BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PWRD ECH FLEX 60MM

    MDR report key: 2982367 · Received February 28, 2013

    Report

    Report Number
    3005075853-2013-00902
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 6, 2013
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4); DAMAGED CARTRIDGE, DAMAGED DRIVERS, DAMAGED ONE PIECE SLED; PHOTOGRAPHS THE DEVICE WA RECEIVED WITH THE BATTERY PACK THAT WAS DRAINED. THE BATTERY PACK HAS A DRAIN FEATURE THAT DRAINS THE PACK WITHIN 24 HOURS OF THE PROCEDURE; THEREFORE TESTING CANNOT BE COMPLETED ON THE ORIGINAL BATTERY USED IN THE PROCEDURE. AS A RESULT, PRODUCT INQUIRIES ARE TESTED WITH NON-DRAINING PACKS/SIMULATORS. CARTRIDGE BODY, ONE PIECE SLED AND DRIVERS WERE FOUND DAMAGED. THE ANALYSIS FOUND THAT ONE DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH A RELOAD LOADED IN THE DEVICE. THE RELOAD WAS NOTED ON THE RIGHT SIDE FULLY FIRED AND THE LEFT SIDE HAVE THE TWO INNER ROWS PARTIALLY FIRED. UPON EVALUATION OF THE RELOAD, THE CARTRIDGE BODY, SOME DRIVERS AND ONE PIECE SLED WERE NOTED TO BE DAMAGED. 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 MANUFACTURING RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE FOUND DURING THE MANUFACTURING PROCESS. AN INTRA OPERATIVE PHOTOGRAPH WAS RETURNED. BASED ON THE STAPLE FORMATION OBSERVED IN THE PHOTOGRAPHS, THE INNER TWO STAPLE ROWS ON THE PATIENT SIDE APPEAR AS IF THEY WERE PARTIALLY DEPLOYED. PARTIAL STAPLE DEPLOYMENT, WHILE ACHIEVING A COMPLETE CUT LINE MAY OCCUR IF THE STAPLE DRIVERS ARE IN SOME WAY RESTRICTED FROM ADVANCING UP WARD 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 MADE WITH THE ANVIL. SINCE THESE STAPLES APPEAR TO BE COMPLETELY UNFORMED DEPLOYMENT WAS MINIMAL IF ANY. THE ACTUAL STAPLE DEPLOYMENT IN THIS CASE WAS PROBABLY THE RESULT STAPLE TIPS STICKING INTO THE BUTTRESSING MATERIAL AND THE BUTTRESSING PULLING OUT THE STAPLES DURING DEVICE REMOVAL.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: THE SURGEON WAS USING OUR POWERED 60 ECHELON ON A SLEEVE GASTRECTOMY. HIS FIRST FIRING WAS A BLACK CARTRIDGE. SECOND FIRING WAS A BLACK AS WELL. ON THE SECOND FIRING HE NOTICED NO STAPLE FORMATION ON THE SLEEVE SIDE. THE ONLY STAPLES THAT FORMED WERE ON THE STOMACH SIDE. SURGEON COMMUNICATED THAT THE SLEEVE SIDE APPEARED TO ONLY FIRE ONE LINE OF STAPLES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY PROCEDURE, THE SURGEON COMPLETED FIRST FIRING WITH A BLACK RELOAD. THE POWERED ECHELON WAS RELOADED AND ON THE SECOND FIRING THERE WAS A MISFIRE (IT WAS HALF FIRED), THE SECOND FIRING STAPLES APPEARED TO ONLY BE ON THE SLEEVE SIDE AND UNFORMED STAPLES ON THE STOMACH SIDE. THEY CALLED FOR ANOTHER POWERED ECHELON, BUT THE CORE BROUGHT THE SURGEON A FLEX 60 ARTICULATING LONG AND THEY CHANGED TO GREEN RELOADS TO COMPLETE THE CASE. THERE WERE NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85882 PWRD ECH FLEX 60MM STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA K4C154

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOAD-ECR60T