BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III VIDEO SYSTEM CENTER

    MDR report key: 19997000 · Received August 15, 2024

    Report

    Report Number
    3002808148-2024-07798
    Event Type
    Malfunction
    Date Received
    August 15, 2024
    Report Date
    October 9, 2024
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FET
    UDI-DI
    04953170298622
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVALUATION OF THE EVENT IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER SIX (6) YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION, AND THE CUSTOMER'S COMPLAINT/REPORTABLE MALFUNCTION WAS CONFIRMED. BASED ON THE INVESTIGATION RESULTS, ERROR CODE B40, COULD NOT BE IDENTIFIED. THE ROOT CAUSE COULD NOT BE DETERMINED. BASED ON THE QIR, AS CM BOARD FAILURE HAS BEEN CONFIRMED, IT IS PRESUMED THAT ERROR CODE B30 OCCURRED DUE TO CM BOARD FAILURE. THE EVENTS CAN BE DETECTED AND PREVENTED IN ACCORDANCE WITH THE FOLLOWING SECTIONS OF THE INSTRUCTIONS FOR INSTRUCTIONS FOR USE: LABELLING REVIEW: NOT APPLICABLE SINCE IT IS NOT A DEFECT CAUSED BY USER MISUSE. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VIDEO SYSTEM CENTER RECEIVED A B40 COMMUNICATION ERROR CODE. THE ISSUE OCCURRED DURING PREPARATION FOR USE DURING AN UNSPECIFIED DIAGNOSTIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1008259 EVIS EXERA III VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER FET SHIRAKAWA OLYMPUS CO., LTD. CV-190 04953170298622

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown