BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR CURVED CUTTER STAPLER

    MDR report key: 1821112 · Received August 9, 2007

    Report

    Report Number
    1527736-2007-05268
    Event Type
    Malfunction
    Date Received
    August 9, 2007
    Report Date
    July 31, 2007
    Manufacturer
    ETHICON ENDO SURGERY, INC (CINCINNATI)
    Product Code
    GDW
    PMA / PMN Number
    K040038
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE WOULD NOT STAPLE. THE SITE USED ANOTHER DEVICE TO COMPLETE THE CASE. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR CURVED CUTTER STAPLER GDW ETHICON ENDO SURGERY, INC (CINCINNATI) NA D4H15M

    Patients

    Seq Age Sex Outcome Treatment
    1