BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUNA

    MDR report key: 476943 · Received August 1, 2003

    Report

    Report Number
    2950887-2003-00676
    Event Type
    Malfunction
    Date Received
    August 1, 2003
    Date of Event
    June 16, 2003
    Report Date
    June 24, 2003
    Manufacturer
    MEDTRONIC GASTROENTEROLOGY/UROLOGY
    Product Code
    GEI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    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 BEING REMOVED FROM THE PT. NO COMPLICATIONS TO THE PT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TUNA EEA GEI MEDTRONIC GASTROENTEROLOGY/UROLOGY 1900TU H3B006

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other