BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II VIDEO SYSTEM CENTER

    MDR report key: 16765804 · Received April 18, 2023

    Report

    Report Number
    3002808148-2023-03861
    Event Type
    Malfunction
    Date Received
    April 18, 2023
    Date of Event
    March 19, 2023
    Report Date
    May 19, 2023
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FAJ
    UDI-DI
    04953170215513
    PMA / PMN Number
    K133538
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR EVALUATION AND THE CUSTOMER¿S ALLEGATION WAS CONFIRMED. IT WAS NOTED THAT THE VIDEO SOCKET CONNECTOR WAS DEFECTIVE WHICH LED TO NOISE IN THE IMAGE WHEN THE CONNECTOR WAS MOVED. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY.

    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 11 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE LEGAL MANUFACTURER'S INVESTIGATION, A DEFINITIVE ROOT CAUSE OF THE DEFECTIVE VIDEO SOCKET/CABLE CONNECTOR COULD NOT BE IDENTIFIED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO OLYMPUS, THAT THE EVIS EXERA II VIDEO SYSTEM CENTER HAD A DAMAGED CONNECTOR AND NOISY IMAGE. THE ISSUE OCCURRED DURING PREPARATION FOR USE FOR A DIAGNOSTIC PROCEDURE AND IT WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541291 EVIS EXERA II VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER FAJ SHIRAKAWA OLYMPUS CO., LTD. CV-180 04953170215513

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown