BEUDAMED
    FDA Adverse Event Injury Summary report: N

    75MM SELECTABLE NEW TLC

    MDR report key: 2183029 · Received July 28, 2011

    Report

    Report Number
    3005075853-2011-03083
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    July 3, 2011
    Report Date
    July 6, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K092577
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2011: PER THE SURGEON, THE STAPLE LINE FAILURE WAS ONLY ONE STAPLE LINE FAILURE FROM THE ORIGINAL PROCEDURE. IT WAS THE THIRD FIRING WHERE THE SURGEON PERFORMED THE ANASTOMOSIS. IT WAS ON ONE SIDE. THE AREA WAS SUTURED. THEN THE PATIENT CAME BACK A SECOND TIME ON (B)(6) 2011 FOR A LEAK AND FOUND THE LEAK WAS FROM THE SAME STAPLE LINE BUT ON THE OTHER SIDE. THIS AREA WAS CORRECTED. THE PATIENT IS CURRENTLY FINE. PER THE SURGEON, THERE WAS NOT A DEVICE PERFORMANCE ISSUE DURING THE ORIGINAL PROCEDURE. THE DEVICE PERFORMED AS INTENDED. THE PATIENT HAD DIVERTICULITIS. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2011: THIS WAS A (B)(6) AND GENERALLY (B)(6) PATIENTS HAVE POOR TISSUE MAKING THIS TYPE OF PROCEDURE MORE CHALLENGING. AT THIS TIME, THE PATIENT IS STILL IN THE HOSPITAL, BUT APPEARS TO BE IMPROVING AND THERE HAVE BEEN NO DETECTED LEAKS SINCE THE PROCEDURE ON (B)(6) ((B)(6) 2011) EVENING. SURGEON SAID THAT THE LEAKS WERE ON BOTH SIDES OF THE ANASTOMOSIS AND HE USED SUTURES TO REPAIR THEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2011, THE PATIENT UNDERWENT A LOW ANTERIOR RESECTION PROCEDURE. (B)(6), ON (B)(6) 2011, THE PATIENT WAS GETTING SEPTIC AND HAD TO BE RETURNED TO THE OPERATING ROOM. THE PATIENT WAS OPENED AND THEY FOUND THERE WAS A STAPLE LINE LEAK. THE LEAK WAS REPAIRED. THERE WAS NO INFORMATION PROVIDED ON THE STAPLE FORMATION. PER THE CONTACT, THE DEVICE PERFORMED AS INTENDED DURING THE PROCEDURE. THE DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 75MM SELECTABLE NEW TLC STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R CARTRIDGE