BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR CURVED CUTTER STAPLER

    MDR report key: 2942301 · Received February 4, 2013

    Report

    Report Number
    3005075853-2013-00455
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Date of Event
    December 11, 2012
    Report Date
    January 9, 2013
    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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DAMAGED CARTRIDGE. THE ANALYSIS RESULTS SHOWED THAT THE DEVICE WAS RECEIVED WITH THE ORIGINAL CARTRIDGE LOADED IN THE DEVICE. THE CARTRIDGE WAS RECEIVED VOID OF STAPLES, WITH THE WASHER UNCUT, WITH THE DRIVERS EXPOSED AND WITH THE KNIFE RECESS BELOW THE CARTRIDGE DECK. THE KNIFE WAS NOTED TO BE NICKED AND THE PUSH ROD WAS BENT. IN ADDITION THE RETURNED CARTRIDGE WAS NOTED TO HAVE FIVE STAPLES STUCK IN THE WASHER, IT APPEARS POSSIBLE THAT EXCESS OF PRESSURE WAS PLACED ON THE DISTAL END OF THE DEVICE NOT ALLOWING THE RETAINING PIN TO PROPERLY ASSEMBLE BECOMING MISALIGNED WITH THE ANVIL CAUSING THE STAPLES NOT TO PROPERLY FORM AND DAMAGING THE KNIFE AS THE KNIFE HIT THE ANVIL AND NOT THE WASHER. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST CARTRIDGE 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 CARTRIDGE LOCKOUT WERE FUNCTIONAL. THE DEVICE FIRED WITHOUT ANY DIFFICULTIES. THE MANUFACTURING RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A COLON PROCEDURE, THE DEVICE WOULD CUT BUT STAPLED PARTIALLY. MANUAL SUTURES WERE USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46764 CONTOUR CURVED CUTTER STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK J4AD3G

    Patients

    Seq Age Sex Outcome Treatment
    1