BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60 ARTICULATING

    MDR report key: 1884591 · Received October 28, 2010

    Report

    Report Number
    1527736-2010-00087
    Event Type
    Malfunction
    Date Received
    October 28, 2010
    Date of Event
    October 5, 2010
    Report Date
    October 8, 2010
    Manufacturer
    ETHICON ENDO SURGERY, INC (CINCINNATI)
    Product Code
    GDW
    PMA / PMN Number
    K081146
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS FOUND THAT ONE EC60A DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH ONE ECR60W CARTRIDGE RELOAD PRESENT. THE CARTRIDGE RELOAD WAS RECEIVED FULLY FIRED. THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE ARTICULATED POSITION WITH A TEST CARTRIDGE RELOAD AND ACHIEVED ITS COMPLETE 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. IT SHOULD BE NOTED THAT ALL RELOADS 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 LOW ANTERIOR RESECTION PROCEDURE, IT WAS THE SURGEON'S FIRST FIRE OF THE CASE. THE SURGEON SAID, THE DEVICE MISS FIRED AS THERE WAS A LEAK IN THE STAPLE LINE. THE SALES REP WAS ABLE TO SEE THAT THE MIDDLE OF THE STAPLE LINE WAS WHERE THE LEAK WAS AND THE SURGEON SEALED IT BY USING THE HARMONIC AND AN ENDO LOOP. THE SURGEON CONTINUED TO USE THE SAME DEVICE FOR THE SECOND FIRING ON THE LEFT ILEOCOLIC ARTERY BY USING A SECOND RELOAD. THE SURGEON WAITED TEN TO FIFTEEN SECONDS AND FIRE FULLY PLASTIC TO PLASTIC. THE SECOND FIRE WAS PERFECT. THE SURGEON THEN FIRED A THIRD RELOAD ON THE SMALL BOWEL. THIS ALSO FIRED PERFECTLY, SO THE ISSUE DID NOT APPEAR TO BE THE STAPLER. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON*FLEX60 ARTICULATING STAPLE, IMPLANTABLE GDW ETHICON ENDO SURGERY, INC (CINCINNATI) UNK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1