BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR CUTTER, 45 MM STAPLE LINE - 2

    MDR report key: 1820989 · Received October 9, 2007

    Report

    Report Number
    1527736-2007-06664
    Event Type
    Malfunction
    Date Received
    October 9, 2007
    Date of Event
    September 18, 2007
    Report Date
    September 21, 2007
    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
    FL, 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 LAP APPENDECTOMY PROCEDURE ON THE THIRD FIRING OF THE DEVICE THE STAPLE LINE WAS INCOMPLETE. THEY OPENED A SECOND DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR CUTTER, 45 MM STAPLE LINE - 2 GDW ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA D4GHIG

    Patients

    Seq Age Sex Outcome Treatment
    1