BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUNA

    MDR report key: 511207 · Received January 13, 2004

    Report

    Report Number
    2950887-2004-00029
    Event Type
    Malfunction
    Date Received
    January 13, 2004
    Date of Event
    November 12, 2003
    Report Date
    December 18, 2003
    Manufacturer
    MEDTRONIC GASTROENTEROLOGY/UROLOGY
    Product Code
    GEI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE HCP REPORTED THAT DURING A TUNA PROCEDURE, THE NEEDLES WOULD NOT FULLY RETRACT 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 3E033V

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other