BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISERA ELITE VIDEO SYSTEM CENTER

    MDR report key: 17773525 · Received September 19, 2023

    Report

    Report Number
    3002808148-2023-10020
    Event Type
    Malfunction
    Date Received
    September 19, 2023
    Date of Event
    August 22, 2023
    Report Date
    November 13, 2023
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    HET
    UDI-DI
    04953170301964
    PMA / PMN Number
    K111425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2: ADDITIONAL PRODUCT CODES- EOB, EOQ, FGB, GCJ, NWB. THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED 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 FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS, THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, THE ROOT CAUSE COULD NOT BE DETERMINED, AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS, THE IMAGE ON THE VISERA ELITE VIDEO SYSTEM CENTER WENT BLACK DURING PREPARATION FOR USE IN A CYTOSCOPY PROCEDURE. THE IMAGE RETURNED AFTER REBOOTING WITH ANOTHER CONNECTED SCOPE. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THE EVENT NOR ANY REPORTED MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1986386 VISERA ELITE VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER HET SHIRAKAWA OLYMPUS CO., LTD. OTV-S190 04953170301964

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown MODEL# CYF-VH, SERIAL# (B)(6).