BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON LINEAR CUTTER

    MDR report key: 3790092 · Received May 5, 2014

    Report

    Report Number
    3005075853-2014-03030
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    April 9, 2014
    Report Date
    April 10, 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). 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: F/U RESPONSE: WAS THE POST-OPERATIVE CARE FOR THE PATIENT CHANGED AS A RESULT OF THE EVENT? POST OP CARE NOT CHANGED DID THE CHUNK FROM THE CARTRIDGE FALL INTO THE PATIENT? IF YES, WAS THE PIECE RETRIEVED? IT WAS ONLY REPORTED THAT THERE WAS A VERY SMALL PART MISSING. SURGICAL SITE WAS IRRIGATED EXTENSIVELY & THOROUGHLY CHECKED AFTER REPAIR. PHOTOGRAPH ANALYSIS: BASED ON THE LACK OF STAPLES VISIBLE AND OBSERVED IN THE PHOTOGRAPHS PROVIDED, THE THREE STAPLE ROWS ON THE PATIENT SIDE APPEAR AS IF SOME WERE NOT DEPLOYED AT ALL AND SOME WERE PARTIALLY DEPLOYED. PARTIAL OR NO STAPLE DEPLOYMENT, WHILE ACHIEVING A COMPLETE CUT, MAY OCCUR IF THE STAPLE DRIVERS ARE IN SOME WAY RESTRICTED FROM ADVANCING UPWARD AND BEYOND THE STAPLE CARTRIDGE DECK. WHEN PARTIAL DEPLOYMENT OCCURS, THE STAPLE FORM WILL VARY DEPENDING ON HOW FAR THE STAPLES GET ADVANCED AND HOW MUCH CONTACT THE STAPLES MAKE WITH THE ANVIL. SINCE THESE STAPLES APPEAR TO BE COMPLETELY UNFORMED DEPLOYMENT WAS MINIMAL IF ANY. BASED ON THE PHOTOGRAPHIC EVIDENCE, THE BELIEF IS THAT THE THREE ROWS OF STAPLES, SECOND FIRING, ON THE PATIENT SIDE DID NOT PROPERLY DEPLOY AND SUPPORTS THE COMPLICATION DESCRIBED IN THE EVENT DESCRIPTION. HOWEVER, THE PHOTOGRAPHS DO NOT PROVIDE EVIDENCE RELATIVE TO WHAT MAY HAVE CAUSED THE INCOMPLETE STAPLE DEPLOYMENT. HANDS ON ANALYSIS OF THE RETURNING STAPLE CARTRIDGE MAY CONFIRM THE CAUSE OF THIS COMPLICATION.

    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 1/2, TWO INNER ROWS PARTIALLY FIRED 1/16. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY PROCEDURE, ON THE SECOND FIRE WITH A GREEN RELOAD AND SEAMGUARD THE STAPLES WERE NOT COMPLETE ON THE PATIENT SIDE. THE SURGEON WAITED APPROXIMATELY FORTY SECONDS BEFORE FIRING. THE SPECIMEN SIDE FIRED AS USUAL. ON THE PATIENT SIDE, ONLY THE PROXIMAL 10MM HAD DEPLOYED STAPLES WITH THE REMAINING DISTAL 50MM CUT WITH NO STAPLES DEPLOYED. THE DEVICE WAS ARTICULATED AT THE TIME OF FIRING. THERE WERE SOME STRAIGHT LEGGED STAPLES ON THE PATIENT SIDE JUST BEFORE THERE WERE ZERO STAPLES. NO ABNORMAL NOISES WERE HEARD. AS USUAL, THE MOTOR SLOWED DOWN AS IT PROGRESSED IN THE FIRING CYCLE. THE SURGEON REPORTED SEEING A SMALL 'CHUNK' OF THE RELOAD MISSING. THE SURGEON CLOSED THE 50MM GASTRONOMY WITH A TWO LAYER SILK HAND SEWED OVER SEW. A SECOND GUN AND RELOAD WERE OPEN TO COMPLETE THE CASE. THE SURGEON HAND SEWED THE GASTRONOMY AND IT TOOK AN ADDITIONAL ONE HOUR TO FIX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267393 ECHELON LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOAD-ECR60G