BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON LINEAR CUTTER

    MDR report key: 3890045 · Received June 24, 2014

    Report

    Report Number
    3005075853-2014-04292
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    May 30, 2014
    Report Date
    May 30, 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
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE ANALYSIS FOUND THAT ONE PLE60A DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH AN ECR60G LOADED IN THE DEVICE. ADDITIONALLY, THE RELOAD WAS RECEIVED WITH THE LEFT SIDE FULLY FIRED, RIGHT SIDE OUTER ROW PARTIALLY FIRED 1/3 AND THE LEFT TWO INNER ROWS UNFIRED. UPON EVALUATION OF THE RELOAD, THE CARTRIDGE BODY, ONE PIECE SLED AND SOME DRIVERS WERE NOTED TO BE DAMAGED. NO OBVIOUS DAMAGE TO THE CARTRIDGE DECK WAS NOTED, WHICH SUGGESTS THE CARTRIDGE, MAY NOT HAVE BEEN FIRED OVER A HARD OBJECT. AS ADDITIONAL TESTING, 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. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. AT THE TIME OF THIS SUBMISSION, THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: IT WAS COMMUNICATED THAT THE SURGEON STATED THE TISSUE WAS OF NORMAL THICKNESS FOR THE RELOAD SIZE. BMI OF THE PATIENT UNKNOWN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SLEEVE GASTRECTOMY PROCEDURE THE SURGEON FIRED THE SECOND FIRING ACROSS THE STOMACH WITH A GREEN RELOAD, THE KNIFE BLADE CUT AND THE STAPLES FIRED ON THE REMNANT SIDE BUT NOT ON THE PATIENT SIDE. WHEN THE SURGEON OBSERVED THE STAPLE LINE THERE WAS BLEEDING AT THE SITE; THEY CONTROLLED THE BLEEDING BY USING A SECOND DEVICE WITH A GREEN RELOAD AND FIRING NEXT TO THE FIRST STAPLE LINE. WHEN THEY OBSERVED THAT FIRING THE DEVICE HAD FIRED A GOOD STAPLE LINE BUT THE SURGEON HAD TO SHORTEN THE SLEEVE. NO PATIENT CONSEQUENCE. PATIENT DID NOT REQUIRE BLOOD PRODUCTS. THE DEVICE IS RETURNING FOR ANALYSIS. THERE WAS NO OTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369140 ECHELON LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOAD: ECR60G