BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE ILS CURVED CIR STAPL

    MDR report key: 2944449 · Received February 5, 2013

    Report

    Report Number
    3005075853-2013-00495
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    January 18, 2013
    Report Date
    January 18, 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
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SAFETY RELEASE DAMAGED, UNCUT WASHER - BLEMISHED. ADDITIONAL INFORMATION PROVIDED: WHAT TYPE OF ANASTOMOSIS WAS CREATED? (END TO END, END TO SIDE) END TO END. WHAT STAPLING TECHNIQUE WAS USED? (SINGLE, DOUBLE, TRIPLE) DOUBLE. IF (SINGLE OR DOUBLE), WHICH PURSE-STRING SUTURE WAS USED? (HAND-SEWN OR SUTURE CLAMP) SUTURE CLAMP. WHAT OTHER DEVICES WERE USED FOR TRANSECTING AND/OR CLOSING OTOMY? CONTOUR. WAS THE SALE REP PRESENT? NO. HOW LONG HAS THE SURGEON BEEN USING THIS DEVICE FOR THIS PROCEDURE? TEN PLUS. WAS THE ATTENDING SURGEON AN EXPERIENCED EES CIRCULAR USER? YES. WHO FIRED THE DEVICE? (B)(6), RN UNDER SURGEON'S DIRECTION. WAS THE PERSON FIRING THE DEVICE AN EXPERIENCED EES CIRCULAR USER? YES. WAS THE OPERATING ROOM STAFF EXPERIENCED IN PREPARING THE EES CIRCULAR DEVICE? YES. WAS THERE A RECENT CONVERSION TO EES DEVICES IN THIS ACCOUNT OR THIS SURGEON? NO. IS THERE ANY ADDITIONAL INFORMATION YOU WOULD LIKE TO SHARE RELATIVE TO THE ISSUE? NO WHAT IS THE PATIENT'S PRESENT CONDITION? STABLE. ARE THERE ANY X-RAYS AND/OR PICTURES AVAILABLE FOR ANALYSIS? NONE. WERE MALFORMED STAPLES OBSERVED? PARTIALLY AND MALFORMED STAPLES DUE TO THE DEVICE COULD NOT BE FULLY FIRED. DID THE RED SAFETY REMAIN ENGAGED UNTIL FIRING? YES. WAS THE SAFETY RESET BEFORE REMOVAL ATTEMPTED? SAFETY WOULD NOT RELEASE AND COULD NOT BE MOVED EITHER WAY. WHEN WAS THE LEAK DISCOVERED? YES HOW WAS THE LEAK DISCOVERED? DEVICE DID NOT FULLY FIRE DUE TO THE SAFETY NOT RELEASING HOW WAS THE LEAK ADDRESSED? RE-ANASTOMOSED WITH NEW DEVICE WHAT WAS THE REASON FOR THE SURGICAL PROCEDURE? DIVERTICULITIS WITH PERFORATION OF BOWEL. WHAT WAS THE PATIENT'S PRE-OP DIAGNOSIS? SIGMOID COLON DIVERTICULITIS. DID THE PATIENT HAVE PRE-EXISTING CONDITIONS THAT COULD HAVE IMPACTED THE PATIENT'S HEALTH/SURGICAL OUTCOME? NO. HAS THE PATIENT UNDERGONE ANY RADIATION OR CHEMO THERAPY? NO. WERE THERE ANY CO-MORBIDITY CONCERNS (DIABETES, CROHNS, AUTO-IMMUNE DISORDERS, COAGULATION ISSUES)? NO. THE ANALYSIS RESULTS FOUND THAT THE DEVICE ARRIVED WITH THE SAFETY DAMAGED AND WITH THE HANDLES CRACKED. IT APPEARS THAT AN ATTEMPT WAS MADE TO FIRE THE DEVICE WITH THE SAFETY ENGAGED. IT SHOULD BE NOTICE THAT TO FIRE THE DEVICE, DRAW THE RED SAFETY BACK TOWARD THE ADJUSTING KNOB UNTIL IT SEATS INTO THE BODY OF THE DEVICE. IF THE SAFETY CANNOT BE RELEASED, THE DEVICE IS NOT IN THE SAFE FIRING RANGE. IN ADDITION THERE WERE NO STAPLES PRESENT IN THE DEVICE AND THE BREAKAWAY WASHER WAS UNCUT AND INDENTED, INDICATING THAT THE DEVICE HAD NOT BEEN FIRED THROUGH A FULL FIRING STROKE, THE ORANGE INDICATOR WAS NOT FULLY INTO THE SAFE GREEN FIRING RANGE OR THE ANVIL WAS NOT REATTACHED CORRECTLY. IT SHOULD BE NOTED THAT BEFORE FIRING, ENSURE THAT THE ORANGE INDICATOR IS FULLY WITHIN THE GREEN RANGE OF THE GAP SETTING SCALE. IN ADDITION IF THE FIRING SEQUENCE IS NOT COMPLETE, YOU COULD DEPLOY THE STAPLES WITHOUT CUTTING THE WASHER. IT SHOULD ALSO BE NOTED WHEN ATTEMPTING TO REATTACH THE DETACHABLE HEAD OR ANVIL DO NOT CLAMP ACROSS OR GRIP ON THE LOCKING SPRINGS WHEN AS IT MIGHT NOT CLICK INTO PLACE. 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 ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS USED DURING A LAPAROSCOPIC LEFT HEMI COLECTOMY. THE HANDLE FAILED TO FULLY FIRE DUE TO THE SAFETY NOT RELEASING. THE HANDLE CRACKED AND A COMPLETE STAPLE LINE WAS NOT FORMED. THE DEVICE WAS REMOVED FROM THE PATIENT AFTER THE PARTIAL STAPLE LINE WAS REMOVED AND THEY RECUT BELOW THE FIRST STAPLE LINE TO INSERT A NEW DEVICE TO REANASTOMOS THE BOWEL. THE SECOND DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49193 PROXIMATE ILS CURVED CIR STAPL STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK H43271

    Patients

    Seq Age Sex Outcome Treatment
    1