BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETS FLEX ARTICNG LNR CUTR 45MM

    MDR report key: 1160608 · Received September 5, 2008

    Report

    Report Number
    3005075853-2008-01521
    Event Type
    Malfunction
    Date Received
    September 5, 2008
    Date of Event
    August 12, 2008
    Report Date
    August 14, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP NEPHRECTOMY PROCEDURE, HALFWAY THROUGH THE FIRING THE RELOAD FELL OUT INTO THE PT. THE RELOAD WAS RETRIEVED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETS FLEX ARTICNG LNR CUTR 45MM GDW ETHICON ENDO-SURGERY, LLC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1