BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE ILS CURVED CIR STAPL

    MDR report key: 2991388 · Received March 6, 2013

    Report

    Report Number
    3005075853-2013-01087
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 17, 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 PROVIDED: WHAT CONFIRMATION WAS RECEIVED INDICATING THE DEVICE WAS FULLY FIRED (SUCH AS CRUNCH, COMPRESSED UNTIL UNABLE TO FIRE FURTHER, ETC.)? CRUNCH. WHERE WITHIN THE GREEN TISSUE COMPRESSION/GAP SETTING SCALE WAS THE ORANGE INDICATOR SET FOR FIRING? BEHIND 2/3 OF INDICATOR. WAS THE BREAKAWAY WASHER COMPLETELY CUT THROUGH? YES. FOR CLARIFICATION, ONLY ONE STAPLE WAS MALFORMED? YES. WHAT DID THE STAPLE FORM LOOK LIKE? ONE LEG WAS NOT FORMED. WHAT AREA OF THE STAPLE LINE WERE STAPLES MISSING? UNK. WERE THERE TWO COMPLETE TISSUE DONUTS? YES. BUT THE THICKNESS IS NOT EVEN. WERE ALL TISSUE LAYERS PRESENT IN BOTH DONUTS WHEN INSPECTED? YES. WERE THERE ANY ISSUES WITH REMOVAL OF THE DEVICE? NO. WAS THERE A RECENT CONVERSION TO EES DEVICES IN THIS ACCOUNT OR WITH THIS SURGEON? NO. WHO FIRED THE DEVICE? PRIMARY SURGEON. HAS THE PERSON FIRING BEEN TRAINED ON HOW TO USE 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 ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE FOR RECTAL CARCINOMA UNDER LAP, ONE STAPLE WAS MALFORMED AND STUCK ON THE DONUT AFTER THE FIRING. 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
    95740 PROXIMATE ILS CURVED CIR STAPL STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK J4C60F

    Patients

    Seq Age Sex Outcome Treatment
    1