BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III VIDEO SYSTEM CENTER

    MDR report key: 17592214 · Received August 21, 2023

    Report

    Report Number
    3002808148-2023-08697
    Event Type
    Malfunction
    Date Received
    August 21, 2023
    Date of Event
    July 26, 2023
    Report Date
    October 2, 2023
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FET
    UDI-DI
    04953170298622
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: H6 AND H10 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, THE LACK OF IMAGE WAS CAUSED BY THE DEVICE NOT BEING PLUGGED INTO THE CORRECT RECEPTACLE. HOWEVER, THE CAUSE OF THE DEVICE BEING PLUGGED INTO THE WRONG RECEPTACLE WAS NOT ESTABLISHED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION HOWEVER TROUBLESHOOTING WAS PERFORMED BY THE OLYMPUS TECHNICAL ASSISTANCE CENTER (TAC), WITH THE CUSTOMER. IN SPEAKING WITH OLYMPUS TAC, THE CUSTOMER REPORTED THE DISPLAY IMAGE WAS LOST DURING A PROCEDURE. THE CUSTOMER STATED THE DETAILS OF THE TROUBLESHOOTING, ¿WHEN THE IMAGE WAS LOST THE SYSTEM WAS SWAPPED OUT. THE SYSTEM USES THE SCALOR VIDEO CONVERTER TO CONVERT THE DIGITAL VISUAL INTERFACE (DVI) SIGNAL FROM THE ARIETTA 850 TO SDI (SERIAL DIGITAL INTERFACE). THE SYSTEM ALSO USES THE OEV-262H MONITOR. TAC ASKED THE CUSTOMER TO BYPASS THE VIDEO SYSTEM CENTER COMPLETELY AND GO DIRECTLY FROM THE SCALOR TO THE MONITOR AND OBSERVE THE RESULT. THE CUSTOMER SAID THE MONITOR DOES NOT DETECT THE SIGNAL EITHER. TAC ADVISED THE CUSTOMER THAT IF THE MONITOR DOES DETECT IT THEN THE VIDEO SYSTEM CENTER WON'T DETECT IT. TAC ADVISED CUSTOMER TO TEST THE INPUT PORT ON THE MONITOR USING THE SIGNAL FROM THE VIDEO SYSTEM CENTER TO MAKE SURE THAT IT'S OPERATIONAL. IF IT IS, THEN THE ISSUE COULD BE THE ARIETTA 850, THE DVI CABLE FROM THE ARIETTA TO THE SCALOR, THE SCALOR, OR THE SERIAL DIGITAL INTERFACE CABLE ATTACHED TO THE SCALOR, OR THE SIGNAL IS NOT IN THE CORRECT FORMAT. THE CUSTOMER SAID HE WOULD INVESTIGATE. TAC RECEIVED A CALL FROM THE CUSTOMER ABOUT THIS SERVICE CASE. THE CUSTOMER STATED THAT HE WAS ABLE TO SEE THE ENDOSCOPIC ULTRASOUND IMAGE FROM THE ARIETTA 850 AND THE VIDEO SYSTEM CENTER IMAGE. HE WANTED TO KNOW HOW TO MAKE THE ENDOSCOPIC ULTRASOUND IMAGE LARGER. TAC INSTRUCTED HIM TO PRESS THE PICTURE IN PICTURE MODE BUTTON ON THE VIDEO SYSTEM CENTER KEYBOARD. HE WAS THEN ABLE TO MAKE THE ENDOSCOPIC ULTRASOUND IMAGE LARGER. THE INVESTIGATION IS ONGOING AND FOLLOW-UP WITH THE USER FACILITY IS CURRENTLY BEING PERFORMED. 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, THE EVIS EXERA III VIDEO SYSTEM CENTER HAD NO VIDEO DETECTED AT THE SERIAL DIGITAL INTERFACE INPUT TERMINAL. THE ISSUE WAS FOUND DURING PREPARATION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2330935 EVIS EXERA III VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER FET SHIRAKAWA OLYMPUS CO., LTD. CV-190 04953170298622

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ARIETTA 850| DIGITAL VIDEO INTERFACE CABLE| OEV-262H, MONITOR| SCALOR VIDEO CONVERTER| SERIAL DIGITAL INTERFACE CABLE