BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 15034008 · Received July 15, 2022

    Report

    Report Number
    9610595-2022-00044
    Event Type
    Malfunction
    Date Received
    July 15, 2022
    Report Date
    August 11, 2022
    Manufacturer
    AIZU- AIZU OLYMPUS CO., LTD.
    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

    THE SUBJECT DEVICE WAS RECEIVED AND EVALUATED. DEVICE INSPECTION AND EVALUATION , SERVICE FOUND NOZZLE HAS FOREIGN OBJECTS. IN ADDITION, IT WAS NOTED THAT CUSTOMER COMPLAINT OF BENDING TUBE COMPRESSED WAS NOT FOUND, HOWEVER, DENT ON CH-TUBE (CHANNEL TUBE) WAS FOUND. DUE TO DENT ON THE CH-TUBE, FORCEPS CANNOT BE INSERTED SMOOTHLY. FURTHERMORE, THE FOLLOWING FINDINGS DURING DEVICE EVALUATION WERE NOTED : C-COVER IS SHAVED . ADHESIVE ON A-RUBBER HAS A CRACK . A-RUBBER HAS DISCOLORATION . CONNECTING TUBE HAS A SCRATCH . UNIVERSAL CORD HAS A SCRATCH. S-CONNECTOR HAS A DENT . PLUG UNIT HAS A SCRATCH , BENDING ANGLE DOES NOT MEET THE STANDARD VALUE. INVESTIGATION IS ONGOING. THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY FOLLOWING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    CORRECTION: E1 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, A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED. THE SUGGESTED PHENOMENON WAS PRESUMED TO HAVE BEEN DUE TO IMPROPER REPROCESSING OF THE DEVICE, AS IT WAS DEEMED POSSIBLE TO REMOVE THE FOREIGN MATERIAL FROM THE NOZZLE IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). THE USER CAN DETECT THE SUGGESTED EVENT PROPERLY BY HANDLING THE DEVICE IN ACCORDANCE WITH THE FOLLOWING IFU STATEMENT: ¿·OPERATION MANUAL_ 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 ·OPERATION MANUAL_ INSPECTION OF THE ENDOSCOPIC SYSTEM - INSPECTION OF THE AIR-FEEDING FUNCTION - INSPECTION OF THE OBJECTIVE LENS CLEANING FUNCTION¿ THE USER CAN REDUCE AND PREVENT OCCURRENCE OF THE SUGGESTED EVENT BY HANDLING THE DEVICE IN ACCORDANCE WITH THE FOLLOWING IFU STATEMENT: ¿·REPROCESSING MANUAL_ 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_ CLEAN THE EXTERNAL SURFACES OF THE INSERTION SECTION * IMMERSE THE ENDOSCOPE IN THE DETERGENT SOLUTION. * THOROUGHLY BRUSH OR WIPE ALL EXTERNAL SURFACES OF THE ENDOSCOPE, USING CLEAN LINT-FREE CLOTHS, BRUSHES, OR SPONGES. PAY PARTICULAR ATTENTION TO THE AIR/WATER NOZZLE OPENING AND THE OBJECTIVE LENS ON THE DISTAL END OF THE INSERTION SECTION, AND CONFIRM THAT ALL DEBRIS IS REMOVED FROM ALL SURFACES OF THE DISTAL END. - FLUSH THE AIR/WATER CHANNEL WITH DETERGENT SOLUTION - PRESOAKING THE ENDOSCOPE¿ OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    CUSTOMER REPORTED WITH AN ISSUE OF "COMPRESSION ON BENDING UNIT". THE ISSUE FOUND DURING AN UNKNOWN EVENT. THERE WAS NO PATIENT HARM, NO USER INJURY REPORTED . DEVICE EVALUATION FOUND NOZZLE HAS FOREIGN OBJECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    959567 EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS AIZU- AIZU OLYMPUS CO., LTD. GIF-H190

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown