BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BX53 FRAME

    MDR report key: 9731397 · Received February 20, 2020

    Report

    Report Number
    3004182751-2020-00002
    Event Type
    Malfunction
    Date Received
    February 20, 2020
    Date of Event
    December 25, 2019
    Report Date
    March 26, 2020
    Manufacturer
    OLYMPUS CORPORATION
    Product Code
    IBJ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS ACTION: VISITED THE CUSTOMER ON DECEMBER 25, 2019 AND CHECKED THE SITUATION. FIND OUT: ON OCTOBER 15, 2019, OLYMPUS ACTED IN CUSTOMER'S BEHALF SETTING UP THE COMPONENTS WHICH CONSIST OF THE BX53 (MICROSCOPE), DP71 (DIGITAL CAMERA) AND CELLSENS (IMAGING SOFTWARE) UPON CUSTOMER REQUEST. OLYMPUS HAS SET UP 5 SYSTEMS. AT THAT TIME, THE MAGNIFICATION SETTING ON THE IMAGING SOFTWARE FOR EACH SYSTEM NEEDED TO SET TO 0.5X, BUT INCORRECTLY SET TO 1X FOR ONE SYSTEM, SO THE MEASUREMENT FIGURE FOR ONE SYSTEM WAS HALF VALUE THAN ACTUAL. IT WAS CONFIRMED THE SETTINGS WERE DONE CORRECTLY FOR THE OTHER FOUR SYSTEMS WORKING ON THE SAME DAY AND ONLY ONE OF THE SYSTEM WAS MISCONFIGURED. THEREFORE, WE CHANGED THE SETTING OF THIS ONE TO THE CORRECT VALUE TEMPORARY. AND ALSO CONFIRMED THERE WERE NO DEVICES ISSUES OTHER THAN THE MISS SET UP. REFERENCE: (1) REGARDING THE BIOLOGICAL MICROSCOPE BX53, DIGITAL CAMERA FOR MICROSCOPE DP71 AND IMAGING SOFTWARE CELLSENS, WHICH WERE SET UP IN THE HOSPITAL, THE DP71 AND CELLSENS ARE NOT REGISTERED AS MEDICAL DEVICES IN THE UNITED STATES. (2) THE INTENDED USE FOR THIS IMAGING SOFTWARE "CELLSENS" IS FOR EDUCATIONAL AND RESEARCH PURPOSES AND IT IS CLEARLY STATED IN THE INSTRUCTION MANUAL THAT "THIS SOFTWARE MUST NOT BE USED FOR MEDICAL PURPOSE". (3) IN (B)(4), THE BX53, DP71, AND CELLSENS ARE ALL TREATED AS NON-MEDICAL DEVICES. ON THE OTHER HAND, IN (B)(4), THE USE OF THE ABOVE NON-MEDICAL DEVICES FOR MEDICAL PRACTICE ARE PERMITTED AT THE DISCRETION OF THE DOCTOR. (4) OLYMPUS LEARNED BY THIS ISSUE TO DECIDE TREATMENT POLICY FOR STOMACH/COLON CANCER USING THE COMPONENTS CONSISTING OF THE BX53, DP71 AND CELLSENS BY OBTAINING THE MEASUREMENT DATA OF THE CANCER CELL AS ONE OF INFORMATION FOR THE DECISION IN (B)(4). CORRECTION: CORRECTED THE MAGNIFICATION SETTING OF THIS CUSTOMER'S IMAGING SOFTWARE BY OLYMPUS SALESPERSON ON DEC. 25, 2019. *SERVICE TECHNICIAN WILL CHECK THE MAGNIFICATION SETTING AGAIN AND CONFIRM THE RESULT WITH CUSTOMER WITHIN FEB. 2020. SUGGESTED DAILY COMPARISON BETWEEN DIGITAL MEASUREMENT DATA AND ACTUAL ONE BY USING MICRO RULER SAMPLE ON FEB 19, 2020, ALTHOUGH THIS CUSTOMER ONCE REJECTED OUR SAME PROPOSAL FOR DAILY INSPECTION ON DEC 25, 2019. SHIPPING HOLD: CARRIED OUT SHIPMENT HOLD OF CELLSENS FOR (B)(4) MARKET ON FEB. 17, 2020. CAPA: OPENED ON FEB. 18, 2020. FUTURE ACTIONS: CARRY OUT OF "INSPECTION LIST" WHEN INSTALLING EQUIPMENT AND CHECK THE CONTENTS OF THE "ACCEPTANCE REPORT" FOR NEW CUSTOMER. EXPLAIN ABOUT RISK OF MISJUDGEMENT FOR TREATMENT POLICY TO THE CUSTOMER AND SUGGEST DAILY COMPARISON BETWEEN DIGITAL MEASUREMENT DATA AND ACTUAL ONE BY NEW CUSTOMER. REVIEW AND RE-EVALUATE THE RISK MANAGEMENT BASELINE. SET THE SKILL LEVEL OF THE MEASUREMENT DATA COMPARISON AND TAKE RECORD OR CREATE SETTING PROCEDURE FOR THE MEASUREMENT DATA COMPARISON.

    Description of Event or Problem · 1

    USING OLYMPUS SYSTEM INCLUDING BIOLOGICAL MICROSCOPE BX53, DIGITAL CAMERA FOR MICROSCOPE DP71 AND IMAGING SOFTWARE CELLSENS, THE USER MEASURED THE SIZE (LENGTH) OF CANCER CELLS. WHEN THE USER NOTICED THE ABNORMALITY IN THE MEASUREMENT RESULT AND CHECKED IT, THE SCALE VALUE ON THE SOFTWARE WAS HALVED THAN ACTUAL VALUE. THEREFORE, RECONFIRMATION OF 20 BIOPSIES PERFORMED WITH THE SYSTEM WAS PERFORMED. AS A RESULT, TWO OF THE 20 CASES HAD INFILTRATION OF 500 OR MORE, WHICH MET DIAGNOSTIC CRITERIA FOR THE SURGERY. THE SIZE (LENGTH) HAD BEEN INCORRECTLY JUDGED TO BE LESS THAN 500, BECAUSE THE MEASUREMENT FIGURE WAS HALVED THAN ACTUAL FIGURE BY INCORRECT SET UP SYSTEM AT THAT TIME. THE OTHER CASE WAS A MEASUREMENT OF GASTRIC CANCER, WHICH WAS FOLLOWED UP WITHOUT REMOVING THE CANCER CELLS BECAUSE OF AN ANOTHER FACTOR FOR THE DIAGNOSIS REGARDLESS OF THE MEASUREMENT RESULT. IN BOTH CASES, THE SIZE (LENGTH) WAS INCORRECTLY DETERMINED ONCE, BUT IT ENDED UP THE MEASUREMENT RESULTS DID NOT AFFECT THE TREATMENT STRATEGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199629 BX53 FRAME OPTICAL MAICROSCOPE IBJ OLYMPUS CORPORATION BX53F

    Patients

    Seq Age Sex Outcome Treatment
    1 Other