BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON LINEAR CUTTER

    MDR report key: 3932957 · Received July 14, 2014

    Report

    Report Number
    3005075853-2014-04939
    Event Type
    Injury
    Date Received
    July 14, 2014
    Report Date
    June 30, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE CONTACT. INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WHO IS THE SURGEON? WHAT WAS THE TIME FRAME BETWEEN INITIAL PROCEDURE AND RE-OP? HOW WAS THE LEAK IDENTIFIED? HOW WAS THE LEAK ADDRESSED? CURRENT PATIENT STATUS? RESPONSE: NO ADDITIONAL INFORMATION AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A SLEEVE GASTRECTOMY PROCEDURE, A POST-OPERATIVE ABSCESS AND LEAK WERE FOUND. THERE WERE NO ISSUES REPORTED DURING THE ORIGINAL PROCEDURE. THE PATIENT STATUS IS UNKNOWN. BLACK, GREEN AND GOLD CARTRIDGES WERE USED IN THE ORIGINAL PROCEDURE. ONE DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410714 ECHELON LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOAD - ECR60T, ECR60G, ECR60D