BEUDAMED
    FDA Adverse Event Injury Summary report: N

    45MM ARTICNG LNR CUR/6 ROW BL

    MDR report key: 1022841 · Received March 24, 2008

    Report

    Report Number
    1527736-2008-01823
    Event Type
    Injury
    Date Received
    March 24, 2008
    Date of Event
    March 4, 2008
    Report Date
    March 4, 2008
    Manufacturer
    ETHICON ENDO SURGERY, INC (CINCINNATI)
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 3/24/2008. INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROUX-EN-Y, WHEN CREATING THE GASTRIC POUCH, THE DEVICE FIRED WITH AN UNUSUAL NOISE AND WOULD NOT OPEN. HAD TO CUT THE DEVICE OUT OF THE TISSUE AND USED ANOTHER DEVICE TO COMPLETE. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 45MM ARTICNG LNR CUR/6 ROW BL GDW ETHICON ENDO SURGERY, INC (CINCINNATI) NA D4JV58

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention