BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    75MM SELECTABLE NEW TLC

    MDR report key: 3241250 · Received July 22, 2013

    Report

    Report Number
    3005075853-2013-03673
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    June 27, 2013
    Report Date
    June 28, 2013
    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). THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH A RELOAD LOADED IN THE DEVICE. THE RELOAD WAS RETURNED FULLY FIRED. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD AND IT FIRED, CUT AND FORMED ALL THE STAPLES AS INTENDED. THE DEVICE FIRED WITHOUT ANY DIFFICULTIES, THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. THE MANUFACTURING RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC ILEOCECAL RESECTION, THE FIRING STOPPED AT ABOUT 1/2 FROM THE PROXIMAL END WHEN THE DEVICE WAS FIRED ACROSS AN EXISTING STAPLE LINE ON THE COLON AT THE 4TH FIRING. IT WAS THE LAST FIRING OF FUNCTIONAL END TO END ANASTOMOSIS. THE SURGEON WHO FIRED THE DEVICE WAS FEMALE. THEN, ANOTHER MALE SURGEON FIRED THE DEVICE FROM THE STOPPED POSITION WITH FORCE. ALTHOUGH THE FIRING WAS COMPLETED, THERE WAS AN UNEXPECTED RESISTANCE LIKE THE TARGET TISSUE SLID FORWARD WHILE FIRING. THE DEPLOYED STAPLES THAT THE MALE SURGEON FIRED WERE MALFORMED. ALL STAPLES ON ONE OF THE LINES AND SOME STAPLES ON THE OTHER LINES WERE MALFORMED. ADDITIONAL SUTURE WAS PERFORMED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341440 75MM SELECTABLE NEW TLC STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOAD SR75