BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILS 29MM, CURVED

    MDR report key: 2221761 · Received August 24, 2011

    Report

    Report Number
    3005075853-2011-03484
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 2, 2011
    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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): UNCUT WASHER - BLEMISHED. THE ANALYSIS RESULTS FOUND THAT THE DEVICE ARRIVED IN GOOD VISUAL CONDITION, WITHOUT STAPLES PRESENT AND WITH THE BREAKAWAY WASHER UNCUT, 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 THE FIRING SEQUENCE IS NOT COMPLETE (PLASTIC TO PLASTIC), STAPLES COULD BE DEPLOYED WITHOUT COMPLETELY FORMING AND WITHOUT CUTTING THE WASHER. WHEN EITHER OR BOTH OF THESE SCENARIOS OCCUR THE DEVICE WILL NOT TRANSECT THE TISSUE COMPLETELY RESULTING IN DIFFICULTIES TO REMOVE THE DEVICE. FOR MORE INFORMATION PLEASE REFER TO THE INSTRUCTIONS FOR USE. THE DEVICE WAS RELOADED WITH STAPLES AND TESTED FOR FUNCTIONALITY; 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. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SIGMOID COLECTOMY PROCEDURE, THE DEVICE WAS INSERTED TO BE FIRED. IT WAS TIGHTENED DOWN AND FIRED; SURGEON MADE SURE IT STAYED FIRED AND IT CUT THE STRING. THEY USE PROLENE SUTURE. THE SURGEON WENT TO PULL IT OUT AFTER IT WAS LOOSENING AND IT STUCK A LITTLE. THE SURGEON STATED IT DID NOT FEEL RIGHT. THE SURGEON WENT TO PULL IT OUT AND THE ANASTOMOSIS FELL APART. THE STAPLES DID NOT FORM AT ALL. ALL THE STAPLES WERE REMOVED AND THE AREA WAS HAND SUTURED. THE PATIENT IS CURRENTLY FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ILS 29MM, CURVED STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA H4364N

    Patients

    Seq Age Sex Outcome Treatment
    1