BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BX53 FRAME

    MDR report key: 15664390 · Received October 24, 2022

    Report

    Report Number
    3021720733-2022-00002
    Event Type
    Malfunction
    Date Received
    October 24, 2022
    Date of Event
    September 27, 2022
    Report Date
    February 16, 2023
    Manufacturer
    EVIDENT CORPORATION
    Product Code
    IBJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IMPACT OF THIS ISSUE: A SURGERY WAS POSTPONED BECAUSE IT WAS JUDGED THAT THE CLINICAL FOLLOW-UP IS AN ADEQUATE TREATMENT AT PRESENT BASED ON THE PATHOLOGICAL DIAGNOSIS FINDINGS REFERENCE TO SCALE NOT SET CORRECTLY. DOCTORS AT THE HOSPITAL RE-DIAGNOSED THE PATIENT AND SURGERY WAS PERFORMED USING AN ENDOSCOPE IN (B)(6) 2022. SINCE THEN, THE HOSPITAL HAS NOT CONTACTED EVIDENT REGARDING PATIENT'S PROGNOSIS. CORRECTIVE ACTION: EVIDENT OPENED TWO CORRECTIVE ACTION. CAPA NO. FY2023-CO0008 OPENED ON (B)(6) 2022. THIS IS CORRECTIVE ACTION ABOUT RISK ASSESSMENT PROCESS. FY2023-CO0009 OPENED ON 13 FEB, 2023. THIS CAPA WAS OPENED AS A RESULT OF INVESTIGATION IN FY2023-CO0008. THIS IS CORRECTIVE ACTION ABOUT THE PROCEDURE OF SOFTWARE SET UP.

    Additional Manufacturer Narrative · 0

    ISSUE: THE SCALE OF IMAGING SOFTWARE WAS NOT CORRECT. THEN THE SIZE OF SPECIMEN DISPLAYED AT HALF. SIMILAR COMPLAINT IN THE PAST: MEDWATCH#(B)(4). CAUSE: SALES REP RE-INSTALLED CELLSENS SOFTWARE TO PC AT THE HOSPITAL ON (B)(6) 2021. THE CAMERA ADAPTER ON THE MICROSCOPE WAS TV0.5X. SALES REP MISSED TO SET THE CAMERA ADAPTER SETTING (TV0.5X) ON CELLSENS. THEN THE CAMERA ADAPTOR SETTING ON CELLSENS SOFTWARE SET TX1.0X AS A DEFAULT SOFTWARE SETTING. IMPACT: IT IS POSSIBLE THAT THE SURGERY WAS POSTPONED BECAUSE IT WAS JUDGED THAT THE CLINICAL FOLLOW-UP IS AN ADEQUATE TREATMENT AT PRESENT BASED ON THE PATHOLOGICAL DIAGNOSIS FINDINGS. SAMPLING OF PATHOLOGICAL SPECIMENS BEFORE (B)(6) 2021 WAS CONFIRMED, BUT NO MEASUREMENT ABNORMALITIES WERE FOUND. THE RISK IS UNDER INVESTIGATION AT THE HOSPITAL. CORRECTION: SALES REP CHANGED THE SETTING FROM TV1.0X TO TV0.5X ON SEPTEMBER, 2022 AFTER THE COMPLAINT.

    Description of Event or Problem · 0

    PROBLEM: CUSTOMER POINTED OUT THAT THERE ARE A DIFFERENCE BETWEEN THE ACTUAL LENGTH OF THE SPECIMEN AND THE VALUE DISPLAYED BY THE SOFTWARE. DESPITE CUSTOMER USED A COMBINATION OF DP27 AND 0.5XC MOUNT ADAPTER, THE CAMERA ADAPTER MAGNIFICATION WAS REGISTERED AS 1X ON CELLSENS SOFTWARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361208 BX53 FRAME OPTICAL MICROSCOPE IBJ EVIDENT CORPORATION BX53F

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention