BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISERA ELITE VIDEO SYSTEM CENTER

    MDR report key: 19051384 · Received April 5, 2024

    Report

    Report Number
    3002808148-2024-03210
    Event Type
    Malfunction
    Date Received
    April 5, 2024
    Date of Event
    March 12, 2024
    Report Date
    September 12, 2024
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FET
    UDI-DI
    04953170301964
    PMA / PMN Number
    K111425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    REGARDING THE FIRST FOLLOW UP REPORT WITH MFR# 3002808148-2024-03210 WHICH WAS SUBMITTED ON 22MAY2024, IT MADE REFERENCE TO MEDWATCH NUMBER (B)(4) WHICH IS AN OLYMPUS SYSTEM GENERATED REFERENCE NUMBER, THE FOLLOW UP REPORT SHOULD HAVE REFERENCED THE INITIAL REPORT WITH MFR# 3002808148-2024-03210.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: G3 (ORIGINALLY REPORTED ON MW: 234085) AS 18MAR2024, ACTUAL DATE AS FOLLOWS 12MAR2024. THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE APPROVED FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 3 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, AND SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION, THE DEFINITIVE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. CORRECTIONS TO D5, D9, H2, H3, H6, H11. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION, AND THE CUSTOMER'S COMPLAINT WAS PARTIALLY CONFIRMED. THE NO IMAGE WAS ABLE TO BE REPRODUCED. HOWEVER, THE FLICKERING IMAGE WAS NOT ABLE TO BE REPRODUCED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THAT NO IMAGE IS DISPLAYED DUE TO A FAILURE OF THE LOOSE VIDEO CONNECTOR. THE ROOT CAUSE WAS UNABLE TO BE DETERMINED FOR THE FLICKERING IMAGE. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE VIDEO SYSTEM CENTER EXHIBITED THE IMAGE FLICKERING OCCASIONALLY DUE TO POOR CONTACT. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THE VIDEO SYSTEM CENTER HAS POOR CONTACT OF THE VIDEO CONNECTOR CAUSING THE IMAGE TO OCCASIONALLY FLICKER. THE IMAGE WAS RETURNED BACK TO NORMAL AFTER RECONNECTING. THE ISSUE OCCURRED DURING PREPARATION FOR USE FOR AN EAR, NOSE AND THROAT EXAMINATION. THE PROCEDURE WAS COMPLETED USING THE SAME SET OF EQUIPMENT. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2334571 VISERA ELITE VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER FET SHIRAKAWA OLYMPUS CO., LTD. OTV-S190 04953170301964

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ENF-VT2.