BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILS 29MM, CURVED

    MDR report key: 3230309 · Received July 16, 2013

    Report

    Report Number
    3005075853-2013-03587
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Date of Event
    June 20, 2013
    Report Date
    June 21, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K983536
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE B: BATCH# K5AR3C, EXPIRATION DATE: 4/9/2018, MANUFACTURING DATE: 5/9/2013. DEVICE C: BATCH# K59F5N, EXPIRATION DATE: 1/7/2018, MANUFACTURING DATE: 2/7/2013. THERE DEVICES WERE RETURNED: DEVICE (A) 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 ANVIL WAS ATTACHED ON THE DEVICE COMPLETELY AND WITHOUT ANY DIFFICULTIES AND DID NOT DETACH DURING FUNCTIONAL TESTING. DEVICE (B) 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 ANVIL WAS ATTACHED ON THE DEVICE COMPLETELY AND WITHOUT ANY DIFFICULTIES AND DID NOT DETACH DURING FUNCTIONAL TESTING. DEVICE (C) ARRIVED IN GOOD VISUAL CONDITION. THE BREAKAWAY WASHER 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 BEFORE FIRING THE DEVICE THE ORANGE INDICATOR SHOULD BE FULLY WITHIN THE GREEN RANGE OF THE GAP SETTING SCALE. IN ADDITION IT SHOULD BE NOTED THAT IF THE FIRING SEQUENCE IS NOT COMPLETE (THE FIRING HANDLE REACHES ITS STOPPING POINT, AND THE FIRING TRIGGER IS PARALLEL TO THE INSTRUMENT HANDLE) STAPLES COULD BE PARTIALLY DEPLOYED WITHOUT CUTTING THE WASHER. THE DEVICE WAS RELOADED WITH STAPLES AND TESTED FOR FUNCTIONALITY WITH A TEST WASHER; 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. THE ANVIL WAS ATTACHED ON THE DEVICE COMPLETELY AND WITHOUT ANY DIFFICULTIES AND DID NOT DETACH DURING FUNCTIONAL TESTING. THE MANUFACTURING RECORDS WERE REVIEWED AND NO DISCREPANCIES 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

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC COLON PROCEDURE, THE ANVIL COULD NOT BE WELL ATTACHED TO THE REST OF THE STAPLER AND AFTER THEY HAVE CONNECTED IT, FIRING WAS NOT COMPLETE. THE STAPLE AND CUTTING LINE WAS NOT PERFORMED AS IT SHOULD BE. THERE WAS BLEEDING AND ANASTOMOSIS WAS NOT COMPLETELY DONE. THE CASE WAS CONVERTED TO SUTURE ANASTOMOSIS TO COMPLETE THE PROCEDURE. SURGERY WAS PROLONGED SIXTY MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328996 ILS 29MM, CURVED STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1