BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR CURVED CUTTER STAPLER

    MDR report key: 1830362 · Received January 2, 2008

    Report

    Report Number
    1527736-2008-00023
    Event Type
    Malfunction
    Date Received
    January 2, 2008
    Date of Event
    December 13, 2007
    Report Date
    December 17, 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
    NL
    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 RECTUM RESECTION, THE STAPLE LINE WAS INCOMPLETE. COMPLETED WITH HAND SUTURING. NO PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR CURVED CUTTER STAPLER GDW ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA D4HX6U

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR