BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETS-FLEX - ENDOSCOPIC ARTICULATING LINEAR CUTTER

    MDR report key: 1880118 · Received October 22, 2010

    Report

    Report Number
    3005075853-2010-06000
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Report Date
    October 8, 2010
    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
    ME, 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 LAPAROSCOPIC APPENDECTOMY PROCEDURE, THE DEVICE WAS FIRED AND THERE WAS BLEEDING. THE SURGEON NOTICED THAT THE STAPLES WERE NOT CLOSING ALL THE WAY AND THE DEVICE WAS HELD LONGER FOR COMPRESSION. IT IS UNKNOWN HOW THE BLEEDING WAS CONTROLLED AND THERE WAS NO NEED FOR A BLOOD TRANSFUSION. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES REPORTED. THE DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETS-FLEX - ENDOSCOPIC ARTICULATING LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1