BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III VIDEO SYSTEM CENTER

    MDR report key: 16019986 · Received December 21, 2022

    Report

    Report Number
    3002808148-2022-05448
    Event Type
    Malfunction
    Date Received
    December 21, 2022
    Date of Event
    November 21, 2022
    Report Date
    February 6, 2023
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FET
    UDI-DI
    04953170298622
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IN SPEAKING WITH OLYMPUS TECHNICAL ASSISTANCE CENTER (TAC), THE CUSTOMER REPORTED THERE WAS NO VIDEO AT EITHER SERIAL DIGITAL INTERFACE (SDI) OUTPUTS (1 OR 2) AND USED MULTIPLE SDI VIDEO CABLES. NO VIDEO SIGNAL WAS PRESENT. TAC ADVISED USING COMPONENT (COMP) OUTPUT ON THE REAR OF THE PROCESSOR. THE IMAGE WAS AVAILABLE AFTER SWITCHING TO COMP OUTPUT. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 8 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE LEGAL MANUFACTURER'S INVESTIGATION, AND THE INABILITY TO EVALUATE THE SUBJECT DEVICE AND DUPLICATE THE EVENT, A DEFINITIVE ROOT CAUSE OF NO SDI (SERIAL DIGITAL INTERFACE) OUTPUT COULD NOT BE IDENTIFIED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS THAT THE EVIS EXERA III VIDEO SYSTEM CENTER DID NOT HAVE SERIAL DIGITAL INTERFACE (SDI) OUTPUT ON LOANER PROCESSOR. IT WAS REPORTED THAT IT DID NOT OCCUR DURING THE FIRST INSTALLATION. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457371 EVIS EXERA III VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER FET SHIRAKAWA OLYMPUS CO., LTD. CV-190 04953170298622

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown