BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II VIDEO SYSTEM CENTER

    MDR report key: 10744433 · Received October 27, 2020

    Report

    Report Number
    8010047-2020-08202
    Event Type
    Malfunction
    Date Received
    October 27, 2020
    Date of Event
    September 29, 2020
    Report Date
    December 22, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FAJ
    PMA / PMN Number
    K133538
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT RETURNED. AS SUCH, AN ACTUAL DEVICE EVALUATION IS NOT PERFORMED. AN EVALUATION IS DONE BASED ON HISTORICAL RECORDS. THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THIS INFORMATION. THE DEVICE HISTORY RECORD REVIEW CONFIRMED THAT DEVICE HAS NO ABNORMALITIES, SPECIAL ADOPTION, OR VARIATIONS IN MANUFACTURING. THE REPORTED ISSUE WAS THAT THE DEVICE DISPLAYED A YELLOW TINT IMAGE ON THE MONITOR. THE CUSTOMER REMOVED THE MONITOR CABLE (MAJ-1462) AND CONNECTED THE SDI CABLE FROM THE CV-180 TO THE OEV-261H. WHEN CHANGING THE INPUT SOURCE FROM RGB TO SDI, THE PROBLEM WAS RESOLVED. ROOT CAUSE OF THE EVENT CANNOT BE DETERMINED, SINCE THE CUSTOMER DID NOT RETURN THE DEVICE AS THE IMAGE ISSUE WAS RESOLVED. SINCE THE PROBLEM WAS RESOLVED WHEN CONNECTION TO THE MONITOR WAS CHANGED FROM RGB TO SDI, IT COULD BE POSSIBLE THAT THERE WAS A PROBLEM IN RGB SIGNALS. MORE THAN 14 YEARS HAVE PASSED SINCE THE SUBJECT PRODUCT WAS DELIVERED, AND THE DP BOARD COULD HAVE FAILED BECAUSE THE PARTS ON THE BOARD BROKE DOWN BY REPEATED USE FOR A LONG PERIOD, OR THERE WAS NO PROBLEM IN THE SUBJECT PRODUCT AND THE MONITOR CABLE WAS BROKEN, CAUSING THE PHENOMENON. EITHER BECAUSE OF BOARD FAILURE OR BECAUSE OF A BREAK IN THE MONITOR CABLE, A BLUE SIGNAL WAS NOT INPUT INTO THE MONITOR, CAUSING THE YELLOWISH IMAGE.

    Additional Manufacturer Narrative · 1

    THERE IS NO ADDITIONAL INFORMATION FOR THIS EVENT AS YET. UPON TROUBLESHOOTING, THE ISSUE WAS RESOLVED BY FIRST REMOVING THE MAJ-1462 AND THEN CONNECTING THE SDI CABLE FROM THE DEVICE TO THE MONITOR. THE INPUT ON THE MONITOR WAS CHANGED FROM RGB TO SDI AND THE COLOR ISSUE WAS RESOLVED. THE DEVICE IS NOT RETURNED, AS SUCH A DEFINITIVE ROOT CAUSE OF THE REPORTED COMPLAINT CANNOT BE DETERMINED AT THIS TIME. SUPPLEMENTAL REPORT(S) WILL BE FILED AS ANY INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED FOR THIS EVENT, THE DEVICE DISPLAYED A YELLOW TINT IMAGE ON THE MONITOR. THERE IS NO REPORTED HARM OR ADVERSE IMPACT TO ANY PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1208657 EVIS EXERA II VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER FAJ OLYMPUS MEDICAL SYSTEMS CORP. CV-180

    Patients

    Seq Age Sex Outcome Treatment
    1