BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH DEFINITION LCD MONITOR

    MDR report key: 16048724 · Received December 26, 2022

    Report

    Report Number
    3002808148-2022-05581
    Event Type
    Malfunction
    Date Received
    December 26, 2022
    Date of Event
    November 29, 2022
    Report Date
    April 5, 2023
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FET
    PMA / PMN Number
    K954451
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS THE POWER WAS RESTORED ON THE DEVICE AND THE PROCEDURE WAS CONTINUED AND COMPLETED, THIS DEVICE IS NOT EXPECTED TO BE RETURNED AT THIS TIME. THE INVESTIGATION IS ONGOING, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY. THE FOLLOWING FIELD DID NOT CONTAIN COMPLETED INFORMATION DUE TO MAXIMUM CHARACTER LIMITS: CONCOMITANT MEDICAL PRODUCTS: CV-290: 7210535, CLV-290: 7200104, OEV261H: 7247128, WM-NP2: 21211400.

    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. IT HAS BEEN OVER 10 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. THE DEVICE WAS NOT RETURNED FOR EVALUATION, AS A RESULT THE ROOT CAUSE OF THE POWER ISSUE WAS UNABLE TO BE IDENTIFIED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS THAT WHILE USING THE HIGH-DEFINITION LCD MONITOR, THE DEVICE LOST POWER. THE ISSUE OCCURRED DURING THE DIAGNOSTIC PROCEDURE (COLONOSCOPY). THE POWER WAS EVENTUALLY RESTORED, THERE WAS A 5-MINUTE DELAY, AND THE PROCEDURE WAS COMPLETED WITH THE SAME SET OF EQUIPMENT. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2590587 HIGH DEFINITION LCD MONITOR MONITOR FET SHIRAKAWA OLYMPUS CO., LTD. OEV261H

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown CV-290, CLV-290, WM-NP2, OEV261H