BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    45MM ARTICNG LNR CUTR/6 ROW BL

    MDR report key: 1820836 · Received August 16, 2007

    Report

    Report Number
    1527736-2007-05462
    Event Type
    Malfunction
    Date Received
    August 16, 2007
    Date of Event
    August 7, 2007
    Report Date
    August 7, 2007
    Manufacturer
    ETHICON ENDO-SURGERY, INC (CINCINNATI)
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP ROUX-EN-Y PROCEDURE, THERE WERE MALFORMED STAPLES. USED ANOTHER DEVICE TO COMPLETE THE CASE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 45MM ARTICNG LNR CUTR/6 ROW BL GDW ETHICON ENDO-SURGERY, INC (CINCINNATI) NA D4GM2T

    Patients

    Seq Age Sex Outcome Treatment
    1