BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 15033874 · Received July 15, 2022

    Report

    Report Number
    9610595-2022-00043
    Event Type
    Malfunction
    Date Received
    July 15, 2022
    Report Date
    September 1, 2022
    Manufacturer
    AIZU- AIZU OLYMPUS CO., LTD.
    Product Code
    FDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDRESS: THE FULL NAME OF THE CUSTOMER ESTABLISHMENT IS (B)(6). THE SUBJECT DEVICE WAS EVALUATED. CUSTOMER NOTED WITH ISSUE OF CRACK/CHIPPING/GAP OF ADHESIVE ON THE INSERTION SECTION NOTED ON REPAIR REQUEST RECEIVED BY SERVICE. DEVICE INSPECTION FOUND AIR WATER CHANNEL IS CLOGGED WITH FOREIGN MATERIAL. FURTHERMORE, THE FOLLOWING FINDINGS WERE NOTED DURING INSPECTION. INSERTION PART DISTAL END C-COVER CRACKED FOUND. INSERTION PART A RUBBER GLUE SEPARATED. INSERTION PART BENDING TUBE FOUND DEFORMED INSERTION PART CONNECTING TUBE BUCKLES NOTED. CONTROL UNIT GRIP UNIT SCRATCHED NOTED. CONTROL UNIT SCOPE COVER SCRATCHED NOTED. CONTROL UNIT AIR /WATER NUT PAINTING PEEL OFF. SWITCH SECTION SWITCH BOX UNIT SCRATCHED. UNIVERSAL CORD -SCRATCH. CONNECTOR SCOPE CONNECTOR COVER -DAMAGED. CONNECTOR PLUG UNIT -DAMAGED HOUSING FOUND. CONTROL UNIT WIRE STOPPER ANGULATION LESS OR SPECIFIED VALUE NOTED. WATER CONTACT / WATER REMOVAL SPEC. VALUE (LESS THAN THE SPECS VALUE). AIR FUNCTION SPECIFY AIR FLOW (ML/MIN) FAILED. WATER FUNCTION SPECIFY WATER FLOW (ML/MIN) FAILED. INVESTIGATION IS ONGOING. THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY FOLLOWING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    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, THE ROOT CAUSE OF THE REPORTED EVENT IS UNABLE TO BE DETERMINED. HOWEVER, THE CAUSE OF THE EVENT IS LIKELY DUE TO INAPPROPRIATE OR INSUFFICIENT REPROCESSING METHODS OR HANDLING THE EVENT CAN BE DETECTED BY FOLLOWING THE INSTRUCTIONS FOR USE (IFU) WHICH STATE: OPERATION MANUAL_ PREPARATION AND INSPECTION OF THE ENDOSCOPE: ¿INSPECT THE EXTERNAL SURFACE OF THE ENTIRE INSERTION SECTION INCLUDING THE BENDING SECTION AND THE DISTAL END FOR DENTS, BULGES, SWELLING, SCRATCHES, HOLES, SAGGING, TRANSFORMATION, BENDS, ADHESION OF FOREIGN BODIES, MISSING PARTS, PROTRUDING OBJECTS, OR OTHER IRREGULARITIES.¿ ¿ INSPECTION OF THE ENDOSCOPIC SYSTEM¿. ¿ INSPECTION OF THE AIR-FEEDING FUNCTION¿. ¿ INSPECTION OF THE OBJECTIVE LENS CLEANING FUNCTION¿. IFU SAYS ABOUT REPROCESSING ON A/W CHANNEL AS BELOW: ·REPROCESSING MANUAL_ REPROCESSING THE ENDOSCOPE (AND RELATED REPROCESSING ACCESSORIES)_ PRECLEANING THE ENDOSCOPE AND ACCESSORIES 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¿. ¿FLUSH THE AIR/WATER CHANNEL WITH DETERGENT SOLUTION. ¿REMOVE DETERGENT SOLUTION FROM ALL CHANNELS. ¿PRESOAK FOR EXCESSIVE BLEEDING AND/OR DELAYED REPROCESSING AFTER EACH PROCEDURE¿"). IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING ANNUAL PERIODIC TECHNICAL INSPECTION, THE A/W (AIR/WATER) CHANNEL IS CLOGGED. THERE WAS NO PATIENT HARM, NO USER INJURY REPORTED DUE TO THE EVENT.

    Description of Event or Problem · 0

    A USER FACILITY REPORTED TO OLYMPUS THEIR EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE A/W (AIR/WATER) CHANNEL IS CLOGGED. UPON INSPECTION AND TESTING OF THE CUSTOMER RETURNED DEVICE, IT WAS OBSERVED HAVING RED FOREIGN MATERIAL EXITING FROM THE CHANNEL. THIS REPORT IS BEING SUBMITTED FOR THE MALFUNCTION FOUND DURING EVALUATION. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2892427 EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS AIZU- AIZU OLYMPUS CO., LTD. GIF-H185

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown