BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON LINEAR CUTTER RELOAD

    MDR report key: 3950114 · Received July 22, 2014

    Report

    Report Number
    3005075853-2014-05143
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    July 9, 2014
    Report Date
    July 9, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. AT THE TIME OF THIS SUBMISSION, THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SLEEVE GASTRECTOMY PROCEDURE, THE SURGEON OBSERVED TWO RELOADS THAT DID NOT DEPLOY ALL STAPLE LINES. FOR THE FIRST RELOAD ON THE SECOND FIRING, THE SURGEON USED A BLACK RELOAD. THE STAPLER SOUNDED LIKE IT WAS GOING THROUGH THICK TISSUE AS THE TONE OF THE FIRING LOWERED. UPON OPENING OF THE STAPLER, IT WAS OBSERVED THAT THE TWO OUTER ROWS OF THE RELOAD ON THE PATIENT SIDE DID NOT FULLY DEPLOY. A SECOND RELOAD WAS USED TO STAPLE OVER THE AREA OF OPEN STAPLES. CLIPS AND TISSEAL WERE ALSO APPLIED ON THE STOMACH. ON THE 3RD FIRING, FIRST USE OF THE SECOND (GREEN) RELOAD, ALL THREE ROWS OF STAPLES DEPLOYED ON THE PATIENT SIDE, BUT ONLY THE OUTER MOST ROW ON THE REMNANT/SPECIMEN SIDE. THE RELOAD SHOWED VISIBLE DAMAGE. APPLICATIONS OF CLIPS AND TISSEAL WERE USED ON THE STAPLE LINE ON THE PATIENT SIDE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ONE RELOAD (BLACK) WILL NOT BE RELEASED; ONE RELOAD (GREEN) WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428935 ECHELON LINEAR CUTTER RELOAD STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA L4EM9Z

    Patients

    Seq Age Sex Outcome Treatment
    1 DEVICE - PLE60A