BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA ELITE GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 8783439 · Received July 11, 2019

    Report

    Report Number
    8010047-2019-02516
    Event Type
    Malfunction
    Date Received
    July 11, 2019
    Date of Event
    June 16, 2019
    Report Date
    August 29, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDS
    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 DEVICE EVALUATION RESULT. THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. FOR EVALUATION. IN THE EVALUATION, OMSC CONFIRMED THE FOLLOWINGS; INSUFFICIENT ANGULATION RANGE FOR SPECIFICATION. MISSING THE GLUE ON THE BENDING RUBBER. SCRATCHES ON THE INSIDE OF THE INSTRUMENT CHANNEL. FOREIGN MATERIALS ON THE UNIVERSAL CORD, THE SUCTION CYLINDER, AND THE INSTRUMENT CHANNEL PORT. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. THE SUBJECT DEVICE IS PLANNED TO BE REPAIRED.

    Additional Manufacturer Narrative · 1

    THE SUBJECT GIF-HQ290 WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THE EVALUATION IS IN PROGRESS. 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 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 ROUTINE MICROBIOLOGICAL TESTING BY THE USER FACILITY, FOLLOWING MICROBES WERE DETECTED FROM THE SAMPLE COLLECTED FROM THE SUBJECT DEVICE: [FIRST TIME; (B)(6) 2019]: SUCTION CHANNEL AND/OR INSTRUMENT CHANNEL: PSEUDOMONAS AERUGINOSA (5CFU). [SECOND TIME; (B)(6) 2019]: A PART OF THE DEVICE NOT IDENTIFIED: PSEUDOMONAS AERUGINOSA (13CFU).: PSEUDOMONAS AERUGINOSA (13CFU). THE DEVICE HAD BEEN REPROCESSED WITH ENDOCLENS D USING PHTHARAL. THERE WAS NO REPORT OF INFECTION ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576690 EVIS LUCERA ELITE GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS OLYMPUS MEDICAL SYSTEMS CORP. GIF-HQ290

    Patients

    Seq Age Sex Outcome Treatment
    1