BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX45 LONG

    MDR report key: 2030991 · Received March 28, 2011

    Report

    Report Number
    3005075853-2011-01201
    Event Type
    Malfunction
    Date Received
    March 28, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 3, 2011
    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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BUCKLED KNIFE, CARTRIDGE. THE ANALYSIS RESULTS FOUND THAT ONE EC45AL DEVICE WAS RETURNED WITH THE ANVIL DAMAGED AND CLOSED THE FIRING MECHANISM JAMMED AND WITH A PARTIALLY FIRED CARTRIDGE RELOAD LOADED ON THE DEVICE. NO FUNCTIONAL TEST COULD BE PERFORMED DUE TO THE CONDITIONS OF THE DEVICE. THE DEVICE WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS AND IT WAS NOTED THAT THE KNIFE HAD BUCKLED, AND CARTRIDGE RELOAD WAS DAMAGED. THE DAMAGE TO THE CARTRIDGE, KNIFE AND ANVIL IS CONSISTENT WITH THE DEVICE BEING CLAMPED OVER A HARD OBJECT OR THICKER TISSUE THEN INDICATED. WHEN THIS HAPPENS THE CARTRIDGE GETS INDENTED THEREFORE THERE IS NOT ENOUGH SPACE FOR THE SLED PUSHING THE DRIVER TO CONTINUE ITS RUN. IF ENOUGH FORCE IS APPLIED TO THE FIRING TRIGGER THE ANVIL WILL DEFORM AND THE KNIFE WILL BUCKED, AS THE KNIFE IS ATTEMPTING TO PULL THE ANVIL TOWARDS THE CARTRIDGE TO FORM THE STAPLES. WHEN PLACING THE INSTRUMENT ON THE TISSUE TO BE STAPLED, ENSURE THAT NO HARD OBSTRUCTION ARE INCLUDED WITH THE TISSUE INSIDE THE JAWS AND THE TISSUE IS WITHIN THE APPROPRIATE THICKNESS FOR THE RELOAD. IT SHOULD BE NOTED THAT IF RESISTANCE IS FELT DURING FIRING, THE FIRING SEQUENCE SHOULD BE STOPPED AND THE CARTRIDGE RELOAD SHOULD BE REPLACED. PLEASE REFERENCE THE INSTRUCTION FOR USE FOR WARNINGS AND PRECAUTION REGARDING FIRING ACROSS HARD OBJECTS. IN ADDITION, THE CLOSURE TRIGGER TOP WAS DAMAGED. ONE POSSIBLE SCENARIO FOR THE DESCRIBED EVENT IS DUE TO APPLYING A LARGE PRYING FORCE ON THE CLOSURE TRIGGER HANDLE IN THE OPENING DIRECTION. THIS CAN THEN RESULT IN DAMAGE TO THE CLOSURE TRIGGER TOP COMPONENT IF THE APPLIED LOAD IS HIGH ENOUGH. IT SHOULD BE NOTED THAT AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING MANUFACTURING TO ENSURE THAT THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. RN IN THE ROOM REPORTED: THE DEVICE WAS CLAMPED DOWN AND GOING TO BE FIRED ACROSS THE POUCH AND WOULD NOT OPEN, IT IS UNKNOWN IF THE TISSUE WAS TOO THICK. THE SURGEON DISSECTED AROUND THE JAWS AND PULLED THE DEVICE OFF TISSUE. ANOTHER DEVICE WAS USED SAME PRODUCT CODE; HOWEVER, THERE ARE NO DETAILS AS TO WHAT HAPPENED WITH THE SECOND DEVICE. THERE WERE NO PATIENT CONSEQUENCES.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT DURING AN UNKNOWN SURGERY, THE INSTRUMENT HAS BEEN FIRED AND THE SURGEON IS UNABLE TO REMOVE THE INSTRUMENT FROM THE TISSUE. INSTRUCTIONS WERE GIVEN FROM THE PACKAGE INSERT ON HOW TO RELEASE THE INSTRUMENT. THE SURGEON HAD TRIED THIS SEVERAL TIMES AND STILL UNABLE RELEASE FROM TISSUE. THE NURSE REPORTED THE SURGEON DISSECTED THE TISSUE AROUND THE INSTRUMENT AND PULLED THE INSTRUMENT OFF. THE CASE WAS ONGOING AND NO OTHER INFORMATION AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON*FLEX45 LONG STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK NI

    Patients

    Seq Age Sex Outcome Treatment
    1