BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR CURVED CUTTER STAPLER

    MDR report key: 2100947 · Received May 24, 2011

    Report

    Report Number
    3005075853-2011-02116
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Date of Event
    May 4, 2011
    Report Date
    May 4, 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
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). DAMAGED CARTRIDGE. THE ANALYSIS RESULTS SHOWED THAT THE DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH A RELOAD LOADED IN THE DEVICE. THE RELOAD WAS RECEIVED WITH THE WASHER UNCUT, WITHOUT STAPLES PRESENT; 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. IN ADDITION, THE KNIFE AND FOUR DRIVERS WERE FOUND DAMAGED. ONE POSSIBLE CAUSE FOR THE DAMAGED KNIFE MAY BE IF THE DEVICE IS FIRED OVER AN ALREADY EXISTING STAPLE LINE, HARD OBJECT OR THICKER TISSUE THAN INDICATED. REPEATEDLY FIRING ACROSS EXISTING STAPLE LINES CAN ALSO REDUCE THE ABILITY TO CUT CLEANLY. TO MITIGATE THE POTENTIAL FOR STAPLES GETTING INTO THE CARTRIDGE, PROPER CARE SHOULD BE TAKEN WHEN PLACING THE DEVICE ON THE TISSUE TO BE STAPLED 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. THE DEVICE OPENED AND CLOSED WITHOUT ANY DIFFICULTIES. IT SHOULD BE NOTED THAT ALL DEVICES ARE INSPECTED 100% FOR STAPLE PRESENCE BY AN (B)(4). IN ADDITION, AT FINISHED GOODS THE DEVICES ARE VISUALLY INSPECTED BASED ON A SAMPLE. THE BATCH RECORDS WERE REVIEWED AND THE FINAL QUALITY RELEASE CRITERIA WERE MET BEFORE THE BATCHES WERE RELEASED FOR DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, WHEN THE SURGEON CLOSED THE TRIGGER, THERE WAS NO SOUND FEEDBACK. DURING THE FIRING, THE KNIFE COULD ONLY CUT A SMALL PART OF TISSUE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR 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 G4UA0R

    Patients

    Seq Age Sex Outcome Treatment
    1 CARTRIDGE