BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 7008584 · Received November 7, 2017

    Report

    Report Number
    8010047-2017-01676
    Event Type
    Malfunction
    Date Received
    November 7, 2017
    Report Date
    March 3, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. BUT WAS RETURNED TO OLYMPUS (B)(4). FOLLOWING ADDITIONAL HIGH LEVEL DISINFECTION AT (B)(4), THE SUBJECT DEVICE WAS SENT TO A THIRD PARTY LABORATORY FOR ADDITIONAL MICROBIOLOGICAL TESTING. IN THE ADDITIONAL TEST, UNSPECIFIED BACTERIA (15CFU/CHANNEL) WERE DETECTED FROM THE AIR/WATER CHANNEL OF SUBJECT DEVICE. THE TEST RESULT CLEARED THE (B)(4) GUIDELINE. OMSC REVIEWED THE MANUFACTURING HISTORY OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. 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

    THIS SUPPLEMENTAL REPORT IS SUBMITTING TO CORRECT "DEVICE PRODUCT CODE".

    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 INSTRUMENT CHANNEL OF THE SUBJECT DEVICE TESTED POSITIVE FOR STENOTROPHOMONAS MALTOPHILIA (50CFU/20ML) AND THE AIR/WATER CHANNEL OF THE SUBJECT DEVICE TESTED POSITIVE FOR STENOTROPHOMONAS MALTOPHILIA (15CFU/20ML). THE SUBJECT DEVICE HAD BEEN DISINFECTED USING AN OLYMPUS AUTOMATED ENDOSCOPE REPROCESSOR MODEL ETD 3 BASIS (NOT AVAILABLE IN THE U.S.) WITH GLUTARALDEHYDE. THERE WAS NO REPORT OF INFECTION ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785887 EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS OLYMPUS MEDICAL SYSTEMS CORP. GIF-H185

    Patients

    Seq Age Sex Outcome Treatment
    1