BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISERA ELITE II VIDEO SYSTEM CENTER

    MDR report key: 17674304 · Received September 1, 2023

    Report

    Report Number
    3002808148-2023-09339
    Event Type
    Malfunction
    Date Received
    September 1, 2023
    Date of Event
    August 7, 2023
    Report Date
    November 8, 2023
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FET
    UDI-DI
    04953170386022
    PMA / PMN Number
    K200542
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FIELD TROUBLESHOOTING OF THE DEVICE WAS PERFORMED: POWER OFF THE CART, INSTALL A PROCURED CH-S190-XZ-E: HD AUTOCLAVABLE CAMERA HEAD INTO THE VIDEO SOCKET OF THE PROCESSOR AND POWER THE PROCESSOR ON. A SCOPE IMAGE WAS PRESENT. THE DEVICE WILL NOT BE RETURNED DUE TO THE ISSUE BEING RESOLVED THROUGH TROUBLESHOOTING. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. BASED ON THE RESULTS OF THE INVESTIGATION, THE CUSTOMER¿S ALLEGATION WAS CONFIRMED. IT WAS DETERMINED THE EVENT ¿NO IMAGE (COLOR BAR IS DISPLAYED)¿ OCCURRED BECAUSE THE CAMERA WAS NOT INSERTED/INSTALLED LEADING TO COMMUNICATION FAILURE. UPON FOLLOW UP, THE CUSTOMER STATED THAT USE ERROR CONTRIBUTED TO THE EVENT SINCE, UPON ADVICE FROM OLYMPUS TECHNICIAN, IF A CAMERA WAS NOT INSTALLED, THE DISPLAY WOULD SHOW COLOR BARS. THEREFORE, THE CUSTOMER INSERTED A CAMERA, AND THE DISPLAY WORKED AS DESIGNED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 4 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS THAT THE VIDEO SYSTEM CENTER NO SCOPE IMAGE PRESENT. IT IS UNKNOWN WHEN THE REPORTED ISSUE WAS FOUND. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2155470 VISERA ELITE II VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER FET SHIRAKAWA OLYMPUS CO., LTD. OTV-S200 04953170386022

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown CH-S190-XZ-E: HD AUTOCLAVABLE CAMERA HEAD