BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE ILS STRAIGHT INTRALUMINAL STAPLER - 29MM

    MDR report key: 1822608 · Received November 27, 2007

    Report

    Report Number
    1527736-2007-07963
    Event Type
    Malfunction
    Date Received
    November 27, 2007
    Date of Event
    November 2, 2007
    Report Date
    November 5, 2007
    Manufacturer
    ETHICON ENDO-SURGERY, INC. (CINCINNATI)
    Product Code
    GDW
    PMA / PMN Number
    K983536
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP GASTRECTOMY PROCEDURE, ONE-FOURTH OF RING WHICH WAS A SIDE OF DUODENUM BROKEN. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE ILS STRAIGHT INTRALUMINAL STAPLER - 29MM GDW ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1