BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA ELITE COLONOVIDEOSCOPE

    MDR report key: 8853918 · Received August 2, 2019

    Report

    Report Number
    8010047-2019-02800
    Event Type
    Malfunction
    Date Received
    August 2, 2019
    Date of Event
    July 8, 2019
    Report Date
    October 1, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE SUBJECT DEVICE EVALUATION RESULT. THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. IN THE EVALUATION, OMSC CONFIRMED THE FOLLOWING: INSUFFICIENT ANGULATION RANGE FOR SPECIFICATION, THE ANGULATION CONTROL KNOB WAS LOOSE, MISSING PART OF THE GLUE ON THE BENDING RUBBER, FOREIGN MATERIAL ATTACHED ON THE UNIVERSAL CODE, FOREIGN MATERIAL IN THE INSTRUMENT CHANNEL. 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 SUBJECT DEVICE WAS RETURNED TO OMSC FOR EVALUATION. AS THE EVALUATION IS IN PROGRESS, THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. OMSC REVIEWED THE MANUFACTURING HISTORY (DHR) OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. 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 ROUTINE MICROBIOLOGICAL TESTING BY THE USER FACILITY, THE SAMPLE COLLECTED FROM THE SUCTION CHANNEL AND THE INSTRUMENT CHANNEL OF THE SUBJECT DEVICE TESTED POSITIVE FOR THE PSEUDOMONAS AERUGINOSA AND THE ENTEROCOCCI. THE DEVICE HAD BEEN REPROCESSED WITH AN OLYMPUS AUTOMATED ENDOSCOPE REPROCESSOR MODEL OER-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
    649263 EVIS LUCERA ELITE COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF OLYMPUS MEDICAL SYSTEMS CORP. PCF-H290I

    Patients

    Seq Age Sex Outcome Treatment
    1