BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH DEFINITION LCD MONITOR

    MDR report key: 11391309 · Received March 1, 2021

    Report

    Report Number
    8010047-2021-03117
    Event Type
    Malfunction
    Date Received
    March 1, 2021
    Date of Event
    February 4, 2021
    Report Date
    April 12, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    PMA / PMN Number
    K102379
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. DEVICE HISTORY RECORD REVIEW INDICATES THAT THE DEVICE WAS MANUFACTURED AND TESTED IN ACCORDANCE WITH ALL APPLICABLE PROCEDURES AND MET ALL FINAL PRODUCT RELEASE CRITERIA. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, BASED ON THE INVESTIGATION RESULT, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) ASSUMED THAT THE ENDOSCOPIC IMAGE ABNORMALITY WAS CAUSED BY THE DEFECT OF THE DVI TERMINAL DUE TO EXTERNAL STRESS. THIS STRESS MAY HAVE BEEN CAUSED BY USER HANDLING. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    OLYMPUS INSPECTED THE DEVICE AT THE SERVICE DEPARTMENT OF OLYMPUS (B)(4) PTY LTD AND FOUND FOLLOWINGS; AS REPORTED, THE IN AND OUT OF THE DVI CONNECTOR WERE DAMAGED. THERE WERE NO SCREWS ON THE DVI1 IN AND SDI1 IN. THERE WERE DENTS AND SCRATCHES ON THE FRONT BEZEL PLATE. THE EXACT CAUSE OF THE REPORTED EVENT HAS NOT YET BEEN IDENTIFIED BY LEGAL MANUFACTURER OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR THIS DEVICE. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    THE DEVICE HAD BEEN SENT TO BIOMEDICAL ENGINEERING AT THE USER FACILITY FOR INSPECTION. THEY FOUND THAT THE DEVICE WAS EXPERIENCING AN INTERMITTENT ENDOSCOPIC IMAGE. THEY ASSUMED THAT THE PHENOMENON WAS CAUSED BY A DAMAGED DVI PORT. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291067 HIGH DEFINITION LCD MONITOR HIGH DEFINITION LCD MONITOR FET OLYMPUS MEDICAL SYSTEMS CORP. OEV262H

    Patients

    Seq Age Sex Outcome Treatment
    1