BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH DEFINITION LCD MONITOR

    MDR report key: 16091169 · Received January 3, 2023

    Report

    Report Number
    3002808148-2023-00040
    Event Type
    Malfunction
    Date Received
    January 3, 2023
    Date of Event
    December 5, 2022
    Report Date
    February 2, 2023
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FET
    UDI-DI
    04953170363498
    PMA / PMN Number
    K102379
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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. BASED ON THE RESULTS OF THE INVESTIGATION, THE ROOT CAUSE OF THE NO IMAGE COULD NOT BE DETERMINED AS THE ISSUE WAS NOT REPRODUCED. POSSIBLE CAUSES FOR THE ¿NO IMAGE¿ MIGHT HAVE BEEN DUE TO A FAULTY CIRCUIT BOARD (QB), A HARNESS CONNECTION FAILURE WITH THE LIQUID CRYSTAL DISPLAY (LCD) PANEL, OR A FAULTY LCD PANEL. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE HAS BEEN RETURNED TO OLYMPUS FOR EVALUATION AND THE REPORTED ISSUE WAS NOT CONFIRMED. DURING EVALUATION, IT WAS OBSERVED, THE SCREEN IF THE SUBJECT DEVICE WAS SCRATCHED. THE INVESTIGATION IS ONGOING, AND A DEFINITIVE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS, DURING REPROCESSING FOR A DIAGNOSTIC GASTROSCOPIC PROCEDURE, THE HIGH-DEFINITION LCD MONITOR HAD NO IMAGE. SUBSEQUENTLY, THE INTENDED PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146183 HIGH DEFINITION LCD MONITOR HIGH DEFINITION LCD MONITOR FET SHIRAKAWA OLYMPUS CO., LTD. OEV262H 04953170363498

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown MODEL NUMBER: CV-290, NO SERIAL NUMBER PROVIDED