BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA ELITE GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 12057020 · Received June 24, 2021

    Report

    Report Number
    8010047-2021-07925
    Event Type
    Malfunction
    Date Received
    June 24, 2021
    Report Date
    June 24, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS TRANSFERRED TO OMSC. OMSC REVIEWED THE MANUFACTURE HISTORY (DHR) OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. OMSC CHECKED THE SUBJECT DEVICE AND FOUND RED-BROWN LIQUID WHICH WAS PARTIALLY DRIED IN THE AIR/WATER CHANNEL. AS A RESULT OF ANALYSIS OF RED-BROWN LIQUID, PROTEIN WAS DETECTED. BASED UPON THE RESULT OF ANALYSIS OF RED-BROWN LIQUID, THERE WAS THE POSSIBILITY THAT THE DETECTED PROTEIN MIGHT BE DERIVED FROM HUMAN, MEDICAL AGENT AND/OR BACTERIA AND SO ON. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM THE USER THAT DURING THE UNSPECIFIED TIMING, IT WAS FOUND THE AIR/WATER NOZZLE OF THE SUBJECT DEVICE WAS CLOGGED. DURING REPAIR AT OLYMPUS SERVICE OPERATION REPAIR CENTER (SORC), SORC FOUND THAT THE FOREIGN MATERIAL CLOGGED IN THE AIR/WATER CHANNEL. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    958477 EVIS LUCERA ELITE GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS OLYMPUS MEDICAL SYSTEMS CORP. GIF-XP290N

    Patients

    Seq Age Sex Outcome Treatment
    1