BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE CURVED CIR STAPL

    MDR report key: 4240930 · Received November 10, 2014

    Report

    Report Number
    3005075853-2014-07786
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    October 16, 2014
    Report Date
    October 25, 2014
    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
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE ANALYSIS RESULTS FOUND THAT THE CDH25 DEVICE 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. PLEASE REFERENCE THE INSTRUCTIONS FOR USE FOR ADDITIONAL INFORMATION. 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. NO INCIDENT RELATED TO THE REPORTED EVENT WAS OBSERVED DURING THE BATCH RECORD REVIEW.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE PARTIALLY FORMED STAPLES ARE INDICATORS OF ONE OF OR A COMBINATION OF THE FOLLOWING FACTORS: 1. TISSUE WAS THICK AND GAP SETTING SCALE WAS AT HIGH ¿B¿. 2. FIRING STROKE WAS NOT COMPLETED. 3. ADJUSTING KNOB WAS COUNTER ROTATED DURING THE FIRING STROKE. BASED ON THE PHOTOGRAPHIC EVIDENCE AND THE EVENT DESCRIPTION, THE BELIEF IS THAT THE POTENTIAL CAUSE FOR THE CHD25 COMPLICATION EXPERIENCED WAS AN INTERACTION OF TISSUE THICKNESS, INCOMPLETE FIRING STROKE, AND/OR COUNTER ROTATION OF THE FIRING KNOB DURING FIRING. HANDS ON ANALYSIS OF THE DEVICE MAY PROVIDE THE ADDITIONAL EVIDENCE NEEDED TO CONFIRM THE CAUSE OF THE COMPLICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TISSUE WAS CUT BUT THE WASHER WAS NOT CUT. ALL THE STAPLES WERE UNFORMED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721963 PROXIMATE CURVED CIR STAPL STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA K4DU3T

    Patients

    Seq Age Sex Outcome Treatment
    1