BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS EXERA III VIDEO SYSTEM CENTER

    MDR report key: 20053309 · Received August 23, 2024

    Report

    Report Number
    3002808148-2024-08074
    Event Type
    Injury
    Date Received
    August 23, 2024
    Report Date
    January 6, 2025
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FET
    UDI-DI
    04953170298622
    PMA / PMN Number
    K131780
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN SUBMITTED BY THE IMPORTER UNDER THIS MDR REPORT NUMBER-2429304-2024-0000410. THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION OBTAINED FROM THE CUSTOMER REGARDING THE REPORTED EVENT. NEW INFORMATION ADDED TO THE FOLLOWING FIELDS:B1, B2, B5, H1, H4, H6 AND H10 AND H11.

    Additional Manufacturer Narrative · 0

    THE DEVICE EVALUATION IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE DEVICE EVALUATION AND THE LEGAL MANUFACTURER'S (LM) INVESTIGATION. THE DEVICE WAS EVALUATED BY OLYMPUS, AND THE REPORTED IMAGE ISSUE WAS REPRODUCED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 9 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, THE IMAGE ISSUE WAS LIKELY DUE TO A DP BOARD FAILURE. HOWEVER, THE ROOT CAUSE COULD NOT BE DETERMINED. THIS SUPPLEMENTAL REPORT INCLUDES A CORRECTION TO E1, E2, E3, AND G2 TO PROVIDE INFORMATION THAT WAS INADVERTENTLY NOT INCLUDED IN THE INITIAL MEDWATCH. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED THAT THE PROCEDURE WAS DELAYED BY 1 1/2 HOURS WHILE THE PATIENT WAS SEDATED FOR APPROXIMATELY ½ HOUR. THE PATIENT WAS AWAKENED AND THEN SEDATED AGAIN AND PROCEDURE WAS COMPLETED.

    Description of Event or Problem · 0

    IT WAS REPORTED, THE VIDEO SYSTEM CENTER HAD NO IMAGE AND KEEPS FLASHING. THE COLOR GOES OUT ON THE SCREEN, IT LOSES ITS PROPER COLOR. AND THE MUCOSA CANNOT BE SEEN. THE ISSUE OCCURRED, DURING UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1742289 EVIS EXERA III VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER FET SHIRAKAWA OLYMPUS CO., LTD. CV-190 04953170298622

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other