BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISERA ELITE II VIDEO SYSTEM CENTER

    MDR report key: 18587472 · Received January 26, 2024

    Report

    Report Number
    3002808148-2024-00800
    Event Type
    Malfunction
    Date Received
    January 26, 2024
    Date of Event
    January 11, 2024
    Report Date
    April 25, 2024
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FET
    UDI-DI
    04953170386022
    PMA / PMN Number
    K200542
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, TROUBLESHOOTING CONFIRMED THAT THE SYSTEM WORKED FINE AFTER RESEATING THE VIDEO CABLES. THE ROOT CAUSE OF THE REPORTED INFORMATION IS UNABLE TO BE DETERMINED. HOWEVER, THE LIKELY CAUSE OF THE REPORTED EVENT IS DUE TO A FAILURE OF A PERIPHERAL DEVICE. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    IN SPEAKING WITH THE OLYMPUS TECHNICAL ASSISTANCE CENTER (TAC), THE CUSTOMER REPORTED THAT THE VIDEO SYSTEM CENTER EXPERIENCED AN E335 (PERIPHERAL DEVICE SETTINGS ERROR) AND THERE WAS NO SIGNAL GOING TO THE OEP-6-COLAR VIDEO PRINTER. THROUGH TROUBLESHOOTING WITH TAC, THE CUSTOMER CONFIRMED THAT THE SYSTEM WORKED FINE AFTER RESEATING THE VIDEO CABLES. THE CUSTOMER WAS USING THE REMOTE 2 TO THE REMOTE 2 CABLE, THE SERIAL DIGITAL INTERFACE (SDI) SIGNAL TO THE MONITOR, AND THE SDI SIGNAL TO THE OEP-6. THE OEP-6>INPUT SETUP WAS SET TO AUTO. THE OTV-S200>PERIPHERALS>REMOTE 2 WAS NOT TO VIDEO PRINTER. ALL THE SOFTWARE SETTING PARAMETERS WERE CORRECT. THE INVESTIGATION OF THE ISSUE REPORTED INDICATES THAT THERE MIGHT HAVE BEEN A LOOSE SDI CABLE CONNECTION. THE DEVICE IS NOT EXPECTED TO BE RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS ONGOING. 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

    IT WAS REPORTED, THAT THE VIDEO SYSTEM CENTER HAD AN ERROR CODE E335 (PERIPHERAL DEVICE SETTINGS ERROR) AND THERE WAS NO SIGNAL GOING TO THE OEP-6-COLAR VIDEO PRINTER. THE ISSUE OCCURRED DURING A DIAGNOSTIC PROCEDURE. THERE WERE NO REPORTS OF PROCEDURAL DELAY OR PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1016646 VISERA ELITE II VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER FET SHIRAKAWA OLYMPUS CO., LTD. OTV-S200 04953170386022

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown OEP-6-COLAR VIDEO PRINTER