BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NTLC LINEAR CUTTER

    MDR report key: 3843224 · Received June 2, 2014

    Report

    Report Number
    3005075853-2014-03029
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    March 14, 2014
    Report Date
    March 26, 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
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: DAMAGED SLIP BLOCK ASSEMBLY, FIRING KNOB DISLODGED. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WAS THE FIRING SEQUENCE COMPLETED PRIOR TO THE FIRING KNOB BREAKING? IF NO, WAS THE STAPLE LINE AND CUT LINE EQUAL? YES, WAS NECESSARY USED A SURGICAL INSTRUMENT TO HELP THE STAPLER TO FINISH THE FIRE. HOW WAS THE CASE COMPLETED? OK. MEDWATCH ORIGINALLY SENT AND ACKNOWLEDGED 2 OF 3 MAY 6 2014. 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 NOT RELOAD LOADED IN THE DEVICE. DUE TO THE CONDITION OF THE DEVICE, NO FUNCTIONAL TEST COULD BE PERFORMED. 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 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, IN THE SECOND FIRING THE TRIGGER OF THE LINEAR CUTTER IS BROKEN. UNKNOWN HOW CASE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321644 NTLC LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA L4E10Z

    Patients

    Seq Age Sex Outcome Treatment
    1