BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE ILS CIRCULAR STAPLER

    MDR report key: 4232673 · Received November 6, 2014

    Report

    Report Number
    3005075853-2014-07680
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 20, 2014
    Report Date
    October 21, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    KOG
    PMA / PMN Number
    K940967
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INCOMPLETE FIRING CYCLE. THE ANALYSIS RESULTS FOUND THAT THE ECS25 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. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WAS MET PRIOR TO THE RELEASE OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN OPEN UNKNOWN PROCEDURE, THE FIRING FORCE WAS HIGHER THAN EXPECTED AND THE FIRING HANDLE WAS NOT ABLE TO BE FULLY GRASPED THOUGH THE DOCTOR TRIED SEVERAL TIMES. AFTER THE DEVICE WAS RELEASED, IT WAS FOUND THAT THE TARGET TISSUE WAS PARTIALLY UNCUT AND SOME STAPLES WERE FORMED IN LUMBRICOID SHAPE. THE SITE WAS RECUT AND ANASTOMOSED AGAIN WITH ANOTHER COMPETITIVE DEVICE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712596 PROXIMATE ILS CIRCULAR STAPLER ENDOSCOPE AND/OR ACCESSORIES KOG ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1