BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISERA 4K UHD CAMERA CONTROL UNIT

    MDR report key: 14568004 · Received June 1, 2022

    Report

    Report Number
    8010047-2022-09227
    Event Type
    Malfunction
    Date Received
    June 1, 2022
    Date of Event
    May 3, 2022
    Report Date
    July 15, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    UDI-DI
    04953170374630
    PMA / PMN Number
    K151011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE DEVICE WAS TESTED, AND THE RESULT WAS POSITIVE. THE INITIAL ERROR AND NO OTHER ERROR WERE PRESENTED. THEREFORE, THE DEVICE WAS RETURNED TO THE CUSTOMER. THE DEVICE REFERENCED IN THIS REPORT HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS ONGOING. THE DEFINITIVE CAUSE OF THE USER¿S EXPERIENCE CANNOT BE DETERMINED AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY.

    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 3 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. SINCE THE PRODUCT WAS NOT RETURNED FOR INSPECTION, QIR AND REPAIR RECORDS ARE NOT AVAILABLE. THEREFORE, THE CAUSE OF THE PHENOMENON COULD NOT BE IDENTIFIED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    A USER FACILITY REPORTED TO OLYMPUS, THE VISERA 4K UHD CAMERA CONTROL UNIT EXHIBITED OTV ERROR CODE E117 (CAMERA CONTROL UNIT MALFUNCTION). THE EVENT OCCURRED DURING A CHOLECYSTECTOMY LAPAROSCOPIC PROCEDURE. IT WAS REPORTED THAT THE PROCEDURE WAS NOT COMPLETED, AND THE DEVICE WAS REPLACED WITH A THIRD-PARTY DEVICE (MARCA MINDRAY). THERE WAS NO REPORT OF PATIENT HARM OR USER INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1932915 VISERA 4K UHD CAMERA CONTROL UNIT VIDEO SYSTEM CENTER FET OLYMPUS MEDICAL SYSTEMS CORP. OTV-S400 04953170374630

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown