BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLUE RELOAD FOR ECHELON 60

    MDR report key: 1812286 · Received August 24, 2010

    Report

    Report Number
    3005075853-2010-04813
    Event Type
    Malfunction
    Date Received
    August 24, 2010
    Date of Event
    July 28, 2010
    Report Date
    July 29, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPY-ASSISTED DISTAL GASTRECTOMY PROCEDURE, THE DEVICE WAS USED AT THE GASTRIC BODY TO CREATE THE ROUX-EN-Y ANASTOMOSE. A FEW DEPLOYED STAPLES OF THE ACRAL PART WERE UNFORMED AT THE THIRD FIRING. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLUE RELOAD FOR ECHELON 60 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. G4T30E

    Patients

    Seq Age Sex Outcome Treatment
    1