BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA DUODENOVIDEOSCOPE

    MDR report key: 6947138 · Received October 13, 2017

    Report

    Report Number
    8010047-2017-01460
    Event Type
    Malfunction
    Date Received
    October 13, 2017
    Date of Event
    September 13, 2017
    Report Date
    February 22, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDT
    PMA / PMN Number
    PK954451
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. BUT WAS RETURNED TO OLYMPUS EUROPA SE & CO. KG (OEKG). FOLLOWING ADDITIONAL HIGH LEVEL DISINFECTION AT OEKG, THE SUBJECT DEVICE WAS SENT TO A THIRD PARTY LABORATORY FOR ADDITIONAL MICROBIOLOGICAL TESTING. IN THE ADDITIONAL TEST, THE TESTING INDICATED NO MICROBIAL GROWTH FOR THE SUBJECT DEVICE. OEKG CONFIRMED THAT THE OBJECTIVE LENS AND LG LENS WERE CRACKED, AND THE BENDING TUBE WAS DAMAGED. 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.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT DURING A SURVEILLANCE CULTURING TEST BY THE FACILITY, THE SUBJECT DEVICE TESTED POSITIVE FOR PSEUDOMONAS AERUGINOSA(98CFU/ML). THE SUBJECT DEVICE HAD BEEN DISINFECTED USING AN OLYMPUS AUTOMATED ENDOSCOPE REPROCESSR MODEL ETD-3 (NOT AVAILABLE IN THE U.S.) WITH PERACETIC ACID. THERE WAS NO REPORT OF INFECTION ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729787 EVIS EXERA DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT OLYMPUS MEDICAL SYSTEMS CORP. TJF-145

    Patients

    Seq Age Sex Outcome Treatment
    1