BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE CIRCULAR STAPLER

    MDR report key: 6086074 · Received November 8, 2016

    Report

    Report Number
    3005075853-2016-06386
    Event Type
    Injury
    Date Received
    November 8, 2016
    Date of Event
    October 19, 2016
    Report Date
    October 20, 2016
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K940967
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # (B)(4). THE ANALYSIS RESULTS FOUND THAT THE ECS29A DEVICE ARRIVED WITH NO APPARENT DAMAGE. THE BREAKAWAY WASHER WAS PRESENT ONLY THE ANVIL HALF 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 BATCH HISTORY RECORD WAS REVIEWED AND NO PROTOCOLS OR NCR RELATED TO THE COMPLAINT WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WHAT IS THE SURGEON/HEALTHCARE PROVIDER¿S EXPERIENCE WITH THE DEVICE? EIGHT YEARS. WAS THE DEVICE DIFFICULT TO CLOSE? NO. WAS THE DEVICE DIFFICULT TO FIRE? NO. DID THE HEALTHCARE PROFESSIONAL RECEIVE AUDIBLE & TACTILE FEEDBACK WHEN FIRING THE DEVICE? YES. WAS THE WASHER INSPECTED? IF SO, PLEASE DESCRIBE. HE DOES NOT KNOW. EACH TIME THE HEALTHCARE PROVIDER FIRES THIS DEVICE, DOES HE/SHE DIAL DOWN INTO THE GREEN RANGE, WAIT 15 SECONDS AND RETIGHTEN? HE TIGHTENS THE STAPLER TO THE MIDDLE OF THE GREEN RANGE, THEN TIGHTENS AND WAITS 30 SECONDS BEFORE FIRING. WHAT IS THE CURRENT PATIENT STATUS? THE PATIENT IS DOING FINE BUT AS THE SURGEON STATED, "HE IS A (B)(6) OLD WITH AN ILEOSTOMY."

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT A LOW ANTERIOR RESECTION (LAR) ON (B)(6) 2016. THERE WERE NO ISSUES NOTED WITH THE DEVICE. THE SURGEON COMMENTED THAT THERE WAS MORE OOZING THAN NORMAL. THE PATIENT RETURNED ON (B)(6) 2016 FOR BLEEDING. THE PATIENT¿S HEMOGLOBIN DROPPED FROM 15 TO 9 AND WAS BLEEDING WAS AT STAPLE LINE. THE BLEEDING WAS NOTED TO BE INTRALUMINAL. THE SURGEON ELECTED TO REDO THE ANASTOMOSIS AS A CONSERVATIVE APPROACH TO MANAGE THE BLEEDING. A SAME LIKE DEVICE FROM THE FIRST PROCEDURE WAS USED TO RE-ANASTOMOSE. PER THE FIRST ASSIST, THE SURGEON ATTEMPTED TO DIAL THE STAPLER DOWN TO "ABOUT THE HALF WAY MARK" AND SQUEEZED THE HANDLE TO FIRE. THE SURGEON DID NOT NOTICE ANYTHING DIFFERENT AND REMOVED WITH A 3/4 TURN WITH NO ISSUES. WHEN CHECKING THE ANASTOMOSIS SHE NOTICED "MANY" UNFORMED STAPLES AND A HOLE IN THE ANASTOMOSIS. THEY RE-TRANSECTED WITH A CONTOUR TO ATTEMPT ANASTOMOSIS AGAIN AND THE EXACT SAME THING HAPPENED. UNFORMED STAPLES ALTHOUGH BOTH SETS OF DONUTS LOOKED COMPLETE. SHE DID SAY THE LAST TIME AFTER SHE FIRED AND ATTEMPTED TO REMOVE SHE HEARD A POP, CLAIMED TO USE THE SAME TECHNIQUE. PATIENT WAS GIVEN A LOOP ILEOSTOMY TO ALLOW THE BOWEL TO HEAL AND SURGEON WILL RE-TRY AT A LATER TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737756 PROXIMATE CIRCULAR STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention