BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON*FLEX60 LONG

    MDR report key: 2142347 · Received June 28, 2011

    Report

    Report Number
    3005075853-2011-02624
    Event Type
    Injury
    Date Received
    June 28, 2011
    Date of Event
    May 31, 2011
    Report Date
    May 31, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K081146
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS USED DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE. THEY LEAK TESTED THE GASTROJEJUNOSTOMY, IT WAS NOTED THE STAPLE LINE WAS LEAKING. UNDER FURTHER INVESTIGATING IT WAS NOTED THAT THE ENTIRE GASTROJEJUNOSTOMY STAPLE LINE HAD COME APART. AT THAT POINT, SURGEON HAD TO RESECT THE ANASTOMOSIS AND PERFORM A ESOPHAGOJEJUNOSTOMY. THE CASE WAS COMPLETED WITH A COMPETITORS DEVICE THERE WAS NO ADDITIONAL ADVERSE PATIENT CONSEQUENCE EXCEPT FOR THE CHANGE IN PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON*FLEX60 LONG STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention