELS OF THE DEVICE TESTED POSITIVE FOR COAGULASE-NAGATIVE STAPHYLOCCOCCI (1 CFU/ENDOSCOPE) THE TESTING RESULT CLEARED THE FRENCH GUIDELINE. 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.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. OMSC REVIEWED THE MANUFACTURING HISTORY (DHR) OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE DEVICE HAD BEEN REPROCESSED WITH A NON-OLYMPUS AUTOMATED ENDOSCOPE REPROCESSOR, WD440, USING PERACETIC ACID. THERE WAS NO REPORT OF INFECTION ASSOCIATED WITH THIS REPORT.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE IN THIS REPORT 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 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, FOLLOWING MICROBES WERE DETECTED FROM THE SAMPLE COLLECTED FROM THE SUBJECT DEVICE. FIRST TIME; FEBRUARY 5TH, 2020; COAGULASE-NEGATIVE STAPHYLOCCOCCI (>100 CFU/100ML), SECOND TIME; FEBRUARY 7TH, 2020, KOCURIA RHIZOPHILA AND KLEBSIELLA OXYTOCA (THE TOTAL CFU OF THE KOCURIA RHIZOPHILA AND KLEBSIELLA OXYTOCA IS 4 CFU/100ML), THE DEVICE HAD BEEN REPROCESSED USING PERACETIC ACID. THERE WAS NO REPORT OF INFECTION ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268460 ULTRASONIC GASTROVIDEOSCOPE ULTRASONIC GASTROVIDEOSCOPE ODG OLYMPUS MEDICAL SYSTEMS CORP. GF-UE160-AL5

    Patients

    Seq Age Sex Outcome Treatment
    1