BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILS 29MM, STRAIGHT

    MDR report key: 2833226 · Received November 15, 2012

    Report

    Report Number
    3005075853-2012-05160
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    October 10, 2012
    Report Date
    October 25, 2012
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K983536
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION UNAVAILABLE. THE DEVICE WAS NOT RETURNED.THE MANUFACTURING RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A LAP ANTERIOR RESECTION OF THE SIGMOID COLON PROCEDURE, THE ANASTOMOSIS WAS NOT COMPLETE ON POST OP DAY TWO. THE ANASTOMOSIS WAS 11 CM FROM ANOCUTANEOUS LINE. DURING THE INITIAL PROCEDURE, THE STAPLER WAS CLOSED VERY TIGHT; APPROXIMATELY ¼ REVOLUTION UNTIL FULL CLOSURE. THERE WAS NO CONSPICUOUS OR OMINOUS NOISE BEFORE, DURING OR AFTER FIRING. THE TISSUE DONUTS WERE PERFECT. A LEAK TEST WITH AIR WAS PERFORMED AND WAS NEGATIVE. THE SURGEON STATED THAT THE STAPLES WERE FORMED PROPERLY. THE STAPLER WORKED AS INTENDED. POSTOPERATIVE ANAL BLEEDING OCCURRED WITHOUT REVISION. PATIENT HAS LEFT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ILS 29MM, STRAIGHT STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK J4AR4K

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention