BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILS 29MM, CURVED

    MDR report key: 1892875 · Received November 8, 2010

    Report

    Report Number
    3005075853-2010-06359
    Event Type
    Injury
    Date Received
    November 8, 2010
    Date of Event
    October 18, 2010
    Report Date
    October 21, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K983536
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). WASHER UNCUT THE ANALYSIS RESULTS FOUND THAT THE DEVICE ARRIVED WITH THE ANVIL SHROUD BROKEN. THE DEVICE WAS VOID OF STAPLES AND THE BREAKAWAY WASHER WAS UNCUT AND INDENTED, INDICATING THAT THE DEVICE HAD NOT BEEN FIRED THROUGH A FULL FIRING STROKE OR POSSIBLY THAT THE ORANGE INDICATOR WAS NOT FULLY INTO THE SAFE GREEN FIRING RANGE. IT SHOULD BE NOTED THAT IF THE INDICATOR IS NOT FULLY WITHIN THE GREEN RANGE OF THE GAP SETTING SCALE OR IF THE FIRING HANDLE IS NOT FIRMLY SQUEEZED USING STEADY PRESSURE UNTIL THE FIRING HANDLE IS FULLY PARALLEL TO THE INSTRUMENT HANDLE, STAPLES COULD BE DEPLOYED WITHOUT COMPLETELY FORMING AND WITHOUT CUTTING THE WASHER. FOR MORE INFORMATION PLEASE REFER TO THE INSTRUCTIONS FOR USE. THE DEVICE WAS RELOADED WITH STAPLES AND TESTED FOR FUNCTIONALITY WITH A TEST WASHER AND WITH THE RETURNED ANVIL; THE DEVICE 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. ALTHOUGH NO CONCLUSION COULD BE REACHED AS TO HOW THE DAMAGE TO THE ANVIL SHROUD OCCURRED, IT SHOULD BE NOTED THAT AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING MANUFACTURING TO ENSURE THAT THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS REQUESTED ON (B)(4) 2010 BUT NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

    Description of Event or Problem · 1

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION PROCEDURE, THERE WAS AN INSTRUMENT ERROR. THE STAPLER FIRED SUCCESSFULLY BUT THE BOWEL PROXIMAL TO IT WAS CUT COMPLETELY, SO THE PROCEDURE WAS COMPLETED TO AN ABDOMINAL PERINAL RESECTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ILS 29MM, CURVED STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. G4TK67

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R