BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GDW

    MDR report key: 1312790 · Received February 17, 2009

    Report

    Report Number
    3005075853-2008-02352
    Event Type
    Malfunction
    Date Received
    February 17, 2009
    Date of Event
    July 19, 2008
    Report Date
    September 15, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 10/14/2008. EVALUATION SUMMARY: THE ANALYSIS SHOWED THAT THE DEVICE WAS RECEIVED WITH THE CLAMPING MECHANISM DAMAGED AND WITH A RELOAD IN THE DEVICE. THE RELOAD WAS RECEIVED FULLY LOADED WITH STAPLES. THE RETURNED DEVICE WAS FOUND TO BE NON-FUNCTIONAL DUE TO THE DAMAGED CLAMPING MECHANISM. THE DEVICE WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS AND THE YOKE WHERE ENGAGES WITH THE CLOSURE TUBE WAS FOUND DAMAGED. NO FUNCTIONAL TEST COULD BE PERFORMED DUE TO THE CONDITION OF THE DEVICE. HOWEVER, THE DEVICE COULD BE OPENED BY USING REVERSE FORCE BETWEEN THE HANDLE AND TUBE. IN ADDITION, THE RETURNED RELOAD WAS TESTED FOR FUNCTIONALITY WITH A TEST DEVICE AND THE DEVICE FIRED WITHOUT ANY DIFFICULTIES, THE STAPLE LINE WAS COMPLETE, THE CUT LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. IT SHOULD BE NOTED THAT AT LEAST A 100% INSPECTION TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRE SPECIFICATIONS; IN ADDITION, A SAMPLE OF THE BATCH IS INSPECTED AT FGQA. THE MANUFACTURING RECORDS WERE REVIEWED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A GASTROPLASTY PROCEDURE, THE DEVICES PRESENTED FAILURE DURING STAPLING. A NOISE WAS HEARD AS IF THE DEVICE BROKE. THE DEVICE DID NOT STAPLE OR CUT THE TISSUE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GDW GDW ETHICON ENDO-SURGERY, LLC NA D4GW64

    Patients

    Seq Age Sex Outcome Treatment
    1