BEUDAMED
    FDA Adverse Event Injury Summary report: N

    45MM ARTICNG LNR CUTR/6 ROW BL

    MDR report key: 1120888 · Received August 18, 2008

    Report

    Report Number
    3005075853-2008-01251
    Event Type
    Injury
    Date Received
    August 18, 2008
    Date of Event
    July 30, 2008
    Report Date
    August 4, 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
    JA
    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 AN LAR PROCEDURE, AFTER PEELING THE TISSUE AROUND THE RECTUM, THE DR FIRED FULLY, ALTHOUGH IT WAS A LITTLE HARD TO FIRE. WHEN THE DEVICE WAS RELEASED, IT WAS FOUND THAT THE STAPLES WERE NOT FORMED, AND ONLY THE KNIFE WAS MOVED. SOME UNFORMED STAPLES WERE SEEN AT THE ISSUE OF THE PROXIMAL PART OF THE JAW. THE CASE WAS SWITCHED TO ABDOMINAL OPERATION, AND ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. HOWEVER, A LEAK WAS FOUND AFTER THE OPERATION.

    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 E4L35V

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention