BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON LINEAR CUTTER

    MDR report key: 4222789 · Received November 4, 2014

    Report

    Report Number
    3005075853-2014-07579
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Date of Event
    October 14, 2014
    Report Date
    October 16, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: WAS THE BULLA BEING TRANSECTED WHEN THE BLEEDING OCCURRED? DID THE PATIENT HAVE PULMONARY HYPERTENSION? WHAT COLOR CARTRIDGE WAS BEING USED? WAS BUTTRESSING MATERIAL USED? WHAT WAS THE INTERVENTION USED ON PATIENT? WAS THE DEVICE DIFFICULT TO CLOSE OR FIRE? WAS THE DEVICE STRAIGHT OR ARTICULATED WHEN FIRED? WAS THE BLEEDING LOCAL TO ONE SIDE OF THE STAPLE LINE OR ALL? THE ANALYSIS RESULTS FOUND THAT THE 6TB45 DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH NO RELOAD PRESENT ON THE DEVICE. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD AND IT FIRED, CUT AND FORMED THE STAPLES AS INTENDED. THE DEVICE FIRED WITHOUT ANY DIFFICULTIES, THE STAPLE LINE WAS COMPLETE, THE CUT LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. EVENT COULD NOT BE CONFIRMED AS NO CARTRIDGE WAS RECEIVED FOR ANALYSIS. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WAS MET PRIOR TO THE RELEASE OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: UPON REVIEW OF THE INFORMATION PROVIDED, IT WAS CONCLUDED THAT THIS EVENT DOES NOT MEET THE FDA DEFINED CRITERIA FOR A REPORTABLE SERIOUS INJURY, AND HAS BEEN REVISED TO MALFUNCTION. ADDITIONAL INFORMATION REQUESTED AND RECEIVED: THE PATIENT DIDN¿T REQUIRE ANY BLOOD PRODUCTS AND THE SURGERY WAS COMPLETED IN LAPAROSCOPIC OPERATION. WAS THE BULLA BEING TRANSECTED WHEN THE BLEEDING OCCURRED? NO. AFTER THE BULLA WAS TRANSECTED, SLIGHT BLEEDING WAS FOUND AROUND THE STAPLE LINE. DID THE PATIENT HAVE PULMONARY HYPERTENSION? UNK. WHAT COLOR CARTRIDGE WAS BEING USED? BLUE. WAS BUTTRESSING MATERIAL USED? NO. WHAT WAS THE INTERVENTION USED ON PATIENT? 2 MORE RELOADS AND 1 EC60 WERE USED TO STOP THE BLEEDING ISSUE. WAS THE DEVICE DIFFICULT TO CLOSE OR FIRE? NO. WAS THE DEVICE STRAIGHT OR ARTICULATED WHEN FIRED? UNK. WAS THE BLEEDING LOCAL TO ONE SIDE OF THE STAPLE LINE OR ALL? UNK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PULMONARY BULLA RESECTION PROCEDURE, THE CUT LINE AND ¿B-FORMED¿ STAPLE LINE DEPLOYED ON THE TISSUE AFTER THE FIRST FIRING WITH RELOAD, BUT BLEEDING WAS FOUND. TWO MORE RELOADS WERE USED TO STOP THE BLEEDING BUT STILL HAD THE SAME ISSUE. THE PATIENT LOST ABOUT 400ML OF BLOOD TOTAL. IT WAS REPORTED THAT INTERVENTION WAS REQUIRED TO PREVENT PERMANENT IMPAIRMENT/DAMAGE. THE TYPE OF INTERVENTION IS UNKNOWN. THE SURGEON CHANGED TO ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE PATIENT IS NOW DOING FINE. THE THREE RELOADS HAVE BEEN DISCARDED, BUT ONE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707242 ECHELON LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA J4CL94

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention RELOAD - 6R45B