BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA ELITE COLONOVIDEOSCOPE

    MDR report key: 13540397 · Received February 16, 2022

    Report

    Report Number
    8010047-2022-03022
    Event Type
    Malfunction
    Date Received
    February 16, 2022
    Date of Event
    August 3, 2021
    Report Date
    March 22, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    LOCAL SERVICE DEPARTMENT CHECKED THE SUBJECT DEVICE AND FOUND THE PHENOMENON. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 0

    THIS IS A SUPPLEMENTAL REPORT TO PROVIDE ADDITIONAL INFORMATION. THE MANUFACTURING RECORD WAS REVIEWED AND FOUND NO IRREGULARITIES. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. BASED ON THE FOLLOWING INFORMATION, OMSC PRESUMED THAT DETERGENT SOLUTION/ STERILIZER/ USED CHEMICAL AGENTS, ETC. REMAINED AND CLOGGED IN NOZZLE DUE TO INAPPROPRIATE REPROCESSING AFTER PREVIOUS PROCEDURE. * ACCORDING TO THE INSPECTION RESULT BY LOCAL SERVICE DEPARTMENT, THE FOLLOWING WERE CONFIRMED. - A/W NOZZLE WAS CLOGGED WITH YELLOW FINE PARTICLES. - THE FOREIGN MATERIAL COULD BE REMOVED. - THE FOREIGN MATERIAL WAS ASSUMED TO BE GLUTARALDEHYDE CRYSTALS. * ACCORDING TO THE PAST SIMILAR CASE, FOREIGN MATERIAL SUCH AS RESIDUES FROM USED CHEMICAL AGENTS MAY HAVE CLOGGED IN NOZZLE DUE TO INAPPROPRIATE REPROCESSING AFTER PREVIOUS PROCEDURE. * IFU STATES THE FOLLOWING. - HOW TO REMOVE DETERGENT SOLUTION FROM CHANNEL - HOW TO RINSE DEVICE AFTER STERILIZATION NO MORE INFORMATION CAN BE PROVIDED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 0

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT DURING THE INCOMING INSPECTION FOR REPAIR AT LOCAL SERVICE DEPARTMENT OF OLYMPUS, IT WAS FOUND THAT THE NOZZLE WAS CLOGGED BY YELLOW FINE PARTICLES WHICH WAS SUSPECTED TO BE GLUTARALDEHYDE CRYSTALS. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17089 EVIS LUCERA ELITE COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF OLYMPUS MEDICAL SYSTEMS CORP. CF-HQ290I

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown