BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60 LONG ARTICULATING ENDOSCOPIC LINEAR CUTTER, 60 MM

    MDR report key: 3060167 · Received April 16, 2013

    Report

    Report Number
    3005075853-2013-01824
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 25, 2013
    Report Date
    March 26, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K081146
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION ASKED FOR BUT UNKNOWN OR NOT PROVIDED DURING INITIAL CONTACT. SHOULD THE INFORMATION BE PROVIDED LATER, A SUPPLEMENTAL MEDWATCH WILL BE SENT. THE ANALYSIS FOUND THAT ONE DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH NO CARTRIDGE RELOAD LOADED ON THE DEVICE. THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE ARTICULATED 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. THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT WE WERE UNABLE TO DUPLICATE DURING OUR LABORATORY ANALYSIS. INTRA OPERATIVE PHOTOGRAPHS WERE RECEIVED. UPON REVIEW OF THE IMAGES, IT APPEARS THAT THE INNER TWO ROWS OF STAPLES, FIRST FIRING, ON PATIENT SIDE DID NOT PROPERLY DEPLOY AND SUPPORTS THE COMPLICATION DESCRIBED IN THE EVENT. HOWEVER THE PHOTOGRAPHS DID NOT PROVIDE EVIDENCE RELATIVE TO WHAT MAY HAVE CAUSED THE INCOMPLETE STAPLE DEPLOYMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY PROCEDURE, DURING THE FIRST APPLICATION ON THE STOMACH (FIRST APPLICATION OVERALL), USING A BLACK LOAD ON THE ANTRUM 2-4CM FROM THE PYLORUS/LESSER CURVE, SEVERAL OF THE STAPLES MISSED THE ANVIL COMPLETELY, AND DIDN'T FORM PROPERLY, PRIMARILY THE DISTAL THIRD OF THE STAPLE LINE. PRIOR TO FIRING, THE SURGEON HOLDS COMPRESSION ON THE TISSUE FOR THIRTY SECONDS, AND HESITATES FOR FIVE-TEN SECONDS BETWEEN SQUEEZES. THEN COMES BACK TO CLOSELY INSPECT THE STAPLE LINE. A TOTAL OF TWO BLACK RELOADS WERE USED AND ARE BEING RETURNED. THE AREA WAS OVER SEWN FOR REINFORCEMENT. THE SAME INSTRUMENT WAS USED TO COMPLETE THE CASE, AND ALL OTHER SIX FIRINGS/STAPLE LINES WERE NORMAL. THERE WERE NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162313 ECHELON*FLEX60 LONG ARTICULATING ENDOSCOPIC LINEAR CUTTER, 60 MM STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK J4CU7M

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOAD - (B)(4)