BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDEO SYSTEM CENTER

    MDR report key: 11694009 · Received April 20, 2021

    Report

    Report Number
    8010047-2021-05154
    Event Type
    Malfunction
    Date Received
    April 20, 2021
    Date of Event
    March 26, 2021
    Report Date
    June 9, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    UDI-DI
    04953170338502
    PMA / PMN Number
    K122831
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER¿S INVESTIGATION AND DEVICE HISTORY RECORD (DHR) REVIEW. AS THE RESULTS OF THE DHR REVIEW, IT WAS CONFIRMED THAT THERE WAS NO ABNORMALITY IN MANUFACTURING, CONCESSION, AND VARIATION. IT WAS CONFIRMED ALL SPECIFICATIONS WERE MET. THE SUBJECT DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED FOR EVALUATION. THEREFORE, THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. THE LEGAL MANUFACTURER DETERMINED THE PROBABLE CAUSE IS LIKELY TO BE A CABLE MALFUNCTION OR CONNECTION FAILURE.

    Additional Manufacturer Narrative · 1

    IN TROUBLESHOOTING THE ISSUE WITH OLYMPUS TECHNICAL SUPPORT VIA THE PHONE, THE EAM WAS TRYING TO CONNECT A DVI CABLE FROM THE PROCESSOR TO A CONVERTER AND THEN FROM THE CONVERTER HIGH-DEFINITION MULTIMEDIA INTERFACE (HDMI) TO THE MONITOR. IT WAS NOTED THAT THE EAM DID NOT HAVE A TRUE HDMI CABLE, BUT A DISPLAY PORT CABLE WHICH MAY HAVE CAUSED THE PROBLEM. IT WAS UNKNOWN IF THE CABLES OF THE CONVERTER WORKED. IT WAS ALSO UNKNOWN IF THE DVI WAS WORKING ON THE PROCESSOR AS IT WAS NEVER UTILIZED BEFORE. THE DVI OUTPUT WAS CHANGED ON THE PROCESSOR FROM 1080 TO THE OTHER TWO ASPECT RATIO SETTINGS AND IT DID NOT WORK. THE EAM WAS ADVISED TO GET A PROPER HDMI CABLE TO SEE IF THAT WAS PART OF THE ISSUE, OR ANOTHER MONITOR SINCE THERE WAS OTHER OUTPUTS ON THE PROCESSOR TO USE. THE SUBJECT DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED FOR EVALUATION. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    AN OLYMPUS ENDOSCOPY ACCOUNT MANAGER (EAM) REPORTED THAT THERE WAS NO DIGITAL VISUAL INTERFACE (DVI) VIDEO/NO IMAGE TO AN ELO MONITOR FROM THE CV-170 VIDEO SYSTEM CENTER. NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595801 VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER FET OLYMPUS MEDICAL SYSTEMS CORP. CV-170 04953170338502

    Patients

    Seq Age Sex Outcome Treatment
    1 DIGITAL INTERFACE VIDEO (DVI) CABLE| ELO MONITOR| DIGITAL INTERFACE VIDEO (DVI) CABLE| ELO MONITOR