BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR CUTTER STAPLER

    MDR report key: 3922164 · Received July 9, 2014

    Report

    Report Number
    3005075853-2014-04767
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    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
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS SHOWED THAT THE CS40G DEVICE WAS RECEIVED IN GOOD VISUAL CONDITIONS AND WITH A CARTRIDGE RELOAD LOADED IN THE DEVICE. THE RELOAD WAS RECEIVED VOID OF STAPLES, WITH THE WASHER COMPLETELY CUT, WITH THE DRIVERS EXPOSED AND WITH THE KNIFE RECESS BELOW THE CARTRIDGE DECK. IN ADDITION ANOTHER CARTRIDGE WAS RECEIVED FULLY FIRED. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH AN ENGINEERING SAMPLE RELOAD AND THE DEVICE FIRED, FORMING ALL STAPLES AND CUTTING AS INTENDED. THE CUT LINE WAS COMPLETE, THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. THE DEVICE LOCKOUT AND THE RELOAD LOCKOUT WERE FUNCTIONAL. A BATCH RECORD REVIEW WAS PERFORMED AND THE BATCH HAD NO ANOMALIES NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, ONE THIRD OF THE STAPLES WERE UNFORMED AFTER FIRING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401770 CONTOUR CUTTER STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA L4E424

    Patients

    Seq Age Sex Outcome Treatment
    1