BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDEO SYSTEM CENTER

    MDR report key: 10967504 · Received December 8, 2020

    Report

    Report Number
    8010047-2020-10023
    Event Type
    Malfunction
    Date Received
    December 8, 2020
    Date of Event
    November 3, 2020
    Report Date
    January 14, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    PMA / PMN Number
    K122831
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER¿S FINAL INVESTIGATION. THE DEVICE WAS RETURNED TO AN OLYMPUS REPAIR CENTER FOR EVALUATION. IT WAS FOUND THAT IN CONNECTING THIS PRODUCT TO THE SONY MONITOR (LMD-1951MC) USING THE ORIGINAL DVI CABLE (WHICH THE CUSTOMER STATED THEY HAD DONE), THE PHENOMENON OF FLICKER AND HORIZONTAL INTERFERENCE FRINGES OCCURRED IN THE DVI OUTPUT IMAGE. IN CONNECTING THIS PRODUCT TO AN OLYMPUS OEV262H, THE ABOVE FAILURE WAS NOT REPRODUCED. BASED ON THE LEGAL MANUFACTURER¿S INVESTIGATION, THE DHR WAS REVIEWED AND THERE WERE NO PROBLEMS FOUND DURING THE MANUFACTURING OF THE DEVICE. THE DEVICE MET ALL SPECIFICATIONS AT THE TIME OF SHIPMENT. REGARDING THE COMPATIBLE DEVICES, THE INSTRUCTION MANUAL CONTAINS THE FOLLOWING DESCRIPTION: REFER TO ¿¦ SYSTEM CHART¿ ON PAGE 301 TO CONFIRM THAT THE VIDEO SYSTEM CENTER IS COMPATIBLE WITH THE ANCILLARY EQUIPMENT BEING USED. USING INCOMPATIBLE EQUIPMENT CAN RESULT IN PATIENT INJURY OR EQUIPMENT DAMAGE AND MAKES IT IMPOSSIBLE TO OBTAIN THE EXPECTED FUNCTIONALITY.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS NOT RETURNED TO OMSC FOR EVALUATION. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM THE FIELD SERVICE ENGINEER THAT THE IMAGE OUTPUT FROM THE DVI OUT TERMINAL OF THE SUBJECT FLASHED WHILE THE SUBJECT DEVICE WAS INSTALLED TO THE FACILITY. DURING THE INCOMING INSPECTION AT OLYMPUS CHINA (OSH), IT WAS FOUND THAT THE IMAGE OUTPUT FROM THE DVI OUT TERMINAL OF THE SUBJECT DEVICE FLASHED WHILE CONNECTING A NON-OLYMPUS MONITOR SONY 1951, BUT THE PHENOMENON WAS NOT DUPLICATED WHILE CONNECTING AN OLYMPUS MONITOR OEV262H. THERE WAS NO ABNORMALITY ON THE EXTERNAL AND INSIDE OF THE SUBJECT DEVICE. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1429826 VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER FET OLYMPUS MEDICAL SYSTEMS CORP. CV-170

    Patients

    Seq Age Sex Outcome Treatment
    1