BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDEO SYSTEM CENTER

    MDR report key: 14110819 · Received April 14, 2022

    Report

    Report Number
    8010047-2022-06287
    Event Type
    Malfunction
    Date Received
    April 14, 2022
    Date of Event
    March 15, 2022
    Report Date
    August 8, 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
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION. THE EVALUATION DID NOT CONFIRM THE CUSTOMER ISSUE THAT THE IMAGE GOES OUT. THE INVESTIGATION IS ONGOING, AND A DEFINITIVE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

    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. BASED ON THE RESULTS OF THE LEGAL MANUFACTURER'S INVESTIGATION, A ROOT CAUSE COULD NOT BE IDENTIFIED. ACCORDING TO QUALITY INSPECTION REPORT (QIR), ALL ITEMS PASSED. THERE WAS NO DEFECTIVE PART AND THERE WAS NO ABNORMALITY IN MANUFACTURING HISTORY. THE CAUSE OF THE REPORTED EVENT CANNOT BE CONCLUSIVELY DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    A USER FACILITY REPORTED TO OLYMPUS DURING PREPARATION FOR USE, IMAGE WAS PRESENT, BUT DEFECTIVE. A BAD CONNECTION AND THE IMAGE DISAPPEARS ON THE VIDEO SYSTEM CENTER. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1323048 VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER FET OLYMPUS MEDICAL SYSTEMS CORP. CV-170 04953170338502

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown