BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON LINEAR CUTTER

    MDR report key: 4641157 · Received March 30, 2015

    Report

    Report Number
    3005075853-2015-02006
    Event Type
    Malfunction
    Date Received
    March 30, 2015
    Date of Event
    March 12, 2015
    Report Date
    March 17, 2015
    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
    SZ
    Reporter Occupation
    OTHER

    Narratives

    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 Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE ANALYSIS FOUND THAT ONE PSE60A DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH THE MANUAL OVERRIDE DOOR OUT OF POSITION AND MISSING; THE OVERRIDE LEVER WAS UP WHICH DENOTES THAT THE KNIFE WAS MANUALLY RETURNED TO HOME POSITION. IT SHOULD BE NOTED AFTER THE MANUAL OVERRIDE SYSTEM IS USED THE INSTRUMENT IS DISABLED AND CANNOT BE USED FOR ANY SUBSEQUENCE FIRINGS. THREE ECR60D CARTRIDGE RELOADS WERE RECEIVED FOR ANALYSIS. CARTRIDGE (C) ECR60D, L5578A WAS RECEIVED UNFIRED AND IN GOOD VISUAL CONDITIONS. CARTRIDGE (D) ECR60D, L5578A WAS RECEIVED PARTIALLY FIRED 1/16 AND IN GOOD VISUAL CONDITIONS. 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. CARTRIDGE (E) ECR60D, L5578A WAS LEFT SIDE FULLY FIRED, RIGHT SIDE PARTIALLY FIRED 1/3. 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. AS ADDITIONAL TESTING, THE BAILOUT SYSTEM WAS RESET AND THEN 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. ONCE THE DEVICE COMPLETED THE FIRING SEQUENCE THE KNIFE RETURNED HOME AUTOMATICALLY AS INTENDED. THE KNIFE REVERSE BUTTON FORCE WORKED PROPERLY DURING TESTING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SLEEVE GASTRECTOMY PROCEDURE, THE SURGEON PLACED THE DEVICE ON THE TISSUE AND WAS ABLE TO FIRE A GREEN AND GOLD RELOAD. UPON PLACING THE STAPLER WITH A SECOND GOLD RELOAD ON THE TISSUE, ACTIVATION TOOK PLACE, BUT ALMOST IMMEDIATELY STOPPED AGAIN. THE SURGEON TRIED TO USE THE KNIFE-REVERSE-SWITCH WHICH DID NOT RESPOND AND EVENTUALLY ACTIVATED THE MANUAL OVERRIDE. HE NOTICED THAT THE PATIENT-SIDE OF THE TISSUE WAS STAPLED PROPERLY, BUT THAT THE OPPOSITE SITE (RESECTED TISSUE SIDE) WAS NOT STAPLED. HE SUTURED THE DEFECT. THE PROCEDURE COMPLETED WITH A COMPETITOR'S DEVICE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209961 ECHELON LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA M9081X

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOAD - ECR60D, ECR60G