BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX45 ARTICULATING

    MDR report key: 2120993 · Received June 13, 2011

    Report

    Report Number
    3005075853-2011-02372
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    May 18, 2011
    Report Date
    May 19, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS FOUND THAT ONE EC45A DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH ONE ECR45B CARTRIDGE RELOAD LOADED IN THE DEVICE. THE CARTRIDGE RELOAD WAS RECEIVED FULLY FIRED. THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE ARTICULATED POSITION WITH A TEST CARTRIDGE RELOAD AND ACHIEVED ITS COMPLETE FIRING SEQUENCE WITHOUT ANY DIFFICULTIES. THE STAPLE LINE AND CUT LINE WERE COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORM SHAPE. EVENT COULD NOT BE CONFIRMED AS THE DEVICE OPENED AND CLOSED WITHOUT ANY DIFFICULTIES NOTED. IT SHOULD BE NOTED THAT ALL DEVICES ARE INSPECTED 100% FOR STAPLE PRESENCE BY AN AUTOMATED VISION SYSTEM, AND ARE VISUALLY INSPECTED 100% AS A FINAL CHECK. IN ADDITION, AT FINISHED GOODS THE DEVICES ARE VISUALLY INSPECTED BASED ON A SAMPLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC SEGMENTECTOMY PROCEDURE, THE INSTRUMENT LOADING WAS FIRED ON THE BRONCHUS. A PART OF THE DEPLOYED STAPLES WERE UNFORMED AND LEAK WAS FOUND ON THE EDGE AFTER THE FIRST FIRING. ADDITIONAL SUTURE WAS PERFORMED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE DOCTOR COMMENTED AS FOLLOWS; THE GRASPING FORCES OF THE CLOSING LEVER AND THE FIRING TRIGGER WERE LOWER THAN USUAL. THE ACRAL PART OF THE JAW SEEMED TO BE NOT CLOSED COMPLETELY, BUT THE DEVICE WAS FIRED AS-IS. THE TARGET TISSUE WAS DROPPED BEFORE THE FIRING WAS COMPLETED AND A PART OF DEPLOYED STAPLES SEEMED TO BE UNFORMED. AN UNEXPECTED SOUND WAS NOT HEARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON*FLEX45 ARTICULATING STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOAD-(B)(4)