BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE** ILS STRAIGHT INTRALUMINAL STAPLER - 29MM

    MDR report key: 3132159 · Received May 29, 2013

    Report

    Report Number
    3005075853-2013-02616
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 4, 2013
    Report Date
    May 6, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K983536
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WHAT CONFIRMATION WAS RECEIVED INDICATING THE DEVICE WAS FULLY FIRED (SUCH AS A CRUNCH, COMPRESSED UNTIL UNABLE TO FIRE FURTHER, ECT.)? THE SURGEON COMPRESSED THE DEVICE UNTIL UNABLE TO FIRE FURTHER TO INDICATE THE DEVICE WAS FULLY FIRED, AND THERE WAS NO CRUNCH TOO. WHERE WITHIN THE GREEN TISSUE COMPRESSION/GAP SETTING SCALE WAS THE ORANGE INDICATOR SET FOR FIRING? IN THE BACK PART OF GREEN TISSUE COMPRESSION/GAP WHAT WAS THE APPEARANCE OF THE STAPLES (IRREGULAR SHAPES OR LEGS STRAIGHT)? IRREGULAR SHAPES. WHEN WAS THE RED SAFETY REMOVED PRIOR TO FIRING? BEFORE FIRING. WAS THE BREAKAWAY WASHER COMPLETELY CUT THROUGH? YES. WAS THERE A RECENT CONVERSION TO EES DEVICES IN THIS ACCOUNT OR WITH THIS SURGEON? NO. WHO FIRED THE DEVICE? THE SURGEON. HAS THE PERSON FIRING BEEN TRAINED ON HOW TO USE THE EES CIRCULAR DEVICE? YES. HAS THE O.R. STAFF BEEN TRAINED IN PREPARING THE EES CIRCULAR DEVICE? YES. THE ANALYSIS RESULTS FOUND THAT THE DEVICE ARRIVED IN GOOD VISUAL CONDITION. THE BREAKAWAY WASHER WAS PRESENT AND CUT AND THERE WERE NO STAPLES PRESENT, INDICATING THAT THE DEVICE ACHIEVED A FULL FIRING STROKE. THE DEVICE WAS RELOADED WITH STAPLES, A NEW WASHER WAS PLACED ON THE DEVICE AND IT WAS TESTED FOR FUNCTIONALITY. IT FIRED AND FORMED ALL THE STAPLES AS WELL AS COMPLETELY CUT THE TEST MEDIA AND THE BREAKAWAY WASHER WITHOUT INCIDENT. THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. THE MANUFACTURING RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION PROCEDURE, THE SURGEON USED A CIRCULAR DEVICE FOR INTESTINAL ANASTOMOSIS. SOME MALFORMED STAPLES WERE FOUND AT THE CROSS OF THE STAPLE LINES. USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. NO ADVERSE EVENT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235685 PROXIMATE** ILS STRAIGHT INTRALUMINAL STAPLER - 29MM STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. J4CR2Y

    Patients

    Seq Age Sex Outcome Treatment
    1