BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDEO SYSTEM CENTER

    MDR report key: 11998930 · Received June 15, 2021

    Report

    Report Number
    8010047-2021-07545
    Event Type
    Malfunction
    Date Received
    June 15, 2021
    Date of Event
    May 21, 2021
    Report Date
    July 15, 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 SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE SUBJECT DEVICE WAS NOT RETURNED TO ANY OF OLYMPUS LOCATIONS. OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) REVIEWED THE MANUFACTURING HISTORY (DHR) OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. BASED UPON THE INFORMATION FROM THE FIELD SERVICE ENGINEER OF OLYMPUS CHINA SUCH AS THAT THE "BLINKING IMAGE" WAS ATTRIBUTED TO THE FAILURE OF THE SONY MONITOR, OMSC SURMISED THAT THE REPORTED PHENOMENON WAS ATTRIBUTED TO THE FAILURE OF THE SONY MONITOR, NOT THE SUBJECT DEVICE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS NOT RETURNED TO ANY OF OLYMPUS LOCATIONS. THE FIELD SERVICE ENGINEER OF OLYMPUS (B)(6) PERFORMED THE TROUBLESHOOTING WITH TWO PROCESSORS AND TWO VIDEO CABLES AND FOUND THAT THE REPORTED PHENOMENON WAS ATTRIBUTED TO THE FAILURE OF THE (B)(6) MONITOR. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM THE USER THAT DURING UNSPECIFIED DIAGNOSTIC PROCEDURE, THE ENDOSCOPIC IMAGE FLASHED. THE USER COMPLETED THE PROCEDURE WITH THE SUBJECT DEVICE. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    900396 VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER FET OLYMPUS MEDICAL SYSTEMS CORP. CV-170

    Patients

    Seq Age Sex Outcome Treatment
    1