BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II VIDEO SYSTEM CENTER

    MDR report key: 12074895 · Received June 28, 2021

    Report

    Report Number
    8010047-2021-08060
    Event Type
    Malfunction
    Date Received
    June 28, 2021
    Date of Event
    June 1, 2021
    Report Date
    July 7, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FAJ
    UDI-DI
    04953170215513
    PMA / PMN Number
    K133538
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE LM INVESTIGATION. PLEASE SEE THE UPDATES IN SECTIONS: G4, G7, H2, H4, H6 AND H10. THE LEGAL MANUFACTURER (LM) REVIEWED THE CONTENT OF THIS COMPLAINT FOR FURTHER INVESTIGATION. THE LM REPORTS THAT THE ROOT CAUSE COULD NOT BE IDENTIFIED. THE UNIT WAS DELIVERED TO THE CUSTOMER ON (B)(6) 2011. THE LEGAL MANUFACTURER PROVIDED THE FOLLOWING POSSIBLE CAUSE FOR THE REPORTED EVENT ARE PRESUMED AS FOLLOWS: THE USE OF S-VIDEO CABLE YIELDS STABLE IMAGES, AND THE USE OF THE RED, GREEN AND BLUE (RGB) SIGNAL CABLE CAUSES MALFUNCTION. THEREFORE, WE SPECULATE THAT THE DEVICE IS NOT ABNORMAL AND THAT THE RGB SIGNAL CABLE ITSELF IS PROBLEMATIC. AS THE RESULTS OF THE DHR REVIEW, IT WAS CONFIRMED THAT THERE WAS NO ABNORMALITY IN MANUFACTURING, CONCESSION, AND VARIATION.

    Additional Manufacturer Narrative · 1

    AS PART OF OUR INVESTIGATION, THE TECHNICAL ASSISTANCE CENTER (TAC) ASSISTED THE CUSTOMER WITH TROUBLESHOOTING. THE CUSTOMER REPORTED THAT ATTEMPTS WERE MADE TO RESEAT THE LIGHT SOURCE CABLES AND THAT DID NOT RESOLVE ISSUE. THE IMAGE ISSUE WAS OCCURRING WITH MULTIPLE SCOPES. THE CUSTOMER REPORTED THAT THEY WERE USING RED, GREEN AND BLUE (RGB) INPUT AND WHEN THE SYNC CABLE WAS DISCONNECTED RGB IMAGE DID NOT DISPLAY AT ALL. TAC INSTRUCTED THE CUSTOMER TO CHOOSE THE S-VIDEO INPUT ON THE MONITOR AND THE IMAGE APPEARED WITH NO LINES AND DID NOT INTERMITTENTLY GO IN AND OUT. THE CUSTOMER IS GOING TO REPLACE THE MONITOR OUT VIDEO CABLE MAJ-1462 OF THE CV-180. THE CUSTOMER WILL NOT BE RETURNING THE UNIT AS THE FACILITY HAS DECIDED TO REPLACE IT.

    Description of Event or Problem · 1

    THE SERVICE CENTER WAS INFORMED THAT THE CUSTOMER OBSERVED AN INTERMITTENT IMAGE WITH LINES ACROSS THE DISPLAY. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    973579 EVIS EXERA II VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER FAJ OLYMPUS MEDICAL SYSTEMS CORP. CV-180 04953170215513

    Patients

    Seq Age Sex Outcome Treatment
    1