BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TLC LINEAR CUTTER

    MDR report key: 3883719 · Received June 19, 2014

    Report

    Report Number
    3005075853-2014-04124
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    April 28, 2014
    Report Date
    April 30, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K092577
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) = DAMAGED SLIP BLOCK ASSEMBLY, FIRING KNOB DISLODGED. THE ANALYSIS RESULTS FOUND THAT THE NTLC75 DEVICE WAS RECEIVED WITH THE FIRING MECHANISM DAMAGED AS THE FIRING KNOB WAS DETACHED AND THE SLIP BLOCK ASSEMBLY WAS NOTED TO BE DAMAGED. THE DEVICE WAS RECEIVED WITH ONE RELOAD PRESENT. THE RELOAD WAS RETURNED WITH THE PROXIMAL 54 DRIVERS UP WITHOUT STAPLES, AND THE REMAINING DRIVERS DOWN WITH STAPLES PRESENT; THE SWING TAB IN THE LOCKED POSITION, WHICH INDICATES THAT THE DEVICE'S FIRING CYCLE WAS INTERRUPTED. THE DAMAGE TO THE FIRING KNOB AND SLIP BLOCK ASSEMBLY IS CONSISTENT WITH HIGH (OUTSIDE INDICATED USE) STAPLE FORMING FORCES; HOWEVER, THERE IS INSUFFICIENT EVIDENCE TO DETERMINE THE CAUSE OF THE HIGHER LOADS. IT SHOULD BE NOTED THAT THE CARTRIDGE RELOAD IS DESIGNED TO LOCKOUT, AS A SAFETY FEATURE, IF ANY STAPLES HAVE BEEN FIRED FROM THE CARTRIDGE RELOAD. IF ENOUGH FORCE IS APPLIED THE DEVICE COULD BE DAMAGED. IN ADDITION FAILURE TO COMPLETE THE STROKE MAY RESULT IN INCOMPLETE STAPLE LINE. DUE TO THE CONDITION OF THE DEVICE, NO FUNCTIONAL TEST COULD BE PERFORMED WITH IT. 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 OPEN PANCREATODUODENECTOMY, THE FIRING KNOB WAS BROKEN OFF WHEN THE FIRING KNOB WAS STUCK DURING THE 5TH FIRING AND THEN MOVED FORWARD FORCIBLY. THE DEVICE WAS USED TO ANASTOMOSE BETWEEN THE JEJUNUM AND THE COLON. THE STAPLE HEIGHT WAS GREEN. REINFORCEMENT MATERIAL WAS NOT USED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359910 TLC LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOAD - SR75