BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILS 33MM, CURVED

    MDR report key: 3011166 · Received March 19, 2013

    Report

    Report Number
    3005075853-2013-01294
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    February 27, 2013
    Report Date
    February 28, 2013
    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
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE DEVICE ARRIVED IN GOOD VISUAL CONDITION. THE BREAKAWAY WASHER WAS PRESENT AND CUT AND THERE WERE NO STAPLES PRESENT, INDICATING THAT THE DEVICE ACHIEVED A FULL FIRING STROKE. THE DEVICE WAS RELOADED WITH STAPLES, A NEW WASHER WAS PLACED ON THE DEVICE AND IT WAS TESTED FOR FUNCTIONALITY. IT FIRED AND FORMED ALL THE STAPLES AS WELL AS COMPLETELY CUT THE TEST MEDIA AND THE BREAKAWAY WASHER WITHOUT INCIDENT. 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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION PROCEDURE, THE STAPLER FIRED FINE INITIALLY. UPON INSPECTION, THE DISTAL DONUT WAS ONLY 50% INTACT. THE PROXIMAL DONUT WAS INTACT HOWEVER. THE SURGEON THEN LEAK-TESTED THE ANASTOMOSIS AND THERE WAS A LARGE LEAK. THE SURGEON THAN INSPECTED THE ANASTOMOSIS VISUALLY TRANSANALLY, AND THERE WAS A COMPLETE DISRUPTION. 0% OF THE ANASTOMOSIS WAS INTACT. THE SURGEON SEWED THE RECTAL STUMP SHUT TRANSANALLY AND DID A COLOSTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113328 ILS 33MM, CURVED STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention