BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON LINEAR CUTTER

    MDR report key: 3911301 · Received July 2, 2014

    Report

    Report Number
    3005075853-2014-04627
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 10, 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). DEVICE WAS NOT RETURNED FOR EVALUATION. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: WHAT WAS THE INDICATION FOR SURGERY? DOES THE SURGEON WAIT 15 SECS PRIOR TO FIRING? DOES SURGEON USE GOLD CARTRIDGES FOR THE ENTIRE GASTRIC TUBE FORMATION? PROCEDURE DONE OPEN OR LAP? HOW CLOSE THE PYLORUS WAS THE 6TH AND 7TH FIRING? WAS THE LEAK IDENTIFIED AT THE STAPLE LINE? WHAT DID STAPLE FORM LOOK? HOW WAS LEAK ADDRESSED? CURRENT PATIENT STATUS?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A GASTRIC TUBE FORMATION, THE AMYLASE LEVEL WAS OVER 50,000 WITHIN 9 HOURS AFTER SURGERY. WHEN THE PATIENT WAS INVESTIGATED, A MAJOR LEAK WAS FOUND. IN THE INITIAL PROCEDURE, THE DEVICE WAS FIRED ON THE LESSER CURVATURE FROM THE HEAD SIDE 7 TIMES WITH ECR45D TO FORM THE GASTRIC TUBE. THE FIRED SITE WAS THE SIDE OF POSTERIOR STERNUM. AFTER THAT, A BURIED SUTURE WAS PERFORMED FOR THE STAPLE LINE. AT THE 7TH FIRING, THE DEVICE WAS FIRED ACROSS THE 6TH STAPLE LINE AROUND THE PYLORIC RING. THE LEAK SITE WAS JUST BELOW THE BRONCHIAL BIFURCATION AND IT WAS CLOSE TO THE PYLORIC RING. WHEN THE FIRED SITE WAS CHECKED WITH CT, THE STAPLE LINES SEEMED TO BE PROPER. DURING THE PROCEDURE, THE DEVICE FUNCTIONED PROPERLY. REINFORCEMENT MATERIAL WAS NOT USED. AS OF NOW, THE PATIENT IS BEING TREATED IN ICU. NO DEVICE WILL BE RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385646 ECHELON LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention RELOAD - ECR45D (LOT#:UNK)X1