BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON LINEAR CUTTER

    MDR report key: 4090322 · Received September 15, 2014

    Report

    Report Number
    3005075853-2014-06426
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Date of Event
    August 29, 2014
    Report Date
    August 29, 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
    NV, 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 FOUR ECR60G CARTRIDGE RELOADS PRESENT. CARTRIDGE (B) ECR60G, K5E70K WAS RECEIVED WITH THE LEFT SIDE FULLY FIRED AND THE RIGHT SIDE OUTER ROW FULLY FIRED, LEFT TWO INNER ROWS PARTIALLY FIRED 1/4. IN ADDITION, THE CARTRIDGE PAN WAS NOTED TO BE PARTIALLY DETACHED. 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. CARTRIDGE (C, D, E) ECR60G, K5E70K, WERE RECEIVED INSIDE THEIR STERILE PACKAGE AND IN GOOD VISUAL CONDITIONS. AS ADDITIONAL TESTING, THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE STRAIGHT POSITION WITH A TEST CARTRIDGE RELOAD AND RETURNED RELOADS; IT 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. ONCE THE DEVICE COMPLETED THE FIRING SEQUENCE THE KNIFE RETURNED HOME AUTOMATICALLY AS INTENDED. THE KNIFE REVERSE BUTTON WORKED PROPERLY DURING TESTING. EVENT COULD NOT BE CONFIRMED AS THE DEVICE CLOSED AND OPENED WITHOUT ANY DIFFICULTIES NOTED. THE ARTICULATION ISSUE COULD NOT BE CONFIRMED AS THE DEVICE WAS ARTICULATED AND DE-ARTICULATED AS INTENDED. IT SHOULD BE NOTED THAT TO DE-ARTICULATE THE DEVICE THE ANVIL NEEDS TO BE IN THE OPEN POSITION. THE MANUAL OVERRIDE WORKED AS INTENDED. INTRA-OPERATIVE PHOTOS WERE RECEIVED. BASED ON THE PHOTOGRAPHIC EVIDENCE OF THE SUBJECT PLE60A DEVICE FIRING OF AN ECR60G CARTRIDGE, UNFORMED STAPLES CAN BE CONFIRMED, HOWEVER THE PHOTOGRAPHS DO NOT PROVIDE EVIDENCE RELATIVE TO WHAT MAY HAVE CAUSED THE ISSUE.

    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 OBTAINED: AN INTRA-OPERATIVE PHOTO WAS RECEIVED- BASED ON THE PHOTOGRAPHIC EVIDENCE OF THE SUBJECT PLE60A DEVICE FIRING OF AN ECR60G CARTRIDGE, UNFORMED STAPLES CANNOT BE CONFIRMED NOR DO THE PHOTOGRAPHS PROVIDE EVIDENCE RELATIVE TO WHAT MAY HAVE CAUSED THE ISSUE. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: HOW MUCH BLOOD WAS LOST (ML)? DID THE PATIENT REQUIRE A TRANSFUSION? I NEED TO MAKE A CORRECTION ON THE GREEN CRTG (3RD STAPLER) ISSUE ¿ IT WAS THE 2ND FIRING, NOT THE 3RD. ADDITIONAL INFORMATION: BLOOD LOSS WAS MINIMAL, NO TRANSFUSION REQUIRED AND AS OF POST-OP DAY 7, PATIENT WAS DOING FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A GASTRIC SLEEVE PROCEDURE, IN THE FIRST FIRING THE SURGEON WENT TO FIRE THE POWERED ECHELON STAPLER WITH A BLACK LOAD WITH SEAM GUARD AND NOTHING HAPPENING. TRIED TO REVERSE THE BLADE, BUT NOTHING HAPPENED, NO SOUND. HE POPPED THE MANUAL OVERRIDE AND TRIED TO RATCHET THE BLADE, BUT NOTHING HAPPENED. UPON SEVERAL ATTEMPTS, THE SURGEON HAD DIFFICULTY OPENING THE JAWS. IT TOOK SEVERAL ATTEMPTS TO DEARTICULATE THE DEVICE, WHICH CAUSED FRUSTRATION IN TRYING TO REMOVE THE DEVICE FROM THE TROCAR. OPENED A SECOND DEVICE, SAME LOT #, SAME ISSUE WITH 0 FEEDBACK AND WOULD NOT FIRE. THIS TIME WAS ABLE TO REMOVE DEVICE MORE EASILY. IT SEEMED TO BE BATTERY ISSUES, NO DEVICE FEEDBACK, AS THE SECOND DEVICE WOULD NOT FIRE ON THE BACK TABLE. OPENED A THIRD STAPLER, FROM DIFFERENT LOT # FOR THE THIRD FIRING WITH A GREEN LOAD WITH SEAM GUARD THIS WAS A THICK TISSUE FIRING. THE STAPLES DID NOT HIT THE POCKETS ON THE SPECIMEN SIDE. THE SURGEON COMMENTED THAT THE CLICK SOUNDED OFF, AND HE FELT THAT IT WAS NOT RIGHT. THE STAPLES ON THE SPECIMEN SIDE WERE STRAIGHT, AND THE PATIENT SIDE SEEMED TO FORM AS INTENDED OPENED A FOURTH DEVICE WITH DIFFERENT LOT # AND USED A GREEN CARTRIDGE WITHOUT SEAM GUARD AND FROM DIFFERENT LOT # THAN PREVIOUSLY USED FOR THE REMAINDER OF FIRINGS. THERE WAS SOME OOZING ALONG THE STAPLE LINE, BUT THE DEVICE PERFORMED AS INTENDED. THE SURGEON OVER SEWED THE ENTIRE LINE WITH A 2-0 VICRYL SH TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568130 ECHELON LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA L4EF025

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOAD-ECR60T & ECR60G