BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PWRD ECH FLEX 60MM 34CM SHAFT

    MDR report key: 3892394 · Received June 24, 2014

    Report

    Report Number
    3005075853-2014-04335
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    May 19, 2014
    Report Date
    May 22, 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
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION REQUESTED AND THE FOLLOWING OBTAINED: DID THE DEVICE DELIVER ANY STAPLES? YES. IF YES, WERE THE STAPLES FORMED PROPERLY? NOT ALL, THE FIRST PART SEEMED OK, BUT AT THE POINT WHERE THE DEVICE WAS BLOCKED THE STAPLES WERE NOT FORMED CORRECTLY. IF YES, WAS THE STAPLE LINE COMPLETE? NO. DID THE DEVICE CUT? YES, UP TO THE POINT WHERE IT JAMMED. IF YES, WAS THE CUT LINE COMPLETE? NO. ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 12TH, ETC.)? 2ND OR 3RD (COULD NOT RECALL EXACTLY), DEFINITELY NOT FIRST. WHAT COLOR CARTRIDGE WAS BEING USED? GREEN. WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? GREEN. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? YES, NEAR STAPLE LINE OF THE FIRST FIRING. WERE ANY UNEXPECTED NOISES HEARD? IF SO, WHEN? YES, THE DEVICE JAMMED AND IT SOUNDED LIKE THE DEVICE WAS STRUGGLING TO GET THROUGH THE TISSUE. THE ANALYSIS FOUND THAT ONE PSE60A DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH NO CARTRIDGE LOADED ON THE DEVICE. IN ADDITION, THE BAILOUT DOOR WAS OUT OF POSITION AND THE LEVER WAS DOWN. IF THE MANUAL OVERRIDE DOOR IS REMOVED THE DEVICE IS DISABLED AND CANNOT BE USED FOR ANY SUBSEQUENCE FIRINGS UNTIL THE DOOR IS INSTALLED. A TEST BAILOUT DOOR WAS PROPERLY INSTALLED AND 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. EVENT COULD NOT BE CONFIRMED AS THE DEVICE CLOSED AND OPENED WITHOUT ANY DIFFICULTIES NOTED. THE MANUFACTURING RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ESOPHAGUS RESECTION, WHILE CREATING THE GASTRIC TUBE, ON PROBABLY THE THIRD FIRING WITH GOLD CARTRIDGE, AFTER THE FIRST OR SECOND CM OF STAPLING, TISSUE WAS PUSHED FORWARD IN THE STAPLER, LEADING TO A HEAP OF STAPLES ON A SHORT STRETCH OF CUT GASTRIC WALL (APPROX 1CM). A NEW STAPLER WAS USED FOR THE NEXT STEP (WITH NORMAL FIRING /UNEVENTFUL) THEN ON THE FIFTH STEP THE SAME THING HAPPENED. AN ECHELON FLEX WAS USED FOR THE FINAL STEPS, THE FIRST OF WHICH SEEMED TO SHOW A SIMILAR EFFECT, THOUGH TO A MUCH LESSER EXTEND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367999 PWRD ECH FLEX 60MM 34CM SHAFT STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK L4EF28

    Patients

    Seq Age Sex Outcome Treatment
    1 RELAOD CR60D