BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60 ARTICULATING

    MDR report key: 1980336 · Received February 7, 2011

    Report

    Report Number
    1527736-2011-00037
    Event Type
    Malfunction
    Date Received
    February 7, 2011
    Date of Event
    January 7, 2011
    Report Date
    January 11, 2011
    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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    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. 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 COLON PROCEDURE, THE DEVICE WOULD NOT STAPLE AND WOULD NOT CUT. THE DEVICE DID NOT WORK AT ALL (NO STAPLING, NO CUT) AT THE FIRST FIRING. THE SURGEON PRESSED THE RED BUTTON AND REFIRED THE DEVICE (THE HANDLES WERE CORRECTLY ACTIVATED) WITH THE SAME ISSUE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. ADDITIONAL FOLLOWUP: MORE DETAILS PROVIDED FROM THE CUSTOMER ABOUT THIS EVENT: THE DEVICE WAS FIRST FIRING WITH A BLUE CARTRIDGE: WHEN THE SURGEON OPENED THE DEVICE AFTER THE FIRING, HE NOTICED THAT THERE IS NO CUT AND A BAD STAPLE LINE (THE STAPLES REMAINED ALMOST OPENED ON THE TISSUES THEN THESE STAPLES WERE REMOVED. THE DEVICE WAS RELOADED WITH A SECOND CARTRIDGE: WHEN THE SURGEON WANTED TO FIRE THE DEVICE, NOTHING TAKES PLACE AS THE DEVICE "WORKED IN VACUUM", THEN A THIRD RELOAD SAME REFERENCE, WAS USED WITH THE SAME ISSUE. NO CUT DURING THESE THREE ACTIVATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON*FLEX60 ARTICULATING STAPLE, IMPLANTABLE GDW ETHICON ENDO SURGERY, INC (CINCINNATI) UNK G4TEOC

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4)