BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILS 25MM, CURVED

    MDR report key: 2991209 · Received March 6, 2013

    Report

    Report Number
    3005075853-2013-01075
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    January 30, 2013
    Report Date
    February 11, 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
    BE
    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. IT SHOULD BE NOTED THAT TO REMOVE THE DEVICE AFTER A COMPLETE FIRING STROKE, OPEN THE INSTRUMENT BY TURNING THE ADJUSTING KNOB COUNTERCLOCKWISE. FOR EASY REMOVAL, ONLY OPEN THE INSTRUMENT ONE-HALF TO THREE-FOURTHS REVOLUTIONS. TO ASSURE THE ANVIL IS FREE FROM TISSUE, ROTATE THE INSTRUMENT 90° IN BOTH DIRECTIONS. TO WITHDRAW THE OPEN INSTRUMENT, GENTLY APPLY REARWARD TRACTION WHILE SIMULTANEOUSLY ROTATING. 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 AN RESTORATION OF CONTINUITY OF THE COLON AFTER HARTMANN PROCEDURE, THE CIRCULAR STAPLER COULD NOT BE REMOVED AFTER FIRING. THEY HAD TO TAKE ANOTHER STAPLER TO FINISH THE PROCEDURE. THE TISSUE AT THE SIDE OF THE ANVIL WAS NORMAL TISSUE, AT THE SIDE OF THE STAPLING DEVICE THICKER. THE SURGEON WAITED ABOUT 40 TO 50 SECONDS TO SQUEEZE OUT LIQUIDS. BEFORE FIRING. THE PURSE STRING TECHNIQUE USED WAS HAND SEWN PURSE STRING WITH PROLENE 2/0. THE SURGEON RECEIVED VISUAL AND TACTILE CONFIRMATION THAT THE ANVIL WAS ATTACHED. ALSO BY CLOSING THE INSTRUMENT THAT THE ANVIL COULDN'T SLIP OFF ANYMORE. THE SPIKE OF THE TROCAR WAS INSERTED R THROUGH THE STAPLE LINE. WHEN THE DEVICE WAS FIRED, IT WAS WITHIN THE GREEN ZONE, FOR THICK TISSUE. THE INSTRUMENT FIRED ACROSS AN EXISTING STAPLE LINE. IT WAS CONFIRMED THAT THE DEVICE WAS FULLY FIRED AS A CLEAR CRUNCH WAS HEARD. NO OTHER UNEXPECTED NOISES HEARD. ANASTOMOSES FAILED, THE SURGEON PLACED A TEMPORARY STOMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95024 ILS 25MM, CURVED STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK J4CF2Y

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention