BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III VIDEO SYSTEM CENTER

    MDR report key: 10268826 · Received July 13, 2020

    Report

    Report Number
    8010047-2020-04329
    Event Type
    Malfunction
    Date Received
    July 13, 2020
    Date of Event
    June 19, 2020
    Report Date
    September 30, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE SUBJECT DEVICE EVALUATION RESULT. THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. OMSC REVIEWED THE MANUFACTURING HISTORY (DHR) OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, BASED ON THE INFORMATION FROM OLYMPUS AUSTRALIA (OAZ), THERE WAS THE POSSIBILITY THAT THIS PHENOMENON WAS ATTRIBUTED TO THE USER SETTING, BECAUSE AFTER OAZ RESET THE ADJUSTMENT OF THE COLOR SETTING, THE ALL COLOR BALANCE HAD BEEN RESTORED.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM THE FACILITY THAT THE ENDOSCOPIC IMAGE COLOR BECAME ABNORMAL DURING AN UNSPECIFIED PROCEDURE. THE SERVICE DEPARTMENT OF OLYMPUS (B)(4) (OAZ) CHECKED THE SUBJECT DEVICE AND FOUND THAT THE ENDOSCOPIC IMAGE COLOR BALANCE WAS ABNORMAL. AFTER THAT, OAZ RESET THE ADJUSTMENT OF THE COLOR SETTING AND THE ALL COLOR BALANCE HAD BEEN RESTORED. IN ADDITIONAL, OAZ FOUND THE CONNECTOR SOCKET ON THE FRONT PANEL WAS DIRTY. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726700 EVIS EXERA III VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER FET OLYMPUS MEDICAL SYSTEMS CORP. CV-190

    Patients

    Seq Age Sex Outcome Treatment
    1