BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III VIDEO SYSTEM CENTER

    MDR report key: 10285507 · Received July 16, 2020

    Report

    Report Number
    8010047-2020-04481
    Event Type
    Malfunction
    Date Received
    July 16, 2020
    Report Date
    July 16, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION. THE REPORTED EVENT COULD NOT BE DUPLICATED. THE CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE AT A LATER TIME, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR THE PROCEDURE, THE CUSTOMER'S LOANER CV-190 WAS HAVING ISSUES DISPLAYING COLOR ON A NON-OLYMPUS MONITOR AS THE OUTPUT WAS PINK. SHE WAS UNABLE TO CONFIRM WHICH MONITOR OR WHAT IT HOOKS UP TO BECAUSE SHE WAS NOT IN FRONT OF THE UNIT. THE CUSTOMER CONFIRMED THERE WAS A RED, GREEN, BLUE (RGB) CABLE GOING FROM MONITOR OUT TO THE CEILING AND THEN FROM THE CEILING, THE RGB CABLE IS CONNECTED TO THE RGB IN IN THE MONITOR. TECHNICAL ASSISTANCE ADVISED THE RGB CABLE LIKELY HAS A BREAK IN THE GREEN SIGNAL AND THAT'S CAUSING THE IMAGE TO APPEAR PINKISH. CHANGING OUT THE RGB CABLE DID NOT RESOLVE THE ISSUE. PER THE CUSTOMER, THIS ISSUE DID NOT OCCUR WHEN USING THE MONITOR WITH A NON-OLYMPUS SYSTEM. THE CUSTOMER HOOKED UP A CV-180 USING MONITOR OUT WITH THE SAME CABLES AND THE MONITOR DISPLAYED AN IMAGE FINE, IT WAS NOT PINK. TECHNICAL ASSISTANCE ADVISED THE CV-190 LOANER NEEDS REPAIR. IT WAS ALSO NOTED THAT CHANGING THE MONITOR OUT TO SDTV AND CHANGING THE MAJ-1430 HAD NO EFFECT ON THE COLOR OF THE IMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745753 EVIS EXERA III VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER FET OLYMPUS MEDICAL SYSTEMS CORP. CV-190

    Patients

    Seq Age Sex Outcome Treatment
    1