BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR CURVED CUTTER STAPLER

    MDR report key: 1083269 · Received July 29, 2008

    Report

    Report Number
    3005075853-2008-00738
    Event Type
    Injury
    Date Received
    July 29, 2008
    Report Date
    July 2, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GDW
    PMA / PMN Number
    K040038
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION PROCEDURE, THE DEVICE CUT, BUT DID NOT STAPLE. AS A RESULT, THE PT REQUIRED A PERMANENT COLOSTOMY. THE SURGEON NOTED THAT THIS PT'S LESION WAS VERY LOW AND MAY HAVE REQUIRED A COLOSTOMY EVEN WITHOUT A PRODUCT ISSUE. THE EES DIVISIONAL MANAGER SPOKE WITH THE SURGEON, AND THE SURGEON INFORMED HIM THAT THE PT DIED. THE SURGEON DOES NOT RELATE THE DEATH TO THE DEVICE ISSUE. THIS PT HAD END STAGE CANCER AND WAS IN VERY POOR HEALTH. THE DEVICE IS BEING RETAINED BY THE ACCOUNT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention