BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAPLE, IMPLANTABLE

    MDR report key: 6303673 · Received February 6, 2017

    Report

    Report Number
    3005075853-2017-00719
    Event Type
    Injury
    Date Received
    February 6, 2017
    Date of Event
    January 10, 2017
    Report Date
    January 11, 2017
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K141952
    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 PATIENT WAS A (B)(6) YEAR OLD FEMALE WITH BMI OF (B)(6). THE APPENDIX WAS NORMAL WITH NO INFLAMMATION. STAPLER WORKED AS INTENDED ON BOTH FIRINGS. THE MESOAPPENDIX APPEARED HEMOSTATIC. HGL. DROPPED TO 8.4 AND A CT SCAN REVEALED BLOOD IN ABDOMEN. A REOPERATION WAS PERFORMED AND ABOUT 1 LITER OF BLOOD WAS REMOVED FROM ABDOMEN. ACTIVE SQUIRTING BLEEDING WAS OBSERVED THROUGH STAPLE LINE. THE PATIENT RECEIVED A UNIT OR TWO OF BLOOD. DURING USE OF DEVICE, A MARYLAND FORCEPS WAS USED TO CREATE A WINDOW IN WHICH THE TIP OF DEVICE WAS PLACED THROUGH. THE DISTAL PART OF STAPLER WAS VISIBLE AND SURGEON BELIEVES THAT ALL TISSUE WAS WITHIN THE BLACK LINE ON JAWS. THE PATIENT HAD NO BLOOD DISORDERS.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION REQUESTED AND RECEIVED: CONFIRM HOW MANY FIRINGS ACROSS THE MESO AND APPENDIX HE COMPLETED? ONE FIRING ACROSS THE APPENDIX FIRST, THEN 1 FIRING ACROSS THE MESO APPENDIX. THE LAST 2 MM NEEDED TO BE CUT WITH A SCISSOR, BUT THIS IS NOT WHERE IT BLED. HOW CLOSE TO THE CECUM WAS HE WHEN HE FIRED? THE FIRING WAS RIGHT ADJACENT TO THE CECUM, LEAVING ABOUT 1MM APPENDICEAL STUMP. WAS THE APPENDIX UNUSUALLY THICK BEYOND WHAT HE NORMALLY SEES? THE APPENDIX WAS NORMAL, AS SHE HAD AN APPENDICOLITH AND CHRONIC RLQ PAIN. WAS THE TISSUE EASILY COMPRESSIBLE TO 1.0MM? THE TISSUE WAS EASILY COMPRESSIBLE IN THE NEW DEVICE, WAITED >10 SECONDS BEFORE FIRING. THE REASON HE USED PVS VERSUS HIS NORMAL DEVICE? THE REASON I USED THE PVS VS MY REGULAR STAPLER IS BECAUSE MY OPERATING ROOM CHIEF NURSE FOR GI ASKED ME FOR THE FIRST TIME IF I WANTED TO TRY A NEW STAPLER. I ASKED IF IT CAN HAVE PERI-STRIPS OR SEAMGUARD, BUT HE SAID NO. I USED IT ANYWAY, HAD INITIALLY NO PROBLEM, THEN SHE BLED 1000ML AND WAS HYPOTENSIVE REQUIRING A 2ND SURGERY WHERE WE COULD SEE CLEARLY A PULSATILE APPENDICEAL ARTERY. ADDITIONAL INFORMATION RECEIVED: THE SALES REP CONFIRM THAT THIS WAS THE FIRST TIME SURGEON USED DEVICE AND HAS NEVER BEEN IN-SERVICED. IT WAS NOT CONFIRMED THAT THERE WAS NO TISSUE BEYOND THE CUT LINE IN BOTH FIRINGS. THE DEVICE WAS USED IN A SIMILAR FASHION AS ATS. THE DOCTOR NORMALLY USES AN ATS45 WITH TWO WHITE RELOADS FOR APPENDECTOMY PROCEDURES AND DECIDED TO USE A PVE35A, INSTEAD, USING THE SAME TECHNIQUES USED WITH THE ATS45, WAITING 10 TO 15 SECONDS BEFORE FIRING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DOCTOR PERFORMED A LAPAROSCOPIC APPENDECTOMY USING A PVE35A ENDOCUTTER, WAITED TEN TO FIFTEEN SECONDS BEFORE FIRING THE ENDOCUTTER AND NOTICED A SMALL SPOT OF BLOOD AFTER THE FIRING WAS COMPLETE. THE DOCTOR HAD MADE SOME COMMENTS ABOUT USING SEAM GUARD AND STERISTRIPS. WHILE THE PATIENT WAS IN RECOVERY, IT WAS REPORTED THE PATIENT'S HEMOGLOBIN DROPPED. THE PATIENT WAS BROUGHT BACK INTO SURGERY AND IT WAS NOTICED THE PATIENT HAD LOST ONE LITER OF BLOOD. THE PATIENT WAS ADMINISTERED A BLOOD TRANSFUSION TO REPLACE THE LOST BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88372 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention