BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    45MM ARTICNG LNR CUTR/6 ROW BL

    MDR report key: 1320799 · Received February 24, 2009

    Report

    Report Number
    3005075853-2008-03412
    Event Type
    Malfunction
    Date Received
    February 24, 2009
    Date of Event
    November 7, 2008
    Report Date
    November 21, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 12/03/2008. INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A GASTROPLASTY PROCEDURE, ON THE SECOND AND FOURTH FIRING, THE DEVICE DID NOT STAPLE. SEVEN FIRINGS WERE PERFORMED. NO FURTHER INFO WAS KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 45MM ARTICNG LNR CUTR/6 ROW BL GDW GDW ETHICON ENDO-SURGERY, LLC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1