BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JUSTRIGHT 5MM STAPLER

    MDR report key: 7956880 · Received October 11, 2018

    Report

    Report Number
    3010377594-2018-00004
    Event Type
    Malfunction
    Date Received
    October 11, 2018
    Date of Event
    September 25, 2017
    Report Date
    October 5, 2018
    Manufacturer
    JUSTRIGHT SURGICAL
    Product Code
    GAG
    UDI-DI
    10865163000109
    PMA / PMN Number
    K132472
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN THIS COMPLAINT WAS RECEIVED/INVESTIGATED IT WAS DETERMINED THAT THE PROTRUDING CAM BLADE WAS A RESULT OF THE TORQUE THAT WAS APPLIED BY THE SURGEON WHEN TRYING TO REMOVE THE DEVICE FROM THE CANNULA. WHEN A SECOND COMPLAINT OF THE SAME NATURE, FROM THE SAME PHYSICIAN, WAS RECEIVED, THERE WAS NOT THE SAME AMOUNT OF DAMAGE TO COMPONENTS. JRS SUSPECTED THAT THE RELOAD CAUGHT ON THE END OF A BENT REUSABLE CANNULA. THE PROBLEM WAS REPRODUCED ONCE BUT IS NOT REPEATABLE.

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC APPENDECTOMY, A JUSTRIGHT 5MM STAPLER WAS USED IN CONJUNCTION WITH A STORZ 5MM METAL CANNULA. THE STAPLER FIRED ACCORDING TO SPECIFICATIONS AND ALL STAPLES FORMED PROPERLY. WHEN REMOVING THE STAPLER, THE SURGEON HAD TROUBLE REMOVING THE DEVICE FROM THE CANNULA. AS THE DEVICE WAS REMOVED, THE SURGEON NOTICED DAMAGE TO THE CARTRIDGE. THE SURGERY WAS COMPLETED, AND THE PATIENT WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796861 JUSTRIGHT 5MM STAPLER JUSTRIGHT 5MM STAPLER GAG JUSTRIGHT SURGICAL JR-ST25-2.0-6 75FG2008 10865163000109

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR