BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III COLONOVIDEOSCOPE

    MDR report key: 11574267 · Received March 25, 2021

    Report

    Report Number
    MW5100272
    Event Type
    Malfunction
    Date Received
    March 25, 2021
    Date of Event
    February 19, 2021
    Report Date
    March 23, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FDF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING PROCEDURE ERROR CODE APPEARED ON SCREEN E216. MD COULD NOT TAKE IMAGES FROM SCOPE PHOTO BUTTON. TECHNICIAN ABLE TO TAKE IMAGES USING MOUSE ON COMPUTER SCREEN IMAGES ABLE TO UPLOAD AND SAVE IN CHART. MD WAS USING ADULT COLONOVIDEOSCOPE COMPUTER SCREENS (THE MD SCREEN AND THE TECHNICIAN SCREEN) WITH CAMERA IMAGES WENT BLACK BUT COULD STILL ACCESS PATIENT CHART AND PACS SYSTEM DURING PROCEDURE. FDA SAFETY REPORT ID#: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469721 EVIS EXERA III COLONOVIDEOSCOPE COLONOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FDF OLYMPUS MEDICAL SYSTEMS CORPORATION CFHQ190L

    Patients

    Seq Age Sex Outcome Treatment
    1