BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR CURVED CUTTER STAPLER

    MDR report key: 2243291 · Received September 12, 2011

    Report

    Report Number
    3005075853-2011-03729
    Event Type
    Malfunction
    Date Received
    September 12, 2011
    Date of Event
    July 22, 2011
    Report Date
    August 3, 2011
    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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TWO DEVICES WERE RECEIVED IN GOOD VISUAL CONDITIONS AND WITH CARTRIDGE RELOADS LOADED IN THE DEVICES. THE RELOADS WERE RECEIVED VOID OF STAPLES, WITH THE WASHERS COMPLETELY CUT, WITH THE DRIVERS EXPOSED AND WITH THE KNIVES RECESSED BELOW THE CARTRIDGE DECKS. THE DEVICES WERE TESTED FOR FUNCTIONALITY WITH ENGINEERING SAMPLE RELOADS AND THE DEVICES FIRED, FORMING ALL STAPLES AND CUTTING AS INTENDED. THE CUT LINES WERE COMPLETE, THE STAPLE LINES WERE COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. THE DEVICE LOCKOUTS AND THE RELOAD LOCKOUTS WERE FUNCTIONAL. EVENT COULD NOT BE CONFIRMED AS THE DEVICES OPENED AND CLOSED WITHOUT ANY DIFFICULTIES NOTED. IT SHOULD BE NOTED THAT ALL DEVICES ARE INSPECTED 100% FOR STAPLE PRESENCE BY AN (B)(4), AND ARE VISUALLY INSPECTED 100% AS A FINAL CHECK. IN ADDITION, AT FINISHED GOODS THE DEVICES ARE VISUALLY INSPECTED BASED ON A SAMPLE. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2011: FIRING TRIGGER WOULD NOT CLOSE PLASTIC TO PLASTIC THUS NO STAPLE OR CUT. SECOND CONTOUR, FIRED BUT NO CONSISTENT STAPLE FORMATION. SOME STAPLES DID NOT STAPLE TO TISSUE. INSTEAD JUST FELL OFF. TWO DEVICES AFFECTED WITH THE SAME PROBLEM - THEY WERE UNABLE TO CLOSE THE DEVICES TO FIRE THEM. THIS OCCURRED ON THE FIRST FIRING OF BOTH DEVICES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION PROCEDURE, THE DEVICE MISFIRED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR CURVED CUTTER STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA G4T37E

    Patients

    Seq Age Sex Outcome Treatment
    1 CARTRIDGE