BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR CUTTER STAPLER

    MDR report key: 3955022 · Received July 24, 2014

    Report

    Report Number
    3005075853-2014-05186
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    June 26, 2014
    Report Date
    June 30, 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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: ACCORDING TO THE NURSE THAT WAS PRESENT DURING THE PROCEDURE. THE STAPLER FIRED BUT WOULD NOT OPEN TO RELEASE THE TISSUE AND THE SURGEON HAD TO CUT IT LOOSE. THE DEVICE WOULD NOT OPEN AFTER IT WAS FIRED. THIS RESULTED IN AN ADDITIONAL 20-30 MINUTES TO REDO THE ANASTOMOSIS. THE ANALYSIS RESULTS SHOWED THAT THE CS40B DEVICE WAS RECEIVED IN GOOD VISUAL CONDITIONS AND 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. IN ADDITION THE RETURNED CARTRIDGE WAS NOTED TO HAVE TWO 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. PLEASE REFERENCE THE INSTRUCTIONS FOR USE FOR ADDITIONAL INFORMATION. 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. EVENT COULD NOT BE CONFIRMED AS THE DEVICE OPENED AND CLOSED WITHOUT ANY DIFFICULTIES NOTED. 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 A SIGMOID COLON RESECTION, THE DEVICE DID NOT FIRE CORRECTLY. THE DEVICE DID OPEN, BUT WOULD NOT RELEASE FROM THE TISSUE. THEY HAD TO CUT THE TISSUE OFF THE DEVICE. THE SURGEON HAD TO REDO THE ANASTOMOSIS WITH A SAME LIKE DEVICE WHICH TOOK ADDED TIME. THE CASE WAS COMPLETED WITH NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433994 CONTOUR CUTTER STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1