BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA ELITE COLONOVIDEOSCOPE

    MDR report key: 12573796 · Received October 4, 2021

    Report

    Report Number
    8010047-2021-12684
    Event Type
    Malfunction
    Date Received
    October 4, 2021
    Report Date
    October 5, 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

    THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THE MANUFACTURING RECORD WAS REVIEWED AND FOUND NO IRREGULARITIES. THERE WAS A WHITE FOREIGN MATERIAL STUCK INSIDE THE NOZZLE. THE COMPONENT OF FOREIGN MATERIAL WAS ANALYZED. AS A RESULT, THE MAIN COMPONENT WAS SILICONE. OMSC PRESUMED THAT SILICONE-BASED DRUGS SUCH AS ANTIFOAMING AGENTS AND CLEANING AGENTS USED DURING THE PROCEDURE AND CLEANING REMAINED AFTER REPROCESSING.

    Description of Event or Problem · 0

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED BY THE CUSTOMER THAT THERE WAS AIR/WATER FLOW ISSUE. THE SUBJECT DEVICE WAS RETURNED TO OMSC FOR EVALUATION. OMSC CHECKED THE SUBJECT DEVICE AND FOUND THAT THERE WAS A FOREIGN MATERIAL IN THE NOZZLE ON (B)(6) 2021. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1468415 EVIS LUCERA ELITE COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF OLYMPUS MEDICAL SYSTEMS CORP. CF-H290I

    Patients

    Seq Age Sex Outcome Treatment
    1