BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60

    MDR report key: 3000392 · Received March 12, 2013

    Report

    Report Number
    3005075853-2013-01216
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Date of Event
    January 21, 2013
    Report Date
    February 1, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K081146
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DAMAGED CARTRIDGE. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: DID THE DEVICE CUT? YES - FIRST, SECOND AND THIRD CARTRIDGE. DID THE DEVICE STAPLE? YES - FIRST, SECOND AND THIRD CARTRIDGE. ON WHAT TISSUE TYPE WAS THE DEVICE USED? AT WHAT LOCATION ON THE TISSUE? LUNG. WAS THE DEVICE FIRED ON TISSUE THAT HAD BEEN RADIATED OR HAS THE PATIENT BEEN TAKING SYSTEMIC STEROIDS? NO. ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 12TH, ETC)? 4TH. IF ECHELON, DURING WHICH STROKE DID THE EVENT OCCUR? 1ST. WHAT COLOR CARTRIDGE WAS BEING USED? BLUE. WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? NONE. WAS BUTTRESSING MATERIAL UTILIZED? IF SO, WHICH PRODUCT? NO. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? MAYBE. WERE ANY UNEXPECTED NOISES HEARD? IF SO, WHEN? NO. AFTER USE, DID EACH OF THE TRIGGERS AND BUTTONS AUTOMATICALLY RETURN TO THEIR ORIGINAL (PRE-FIRED) POSITIONS, WITHOUT INTERVENTION? NO. WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? NO. THE ANALYSIS RESULTS SHOWED THAT ONE WAS RECEIVED WITH AN ECR60B RELOAD LOADED ON IT. THE RELOAD WAS RETURNED PARTIALLY FIRED 1/2 ON THE LEFT SIDE AND FULLY FIRED ON THE RIGHT SIDE, WITH THE CARTRIDGE DECK, ONE PIECE SLED, AND SOME DRIVERS DAMAGED; IN ADDITION, THE KNIFE WAS OUTSIDE THE ANVIL GUIDES AND THE ANVIL WAS NOTED TO BE DAMAGED. THE DAMAGE TO THE INSTRUMENT AND RELOAD IS CONSISTENT WITH THE DEVICE BEING CLAMPED OVER A HARD OBJECT. WHEN THIS HAPPENS THE CARTRIDGE GETS INDENTED THEREFORE, THERE IS NOT ENOUGH SPACE FOR THE SLED PUSHING THE DRIVER TO CONTINUE ITS RUN, THIS IS THE REASON WHY THE SLED GETS DAMAGED. IF ENOUGH FORCE IS APPLIED TO THE FIRING TRIGGER THE ONE PIECE SLED CAN BREAK THROUGH THE CARTRIDGE RELOAD WALL ALLOWING THE FIRING TO CONTINUE. WHEN PLACING THE INSTRUMENT ON THE TISSUE TO BE STAPLED, ENSURE THAT NO HARD OBSTRUCTION (SUCH AS A CLIP) IS INCLUDED WITH THE TISSUE INSIDE THE JAWS. 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. DUE TO THE CONDITION OF THE DEVICE, NO FUNCTIONAL TEST COULD BE PERFORMED. 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. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE USER COULDN'T APPLY FIRMLY THE STAPLE LINE, AS THE FIRING BUTTON WAS BLOCKED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103745 ECHELON*FLEX60 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA J4CR05

    Patients

    Seq Age Sex Outcome Treatment
    1