BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II VIDEO SYSTEM CENTER

    MDR report key: 12174261 · Received July 15, 2021

    Report

    Report Number
    8010047-2021-08907
    Event Type
    Malfunction
    Date Received
    July 15, 2021
    Date of Event
    June 18, 2021
    Report Date
    September 15, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FAJ
    UDI-DI
    04953170215513
    PMA / PMN Number
    K133538
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    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, THERE WAS NO MALFUNCTION IN THE DEVICE CONCERNED AND THAT THE IMAGE WAS SHAKING BECAUSE THERE WAS AN ABNORMALITY IN THE RGB VIDEO CABLE. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE.

    Additional Manufacturer Narrative · 1

    THE REPORTED PROBLEM WAS RESOLVED THROUGH TROUBLESHOOTING WITH OLYMPUS TECHNICAL SUPPORT VIA THE PHONE. UPON TROUBLESHOOTING THE ISSUE, IT WAS DETERMINED THAT THE RED, GREEN, BLUE (RGB) VIDEO CABLE, FROM THE CV-180 TO THE MONITOR, WAS CRIMPED. TO RESOLVE THE PROBLEM, THE REPORTER ORDERED A NEW RGB CABLE. THE INVESTIGATION IS ONGOING AND A DEFINITIVE ROOT CAUSE OF THE REPORTED EVENT HAS NOT BEEN DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

    Description of Event or Problem · 1

    A USER FACILITY REPORTED TO OLYMPUS THAT THE IMAGE DISPLAYED WAS "SHAKING." AS REPORTED TO OLYMPUS, THE PROBLEM WAS IDENTIFIED DURING INSPECTION AND THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1074079 EVIS EXERA II VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER FAJ OLYMPUS MEDICAL SYSTEMS CORP. CV-180 04953170215513

    Patients

    Seq Age Sex Outcome Treatment
    1