BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60

    MDR report key: 2904889 · Received January 9, 2013

    Report

    Report Number
    3005075853-2013-00162
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    December 17, 2012
    Report Date
    December 18, 2012
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K081146
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). INCOMPLETE-INTERRUPTED CYCLE THE DEVICE WAS RECEIVED FOR ANALYSIS WITH NO VISUAL NON-CONFORMANCES AND WITH A WHITE CARTRIDGE RELOAD PRESENT. THE CARTRIDGE RELOAD WAS RECEIVED PARTIALLY FIRED CONSISTENT WITH AN INCOMPLETE OR INTERRUPTED CYCLE. THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE ARTICULATED POSITION WITH THE RETURNED CARTRIDGE RELOAD BY RESETTING AND RELOADING IT INTO THE DEVICE. THE DEVICE ACHIEVED ITS COMPLETE STROKE FIRING SEQUENCE WITHOUT ANY DIFFICULTIES. THE REMAINING STAPLE LINE AND CUT LINE WERE COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORM SHAPE. THE CARTRIDGE WAS LOADED INTO THE DEVICE WITHOUT ANY DIFFICULTIES AND DID NOT FALL OUT DURING THE VISUAL AND FUNCTIONAL TESTING. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE NURSE PUT THE RELOAD INSIDE THE JAWS AND THOUGHT THAT THE PROXIMAL PART OF THE RELOAD WASN'T FIXED FIRMLY ENOUGH INSIDE THE JAWS. THE STAFF OPENED ANOTHER INSTRUMENT WITH THE SAME TYPE AND FINISHED THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11941 ECHELON*FLEX60 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 ECR60W