BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1203786 · Received October 10, 2008

    Report

    Report Number
    3005075853-2008-02278
    Event Type
    Malfunction
    Date Received
    October 10, 2008
    Date of Event
    September 2, 2008
    Report Date
    September 18, 2008
    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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC RIGHT HEMICOLECTOMY PROCEDURE, WHEN THE DEVICE WAS USED FOR ITS SECOND FIRING WITH A GREEN CARTRIDGE, THERE WAS NOT A GOOD STAPLE LINE. ANOTHER SAME DEVICE WAS OPENED, AND THE GREEN CARTRIDGE WAS LOADED AND WORKED FINE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    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, LLC NA E4KP4K

    Patients

    Seq Age Sex Outcome Treatment
    1