BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON 60 ENDOPATH

    MDR report key: 2133374 · Received June 20, 2011

    Report

    Report Number
    3005075853-2011-02464
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Date of Event
    May 24, 2011
    Report Date
    May 25, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AFTER SEVERAL REQUESTS, THE DEVICE WAS NOT RECEIVED FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. THE ANALYSIS RESULTS SHOWED THAT ONE EC60 DEVICE (A) WAS RETURNED WITH NO VISUAL NON-CONFORMANCES AND WITH A FULLY FIRED RELOAD LOADED ON THE DEVICE. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD AND IT ACHIEVED A COMPLETE 3-STROKES FIRE WITHOUT ANY DIFFICULTIES NOTED. THE DEVICE FIRED, CUT AND FORMED ALL THE STAPLES AS INTENDED. THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORM SHAPE. EVENT COULD NOT BE CONFIRMED AS THE DEVICE OPENED AND CLOSED WITHOUT ANY DIFFICULTIES NOTED. IT SHOULD BE NOTED THAT ALL DEVICES ARE INSPECTED 100% FOR STAPLE PRESENCE BY AN AUTOMATED VISION SYSTEM, AND ARE VISUALLY INSPECTED 100% AS A FINAL CHECK. IN ADDITION, AT FINISHED GOODS THE DEVICES ARE VISUALLY INSPECTED BASED ON A SAMPLE. THE ANALYSIS RESULTS FOUND THAT ONE EC60 DEVICE (B) WAS RETURNED IN GOOD VISUAL CONDITION AND WITH NO CARTRIDGE RELOAD PRESENT. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST CARTRIDGE RELOAD AND ACHIEVED ITS COMPLETE 3-STROKE FIRING SEQUENCE WITHOUT ANY DIFFICULTIES. THE STAPLE LINE AND CUT LINE WERE COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORM SHAPE. EVENT DESCRIBED COULD NOT BE CONFIRMED AS THE DEVICE OPENED WITHOUT ANY DIFFICULTIES NOTED. IT SHOULD BE NOTED THAT ALL DEVICES ARE INSPECTED 100% FOR STAPLE PRESENCE BY AN AUTOMATED VISION SYSTEM, AND ARE VISUALLY INSPECTED 100% AS A FINAL CHECK. IN ADDITION, AT FINISHED GOODS THE DEVICES ARE VISUALLY INSPECTED BASED ON A SAMPLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A GASTRECTOMY PROCEDURE, INCOMPLETE STAPLE LINE. THE SURGEON USED THREE GOLD CARTRIDGES WHICH WORKED PROPERLY. AT THE FOURTH CARTRIDGE, THE STAPLE LINE WAS IRREGULAR AND INCOMPLETE. THERE WAS NO UNEXPECTED NOISE HEARD. WHILE FIRING THE SURGEON FELT A HIGHER FORCE THAN EXPECTED AND HE HAD DIFFICULTY REMOVING THE DEVICE. THE DEVICE WAS USED ON THE STOMACH. AFTER USE TRIGGERS AND BUTTONS RETURNED TO THEIR ORIGINAL POSITIONS. THE SURGEON HAD TO SUTURE TO STRENGTHEN THE TISSUE. HE USED ANOTHER LIKE DEVICE TO PERFORM THE PROCEDURE, WHICH ENDED WITHOUT FURTHER ISSUE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. IT IS UNCLEAR HOW MANY DEVICES WILL BE RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON 60 ENDOPATH STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK G4U93N

    Patients

    Seq Age Sex Outcome Treatment
    1