BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS X1 VIDEO SYSTEM CENTER

    MDR report key: 19840012 · Received July 26, 2024

    Report

    Report Number
    3002808148-2024-06907
    Event Type
    Malfunction
    Date Received
    July 26, 2024
    Date of Event
    July 11, 2024
    Report Date
    September 24, 2024
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FET
    UDI-DI
    04953170414596
    PMA / PMN Number
    K222861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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 SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER'S FINAL 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 2 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. A DEFINITIVE ROOT CAUSE WAS NOT IDENTIFIED, HOWEVER BASED ON THE RESULTS OF THE INVESTIGATION, THE PROBABLE CAUSE OF THE MALFUNCTION WOULD LIKELY BE BECAUSE THERE WAS A FAULT IN THE WIRING BETWEEN CV-1500 (COMPLETE VIDEO) AND OIP-1. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED, THE VIDEO SYSTEM CENTER EXPERIENCED NO IMAGE. THE ISSUE OCCURED, DURING AN UNSPECIFIED PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WAS NO DELAY TO THE PATIENT. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    914206 EVIS X1 VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER FET SHIRAKAWA OLYMPUS CO., LTD. CV-1500 04953170414596

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown