BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA ELITE COLONOVIDEOSCOPE

    MDR report key: 12718113 · Received October 29, 2021

    Report

    Report Number
    8010047-2021-13812
    Event Type
    Malfunction
    Date Received
    October 29, 2021
    Report Date
    October 29, 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 · 0

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) COULD NOT INVESTIGATE THE SUBJECT DEVICE, BECAUSE THE SUBJECT DEVICE WAS NOT RETURNED TO OMSC. DEVICE HISTORY RECORD REVIEW INDICATES THAT THE PRODUCT WAS MANUFACTURED AND TESTED IN ACCORDANCE WITH ALL APPLICABLE PROCEDURES AND MET ALL FINAL PRODUCT RELEASE CRITERIA. SINCE THE SUBJECT DEVICE WAS NOT RETURNED TO OMSC, THE EXACT CAUSE WAS UNKNOWN. OMSC SURMISED THAT THE REPORTED PHENOMENON OCCURRED DUE TO THE INSUFFICIENT REPROCESSING OR USER HANDLING.

    Description of Event or Problem · 0

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT DURING THE INCOMING INSPECTION FOR REPAIR AT OLYMPUS SERVICE OPERATION REPAIR CENTER (SORC) ON OCTOBER 7, 2021, IT WAS FOUND THAT THE NOZZLE OF THE SUBJECT DEVICE WAS CLOGGED WITH FOREIGN MATERIAL. OTHER DETAILED INFORMATION WAS NOT PROVIDED. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1615960 EVIS LUCERA ELITE COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF OLYMPUS MEDICAL SYSTEMS CORP. CF-HQ290I

    Patients

    Seq Age Sex Outcome Treatment
    1