BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDEO SYSTEM CENTER

    MDR report key: 12848551 · Received November 19, 2021

    Report

    Report Number
    8010047-2021-14842
    Event Type
    Malfunction
    Date Received
    November 19, 2021
    Date of Event
    October 28, 2021
    Report Date
    January 11, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    UDI-DI
    04953170338502
    PMA / PMN Number
    K122831
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE DHR WAS UNABLE TO BE REVIEWED FOR THIS DEVICE SINCE THE SERIAL NUMBER WAS NOT PROVIDED. HOWEVER, OLYMPUS ONLY RELEASES PRODUCTS TO MARKET THAT MEET ALL MANUFACTURING SPECIFICATIONS AND FINAL PRODUCT RELEASE CRITERIA. THE CASE IS NOT DUE TO DESIGN. BASED ON THE RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED. THIS INFORMATION IS ADDRESSED IN THE INSTRUCTIONS FOR USE (IFU): "CHAPTER 9 TROUBLESHOOTING NEVER USE THE VIDEO SYSTEM CENTER IF AN IRREGULARITY IS OBSERVED. DAMAGE OR IRREGULARITY OF THE VIDEO SYSTEM CENTER MAY COMPROMISE PATIENT OR USER SAFETY AND MAY RESULT IN MORE SEVERE EQUIPMENT DAMAGE. IF AN ACCESSORY OF THE VIDEO SYSTEM CENTER NEEDS TO BE REPLACED, CONTACT OLYMPUS TO PURCHASE A REPLACEMENT." OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE PRIOR TO THE CONCLUSION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE OLYMPUS VIDEO SYSTEM CENTER WAS NOT PRODUCING AN IMAGE WHEN USED IN CONJUNCTION WITH AN OLYMPUS CAMERA HEAD. THE CAMERA HEAD HAS BEEN CAPTURED UNDER REPORT 2010047-2021-14746. ADDITIONAL DETAILS RELATING TO THE PATIENT AND THE EVENT HAVE BEEN REQUESTED, BUT NO RESPONSE HAS BEEN RECEIVED AT THIS TIME. THERE WAS NO PATIENT HARM OR CONSEQUENCE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1743367 VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER FET OLYMPUS MEDICAL SYSTEMS CORP. CV-170 04953170338502

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown OTV-S7H-1D