BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III COLONOVIDEOSCOPE

    MDR report key: 12992041 · Received December 13, 2021

    Report

    Report Number
    8010047-2021-16045
    Event Type
    Malfunction
    Date Received
    December 13, 2021
    Date of Event
    November 14, 2021
    Report Date
    January 31, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION TO SECTION B3 ON THE INITIAL REPORT: THE EVENT DATE IS (B)(6) 2021 WHEN THE CUSTOMER OBSERVED THE INITIAL COMPLAINT. THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THAT FOREIGN MATERIAL SUCH AS GAUZE, BODY FLUID, A CHEMICAL AGENT OR THE LIKE FELL IN THE AIR/WATER NOZZLE AND CAUSED IT TO BE CLOGGED. THE ROOT CAUSE OF WHY THE FOREIGN MATERIAL WAS FOUND IN THE AIR/WATER NOZZLE COULD NOT BE DETERMINED. THE FOLLOWING IS INCLUDED IN THE INSTRUCTIONS FOR USE (IFU) AND MAY HELP DETECT THE FOREIGN MATERIAL: "PREPARATION AND INSPECTION: -INSPECTION OF THE ENDOSCOPE: INSPECT THE AIR/WATER NOZZLE AT THE DISTAL END OF THE ENDOSCOPE¿S INSERTION SECTION FOR ABNORMAL SWELLING, BULGES, DENTS, OR OTHER IRREGULARITIES." THE FOLLOWING IS INCLUDED IN THE INSTRUCTIONS FOR USE (IFU) AND MAY HELP PREVENT THE FOREIGN MATERIAL FROM CLOGGING THE AIR/WATER NOZZLE: "REPROCESSING MANUAL_PRECLEANING THE ENDOSCOPE AND ACCESSORIES -WARNING: IF THE ENDOSCOPE AND ACCESSORIES USED IN THE PATIENT PROCEDURE ARE NOT IMMEDIATELY CLEANED AFTER EACH PATIENT PROCEDURE, RESIDUAL ORGANIC DEBRIS WILL BEGIN TO DRY AND SOLIDIFY, HINDERING EFFECTIVE REMOVAL AND REPROCESSING EFFICACY. PRECLEAN THE ENDOSCOPE AND THE ACCESSORIES AT THE BEDSIDE IMMEDIATELY AFTER EACH PATIENT PROCEDURE. - FLUSH THE AIR/WATER CHANNEL WITH WATER AND AIR CAUTION: TO PREVENT CLOGGING OF THE AIR/WATER NOZZLE OF THE ENDOSCOPE, FLUSH WATER INTO THE AIR CHANNEL OF THE ENDOSCOPE, USING THE AW CHANNEL CLEANING ADAPTER (MH-948) AFTER EACH PATIENT PROCEDURE. ·MANUALLY CLEANING THE ENDOSCOPE AND ACCESSORIES -CLEAN THE EXTERNAL SURFACE_ CLEAN THE EXTERNAL SURFACES OF THE INSERTION SECTION: WHILE IMMERSING THE ENDOSCOPE COMPLETELY IN THE DETERGENT SOLUTION, THOROUGHLY WIPE ALL EXTERNAL SURFACES OF THE INSERTION SECTION, USING CLEAN LINT-FREE CLOTHS OR SPONGES. -TAKE THE INSERTION SECTION OUT OF THE DETERGENT SOLUTION AND CONFIRM THAT NO DEBRIS REMAINS ON ALL EXTERNAL SURFACES, PARTICULARLY THE AIR/WATER NOZZLE OPENING AND THE OBJECTIVE LENS ON THE DISTAL END. -FLUSH THE AIR/WATER CHANNEL WITH DETERGENT SOLUTION - REMOVE DETERGENT SOLUTION FROM ALL CHANNELS ·PRESOAKING THE ENDOSCOPE IF THERE WAS EXCESSIVE BLEEDING DURING THE PATIENT PROCEDURE OR IF PRECLEANING COULD NOT BE PERFORMED IMMEDIATELY AFTER THE PATIENT PROCEDURE, PRESOAKING THE ENDOSCOPE IN DETERGENT SOLUTION BEFORE MANUALLY CLEANING THE ENDOSCOPE MAY BE REQUIRED TO WET AND LOOSEN DEBRIS THAT HAS DRIED AND HARDENED ONTO THE ENDOSCOPE¿S SURFACES. FOLLOW THE PROCEDURE DESCRIBED BELOW." OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE. INVESTIGATION ACTIVITIES HAVE BEEN OPENED TO MANAGE THE ACTIONS RELATED TO THIS REPORT AND ANY REQUIRED MDR REPORTING.

    Additional Manufacturer Narrative · 0

    THE EVENT DATE IS (B)(6) 2021, WHEN THE RESIDUE WAS NOTED ON THE CCD. THE REPORTER¿S CONTACT INFORMATION, OCCUPATION AND HEALTH PROFESSION ARE UNKNOWN AT THIS TIME. FURTHER INSPECTION OF THE DEVICE FOUND THE CCD UNIT ON THE CAMERA HEAD COULD NO LONGER BE DETACHED FROM THE ADAPTER. THE HOUSING OF THE CCD UNIT WAS BROKEN. THE THREAD WITH WHICH IT IS CONNECTED IS STILL STUCK IN THE OPTICS. THE CUSTOMER DID NOT REMOVE THE CCD UNIT FROM THE ADAPTER WHEN CLEANING THE CAMERA HEAD. CORROSION OCCURS ON THE THREAD OF THE CCD UNIT. DUE TO THIS THE CAMERA HEAD CAN NO LONGER BE DISMANTLED FROM THE ADAPTER. IN ADDITION, THE ADAPTER WAS CORRODED IN SEVERAL PLACES. THE ADAPTER WAS NOTED TO BE VERY WOBBLY. IT WAS DETERMINED TO BE WORN OUT. ALSO, THE STOPPER ON THE ADAPTER WAS BROKEN. AN INVESTIGATION IS ONGOING TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. IF ADDITIONAL INFORMATION IS RECEIVED THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A PROBLEM WITH SCOPES AIR/WATER CHANNEL. THERE WAS NO PATIENT INJURY REPORTED. THE DEVICE WAS RETURNED FOR EVALUATION AND FOREIGN MATERIAL WAS NOTED EXITING THE AIR/WATER NOZZLE. THIS REPORT IS BEING SUBMITTED TO ADDRESS THE FOREIGN MATERIAL NOTED IN THE NOZZLE DURING EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1884315 EVIS EXERA III COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF OLYMPUS MEDICAL SYSTEMS CORP. CF-H185I

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown