BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 17437610 · Received August 1, 2023

    Report

    Report Number
    9610595-2023-10944
    Event Type
    Malfunction
    Date Received
    August 1, 2023
    Report Date
    August 23, 2023
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. BASED ON THE RESULTS OF THE INVESTIGATION, WE COULD NOT SPECIFY THE CAUSE OF THE FOREIGN MATERIAL REMAINING IN THE DEVICE SINCE IT WAS UNKNOWN IF REPROCESSING WAS CONDUCTED IN ACCORDANCE WITH INSTRUCTIONS FOR USE (IFU). HOWEVER, THE CAUSE OF THE EVENT IS LIKELY DUE TO INSUFFICIENT OR INADEQUATE REPROCESSING. THE ROOT CAUSE OF THE REPORTED EVENT IS UNABLE TO BE DETERMINED. THE EVENT CAN BE DETECTED BY FOLLOWING THE IFU SECTIONS WHICH STATE: CHAPTER 3 PREPARATION AND INSPECTION ¿3.2 INSPECTION OF THE ENDOSCOPE¿ AND ¿3.6 INSPECTION OF THE ENDOSCOPIC SYSTEM". [INSPECTION OF THE ENDOSCOPE] 1. INSPECT THE CONTROL SECTION AND THE ENDOSCOPE CONNECTOR FOR EXCESSIVE SCRATCHING, DEFORMATION, LOOSE PARTS, OR OTHER IRREGULARITIES. 3. INSPECT THE EXTERNAL SURFACE OF THE ENTIRE INSERTION TUBE INCLUDING THE BENDING SECTION AND THE DISTAL END FOR DENTS, BULGES, SWELLING, SCRATCHING, HOLES, SAGGING, TRANSFORMATION, BENDS, ADHESION OF FOREIGN BODIES, DROPOUT OF PARTS, ANY PROTRUDING OBJECTS, OR OTHER IRREGULARITIES. ¿INSPECTION OF THE SUCTION FUNCTION¿ 2. IMMERSE THE DISTAL END OF THE INSERTION TUBE IN STERILE WATER WITH THE ENDOSCOPE¿S INSTRUMENT CHANNEL PORT AT THE SAME HEIGHT AS THE WATER LEVEL IN THE WATER CONTAINER. PRESS THE SUCTION VALVE AND CONFIRM THAT WATER IS CONTINUOUSLY ASPIRATED INTO THE SUCTION BOTTLE OF THE SUCTION PUMP. ¿INSPECTION OF THE INSTRUMENT CHANNEL] 1. INSERT THE ENDO-THERAPY ACCESSORY THROUGH THE BIOPSY VALVE. CONFIRM THAT THE ENDO-THERAPY ACCESSORY EXTENDS SMOOTHLY FROM THE DISTAL END. ALSO MAKE SURE THAT NO FOREIGN OBJECTS COME OUT OF THE DISTAL END. 2. CONFIRM THAT THE ENDO-THERAPY ACCESSORY IS WITHDRAWN SMOOTHLY FROM THE BIOPSY VALVE. " CHAPTER 3 PREPARATION AND INSPECTION 3.2 INSPECTION OF THE ENDOSCOPE ". [INSPECTION OF THE ENDOSCOPE] 1. INSPECT THE CONTROL SECTION AND THE ENDOSCOPE CONNECTOR FOR EXCESSIVE SCRATCHING, DEFORMATION, LOOSE PARTS, OR OTHER IRREGULARITIES. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    THE OLYMPUS REPRESENTATIVE REPORTED (ON BEHALF OF THE CUSTOMER) THAT THE EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE HAD A DEFECTIVE FREEZE BUTTON AND SCREEN NOISE ON THE DISPLAY. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT. DURING THE EVALUATION OF THE DEVICE, IT WAS NOTED THAT FOREIGN MATTER WAS FOUND INSIDE THE SUCTION CHANNEL AND FOREIGN MATTER INSIDE THE PIPE OF THE SCOPE CONNECTOR. THIS REPORT IS TO CAPTURE THE REPORTABLE MALFUNCTION OF THE FOREIGN MATTER INSIDE THE SUCTION CHANNEL AND SCOPE CONNECTOR NOTED AT ESTIMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2336183 EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS AIZU OLYMPUS CO., LTD. GIF-XP260NS

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown