BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISERA ELITE II VIDEO SYSTEM CENTER

    MDR report key: 20169076 · Received September 9, 2024

    Report

    Report Number
    3002808148-2024-08528
    Event Type
    Malfunction
    Date Received
    September 9, 2024
    Date of Event
    August 23, 2024
    Report Date
    October 4, 2024
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FET
    UDI-DI
    04953170386022
    PMA / PMN Number
    K200542
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF 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 TWO (2) YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION, AND THE CUSTOMER'S COMPLAINT/REPORTABLE MALFUNCTION WAS CONFIRMED. BASED ON THE INVESTIGATION RESULTS, ERROR CODE E333, COULD NOT BE IDENTIFIED. THE ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE QIR, AS REPRODUCTION OF [ERROR CODE E333] IS NOT CONFIRMED, AND FAILURE HAS NOT BEEN CONFIRMED, PRESUMED CAUSE COULD NOT BE IDENTIFIED. HOWEVER, A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED. THE EVENTS CAN BE DETECTED AND PREVENTED IN ACCORDANCE WITH THE FOLLOWING SECTIONS OF THE INSTRUCTIONS FOR INSTRUCTIONS FOR USE: LABELLING REVIEW: NOT APPLICABLE SINCE IT IS NOT A DEFECT CAUSED BY USER MISUSE. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE EVALUATION OF THE EVENT IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE VIDEO SYSTEM CENTER DISPLAYED AN ERROR CODE E333 DURING A THERAPEUTIC LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM OR DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582767 VISERA ELITE II VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER FET SHIRAKAWA OLYMPUS CO., LTD. OTV-S200 04953170386022

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown