BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX45 LINEAR CUTTER

    MDR report key: 3781225 · Received April 30, 2014

    Report

    Report Number
    3005075853-2014-02945
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    March 6, 2014
    Report Date
    March 11, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - PREMATURE SLED MOVEMENT. ADDITIONAL INFORMATION: WAS THERE A REPORTED ISSUE WITH BOTH RELOADS? YES. CAN YOU PROVIDE MORE INFORMATION ABOUT WHAT STOPPED WORKING WITH EACH RELOAD? DID THE DEVICE FIRE? 1ST DEVICE FIRED CORRECTLY BUT IT GOT STUCK AFTER TWO FIRES AND THEN AFTER TAKING OUT THE RELOAD DEVICE WORKED PROPERLY FOR REST OF THE FIRINGS. WHAT WAS THE PRODUCT CODE AND LOT/BATCH NUMBER FOR THE STAPLER USED WITH THE ECR45B CARTRIDGES (EX, EC45, SC45, ETC)? EC45. ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 12TH, ETC.)? 3RD FIRING. DURING WHICH STROKE DID THE EVENT OCCUR? 2ND STROKE. WERE STAPLES DELIVERED? IF YES, WAS THE STAPLE LINE COMPLETE? WERE THE STAPLES FORMED PROPERLY? STAPLES WERE DELIVERED. STAPLE LINE WAS INCOMPLETE, STAPLES WERE NOT FORMED PROPERLY. DID THE DEVICE CUT? IF YES, WAS THE CUT LINE COMPLETE? YES DEVICE CUT BUT CUT LINE WAS NOT COMPLETE. WAS BUTTRESSING MATERIAL UTILIZED? IF SO, WHICH PRODUCT? NO. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? NO. WERE ANY UNEXPECTED NOISES HEARD? IF SO, WHEN? NO. WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)? NO. THE EC45A DEVICE WAS RECEIVED FOR ANALYSIS WITH THE JOINT COVER MISSING AND THE ROTATION KNOB WAS NOTED TO BE MELTED AS IF IT WAS EXPOSED TO HEAT, WITH AN ECR45W CARTRIDGE LOADED ON THE DEVICE. THE CARTRIDGE RELOAD WAS RECEIVED PARTIALLY FIRED 1/10. IT IS POSSIBLE THAT WHILE LOADING THE RELOAD, THE CARTRIDGE WAS PUSHED FARTHER BACK THAN THE CARTRIDGE ALIGNMENT STOP WINDOWS RESULTING IN THE KNIFE PUSHING THE ONE PIECE SLED FORWARD AND LOCKING THE CARTRIDGE. THE RETURNED DEVICE AND CARTRIDGE RELOAD WERE TESTED FOR FUNCTIONALITY IN THE ARTICULATED POSITION BY RESETTING AND RELOADING IT INTO THE DEVICE. THE DEVICE ACHIEVED ITS COMPLETE STROKE 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. NO INCIDENT RELATED TO THE REPORTED EVENT WAS OBSERVED DURING THE BATCH RECORD REVIEW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE ECHELON FLEX 45 WAS NOT WORKING AND STOPPED FUNCTIONING. NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259869 ECHELON*FLEX45 LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA K4CN71

    Patients

    Seq Age Sex Outcome Treatment
    1 EC45