BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON LINEAR CUTTER

    MDR report key: 4071891 · Received September 9, 2014

    Report

    Report Number
    3005075853-2014-06246
    Event Type
    Malfunction
    Date Received
    September 9, 2014
    Date of Event
    August 19, 2009
    Report Date
    August 25, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K110385
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: BASED ON THE PHOTOGRAPHIC EVIDENCE OF THE SUBJECT DEVICE FIRING OF AN ECR60B CARTRIDGE, THERE ARE NO STAPLES VISIBLE. THE PHOTOGRAPHS DO NOT PROVIDE EVIDENCE RELATIVE TO WHAT MAY HAVE CAUSED THE ISSUE. THE HANDS-ON ANALYSIS FOUND THAT ONE PLE60A DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH NO CARTRIDGE LOADED ON THE DEVICE. THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE STRAIGHT 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. HOWEVER, THE KNIFE WAS NOTED NICKED. ONE POSSIBLE CAUSE FOR THIS TYPE OF DAMAGE TO THE KNIFE IS WHEN THE DEVICE IS FIRED OVER AN ALREADY EXISTING STAPLE LINE, HARD OBJECT OR THICKER TISSUE THAN INDICATED. REPEATEDLY FIRING ACROSS EXISTING STAPLE LINES CAN ALSO REDUCE THE ABILITY TO CUT CLEANLY. TO MITIGATE THE POTENTIAL FOR STAPLES GETTING INTO THE CARTRIDGE AND INTERFERING WITH THE KNIFE PATH DURING DEVICE FIRING, PRIOR TO RELOADING THE DEVICE, RINSE THE ANVIL AND CARTRIDGE JAW IN STERILE SOLUTION AND THEN WIPE THE ANVIL AND CARTRIDGE JAW TO CLEAN ANY FORMED BUT UNUSED STAPLES FROM THE DEVICE. ADDITIONALLY, PROPER CARE SHOULD BE TAKEN WHEN PLACING THE DEVICE ON THE TISSUE TO BE STAPLED, TO ENSURE THAT NO HARD OBSTRUCTION SUCH AS A CLIP IS INCLUDED WITH THE TISSUE INSIDE THE JAWS. AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING MANUFACTURING TO ENSURE THAT THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WAS MET PRIOR TO THE RELEASE OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC SLEEVE PROCEDURE THE SURGEON FIRED THE DEVICE FOR THE THIRD FIRING WITH A BLUE RELOAD AND CONTINUED WITH THE FOURTH FIRING WITH ANOTHER BLUE RELOAD TO COMPLETE THAT PORTION OF THE PROCEDURE. THE SURGEON OBSERVED THE STAPLE LINES AND FOUND THAT THE THIRD STAPLE LINE HAD NO STAPLES ON THE PATIENT SIDE OF THE THIRD FIRING. THEY USED SUTURE AND OVER SEWED THAT AREA OF THE STAPLE LINE. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THEY DID NOT USE BUTTRESSING DURING THE PROCEDURE. THERE WAS NO ISSUE REMOVING THE DEVICE AFTER EACH FIRING AND NO UNUSUAL NOISES REPORTED. NO OTHER INFORMATION WAS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553607 ECHELON LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA L4EP8V

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOAD: ECR60B