BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUNA

    MDR report key: 490666 · Received October 15, 2003

    Report

    Report Number
    2950887-2003-00944
    Event Type
    Malfunction
    Date Received
    October 15, 2003
    Date of Event
    September 23, 2003
    Report Date
    September 23, 2003
    Manufacturer
    MEDTRONIC GASTROENTEROLOGY/UROLOGY
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A TUNA PROCEDURE, THE NEEDLES WOULD NOT FULLY RETRACT INTO THE CARTRIDGE, PRIOR TO THE CARTRIDGE BEING REMOVED FROM THE PT. FOLLOWING THE PROCEDURE THE PT WAS HOSPITALIZED TO MONITOR FOR BLEEDING. THE PT WAS SUBSEQUENTLY DISCHARGED FROM THE HOSP AND REPORTED TO HAVE NO FURTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TUNA EEA GEI MEDTRONIC GASTROENTEROLOGY/UROLOGY 1900TU 3G018V

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other