BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 12573765 · Received October 4, 2021

    Report

    Report Number
    8010047-2021-12683
    Event Type
    Malfunction
    Date Received
    October 4, 2021
    Date of Event
    September 10, 2021
    Report Date
    December 10, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDS
    PMA / PMN Number
    K954451
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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, IT WAS PRESUMED THAT FOREIGN MATERIAL SUCH AS GAUZE, A PIECE OF PARTS FROM PERIPHERAL DEVICE, BODY FLUID, OR CHEMICAL AGENTS RESIDUES CLOGGED IN CHANNEL. - ACCORDING TO THE INSPECTION RESULT BY LOCAL SERVICE DEPARTMENT, AIR/WATER FLOW WAS NOT SMOOTH, AND THE NOZZLE WAS NOT DEFORMED. AFTER THE NOZZLE REPLACEMENT, AIR/WATER FLOW BECAME NORMAL. - AIR/WATER FLOW WAS RESOLVED BY REPLACING THE NOZZLE WITH A NEW ONE. - ACCORDING TO PAST SIMILAR CASES, FOREIGN MATERIALS SUCH AS GAUZE, A PIECE OF PARTS FROM PERIPHERAL DEVICE, BODY FLUID, OR CHEMICAL AGENTS RESIDUES SEEMINGLY CLOGGED IN NOZZLE DUE TO INAPPROPRIATE REPROCESSING AFTER PREVIOUS PROCEDURE. - IFU STATES AS FOLLOWS: * FLUSH WATER INTO AIR/WATER CHANNEL OF DEVICE DURING PRECLEANING TO REMOVE CLOGGING. * CLEAN EXTERNAL SURFACES OF DEVICE WITH SOFT BRUSH / LINT-FREE CLOTH OR SPONGES, PAYING ATTENTION TO NOZZLE OPENING SO THAT ALL DEBRIS IS REMOVED. * HOW TO FLUSH DETERGENT SOLUTION INTO A/W CHANNEL * HOW TO CLEAN DEVICE FOR EXCESSIVE BLEEDING AND/OR DELAYED REPROCESSING AFTER EACH PROCEDURE.

    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.

    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, THERE WAS A FOREIGN MATERIAL INSIDE THE NOZZLE. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1466986 EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS OLYMPUS MEDICAL SYSTEMS CORP. GIF-Q260J

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown