BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETS FLEX ARTICNG LNR CUTR 45MM

    MDR report key: 1081614 · Received July 25, 2008

    Report

    Report Number
    3005075853-2008-00698
    Event Type
    Injury
    Date Received
    July 25, 2008
    Date of Event
    June 1, 2008
    Report Date
    July 9, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 HAND ASSISTED LAP COLON PROCEDURE, THE DEVICE WAS BEING USED WITH A BLUE LOAD AND IT CUT, BUT DID NOT STAPLE. THE PROCEDURE WAS CONVERTED TO AN OPEN PROCEDURE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PT IS FINE.

    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 Required Intervention