BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR CURVED CUTTER STAPLER CS

    MDR report key: 738115 · Received July 14, 2006

    Report

    Report Number
    1527736-2006-03293
    Event Type
    Malfunction
    Date Received
    July 14, 2006
    Report Date
    June 23, 2006
    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
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    458220-0. DATE SENT: 07/14/2006.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING AN LAR PROCEDURE THAT THE DEVICE CUT DID NOT STAPLE COMPLETELY. SUTURED BY HAND. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR CURVED CUTTER STAPLER CS GDW GDW ETHICON ENDO SURGERY, INC. (CINCINNATI) NA C5E85H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN