BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON LINEAR CUTTER RELOAD

    MDR report key: 4060177 · Received September 4, 2014

    Report

    Report Number
    3005075853-2014-06173
    Event Type
    Malfunction
    Date Received
    September 4, 2014
    Date of Event
    August 19, 2014
    Report Date
    August 19, 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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE ANALYSIS FOUND THAT TWO ECR60G CARTRIDGE RELOADS WERE RECEIVED FOR ANALYSIS. CARTRIDGE (A) ECR60G, K5EK21, WAS RECEIVED INSIDE ITS STERILE PACKAGE AND IN GOOD VISUAL CONDITIONS. CARTRIDGE (B) ECR60G, L52N30, WAS RECEIVED WITH THE RIGHT SIDE FULLY FIRED AND THE LEFT SIDE OUTER ROW FULLY FIRED, LEFT TWO INNER ROWS PARTIALLY FIRED 1/4. IN ADDITION THE CARTRIDGE BODY WAS NOTED TO BE DAMAGED. UPON EVALUATION OF THE RELOAD, THE CARTRIDGE BODY, ONE PIECE SLED AND SOME DRIVERS WERE NOTED TO BE DAMAGED. NO OBVIOUS DAMAGE TO THE CARTRIDGE DECK WAS NOTED, WHICH SUGGESTS THE CARTRIDGE, MAY NOT HAVE BEEN FIRED OVER A HARD OBJECT. NO FUNCTIONAL TEST COULD BE PERFORMED DUE TO THE CONDITION OF THE RELOAD (B). AS ADDITIONAL TESTING, THE RETURNED CARTRIDGE RELOAD (A) WAS TESTED FOR FUNCTIONALITY IN THE STRAIGHT POSITION WITH A TEST PLE60A TEST DEVICE AND ACHIEVED ITS COMPLETE FIRING SEQUENCE WITHOUT ANY DIFFICULTIES. THE STAPLE LINE AND CUT LINE WERE COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORM SHAPE. INTRA-OPERATIVE PHOTOS WERE RECEIVED. BASED ON THE PHOTOGRAPHIC EVIDENCE OF THE SUBJECT ECR60G CARTRIDGE STAPLE LINE, THE EVENT DESCRIPTION OF UNFORMED STAPLES CAN BE CONFIRMED, HOWEVER, THE PHOTOGRAPH DOES NOT PROVIDE EVIDENCE RELATIVE TO WHAT MAY HAVE CAUSED THE ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY, ON THE FOURTH FIRING THE KNIFE CUT INTO THE SIDE OF THE CARTRIDGE (GREEN). THIS WAS ON THE PATIENT SIDE. THE STAPLES WERE PARTIALLY DEPLOYED AND MALFORMED. THE STAPLES ON THE SPECIMEN SIDE DEPLOYED AND FORMED AS EXPECTED. SEAMGUARD WAS USED ON ALL FIRINGS. THERE WERE A TOTAL OF SIX FIRINGS (BLACK, BLACK, GREEN, GREEN, GREEN AND GREEN). THE SURGEON CONTINUED TO USE THE SAME GUN. THERE WERE NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541136 ECHELON LINEAR CUTTER RELOAD STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA L4E04R

    Patients

    Seq Age Sex Outcome Treatment
    1