BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60

    MDR report key: 2081585 · Received May 9, 2011

    Report

    Report Number
    3005075853-2011-01851
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Date of Event
    April 12, 2011
    Report Date
    April 13, 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). THE SC60A DEVICE WAS RECEIVED FOR ANALYSIS WITH NO VISUAL NON-CONFORMANCES AND WITH A CARTRIDGE RELOAD PRESENT. THE CARTRIDGE RELOAD WAS RECEIVED PARTIALLY FIRED. THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE ARTICULATED POSITION USING 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. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN OPEN TOTAL ORGAN REMOVAL IN THE PELVIS PROCEDURE, AFTER THE DEVICE CUT THE RECTUM AT THE FIRST FIRING, SOME DEPLOYED STAPLES WERE MALFORMED OR LUMRICOID-FORMED. ADDITIONAL SUTURE WAS PERFORMED AND ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE SALES REP WHO ATTENDED THE OPERATION EXPLAINED TO KEEP CLAMPING THE TARGET TISSUE ABOUT FIFTEEN SECONDS AND THEN FIRE SLOWLY. THE DOCTOR COMMENTED THAT THE JAW WAS NOT CLAMPED ANY CLIPS AND THE FORCE OF GRASPING THE FIRING TRIGGER WAS AS USUAL. THE DEVICE DID NOT USE ON THE ORAL SIDE OF THE TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON*FLEX60 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK H4355L

    Patients

    Seq Age Sex Outcome Treatment
    1 ECR60D