BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAPLE, IMPLANTABLE

    MDR report key: 3111501 · Received May 14, 2013

    Report

    Report Number
    3005075853-2013-02313
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Report Date
    April 19, 2013
    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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS FOUND THAT ONE DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH AN ECR60T RELOAD PRESENT. THE RELOAD WAS RECEIVED WITH THE RIGHT SIDE FULLY FIRED, LEFT OUTER ROW FULLY FIRED AND TWO LEFT INNER ROWS PARTIALLY FIRED. UPON EVALUATION OF THE RELOAD, THE CARTRIDGE BODY, ONE PIECE SLED AND SOME DRIVERS WERE NOTED TO BE DAMAGED. AS ADDITIONAL TESTING, THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE STRAIGHT POSITION WITH A TEST CARTRIDGE RELOAD 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. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS. A PHOTOGRAPH WAS REVIEWED: BASED ON THE PHOTOGRAPHIC EVIDENCE OF THE SUBJECT PLE60A DEVICE, UTILIZING A BLACK CARTRIDGE ECR60T ALONG WITH DOUBLE BUTTRESSING, IT IS BELIEVED THE INNER TWO ROWS OF STAPLES DID NOT PROPERLY DEPLOY AND SUPPORTS THE EVENT DESCRIPTION. HOWEVER THE PHOTOGRAPHS DO NOT PROVIDE EVIDENCE RELATIVE TO WHAT MAY HAVE CAUSED THE INCOMPLETE STAPLE DEPLOYMENT.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION REQUESTED AND RECEIVED: ON WHAT TISSUE TYPE WAS THE DEVICE USED? STOMACH. ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 12TH, ETC.)? ASKU. ECHELON STRAIGHT/FLEX: ASKU. WHAT COLOR CARTRIDGE WAS BEING USED? BLACK. WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? BLACK. WAS BUTTRESSING MATERIAL UTILIZED? YES. IF SO, WHICH PRODUCT? SEAM GUARD. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? ASKU. WERE ANY UNEXPECTED NOISES HEARD? ASKU. WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? NO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SLEEVE GASTRECTOMY PROCEDURE ON THE SECOND FIRING WITH A BLACK CARTRIDGE THE DEVICE FULLY CUT AND STAPLED BUT NOT ALL THE STAPLES FORMED THE PROPER B FORM SHAPE. A SECOND DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211756 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 ECR60T