BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON CUTTER RELOAD

    MDR report key: 3914008 · Received July 3, 2014

    Report

    Report Number
    3005075853-2014-04655
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 12, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WHAT DEVICE WERE THEY USING TO FIRE THE CARTRIDGES? DID THE DEVICE CUT COMPLETELY? DID THE DEVICE LOCK OUT AND CREATE A PARTIAL FIRE? WERE THE STAPLES FORMED IN THE PROPER B FORM SHAPE? AT WHAT FIRING DID THE ISSUE OCCUR? WAS BUTTRESSING USED IN THE PROCEDURE? WERE THERE ANY UNUSUAL NOISES HEARD? WAS THE DEVICE DIFFICULT TO CLOSE OR OPEN? WAS THE DEVICE DIFFICULT TO OPEN AND REMOVE FROM THE TISSUE? RESPONSE FROM THE SALES REP: DEVICE BEING USED WAS PLE60A. DEVICE CUT COMPLETELY. DEVICE DID NOT LOCK OUT. FIRST HALF OF STAPLES FORMED PROPER B, SECOND HALF DID NOT FORM B. 1ST FIRING NO BUTTRESSING MATERIAL USED. NO UNUSUAL NOISES. NO DIFFICULTY CLOSING OR OPENING. THE ANALYSIS RESULTS SHOWED THAT A ECR60G CARTRIDGE RELOAD WAS RECEIVED. CARTRIDGE: ECR60G, L51L2T, WAS RECEIVED FULLY FIRED AND IN GOOD VISUAL CONDITION. IN ADDITION THE RETURNED RELOAD WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS AND NO ANOMALIES WERE NOTED; NO DAMAGE ON DECK WAS FOUND. NO FUNCTIONAL TEST COULD BE PERFORMED DUE TO THE CONDITION OF THE RELOAD. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON TRIED TO FIRE A LINEAR CUTTER RELOAD AND THE STAPLE LINE WAS NOT FULLY COMPLETED. IT WAS NOT REPORTED THAT THE STAPLER WAS LOCKED OUT OR THAT THE REVERSE FUNCTION WAS USED, ONLY THAT THE STAPLE LINE WAS NOT FULLY COMPLETED. AN ADDITONAL RELOAD WERE OPENED AND THE CASE WAS COMPLETED NORMALLY. THE SURGEON CHECKED THE STAPLE LINE FOR LEAKS PRIOR TO FINSHING. NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391143 ECHELON CUTTER RELOAD STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1