BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON LINEAR CUTTER

    MDR report key: 3951887 · Received July 23, 2014

    Report

    Report Number
    3005075853-2014-05161
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 2, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K110385
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WHAT OTHER STRUCTURES WERE FIRED ON BEFORE? OTHER STRUCTURES WERE FIRED WITH SAME PRODUCT BEFORE THE 5TH FIRING. BUT THE INFORMATION ABOUT THE OTHER STRUCTURE WAS NOT PROVIDED. WHAT COLOR CARTRIDGES USED? FOR 5TH FIRING, WHITE WAS USED. BEFORE THE 5TH FIRING, ONE GOLD AND THREE WHITE WERE USED. WAS PROXIMAL AND DISTAL CONTROL USED? NO INFORMATION. WAS IT BEING FIRED OVER THE MAIN PULMONARY ARTERY OF LOBAR BRANCH? --- NO, ANTERIOR SEGMENTAL ARTERY OF LEFT LUNG. WHAT WAS THE CONDITION OF THE STAPLE LINE? THE SURGEON COMMENTED THE STAPLE LINE WAS GOOD, BUT BLEEDING FROM THE CENTRAL PART OF THE STAPLE LINE WAS CONFIRMED. WAS THE DEVICE ARTICULATED? NO INFORMATION. HOW MUCH BLOOD PRODUCT REQUIRED? NO INFORMATION. DID THEY NOTICE STAPLE WHAT THE PROXIMAL AND DISTAL STAPLE LINE? WAS THE BLEEDING HEAVIER ON ONE SIDE VERSUS THE OTHER? BLEEDING FROM THE CENTRAL PART OF THE STAPLE LINE CONFIRMED. DID YOU HEAR OR FEEL ANYTHING DIFFERENT DURING THIS FIRING VERSUS OTHER FIRINGS? THE SURGEON DIDN¿T SAY HE FELT SOMETHING DIFFERENT. BUT THE PATIENT¿S ANTERIOR SEGMENTAL ARTERY WAS BIFORKED. WHAT DOES THE SURGEON FEEL LED TO THE BLEEDING? THE SURGEON COMMENTED THERE MIGHT BE A SOMETHING HARD TISSUE ON THE STAPLE LINE, AND BLEEDING OCCURRED. CURRENT PATIENT STATUS? STABLE. THE ANALYSIS FOUND THAT ONE PCE60A DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH FIVE ECR60W CARTRIDGE RELOADS PRESENT. ALL CARTRIDGES WERE FULLY FIRED AND IN GOOD VISUAL CONDITION. IN ADDITION, THE RETURNED RELOADS WERE DISASSEMBLED AND NO ANOMALIES WERE NOTED. THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE STRAIGHT 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. IT COULD NOT BE DETERMINED WHAT MAY HAVE CAUSED THE INCIDENT REPORTED. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE, A SUPPLEMENTAL MEDWATCH WILL BE SENT. AT THE TIME OF THIS SUBMISSION, THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: WHAT OTHER STRUCTURES WERE FIRED ON BEFORE? WHAT COLOR CARTRIDGES USED? WAS PROXIMAL AND DISTAL CONTROL USED? WAS IT BEING FIRED OVER THE MAIN PULMONARY ARTERY OF LOBAR BRANCH? WHAT WAS THE CONDITION OF THE STAPLE LINE? WAS THE DEVICE ARTICULATED? HOW MUCH BLOOD PRODUCT REQUIRED? DID THEY NOTICE STAPLE WHAT THE PROXIMAL AND DISTAL STAPLE LINE? WAS THE BLEEDING HEAVIER ON ONE SIDE VERSUS THE OTHER? DID YOU HEAR OR FEEL ANYTHING DIFFERENT DURING THIS FIRING VERSUS OTHER FIRINGS? WHAT DOES THE SURGEON FEEL LED TO THE BLEEDING? CURRENT PATIENT STATUS?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC LOBECTOMY PROCEDURE, BLEEDING OCCURRED FROM THE PULMONARY ARTERY AFTER THE 5TH FIRING. 4500 ML BLEEDING IN AMOUNT WAS CONFIRMED. BLOOD INFUSION WAS PERFORMED. THE PROCEDURE WAS CONVERTED FROM A LAPAROSCOPIC PROCEDURE TO AN OPEN PROCEDURE. SUTURE WAS PERFORMED TO STOP THE BLEEDING. ANOTHER COMPETITIVE DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430628 ECHELON LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA L4E170

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOAD - ECR60W (LOT #: L4E473)X1