BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III VIDEO SYSTEM CENTER

    MDR report key: 19127303 · Received April 17, 2024

    Report

    Report Number
    3002808148-2024-03580
    Event Type
    Malfunction
    Date Received
    April 17, 2024
    Date of Event
    April 5, 2024
    Report Date
    May 8, 2024
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FET
    UDI-DI
    04953170298622
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION OF THE REPORTED ISSUE. IN SPEAKING WITH FIELD SERVICE ENGINEER, THE CUSTOMER REPORTED THAT THE VIDEO SYSTEM HAD NO IMAGE. TROUBLESHOOTING EFFORTS WERE MADE AND THE CUSTOMER WAS INSTRUCTED TO SWAP HD/SD SDI OUT 2 AND IN, SELECT PORT A ON OEV-262H (HIGH-DEFINITION LCD MONITOR) GO FROM DVI TO SDI, WHICH RESULTED IN LOSS OF THE ULTRASOUND IMAGE. IT WAS ALSO ADVISED TO MOVE THE COMP OUT CABLE FROM DI IN ON THE OEV-262H TO VIDEO IN. HOWEVER, THEY WERE UNABLE TO SELECT PORT A ON OEV-262H AND HAD TO CHOOSE COMPOSITE. THEY HAD CV-190 (EVIS EXERA III VIDEO SYSTEM CENTER) COLOR BARS THAT DO NOT FILL THE SCREEN. AFTER REVIEWING THE CABLING AGAIN, IT WAS DISCOVERED THAT THE CUSTOMER DID NOT CONNECT ANYTHING TO SDI OUT 2. IT WAS ADVISED TO MOVE THE CABLE FROM COMP OUT ON CV-190 EVIS EXERA III VIDEO SYSTEM CENTER) TO OUT 2 ON CV-190 EVIS EXERA III VIDEO SYSTEM CENTER), AND ON THE OTHER END MOVE IT FROM VIDEO IN TO SDI IN. AFTER SELECTING PORT A SDI, THEY HAD COLOR BARS ON EU-ME2 (EVIS EUS ENDOSCOPIC ULTRASOUND SYSTEM) SCREEN. AFTER CONNECTING US SCOPE, THEY PRESSED CUSTOM 1 ON CV-190 AND CYCLE THROUGH THE MODE BOTH ULTRASOUND AND ENDOSCOPIC IMAGE BEING DISPLAYED, RESOLVING THE ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 8 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, THE IMAGE ISSUE WAS LIKELY DUE TO THE WRONG WIRING AND SETTINGS OF THE MONITOR; HOWEVER, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THE CUSTOMER MAY BE ABLE TO REDUCE AND PREVENT OCCURRENCE OF THE EVENT BY HANDLING DEVICE IN ACCORDANCE WITH THE FOLLOWING IFU: 3.6 CONNECTION OF THE MONITOR. CONNECT THE MONITORS (OEV261H) TO THE VIDEO SYSTEM CENTER USING THE CABLES IN TABLE 3.7 AS SHOWN IN FIGURE 3.13. 7.7 CHANGING THE ENDOSCOPIC IMAGE SCREEN. WHEN THE ENDOSCOPIC IMAGES ARE DISPLAYED IN THE POP MODE WITH THE OEV261H, NO IMAGES MAY BE DISPLAYED DEPENDING ON THE POP MODE. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE DEVICE EVALUATION IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE VIDEO SYSTEM CENTER HAD NO IMAGE. TROUBLESHOOTING WAS CONDUCTED WITH A FIELD SERVICE ENGINEER. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1891852 EVIS EXERA III VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER FET SHIRAKAWA OLYMPUS CO., LTD. CV-190 04953170298622

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown