BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON 45 ENDO LINEAR CUTTER

    MDR report key: 1081611 · Received July 25, 2008

    Report

    Report Number
    3005075853-2008-00678
    Event Type
    Injury
    Date Received
    July 25, 2008
    Date of Event
    June 12, 2008
    Report Date
    June 30, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GDW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    D4; H4, 6: INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP GASTRIC BYPASS, THE DEVICE WOULD NOT OPEN. THEY USED A NEW DEVICE ALONG SIDE OF THE FIRST DEVICE TO GET IT OFF. THE CASE WAS COMPLETED WITH THE SECOND DEVICE WITH NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON 45 ENDO LINEAR CUTTER GDW ETHICON ENDO-SURGERY, LLC NA E4K17

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention