BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON LINEAR CUTTER

    MDR report key: 3911324 · Received July 3, 2014

    Report

    Report Number
    3005075853-2014-04625
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    December 16, 2013
    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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED:ORIGINAL SLEEVE GASTRECTOMY PROCEDURE WAS ON (B)(6), 2013 AND REOPERATION WAS ON (B)(6), 2013. PATIENT IS FEMALE AND BMI IS UNKNOWN.THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: WHEN THE SURGEON SAYS OPEN, WERE THE STAPLES OPEN OR THE STAPLE LINE?DID THE STAPLES HAVE ANY FORM AT ALL?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A SLEEVE GASTRECTOMY PROCEDURE (IN WHICH GREEN RELOADS WERE USED), THE PATIENT WAS BROUGHT BACK FOR REOPERATION. SURGEON NOTED THAT STAPLES WERE OPEN AT APPROXIMATE LOCATION OF THE SECOND FIRING OF DEVICE ON ORIGINAL SLEEVE GASTRECTOMY PROCEDURE (GREEN RELOAD WAS USED). IT IS UNKNOWN HOW THE REOPERATION WAS COMPLETED. THE PATIENT IS CURRENTLY DISCHARGED FROM HOSPITAL BUT STILL HAS DRAINS IN PLACE FROM REOPERATION PROCEDURE. NO DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390356 ECHELON LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention RELOAD - ECR60G