BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH DEFINITION LCD MONITOR OEV262H

    MDR report key: 5368745 · Received January 14, 2016

    Report

    Report Number
    8010047-2016-00025
    Event Type
    Malfunction
    Date Received
    January 14, 2016
    Date of Event
    December 21, 2015
    Report Date
    September 27, 2016
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS COOPERATION
    Product Code
    GCJ
    PMA / PMN Number
    K102379
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECTED DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP.(OMSC) FOR EVALUATION. OMSC CHECKED THE DEVICE HISTORY RECORD OF THE SUBJECT DEVICE, AND THERE WAS NO IRREGULARITY FOUND. OMSC WAS REPORTED THE FOLLOWING FROM THE MEMBER OF SALES DEPARTMENT. - THE MONITOR CONNECTED TO THE ISOLATION TRANSFORMER, AND THIS PHENOMENON WAS ELIMINATED. BASED ON THESE INVESTIGATION RESULTS, OMSC SURMISED THAT THIS EVENT OCCURRED, BECAUSE THE POWER UNIT OF THE MONITOR WAS NOT GROUNDED ENOUGH. ARGON PLASMA COAGULATOR INTERFERED WITH THE FREQUENCY OF THE POWER UNIT OF THE OEV262H, AND THE NOISE WAS CAUSED BY THIS INFLUENCE. THE OEV262H INSTRUCTION MANUAL STATES THE CORRESPONDING METHOD WHEN THERE IS AN ABNORMALITY. THERE WERE NO FURTHER DETAILS PROVIDED. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE IS NOT RETURNED TO OLYMPUS YET. OLYMPUS WILL INVESTIGATE THE SUBJECT DEVICE TO DETERMINE THE CAUSE OF THIS PHENOMENON AFTER OLYMPUS RECEIVES IT. THERE WERE NO FURTHER DETAILS PROVIDED. OLYMPUS WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT AN IMAGE OF THE SUBJECT DEVICE BECAME NOISY WHEN THE FACILITY PERFORMED TREATMENT OF STOMACH WITH ARGON PLASMA COAGULATION. AFTER THE MONITOR IMAGE BECAME NOISY, IT DISAPPEARED. THE FACILITY ABORTED THE PROCEDURE BECAUSE THE PHENOMENON OCCURRED. THERE WAS NO REPORT OF PATIENT'S INJURY IN THIS EVENT, BUT THE FACILITY WOULD PERFORM TREATMENT FOR THE PATIENT ANOTHER DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24326 HIGH DEFINITION LCD MONITOR OEV262H LCD MONITOR GCJ OLYMPUS MEDICAL SYSTEMS COOPERATION OEV262H

    Patients

    Seq Age Sex Outcome Treatment
    1