BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON LINEAR CUTTER

    MDR report key: 3913302 · Received July 3, 2014

    Report

    Report Number
    3005075853-2014-04640
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 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
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DAMAGED ANVIL. ADDITIONAL INFORMATION: WAS THERE ANY PATIENT CONSEQUENCE? THE PATIENT HAD TO HAVE THE STAPLE LINE RE-DONE PROXIMAL TO THE INITIAL LINE, AND THE STAPLE LINE WITH PIECE OF CARTRIDGE SLED REMOVED. WAS THE PROCEDURE OR POST-OP CARE ALTERED FOR THE PATIENT? NO ANSWER. WAS THIS THE FIRST FIRING OF THE DEVICE? IT WAS NOT THE FIRST FIRING, FOR ALL SUBSEQUENT FIRINGS ANOTHER PSEA60 WAS USED. WAS THE CARTRIDGE SEATED PROPERLY IN THE DEVICE PRIOR TO FIRING? THE CARTRIDGE WAS SEATED PROPERLY. WAS THERE ANY TISSUE DAMAGE FROM REMOVING THE STAPLES AND THE CARTRIDGE SLED? IF SO PLEASE EXPLAIN. SEE ANSWER #1. DID THE DEVICE CUT? WERE ANY OF THE STAPLES FORMED? THE DEVICE DID CUT AND MOST OF THE STAPLES WERE FORMED, ALTHOUGH THE STAPLE LINE BLED MORE THAN USUAL, SO THEY MAY NOT HAVE BEEN FULLY FORMED. THE ANALYSIS RESULTS FOUND THAT ONE PSE60A DEVICE WAS RETURNED WITH THE ANVIL BENT UPWARDS AND WITH AN ECR60T CARTRIDGE (A) LOADED ON THE DEVICE. THE RETURNED CARTRIDGE RELOAD (A) WAS RECEIVED UNFIRED AND IN GOOD VISUAL CONDITION. FURTHERMORE, CARTRIDGE (B) ECR60T, L52M5T WAS RECEIVED FULLY FIRED AND IN GOOD VISUAL CONDITION. IN ORDER TO VERIFY THE CONDITION OF INTERNAL COMPONENTS THE RELOADS (A, B) WERE DISASSEMBLED AND NO MISSING DRIVERS WERE NOTED; BOTH ONE PIECE SLEDS WERE PRESENT AND IN GOOD VISUAL CONDITION. IN ADDITION THE MANUAL OVERRIDE DOOR WAS OUT OF POSITION; 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. THE DEVICE WAS DISASSEMBLED TO RESET THE BAILOUT SYSTEM. THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE STRAIGHT POSITION WITH A TEST CARTRIDGE RELOAD HOWEVER THE KNIFE WAS JAMMED. FURTHER ANALYSIS FOUND THAT TWO STAPLES WERE IN THE KNIFE PATH JAMMING THE KNIFE; UPON REMOVAL OF THE STAPLES THE DEVICE 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. HOWEVER, IT IS KNOWN FROM THE HISTORY OF THE DEVICE THAT THE FOUND CONDITION OF THE ANVIL MAY LEAD THAT THE MOST DISTAL STAPLES NOT TO FORM PROPERLY. IT IS POSSIBLE THAT THE DEVICE WAS CLAMPED OVER AN EXCESS OF TISSUE CAUSING THE ANVIL TO BEND AND FOR THE FIRING STROKE AND THE STAPLE FORM TO BE INCOMPLETE. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SURGICAL TECHNICIAN THAT, DURING A SLEEVE GASTRECTOMY, THE BLACK CARTRIDGE FELL APART DURING THE FIRING AND PART OF THE CARTRIDGE SLED WAS IMPLANTED ON THE STOMACH TISSUE WITH THE STAPLES. THE SURGEON CREATED A NEW STAPLE LINE PROXIMAL TO THE AREA WHERE THIS OCCURRED, AND THE STOMACH TISSUE WITH THE STAPLES/CARTRIDGE SLED WERE SAVED FOR RETURN AND ANALYSIS. AT THIS TIME, IT IS UNKNOWN WHETHER THERE ARE ANY ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390237 ECHELON LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOAD - ECR60T