BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILS 29MM, CURVED

    MDR report key: 3081121 · Received April 26, 2013

    Report

    Report Number
    3005075853-2013-02005
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 4, 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
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL COMMENTS: HOW WAS IT CONFIRMED THAT THE ANVIL WAS SECURED TO THE TROCAR? BY HAND, THIS WAS AN OPEN PROCEDURE. WHAT CONFIRMATION WAS RECEIVED INDICATING THE DEVICE WAS FULLY FIRED (SUCH AS CRUNCH, COMPRESSED UNTIL UNABLE TO FIRE FURTHER, FIRED PLASTIC TO PLASTIC, ETC.)? DR. RELAYS THAT HE HEARD A CRUNCH SOUND. WHERE WITHIN THE GREEN TISSUE COMPRESSION/GAP SETTING SCALE WAS THE ORANGE INDICATOR SET FOR FIRING? AT ABOUT 1.5 TO 1.8MM. WHAT WAS THE APPEARANCE OF THE MALFORMED STAPLES (IRREGULAR SHAPES OR WERE THE LEGS STRAIGHT)? MANY STAPLES SEEMED TO BE IN PROPER B-SHAPE. SOME, HOWEVER WERE NOTED TO BE FULLY OPEN WITH STRAIGHT LEGS. WHAT WAS THE APPEARANCE OF THE DONUTS? PERFECT. WERE THERE ANY ISSUES WITH REMOVAL? IF YES, PLEASE EXPLAIN. NONE. HOW MANY COUNTER-CLOCKWISE REVOLUTIONS WERE USED TO OPEN THE DEVICE? 1.5. WHO FIRED THE DEVICE? THE ATTENDING SURGEON. THE ANALYSIS RESULTS FOUND THAT THE DEVICE ARRIVED IN GOOD VISUAL CONDITION. THE BREAKAWAY WASHER UNCUT AND INDENTED, INDICATING THAT THE DEVICE HAD NOT BEEN FIRED THROUGH A FULL FIRING STROKE OR POSSIBLY THAT THE ORANGE INDICATOR WAS NOT FULLY INTO THE SAFE GREEN FIRING RANGE. IT SHOULD BE NOTED THAT BEFORE FIRING THE DEVICE THE ORANGE INDICATOR SHOULD BE FULLY WITHIN THE GREEN RANGE OF THE GAP SETTING SCALE. IN ADDITION IT SHOULD BE NOTED THAT IF THE FIRING SEQUENCE IS NOT COMPLETE (THE FIRING HANDLE REACHES ITS STOPPING POINT, AND THE FIRING TRIGGER IS PARALLEL TO THE INSTRUMENT HANDLE) STAPLES COULD BE PARTIALLY DEPLOYED WITHOUT CUTTING THE WASHER. THE DEVICE WAS RELOADED WITH STAPLES AND TESTED FOR FUNCTIONALITY WITH A TEST WASHER; THE DEVICE 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.

    Additional Manufacturer Narrative · 1

    (B)(4). UNCUT WASHER - BLEMISHED. THE ANALYSIS RESULTS FOUND THAT THE DEVICE ARRIVED IN GOOD VISUAL CONDITION. THE BREAKAWAY WASHER UNCUT AND INDENTED, INDICATING THAT THE DEVICE HAD NOT BEEN FIRED THROUGH A FULL FIRING STROKE OR POSSIBLY THAT THE ORANGE INDICATOR WAS NOT FULLY INTO THE SAFE GREEN FIRING RANGE. IT SHOULD BE NOTED THAT BEFORE FIRING THE DEVICE THE ORANGE INDICATOR SHOULD BE FULLY WITHIN THE GREEN RANGE OF THE GAP SETTING SCALE. IN ADDITION IT SHOULD BE NOTED THAT IF THE FIRING SEQUENCE IS NOT COMPLETE (THE FIRING HANDLE REACHES ITS STOPPING POINT, AND THE FIRING TRIGGER IS PARALLEL TO THE INSTRUMENT HANDLE) STAPLES COULD BE PARTIALLY DEPLOYED WITHOUT CUTTING THE WASHER. THE DEVICE WAS RELOADED WITH STAPLES AND TESTED FOR FUNCTIONALITY WITH A TEST WASHER; THE DEVICE 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 AN EXPLORATORY LAPAROSCOPIC WITH TOTAL GASTRECTOMY PROCEDURE, THE SURGEON FIRED THE INSTRUMENT AND THERE WAS AUDIBLE FEEDBACK. HOWEVER, UPON INSPECTION OF THE DONUTS, THE REP NOTICED THAT THE CUTTING WASHER HAD NOT BEEN BROKEN THROUGH. THIS SURGEON COULD SEE SOME STAPLES HAD NOT FORMED AT ALL, WHILE OTHERS WERE IN THE PROPER B-SHAPE. THE DECISION WAS MADE BY THE SURGEON TO OVER SEW THE ANASTOMOSIS. ANOTHER STERILE DEVICE WAS DRY FIRED ON A NON-STERILE BACK TABLE TO DEMONSTRATE HOW THE BLADE COMPLETE CUTS THROUGH CUTTING WASHER AND SHOULD BE IN TWO SEPARATE PIECES. A THIRD CIRCULAR STAPLER WAS USED FOR THE ESOPHAGOCOLOANASTOMOSIS. APPROXIMATELY TWENTY MINUTES WAS SPENT ON STAPLE LINE INSPECTION AND OVERSEW STAPLE LINE. THERE WERE NO PATIENT CONSEQUENCES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN EXPLORATORY LAPAROSCOPIC WITH TOTAL GASTRECTOMY PROCEDURE, THE SURGEON FIRED THE INSTRUMENT AND THERE WAS AUDIBLE FEEDBACK. HOWEVER, UPON INSPECTION OF THE DONUTS, THE REP NOTICED THAT THE CUTTING WASHER HAD NOT BEEN BROKEN THROUGH. THIS SURGEON COULD SEE SOME STAPLES HAD NOT FORMED AT ALL, WHILE OTHERS WERE IN THE PROPER B-SHAPE. THE DECISION WAS MADE BY THE SURGEON TO OVER SEW THE ANASTOMOSIS. ANOTHER STERILE DEVICE WAS DRY FIRED ON A NON-STERILE BACK TABLE TO DEMONSTRATE HOW THE BLADE COMPLETE CUTS THROUGH CUTTING WASHER AND SHOULD BE IN TWO SEPARATE PIECES. A THIRD CIRCULAR STAPLER WAS USED FOR THE ESOPHAGOCOLOANASTOMOSIS. APPROXIMATELY TWENTY MINUTES WAS SPENT ON STAPLE LINE INSPECTION AND OVERSEW STAPLE LINE. THERE WERE NO PATIENT CONSEQUENCES. PATIENT HAS BEEN DISCHARGED ON (B)(6) 2013 AND HAS BEEN RELEASED ON A FULL DIET. THERE WERE NO LEAKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182781 ILS 29MM, CURVED STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK K4C71W

    Patients

    Seq Age Sex Outcome Treatment
    1