BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    75MM SELECTABLE NEW TLC

    MDR report key: 8824525 · Received July 24, 2019

    Report

    Report Number
    3005075853-2019-20727
    Event Type
    Malfunction
    Date Received
    July 24, 2019
    Report Date
    July 2, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036002628
    PMA / PMN Number
    K092577
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). BATCH # T5AW28 INVESTIGATION SUMMARY THE ANALYSIS FOUND THAT ONE NTLC75 DEVICE WAS RETURNED WITH NO APPARENT DAMAGE, AND WITH ONE RELOAD PRESENT. THE RELOAD WAS RECEIVED FULLY FIRED. THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE THREE STAPLE HEIGHT SELECTOR POSITIONS WITH A TEST CARTRIDGE RELOADS AND ACHIEVED ITS FIRING SEQUENCE WITHOUT ANY DIFFICULTIES. THE STAPLE LINE AND CUT LINE WERE COMPLETE AND THE STAPLES MEET THE STAPLE FORM RELEASE CRITERIA ON THE THREE FIRINGS. THE EVENT DESCRIBED COULD NOT BE CONFIRMED AS THE DEVICE PERFORMED WITHOUT ANY DIFFICULTIES NOTED.THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT WE WERE UNABLE TO DUPLICATE DURING OUR LABORATORY ANALYSIS. IN ADDITION, SEVERAL STAPLES NOT PROPERLY FORMED WERE RECEIVED INSIDE OF A PLASTIC JAR. HOWEVER, NO CONCLUSION COULD BE REACH AS TO HOW STAPLES WERE NOT FORMED. DURING DEVICE ANALYSIS NO MALFORMED STAPLES WERE NOTED WHILE PERFORMING DEVICE TESTING. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # UNK. DATE OF EVENT: DATE OF EVENT IS UNKNOWN. THE LOT/BATCH WAS NOT PROVIDED; THEREFORE, A MANUFACTURING RECORD EVALUATION COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PANCREATODUODENECTOMY PROCEDURE, THE STAPLES WERE UNFORMED DURING USE WHEN THE DEVICE WAS USED IN THE GASTRIC REGION. IT WAS ABLE TO CUT THE TISSUE, BUT THERE WAS UNFORMED STAPLING WHICH WAS INSERTED IN THE TISSUE WITH THE U-FORM. THE SURGEON SUTURED AND FINISHED THE PROCEDURE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THE PATIENT IS GETTING BETTER AND THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618554 75MM SELECTABLE NEW TLC STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. 10705036002628

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR SR75