BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUNA

    MDR report key: 523337 · Received February 9, 2004

    Report

    Report Number
    2950887-2004-00161
    Event Type
    Malfunction
    Date Received
    February 9, 2004
    Date of Event
    February 2, 2004
    Report Date
    February 4, 2004
    Manufacturer
    MEDTRONIC GASTROENTEROLOGY/UROLOGY
    Product Code
    GEI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    DURING A TUNA PROCEDURE, THE NEEDLES WOULD NOT FULLY INTO THE CARTRIDGE PRIOR TO THE CARTRIDGE BEING REMOVED FROM THE PT. NO INJURY TO THE PT WAS REPORTED. NO TREATMENT INTERVENTIONS WERE REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TUNA EEA GEI MEDTRONIC GASTROENTEROLOGY/UROLOGY 1900TU 4A010V

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other