BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON LINEAR CUTTER

    MDR report key: 4191840 · Received October 22, 2014

    Report

    Report Number
    3005075853-2014-07278
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    September 29, 2014
    Report Date
    September 29, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K110385
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE ANALYSIS RESULTS SHOWED THAT THREE CARTRIDGE RELOADS WERE RECEIVED. THREE CARTRIDGES WERE RECEIVED FULLY FIRED AND IN GOOD VISUAL CONDITIONS. NO FUNCTIONAL TEST COULD BE PERFORMED DUE TO THE CONDITION OF THE RELOADS. THE EVENT COULD NOT BE CONFIRMED AS NO MALFORMED STAPLES WERE NOTED DURING FUNCTIONAL TESTING. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS. CARTRIDGE B = K5E50D MFG DATE: 11/05/2013 EXP DATE: 10/05/2018; CARTRIDGE C = L51V6H MFG DATE: 03/06/2014 EXP DATE: 2/6/2019.

    Additional Manufacturer Narrative · 1

    (B)(4). WHEN ADDITIONAL INFORMATION IS RECEIVED AND/OR THE DEVICE ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN OPEN GASTRECTOMY, AN UNFORMED STAPLE WAS FOUND INSIDE THE PATIENT AFTER FIRING. THE TARGET TISSUE WAS CUT AND STAPLED PROPERLY. THE FIRINGS WERE COMPLETED. THE CARTRIDGES WERE LOADED ON A LINEAR CUTTER/STAPLER DEVICE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671440 ECHELON LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 ECR60D AND ECR60B