BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON LINEAR CUTTER

    MDR report key: 4142916 · Received October 6, 2014

    Report

    Report Number
    3005075853-2014-06837
    Event Type
    Injury
    Date Received
    October 6, 2014
    Date of Event
    September 17, 2014
    Report Date
    September 17, 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). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION REQUESTED AND RECEIVED: WHEN UNABLE TO FIRE ON THE SECOND STROKE, WAS THE FIRING HANDLE DIFFICULT TO PULL BACK OR WAS IT LOOSE? THE FIRING HANDLE DIFFICULT TO PULL BACK. WHAT TISSUE TYPE WAS THE DEVICE BEING FIRED ON? ON LOBI PULMONIS. WHAT WERE THE INDICATIONS FOR SURGERY? THE PATIENT HAD LUNG CANCER.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE ANALYSIS RESULTS FOUND THAT ONE EC60 DEVICE WAS RETURNED WITH THE ANVIL BENT UPWARDS AND WITHOUT TWO ECR60G CARTRIDGE RELOADS PRESENT. CARTRIDGE (B) ECR60G, K5EC8X WAS RECEIVED PARTIALLY FIRED 1/3 CONSISTENT WITH AN INCOMPLETE OR INTERRUPTED CYCLE. CARTRIDGE (C) ECR60G, K5EC8X WAS RECEIVED PARTIALLY FIRED 2/3 CONSISTENT WITH AN INCOMPLETE OR INTERRUPTED CYCLE. IN ORDER TO VERIFY THE INTEGRITY OF INTERNAL COMPONENTS THE RETURNED CARTRIDGES (B, C) WERE DISASSEMBLED AND NO ANOMALIES WERE NOTED, NO DAMAGE ON CARTRIDGE DECK WAS FOUND. NO FURTHER FUNCTIONAL TESTING COULD BE PERFORMED DUE TO THE CONDITION OF THE ANVIL. HOWEVER A DRY FIRE WAS PERFORMED TO VERIFY THE FIRING MECHANISM AND THE INSTRUMENT ACHIEVED ITS COMPLETE 3-STROKE FIRING SEQUENCE WITHOUT ANY DIFFICULTIES. IT IS KNOWN FROM THE HISTORY OF THE DEVICE THAT THE FOUND CONDITION OF THE ANVIL MAY LEAD THAT THE MOST DISTAL STAPLES NOT TO FORM PROPERLY. IT IS POSSIBLE THAT THE DEVICE WAS CLAMPED OVER AN EXCESS OF TISSUE CAUSING THE ANVIL TO BENT AND FOR THE FIRING STROKE AND THE STAPLE FORM TO BE INCOMPLETE. IT SHOULD BE NOTED THAT A 100% INSPECTIONS TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRE SPECIFICATIONS PRIOR TO SHIPMENTS, IN ADDITION, A SAMPLE OF THE BATCH IS INSPECTED AT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A VIDEO ASSISTED THORACOSCOPIC SURGERY PROCEDURE, THE SURGEON USED THE DEVICE AND A BLUE RELOAD TO CONTINUE BUT THE DEVICE COULD NOT FIRE AT THE SECOND STROKE. ONE BLUE RELOAD AND GOLD RELOAD WERE USED ON THE DEVICE AFTER THIS EVENT BUT BOTH COULD NOT FIRE AT THE SECOND STROKE. THE PROCEDURE WAS CONVERTED TO OPEN AND THE SURGEON USED HAND SEWING TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623011 ECHELON LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA K4DF50

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR RELOADS - ECR60B, ECR60G