BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 12825072 · Received November 16, 2021

    Report

    Report Number
    8010047-2021-14638
    Event Type
    Malfunction
    Date Received
    November 16, 2021
    Report Date
    January 14, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDS
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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, OMSC PRESUMED THAT FOREIGN MATERIALS SUCH AS A PIECE OF PARTS FROM PERIPHERAL DEVICE, BODY FLUID, RESIDUES FROM USED CHEMICAL AGENTS CLOGGED IN NOZZLE DUE TO INAPPROPRIATE REPROCESSING AFTER PREVIOUS PROCEDURE. - ACCORDING TO THE INSPECTION RESULT BY LOCAL SERVICE DEPARTMENT, BLACK FOREIGN MATERIAL WAS IN THE NOZZLE. - ACCORDING TO PAST SIMILAR CASE, EVENT SEEMINGLY OCCURRED BECAUSE FOREIGN MATERIALS SUCH AS A PIECE OF PARTS FROM PERIPHERAL DEVICE, BODY FLUID, RESIDUES FROM USED CHEMICAL AGENTS CLOGGED IN NOZZLE DUE TO INAPPROPRIATE REPROCESSING AFTER PREVIOUS PROCEDURE. - IFU STATES AS FOLLOWS: * FLUSH WATER INTO A/W CHANNEL OF DEVICE DURING PRECLEANING TO REMOVE CLOGGING. * CLEAN EXTERNAL SURFACES OF DEVICE WITH SOFT BRUSH / LINT-FREE CLOTH / SPONGE 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 DIRT 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 ON OCTOBER 25, 2021, IT WAS FOUND THAT INSUFFICIENT OR INCORRECT REPROCESSING SCOPE WAS USED FOR NEXT PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1716860 EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS OLYMPUS MEDICAL SYSTEMS CORP. GIF-H190

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown