BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BX53 FRAME

    MDR report key: 15081710 · Received July 22, 2022

    Report

    Report Number
    3021720733-2022-00001
    Event Type
    Malfunction
    Date Received
    July 22, 2022
    Date of Event
    June 1, 2022
    Report Date
    September 29, 2022
    Manufacturer
    EVIDENT CORPORATION
    Product Code
    IBJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: ¿THE PROBLEM IS CAUSED BY BUGS OF MEASURING FUNCTION OF IMAGING SOFTWARE CELLSENS V1.16 (RELEASED ON OCTOBER 1, 2016), V1.17 (RELEASED ON APRIL 1, 2017), OR V1.18 (RELEASED ON OCTOBER 1, 2017), WHEN IT IS USED IN COMBINATION WITH DIGITAL CAMERA DP74. ¿IMAGING SOFTWARE CELLSENS V2.1 (RELEASED ON APRIL 1, 2018) OR SUBSEQUENT VERSIONS INCLUDES BUG FIXES. ¿THE BUGS OF IMAGING SOFTWARE CELLSENS V1.16, V1.17, OR V1.18 CAN BE CORRECTED BY UPGRADING TO V2.1 OR SUBSEQUENT VERSIONS. ¿THE BUG OF MEASURING FUNCTION IS NOT MADE KNOWN TO CUSTOMERS. RESPONSE TO THE CUSTOMER: ¿ON (B)(6) 2022, LOCAL SALES UPGRADED THE CUSTOMER¿S IMAGING SOFTWARE CELLSENS TO V2.3 IN JAPAN.

    Additional Manufacturer Narrative · 0

    FIELD NOTICE: EVIDENT ANNOUNCED ON WEBSITE TO UPDATE TO THE V2.3 OR V4.1 FOR CUSTOMERS USING DP74 WITH CELLSENS EARLIER THAN V1.18. WEBSITE:HTTPS://WWW.OLYMPUS LIFESCIENCE.COM/JA/IMPORTANT NOTICES/DETAIL/423 ID.209715638.HTML FIELD ACTION: EVIDENT SCIENTIFIC, INC HAS IDENTIFIED A LIST OF POTENTIALLY AFFECTED CUSTOMERS IN AMERICA AND SENT THE NOTIFICATION ON EVIDENT WEBSITE DIRECTLY TO THESE CUSTOMER VIA E-MAIL. CORRECTIVE ACTION: OPENED ON (B)(6) 2022. CAPA NO.FY2023-CO0002.

    Description of Event or Problem · 0

    PROBLEM: MEASUREMENTS TAKEN ON A SNAPSHOT (SAVED IMAGE) BY IMAGING SOFTWARE CELLSENS MAY BE ABOUT 20% LARGER THAN MEASUREMENTS TAKEN ON A LIVE IMAGE. DETAIL DEVICE CONDITIONS: ¿IMAGING SOFTWARE CELLSENS (NON-MEDICAL DEVICE) V1.18 (RELEASED OCTOBER 1, 2017) OR EARLIER ALONG WITH A DIGITAL CAMERA DP74. ¿THE BIT DEPTH OF CELLSENS IS SET TO 10 BITS AND THE ASPECT LENGTH TO WIDTH RATIO OF CELLSENS IS SET TO ANYTHING OTHER THAN 16:10. ¿BIOLOGICAL MICROSCOPE BX53(MEDICAL DEVICE), DIGITAL CAMERA FOR MICROSCOPE DP74 AND IMAGING SOFTWARE CELLSENS WERE SET UP. HUMAN DAMAGE: OVER THE LAST 5 YEARS, NO SURGICAL OPERATION AT THE HOSPITAL HAS BEEN CONDUCTED BASED ON THE DATA MEASURED AND ACQUIRED BY USING CELLSENS. DAMAGE OF PROPERTY: NONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569704 BX53 FRAME OPTICAL MAICROSCOPE IBJ EVIDENT CORPORATION BX53F

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown