BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE** RELOADABLE LINEAR CUTTER WITH SAFTEY LOCK-OUT

    MDR report key: 3172671 · Received June 17, 2013

    Report

    Report Number
    3005075853-2013-03054
    Event Type
    Injury
    Date Received
    June 17, 2013
    Date of Event
    May 16, 2013
    Report Date
    May 24, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH A RELOAD LOADED IN THE DEVICE. THE RELOAD WAS RETURNED FULLY FIRED. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD AND IT FIRED, CUT AND FORMED ALL THE STAPLES AS INTENDED. THE DEVICE FIRED WITHOUT ANY DIFFICULTIES, THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. THIS REPORT IS NOT INTENDED TO DENY THAT YOU EXPERIENCED A PROBLEM WITH THE DEVICE. THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT WE WERE UNABLE TO DUPLICATE DURING OUR LABORATORY ANALYSIS. THE MANUFACTURING RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE FOUND DURING THE MANUFACTURING PROCESS

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SIGMOID COLECTOMY PROCEDURE, THE SCRUB TECH WAS LOADING THE DEVICE SHE CAME INTO CONTACT WITH THE STAPLES. THE STAPLES PUNCTURED SKIN AND THE GLOVE BEGAN FILLING WITH BLOOD. IT IS UNKNOWN IF THE TECH REMOVED THE SAFETY CAP PRIOR TO LOADING THE CARTRIDGE ONTO THE DEVICE. THERE WERE NO CONSEQUENCE TO THE PATIENT UNDERGOING THE SURGICAL PROCEDURE. THE SURGICAL TECH WILL HAVE TO HAVE CONTINUED TESTING (BLOOD DRAWS) OVER THE NEXT FIVE YEARS FOR MONITORING. LABS WILL BE PERFORMED EVERY SIX WEEKS FOR THE NEXT YEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273568 PROXIMATE** RELOADABLE LINEAR CUTTER WITH SAFTEY LOCK-OUT STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other RELOAD TCT75