BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETS FLEX ARTICNG LNR CUTR 45MM

    MDR report key: 1081091 · Received July 21, 2008

    Report

    Report Number
    3005075853-2008-00605
    Event Type
    Malfunction
    Date Received
    July 21, 2008
    Date of Event
    June 25, 2008
    Report Date
    June 26, 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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 07/21/2008. INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TOTAL COLECTOMY PROCEDURE, THE DEVICE'S CARTRIDGE POPPED OFF DURING THE INITIAL FIRING. THIS CAUSED AN INCOMPLETE STAPLE LINE AND SOME BLEEDING. THE SAME DEVICE WAS RELOADED AND CORRECTED THE PROBLEM AND STOPPED THE BLEEDING. THE PATIENT DID NOT REQUIRE ANY BLOOD PRODUCTS. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO ADVERSE PATIENT CONSEQUENCE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1