BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETS FLEX ARTICNG LNR CUTR 45MM

    MDR report key: 1022844 · Received March 25, 2008

    Report

    Report Number
    1527736-2008-01855
    Event Type
    Injury
    Date Received
    March 25, 2008
    Date of Event
    March 4, 2008
    Report Date
    March 5, 2008
    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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 3/25/2008. INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CYSTECTOMY WITH AN LLOI DEVERATION PROCEDURE, THE DEVICE FIRED AN INCOMPLETE STAPLE LINE WHICH RESULTED IN BLOOD LOSS OF ABOUT 200 CC. PROCEDURE WAS COMPLETED WITH A COMPETITOR'S DEVICE. THE PATIENT RECEIVED 3 UNITS OF BLOOD. PATIENT IS CURRENTLY DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETS FLEX ARTICNG LNR CUTR 45MM GDW ETHICON ENDO SURGERY, INC (CINCINNATI) NA D4JX76

    Patients

    Seq Age Sex Outcome Treatment
    1