BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUSTRIGHT STAPLER

    MDR report key: 6378726 · Received March 4, 2017

    Report

    Report Number
    3010377594-2017-00002
    Event Type
    Injury
    Date Received
    March 4, 2017
    Date of Event
    February 9, 2017
    Report Date
    March 3, 2017
    Manufacturer
    JUSTRIGHT SURGICAL, LLC
    Product Code
    GAG
    UDI-DI
    10865163000109
    PMA / PMN Number
    K132472
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO ROOT CAUSE COULD BE DETERMINED BECAUSE THE DEVICE WAS NOT AVAILABLE FOR RETURN OR EVALUATION. THERE WAS EVIDENCE DURING THE PROCEDURE THAT THE DEVICE FUNCTIONED PROPERLY. THE DEVICE WAS DISPOSED OF ON (B)(6) 2017 AFTER THE APPENDECTOMY PROCEDURE WAS PERFORMED. JUST RIGHT SURGICAL REVIEWED THE MANUFACTURING LOT RELEASE INFORMATION AND CONFIRMED THIS LOT PASSED THE FUNCTIONAL ACCEPTANCE CRITERIA AS SPECIFIED IN THE STAPLER AND RELOAD PRODUCTION QUALITY PLAN, INCLUDING STAPLE FORMATION.

    Description of Event or Problem · 1

    ON (B)(6) 2017, THE SURGEON PERFORMED A LAPAROSCOPICALLY ASSISTED APPENDECTOMY ON A (B)(6) -YEAR OLD PATIENT WEIGHING (B)(4). THE APPENDIX WAS PULLED OUT OF THE UMBILICAL INCISION AND THE STAPLER WAS FIRED EXTRACORPOREALLY. THE STAPLE LINE WAS INSPECTED AND ALL STAPLES WERE PROPERLY FORMED AND CLOSED. THE SURGEON THEN REINSERTED THE APPENDICEAL STUMP INTO THE ABDOMINAL CAVITY THROUGH THE UMBILICUS. THE PATIENT WENT BACK TO THE HOSPITAL ON (B)(6) 2017 FOR A CORRECTIVE PROCEDURE FOR A CLOSED LOOP BOWEL OBSTRUCTION. THE SURGEON STATED THE OBSTRUCTION WAS CAUSED BY A STAPLE THAT HAD BECOME ATTACHED TO PART OF THE BOWEL SEROSA. THE STAPLE WAS REMOVED AND THE PATIENT WAS REPORTED AS FINE. IMAGES FROM THE PROCEDURE INDICATE THAT THE STAPLE WAS FULLY FORMED BUT HAD CAUGHT ON ANOTHER SECTION OF BOWEL FORMING A LOOP. IT IS POSSIBLE THAT THIS OCCURRED WHEN THE STAPLED BOWEL WAS FORCED THROUGH THE UMBILICUS. THE DEVICE WAS DISPOSED OF ON (B)(6) 2017 AND IS NOT AVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161218 JUSTRIGHT STAPLER SURGICAL STAPLER GAG JUSTRIGHT SURGICAL, LLC JR-ST25-2.0-6 75IF1901 10865163000109

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Required Intervention