BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** ETS FLEX45

    MDR report key: 3243621 · Received July 23, 2013

    Report

    Report Number
    3005075853-2013-03690
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 14, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DAMAGED FIRING TRIGGER TEETH. THE ANALYSIS RESULTS FOUND THAT DEVICE (A) WAS RECEIVED WITH THE FIRING MECHANISM DAMAGED AND WITH NO CARTRIDGE RELOAD PRESENT. NO FUNCTIONAL TEST COULD BE PERFORMED DUE TO THE CONDITION OF THE DEVICE. THE DEVICE WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS AND THE FIRING TRIGGER TEETH WERE FOUND BROKEN. WHILE NO CONCLUSION COULD BE REACH ON WHAT CAUSE THE FIRING MECHANISM TO FAIL, IT IS POSSIBLE THAT THE DEVICE WAS ATTEMPTED TO FIRE ON TICKER TISSUE THEN INDICATED OR ATTEMPTED TO FIRE TROUGH A LOCKED RELOAD IN PREVIOUS FIRINGS CAUSING AN INCREASE OF THE INTERNAL FORCES RESULTING IN THE COMPONENT YIELDING. IT SHOULD BE NOTED THAT A 100% INSPECTIONS TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRE SPECIFICATIONS; IN ADDITION, A SAMPLE OF THE BATCH IS INSPECTED AT (B)(4). THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS. THE ANALYSIS RESULTS FOUND THAT DEVICE (B) WAS RECEIVED WITH THE FIRING MECHANISM DAMAGED AND WITH NO CARTRIDGE RELOAD PRESENT. NO FUNCTIONAL TEST COULD BE PERFORMED DUE TO THE CONDITION OF THE DEVICE. THE DEVICE WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS AND THE FIRING TRIGGER TEETH WERE FOUND BROKEN. WHILE NO CONCLUSION COULD BE REACH ON WHAT CAUSE THE FIRING MECHANISM TO FAIL, IT IS POSSIBLE THAT THE DEVICE WAS ATTEMPTED TO FIRE ON TICKER TISSUE THEN INDICATED OR ATTEMPTED TO FIRE TROUGH A LOCKED RELOAD IN PREVIOUS FIRINGS CAUSING AN INCREASE OF THE INTERNAL FORCES RESULTING IN THE COMPONENT YIELDING. IT SHOULD BE NOTED THAT A 100% INSPECTIONS TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRE SPECIFICATIONS; IN ADDITION, A SAMPLE OF THE BATCH IS INSPECTED AT (B)(4). THE ANALYSIS RESULTS FOUND THAT DEVICE (C) WAS RETURNED IN GOOD VISUAL CONDITION AND WITH NO RELOAD PRESENT ON THE DEVICE. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD AND IT FIRED, CUT AND FORMED THE STAPLES AS INTENDED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE TISSUE WAS NOT CUT AFTER THE DEVICE WAS FIRED. ALL THE THREE DEVICES HAVE THE SAME ISSUE. CHANGED TO ANOTHER ONE TO COMPLETE THE PROCEDURE. NO ADVERSE EVENT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342813 ENDOPATH** ETS FLEX45 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA J4CN29

    Patients

    Seq Age Sex Outcome Treatment
    1