BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETS FLEX ARTICNG LNR CUTR 45MM

    MDR report key: 1210136 · Received October 20, 2008

    Report

    Report Number
    3005075853-2008-02467
    Event Type
    Malfunction
    Date Received
    October 20, 2008
    Report Date
    September 29, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE DEVICE FAILED TO CLOSE AND DISCHARGE STAPLES. SOME DRIVERS ARE UP, BUT THERE ARE SOME STAPLES STILL IN THE CARTRIDGE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETS FLEX ARTICNG LNR CUTR 45MM GDW ETHICON ENDO-SURGERY, LLC NA E4KW4N

    Patients

    Seq Age Sex Outcome Treatment
    1