BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR CUTTER, 45 MM STAPLE LINE-3.5

    MDR report key: 1834613 · Received December 6, 2007

    Report

    Report Number
    1527736-2007-08329
    Event Type
    Malfunction
    Date Received
    December 6, 2007
    Date of Event
    November 25, 2007
    Report Date
    November 26, 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
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN APPENDECTOMY, WHEN THEY UNLOCKED THE DEVICE, THE CARTRIDGE WAS STUCK TO THE APPENDIX. REMOVED IT WITH A GRASPER. OPENED ANOTHER DEVICE AND FIRED BELOW THE CUT LINE AND IT WAS FINE. THERE WAS NO PT CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR CUTTER, 45 MM STAPLE LINE-3.5 GDW ETHICON ENDO SURGERY, INC (CINCINNATI) NA D4JK0J

    Patients

    Seq Age Sex Outcome Treatment
    1