BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROX ACCESS 55MM ART STAP REG

    MDR report key: 1316742 · Received February 20, 2009

    Report

    Report Number
    1527736-2008-01813
    Event Type
    Malfunction
    Date Received
    February 20, 2009
    Date of Event
    February 28, 2008
    Report Date
    March 3, 2008
    Manufacturer
    ETHICON ENDO SURGERY, INC. (CINCINNATI)
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 3/24/2008. INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION, THE DEVICE WOULD NOT STAPLE. SUTURES WERE USED TO COMPLETE THE PROCEDURE WITH NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROX ACCESS 55MM ART STAP REG GDW GDW ETHICON ENDO SURGERY, INC. (CINCINNATI) NA D4HZ3X

    Patients

    Seq Age Sex Outcome Treatment
    1