BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA ELITE COLONOVIDEOSCOPE

    MDR report key: 12258714 · Received August 2, 2021

    Report

    Report Number
    8010047-2021-09649
    Event Type
    Malfunction
    Date Received
    August 2, 2021
    Report Date
    August 2, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THEREFORE, THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. THE MANUFACTURING RECORD WAS REVIEWED AND FOUND NO IRREGULARITIES. OMSC PRESUMED THAT THE THE PHENOMENON WAS DUE TO INSUFFICIENT REPROCESSSING OR USER'S HANDLING.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT DURING THE INCOMING INSPECTION FOR REPAIR AT OLYMPUS SERVICE OPERATION REPAIR CENTER (SORC) ON JULY 15, 2021, THE CLIP WAS FOUND IN THE CHANNEL. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1158239 EVIS LUCERA ELITE COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF OLYMPUS MEDICAL SYSTEMS CORP. CF-HQ290ZI

    Patients

    Seq Age Sex Outcome Treatment
    1