BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR CURVED CUTTER STAPLER

    MDR report key: 1172500 · Received September 22, 2008

    Report

    Report Number
    3005075853-2008-01852
    Event Type
    Malfunction
    Date Received
    September 22, 2008
    Date of Event
    August 29, 2008
    Report Date
    September 4, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GDW
    PMA / PMN Number
    K040038
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION, THE STAPLES WERE FORMED ONLY HALF WAY ACROSS THE STAPLED AREA. A COMPETITOR'S DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR CURVED CUTTER STAPLER GDW ETHICON ENDO-SURGERY, LLC NA E4LA24

    Patients

    Seq Age Sex Outcome Treatment
    1