BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II VIDEO SYSTEM CENTER

    MDR report key: 16830871 · Received April 28, 2023

    Report

    Report Number
    3002808148-2023-04344
    Event Type
    Malfunction
    Date Received
    April 28, 2023
    Date of Event
    March 31, 2023
    Report Date
    June 16, 2023
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FAJ
    UDI-DI
    04953170215513
    PMA / PMN Number
    K133538
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S INVESTIGATION. THE DHR WAS UNABLE TO BE REVIEWED FOR THIS DEVICE SINCE THE SERIAL NUMBER WAS NOT PROVIDED. HOWEVER, OLYMPUS ONLY RELEASES PRODUCTS TO MARKET THAT MEET ALL MANUFACTURING SPECIFICATIONS AND FINAL PRODUCT RELEASE CRITERIA. THE CASE IS NOT DUE TO DESIGN. BASED ON THE RESULTS OF THE LEGAL MANUFACTURER'S INVESTIGATION, AND THE INABILITY TO EVALUATE THE SUBJECT DEVICE AND REPRODUCE THE EVENT, A DEFINITIVE ROOT CAUSE OF THE COLOR BAR BEING DISPLAYED COULD NOT BE IDENTIFIED. HOWEVER, IT¿S LIKELY THE CAUSE IS RELATED TO THE SCOPE NOT BEING CONNECTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    IN SPEAKING WITH OLYMPUS TECHNICAL ASSISTANCE CENTER (TAC), THE CUSTOMER REPORTED THAT THERE WERE COLOR BARS SHOWING ON THE DEVICE DISPLAY MONITOR. THE BIOMEDICAL ENGINEER FOLLOWED TROUBLESHOOTING DIRECTIONS AND HELD DOWN THE "STOP," "CAPTURE," AND "PRINT," BUTTONS ON THE DEVICE AT THE SAME TIME IN ORDER TO RESET THE PRINTER TO RED GREEN BLUE (RGB) INPUT. THE ENGINEER THEN CORRECTED THE CABLING AS FOLLOWS: EVIS EXERA VIDEO SYSTEM CENTER (CV-180) PRINTER OUT TO THE OEP-4 RGB (COLOR VIDEO PRINTER) INPUT, AND THE OEP-4 RS232C CABLE GOES FROM THE OEP-4 TO THE CV-180 PRINTER REMOTE. A SCOPE WAS THEN PLUGGED INTO THE CV-180 AND THE REPORTED ISSUE WAS RESOLVED. THE AFFECTED DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION. THE INVESTIGATION IS ONGOING, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS THAT THE EVIS EXERA II VIDEO SYSTEM CENTER HAD COLOR BARS SHOWING ON THE DISPLAY SYSTEM MONITOR. THIS OCCURRED DURING PREPARATION FOR USE. THERE WAS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430296 EVIS EXERA II VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER FAJ SHIRAKAWA OLYMPUS CO., LTD. CV-180 04953170215513

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown