BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    45MM ARTICNG LNR CUTR/6 ROW BL

    MDR report key: 1211899 · Received October 23, 2008

    Report

    Report Number
    3005075853-2008-02543
    Event Type
    Malfunction
    Date Received
    October 23, 2008
    Date of Event
    September 25, 2008
    Report Date
    October 2, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 10/23/2008. INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP BARIATRIC PROCEDURE, THE DEVICE MISFIRED TWICE. THE SECOND TIME THE DEVICE MISFIRED, IT CUT OPEN THE PT'S STOMACH. THE DOCTOR HAD TO CLOSE THE STOMACH WITH A NEW DEVICE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 45MM ARTICNG LNR CUTR/6 ROW BL GDW ETHICON ENDO-SURGERY, LLC NA E4LD2R

    Patients

    Seq Age Sex Outcome Treatment
    1