BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON 60

    MDR report key: 2030964 · Received March 28, 2011

    Report

    Report Number
    3005075853-2011-01202
    Event Type
    Malfunction
    Date Received
    March 28, 2011
    Date of Event
    February 21, 2011
    Report Date
    February 23, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    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 SC45A DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH ONE ECR45W CARTRIDGE RELOAD LOADED IN THE DEVICE. THE CARTRIDGE RELOAD WAS 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. IT SHOULD BE NOTED THAT ALL DEVICES ARE INSPECTED 100% FOR STAPLE PRESENCE BY AN AUTOMATED VISION SYSTEM, AND ARE VISUALLY INSPECTED 100% AS A FINAL CHECK. IN ADDITION, AT FINISHED GOODS THE DEVICES ARE VISUALLY INSPECTED BASED ON A SAMPLE. 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 LAPAROSCOPIC LOBECTOMY PROCEDURE, THE DEVICE WAS FIRED ON THE PULMONARY VEIN AT THE FOURTH FIRING. THE SURGEON CAREFULLY TOOK THE TARGET TISSUE INTO THE JAW TO AVOID CLAMPING THE TISSUE TOO MUCH. THE TARGET TISSUE WAS CLAMPED WITH THE PROXIMAL PART (2/3) OF THE JAW AND FIRED. AFTER THE FIRING, A PART OF THE CUTTING EDGE OPENED AND BLEEDING OCCURRED FROM THE SITE. THE AMOUNT OF THE BLEEDING WAS 50CC. "ASTRICTION" WAS PERFORMED AND THE SITE WAS LIGATURED TO STOP THE BLEEDING. THE DEPLOYED STAPLES SEEMED TO BE B-FORMED SHAPE. REINFORCEMENT MATERIAL WAS NOT USED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON 60 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK G4U39F

    Patients

    Seq Age Sex Outcome Treatment
    1 ECR45W