BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON LINEAR CUTTER

    MDR report key: 3821806 · Received May 20, 2014

    Report

    Report Number
    3005075853-2014-03377
    Event Type
    Injury
    Date Received
    May 20, 2014
    Date of Event
    April 21, 2014
    Report Date
    April 24, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). JAMMED KNIFE, DAMAGED DRIVERS, DAMAGED CARTRIDGE, NICKED KNIFE. THE ANALYSIS FOUND THAT ONE DEVICE WAS RETURNED WITH THE CLOSING TRIGGER AND ANVIL IN THE CLOSED POSITION. AN CARTRIDGE WAS RECEIVED LOADED ON THE DEVICE FULLY FIRED. UPON FURTHER INSPECTION OF THE DEVICE, A CLIP WAS FOUND LODGED IN THE BEHIND THE KNIFE PREVENTING THE KNIFE FROM RETURNING COMPLETELY AND THE ANVIL FROM OPENING. FURTHERMORE, THE RELOAD WAS NOTED TO HAVE THE DECK AND SOME DRIVERS DAMAGED. IN ADDITION, THE KNIFE WAS INSPECTED UNDER MAGNIFICATION AND NICKS WERE FOUND. THE DAMAGE TO THE CARTRIDGE, DRIVERS AND KNIFE IS CONSISTENT WITH THE DEVICE BEING CLAMPED AND FIRED OVER A HARD OBJECT. IT SHOULD BE NOTED THAT PROPER CARE SHOULD BE TAKEN WHEN PLACING THE DEVICE ON THE TISSUE TO BE STAPLED, TO ENSURE THAT NO HARD OBSTRUCTION SUCH AS A CLIP IS INCLUDED WITH THE TISSUE INSIDE THE JAWS. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST CARTRIDGE RELOAD AND IT 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. AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING MANUFACTURING TO ENSURE THAT THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC LIVER RESECTION PROCEDURE, THE JAW OF THE DEVICE COULD NOT OPEN AFTER THE SECOND FIRING. THERE WAS AN RELOAD USED ON THE DEVICE BEFORE THIS EVENT. THE MANUAL FIRING RELEASE LEVER WAS USED BUT STILL COULD NOT OPEN THE DEVICE. THE PROCEDURE WAS CONVERTED TO OPEN AND THE DEVICE WAS REMOVED FROM THE PATIENT AT LAST. THE CUT LINE AND THE STAPLE LINE WERE ALL COMPLETED. NOW THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299434 ECHELON LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA K4DD7Y

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention RELOAD - ECR60W