BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH** ILS ENDOSCOPIC CURVED INTRALUMINAL STAPLER - 29 MM

    MDR report key: 3010902 · Received March 19, 2013

    Report

    Report Number
    3005075853-2013-01288
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    February 25, 2013
    Report Date
    February 28, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    KOG
    PMA / PMN Number
    K940967
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE DEVICE ARRIVED WITH THE ANVIL MISSING, OTHERWISE IN GOOD VISUAL CONDITION. AS THE ORIGINAL ANVIL WAS NOT RECEIVED, FURTHER INVESTIGATION WITH THE ORIGINAL ANVIL COULD NOT BE PERFORMED. THE BREAKAWAY WASHER WAS NOT PRESENT AND THERE WERE NO STAPLES PRESENT. THE DEVICE WAS RELOADED WITH STAPLES, A NEW WASHER WAS PLACED ON THE DEVICE AND IT WAS TESTED FOR FUNCTIONALITY WITH A TEST ANVIL; 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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION RECEIVED: WHAT TYPE OF ANASTOMOSIS WAS CREATED?END TO END. WHICH STAPLING TECHNIQUE WAS USED? DOUBLE. WHICH PURSE-STRING SUTURE TECHNIQUE WAS USED? TOP HAD PURSE STRING. WHAT OTHER DEVICES WERE USED FOR TRANSECTING AND/OR CLOSING OTOMIES? COUNTOUR. WAS THERE A RECENT CONVERSION TO EES DEVICES IN THIS ACCOUNT OR WITH THIS SURGEON? NO. THEY HAVE USED OUR PRODUCTS FOR 10 YEARS. WHO FIRED THE DEVICE? DR SCOTT STEELE. HAS THE O.R. STAFF BEEN TRAINED IN PREPARING THE EES CIRCULAR DEVICE? YES. HOW WAS IT CONFIRMED THAT THE ANVIL WAS SECURED TO THE TROCAR? AUDIBLE CLICK. WHAT CONFIRMATION WAS RECEIVED INDICATING THE DEVICE WAS FULLY FIRED? CRUNCH. WAS MORE THAN ONE FIRING STROKE REQUIRED TO HEAR THE CRUNCH? N/A. WHERE WITHIN THE GREEN TISSUE COMPRESSION/GAP SETTING SCALE WAS THE ORANGE INDICATOR SET FOR FIRING? BOTTOM. DID THE RED SAFETY REMAIN ENGAGED UNTIL FIRING? YES. WERE ANY UNEXPECTED NOISES HEARD? NO. WAS THE BREAKAWAY WASHER COMPLETELY CUT THROUGH? YES. DONUTS WERE GOOD. WERE STAPLES OBSERVED IN THE TISSUE? PARTIAL FIRING OF STAPLES BELOW THE ANASTOMOSIS. WHAT DID THE STAPLE FORM LOOK LIKE? SOME BS AND SOME GOALPOSTS. WERE ANY STAPLES PRESENT? YES, BUT NOT IN THE ANASTOMOSIS. WHAT AREA OF THE STAPLE LINE WERE STAPLES MISSING? THE ANASTOMOSIS WAS NOT ATTACHED AT ALL. WERE ANY REMOVAL ISSUES EXPERIENCE? NO. HOW MANY COUNTER-CLOCKWISE REVOLUTIONS WERE USED TO OPEN THE DEVICE? 3/4. WAS BUTTRESSING MATERIAL USED? NO. WAS THE SAFETY RESET BEFORE REMOVAL ATTEMPTED? NO. WERE ALL TISSUE LAYERS PRESENT IN BOTH DONUTS WHEN INSPECTED? YES. WHAT WAS THE PATIENT'S PRE-OP DIAGNOSIS? ULCERATIVE COLITIS. DID THE PATIENT HAVE PRE-EXISTING CONDITIONS THAT COULD HAVE IMPACTED THE PATIENT'S HEALTH/SURGICAL OUTCOME? N/A. HAS THE PATIENT UNDERGONE ANY RADIATION OR CHEMO THERAPY? NO. WERE THERE ANY COMORBIDITY CONCERNS (DIABETES, CROHN'S, AUTO-IMMUNE DISORDERS, COAGULATION ISSUES, ETC.)? NO. IS THERE ANY ADDITIONAL INFORMATION YOU WOULD LIKE TO SHARE RELATIVE TO THE ISSUE? NO. WHAT IS THE PATIENT'S PRESENT CONDITION? STILL HOSPITALIZED W/COLOSTOMY BAG. UNKNOWN IF HAND SEWN ANASTOMOSIS WILL HOLD. IT IS UNDER TENSION. IS A PATHOLOGY SPECIMEN AVAILABLE? NO. ARE THERE ANY X-RAYS AND/OR PICTURE AVAILABLE FOR ANALYSIS? NO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC COLECTOMY PROCEDURE, THE DONUTS WERE FINE, THERE WERE ONLY A FEW STAPLES IN THE ANASTOMOSIS. CONVERTED LAP PROCEDURE TO OPEN. IT TOOK AND ADDITIONAL FOUR AND A HALF HOURS TO HAND SEW THE ANASTOMOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113800 ENDOPATH** ILS ENDOSCOPIC CURVED INTRALUMINAL STAPLER - 29 MM ENDOSCOPE AND/OR ACCESSORIES KOG ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention