BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISERA ELITE VIDEO SYSTEM CENTER

    MDR report key: 17514897 · Received August 11, 2023

    Report

    Report Number
    3002808148-2023-08278
    Event Type
    Malfunction
    Date Received
    August 11, 2023
    Date of Event
    July 19, 2023
    Report Date
    September 27, 2023
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FET
    UDI-DI
    04953170301964
    PMA / PMN Number
    K111425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IN SPEAKING WITH OLYMPUS TECHNICAL ASSISTANCE CENTER (TAC), TAC HAD THE CUSTOMER CONFIRM THE CABLING AND STATED THERE WAS A SERIAL DIGITAL INTERFACE (SDI) CABLE GOING FROM SDI OUT IN THE OTV- S190 TO SDI IN1 IN THE OEV-262H. TAC INSTRUCTED TO PRESS PORT A AND SELECT SDI1. THE NEW CYSTOSCOPY SCREEN THAT WAS PLUGGED IN MADE IT DEFAULT TO A DIFFERENT INPUT DIGITAL VISUAL INTERFACE (DVI) DVI1 AND IT NEEDED TO BE CHANGED BACK. THE CUSTOMER CONFIRMED THE IMAGE DISPLAYED AND THE ISSUE WAS RESOLVED. 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 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 SPECIFIC CAUSE OF PHENOMENON COULD NOT BE IDENTIFIED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS, THE VISERA ELITE VIDEO SYSTEM CENTER DISPLAYED A BLACK IMAGE ON THE OEV-262H MONITOR AND SHOWED A DIGITAL VISUAL INTERFACE NO SYNC ERROR. THE ISSUE WAS FOUND DURING THE THERAPEUTIC REZUM PROCEDURE RESULTING IN A 30 MINUTE DELAY. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    868515 VISERA ELITE VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER FET SHIRAKAWA OLYMPUS CO., LTD. OTV-S190 04953170301964

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown OEV-262H MONITOR.