BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 10925608 · Received December 1, 2020

    Report

    Report Number
    8010047-2020-09628
    Event Type
    Malfunction
    Date Received
    December 1, 2020
    Report Date
    January 13, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDS
    UDI-DI
    04953170066610
    PMA / PMN Number
    K954451
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. OMSC REVIEWED THE MANUFACTURING HISTORY (DHR) OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. THE EXACT CAUSE OF THE REPORTED PHENOMENON COULD NOT BE CONCLUSIVELY DETERMINED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO OMSC BUT WAS RETURNED TO OLYMPUS (B)(4) (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 DISTAL END, THE INSTRUMENT CHANNEL AND THE AIR/WATER CHANNEL OF THE DEVICE. THE TESTING RESULT CLEARED THE GERMAN 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.

    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; (B)(6) 2019] THE INSTRUMENT CHANNEL YELLOW: COAGULASE-NEGATIVE STAPHYLOCOCCI (<1 KBE/ML) [SECOND TIME; (B)() 2019] THE INSTRUMENT CHANNEL RED: BACILLUS SPECIES (<1 KBE/ML) THE INSTRUMENT CHANNEL YELLOW: MORAXELLA OSLOENSIS (<1 KBE/ML) [THIRD TIME; (B)(6) 2020] THE DISTAL END: COAGULASE-NEGATIVE STAPHYLOCOCCUS (2) THE INSTRUMENT CHANNEL RED: OXIDASE-NEGATIVE, GRAM NEGATIVE STABCHEN (4 KBE/ML) THE INSTRUMENT CHANNEL YELLOW: OXIDASE-NEGATIVE, GRAM NEGATIVE STABCHEN (4 KBE/ML) THE DEVICE HAD BEEN REPROCESSED WITH AN OLYMPUS AUTOMATED ENDOSCOPE REPROCESSOR MODEL ETD-3 (NOT AVAILABLE IN THE USA) USING PERACETIC ACID. THERE WAS NO REPORT OF INFECTION ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1392350 EVIS EXERA GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS OLYMPUS MEDICAL SYSTEMS CORP. GIF-2T160 04953170066610

    Patients

    Seq Age Sex Outcome Treatment
    1