BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III VIDEO SYSTEM CENTER

    MDR report key: 11285267 · Received February 5, 2021

    Report

    Report Number
    8010047-2021-02281
    Event Type
    Malfunction
    Date Received
    February 5, 2021
    Date of Event
    January 8, 2021
    Report Date
    February 26, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE DEVICE EVALUATION RESULT AND CORRECT IN THE INITIAL REPORT SUBMITTED ON FEBRUARY 5, 2021. THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. AS A RESULT OF EVALUATING THE SUBJECT DEVICE, OMSC CONCLUDED THAT THE REPORTED EVENT WAS NOT REPORTABLE EVENT.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OMSC FOR EVALUATION.THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME.IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORPORATION (OMSC) WAS INFORMED THAT DURING THE INCOMING INSPECTION FOR REPAIR AT THE SERVICE DEPARTMENT OF OLYMPUS MEDICAL SYSTEMS (B)(4), IT WAS FOUND THAT THE SWITCHES AND/OR BUTTONS ON THE FRONT PANEL OF THE SUBJECT DEVICE COULD NOT FUNCTION. AFTER THAT (B)(4) CHECKED THE SUBJECT DEVICE AND FOUND THAT THE REPORTED PHENOMENON WAS ATTRIBUTED TO THE CHANGING THE PERIPHERAL SETTINGS. THE SUBJECT DEVICE IS WORKING PROPERLY NOW. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181756 EVIS EXERA III VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER FET OLYMPUS MEDICAL SYSTEMS CORP. CV-190

    Patients

    Seq Age Sex Outcome Treatment
    1