BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60 COMPAC

    MDR report key: 2091688 · Received May 17, 2011

    Report

    Report Number
    3005075853-2011-02008
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    April 21, 2011
    Report Date
    April 22, 2011
    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
    JA
    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 SC60A DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH THREE CARTRIDGE RELOADS PRESENT. THE CARTRIDGE RELOADS WERE 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. EVENT COULD NOT BE CONFIRMED AS THE DEVICE OPENED AND CLOSED WITHOUT ANY DIFFICULTIES NOTED. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    THE DEVICE WAS USED FOR RECONSTRUCTION PROCEDURE OF LAPAROSCOPIC ILEOCECAL RESECTION. WHEN THE DEVICE WAS FIRED TO CLOSE THE INSERTION PART OF THE DEVICE AT THE 2ND FIRING, THE ACRAL PART OF THE STAPLE LINE WAS LUMBRICOID-FORMED. THEN THE CARTRIDGE WAS CHANGED TO ANOTHER ECR60B AND FIRED AT THE SAME PLACE OF THE 2ND FIRING. HOWEVER, THE CLAMPED TISSUE WAS PUSHED TOWARDS THE ACRAL PART OF THE JAW, SO THE ACRAL PART OF THE CLAMPED TISSUE WAS THICK. SO THE DEPLOYED STAPLES WERE MALFORMED AND ALSO 5 OR 6 DEPLOYED STAPLES WERE LUMBRICOID-FORMED. THE DEPLOYED STAPLES OF THE PATIENT SIDE WERE FORMED COMPLETED WITHOUT ANY PROBLEM. TWO CARTRIDGES WHICH WERE USED AT THE 2ND AND THE 3RD FIRING WILL BE RETURNED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOAD-ECR60B