BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISERA VIDEO SYSTEM CENTER

    MDR report key: 15246747 · Received August 17, 2022

    Report

    Report Number
    3002808148-2022-01135
    Event Type
    Malfunction
    Date Received
    August 17, 2022
    Date of Event
    July 21, 2022
    Report Date
    October 6, 2022
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FET
    UDI-DI
    04953170141546
    PMA / PMN Number
    K051645
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE HAS NOT BEEN REPAIRED BEFORE IN THE PAST YEAR. THE FSE REPORTED THE RGB SIGNAL HAD NO OUTPUT WHICH WAS SUSPECTED TO BE CAUSED BY A DEFECTIVE VIDEO CABLE. THE IMAGE AT VIDEO SIGNAL WAS GREEN WHICH WAS RESTORED TO NORMAL BY WHITE BALANCE SO IT MAY BE ATTRIBUTED TO FAILURE OF THE MEMORY BATTERY. THE CUSTOMER WILL NOT RETURN THE DEVICE FOR REPAIR AND WILL BUY A NEW RGB VIDEO CABLE AND THE MEMORY BATTERY. THE INVESTIGATION IS ONGOING. HOWEVER, IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS MEDICAL DEVICE REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    CORRECTION TO D9 AND H3, SUBJECT DEVICE WAS EVALUATED AT THE USER'S FACILITY BY THE OLYMPUS FIELD SERVICE ENGINEER (FSE). 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, IT IS LIKELY THAT THE RGB SIGNAL HAD NO OUTPUT WAS DUE TO A DEFECTIVE VIDEO CABLE. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    THE OLYMPUS (OSH) FIELD SERVICE ENGINEER WAS INFORMED THAT THE CUSTOMER DISPLAY VIDEO SYSTEM CENTER¿S ¿GB SIGNAL CANNOT PRODUCE IMAGE; VIDEO IMAGE IS GREENISH BUT THE VIDEO QUALITY COMES BACK TO NORMAL; MEMORY BATTERY FAILURE¿. THE CUSTOMER¿S REPORTED PROBLEM WAS FOUND AT THE END OF A LAPAROSCOPIC SURGERY CASE. THE PROCEDURE WAS FINISHED WITH ANOTHER SIMILAR DEVICE. THERE WAS NO DELAY AND NO DEATH INJURY OR HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2530704 VISERA VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER FET SHIRAKAWA OLYMPUS CO., LTD. OTV-S7V 04953170141546

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown OLYMPUS MODEL A50002A