BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR CURVED CUTTER STAPLER

    MDR report key: 1993107 · Received February 16, 2011

    Report

    Report Number
    3005075853-2011-00634
    Event Type
    Malfunction
    Date Received
    February 16, 2011
    Date of Event
    January 26, 2011
    Report Date
    January 31, 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
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INCOMPLETE_INTERRUPTED CYCLE. THE ANALYSIS RESULTS SHOWED THAT THE DEVICE WAS RECEIVED IN GOOD VISUAL CONDITIONS AND WITH A RELOAD LOADED IN THE DEVICE. THE RELOAD WAS RECEIVED LOADED, WITHOUT STAPLES, WITH THE WASHER UNCUT AND WITH THE KNIFE RECESS BELOW THE RELOAD DECK. THIS CONDITION IS CONSISTENT WITH THE DEVICE BEING PARTIALLY ACTIVATED. AS A RESULT OF THE PARTIAL FIRING, THE LOCKOUT WAS ENGAGED WHEN THE DEVICE WAS REOPENED. DO NOT FIRE THE INSTRUMENT UNLESS THE CLOSURE TRIGGER IS PROPERLY LATCHED AGAINST THE HANDLE. THE FIRING TRIGGER MUST BE PULLED BACK COMPLETELY AGAINST THE CLOSURE TRIGGER TO PROPERLY FIRE THE INSTRUMENT. IN ADDITION, IF THE FIRING SEQUENCE IS NOT COMPLETE, YOU COULD DEPLOY THE STAPLES WITHOUT CUTTING THE WASHER AND FORMING THE STAPLES. PLEASE REFERENCE INSTRUCTIONS FOR USE FOR ADDITIONAL INFORMATION. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD AND THE DEVICE FIRED, FORMING ALL STAPLES AND CUTTING AS INTENDED. THE CUT LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION PROCEDURE, ON THE INITIAL FIRING OF THE DEVICE, IT WAS DIFFICULT TO OPEN. AFTER OPENING, SOME OF THE STAPLES FORMED AND SOME DID NOT. THE SURGEON HAND SEWED THE ANASTOMOSIS. THERE WAS NO PATIENT IMPACT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 CARTRIDGE