BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE ILS STAPLER

    MDR report key: 3912336 · Received July 3, 2014

    Report

    Report Number
    3005075853-2014-04631
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 6, 2014
    Report Date
    June 12, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K983536
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. THE ANALYSIS RESULTS FOUND THAT THE CDH25 DEVICE ARRIVED AND IN GOOD VISUAL CONDITION. THE BREAKAWAY WASHER WAS PRESENT AND UNCUT AND THE DEVICE WAS FULLY LOADED WITH STAPLES, INDICATING THAT THE DEVICE HAD NOT BEING FIRED. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH THE RETURNED WASHER AND 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. 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. NO INCIDENT RELATED TO THE REPORTED EVENT WAS OBSERVED DURING THE BATCH RECORD REVIEW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN OPEN TOTAL GASTRECTOMY, THE FIRING FORCE OF THE DEVICE WAS HIGHER THAN EXPECTED BUT THE DEVICE WAS FIRED AND THE TARGET TISSUE WAS CUT AND STAPLED PROPERLY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE CONDITION OF THE TARGET TISSUE WAS UNKNOWN. THE DEVICE CLAMPED THE TARGET TISSUE UNIFORMLY. THE DEVICE DID NOT CLAMP SOMETHING HARD SUCH AS AN EXISTING STALE LINE. A PURSE-STRING SUTURE WAS PERFORMED WITH A PURSE-STRING INSTRUMENT AT THE ANVIL SIDE. THE ANVIL WAS SET TO THE DEVICE WITH A CLICKING SOUND. THE INDICATOR WAS WITHIN THE GREEN ZONE BEFORE FIRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390656 PROXIMATE ILS STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1