BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLYMPUS TJF-Q180V

    MDR report key: 5850856 · Received August 3, 2016

    Report

    Report Number
    MW5063858
    Event Type
    Injury
    Date Received
    August 3, 2016
    Date of Event
    August 1, 2016
    Report Date
    August 3, 2016
    Manufacturer
    OLYMPUS TJF-Q180V
    Product Code
    FDT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    OUR HOSPITAL'S GI LABS HAVE EXPERIENCED HIGHER FAILURE RATES OF THE (B)(4) TJF DUODENOSCOPES SINCE USE OF THE STERIS SYSTEM IE REPROCESSORS. FAILURES INCLUDE LEAKAGE, AND POOR VIDEO IMAGE QUALITY OR LOSS OF IMAGE. THE FAILURE AND TIMES REQUIRED TO REPAIR SCOPES HAS REQUIRED MORE RESOURCES TO ARRANGE FOR REPAIRS, AND HAS ALSO REQUIRED PROCUREMENT OF ADD'L ENDOSCOPES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495903 OLYMPUS TJF-Q180V DUODENOSCOPE FDT OLYMPUS TJF-Q180V TJF-Q180V

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention