BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60

    MDR report key: 1974452 · Received January 31, 2011

    Report

    Report Number
    1527736-2011-00029
    Event Type
    Malfunction
    Date Received
    January 31, 2011
    Date of Event
    November 24, 2010
    Report Date
    December 22, 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
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS FOUND THAT ONE EC60A DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH NO CARTRIDGE RELOAD LOADED ON THE DEVICE. 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. THE DEVICE OPENED AND CLOSED WITHOUT ANY DIFFICULTIES NOTED. EVENT COULD NOT BE CONFIRMED AS NO CARTRIDGE WAS RECEIVED FOR ANALYSIS. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PLEURODESE OR BIOPSY PROCEDURE, THE SURGEON FIRED, BUT THE STAPLER LOCKED. IT IS UNKNOWN HOW THE CASE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON*FLEX60 STAPLE, IMPLANTABLE GDW ETHICON ENDO SURGERY, INC (CINCINNATI) UNK G4TNV3

    Patients

    Seq Age Sex Outcome Treatment
    1