BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON ENDO LINEAR CUTTER

    MDR report key: 6101580 · Received November 15, 2016

    Report

    Report Number
    3005075853-2016-06523
    Event Type
    Malfunction
    Date Received
    November 15, 2016
    Date of Event
    September 23, 2016
    Report Date
    September 29, 2016
    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
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # N53N8L. THE ANALYSIS RESULTS FOUND THAT ONE SC60 DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH TWO ECR60D CARTRIDGE RELOADS PRESENT. THE CARTRIDGES WERE RECEIVED PARTIALLY FIRED 1/3 CONSISTENT WITH AN INCOMPLETE OR INTERRUPTED CYCLE. THE DEVICE WAS NOTED TO HAVE THE FIRING MECHANISM DAMAGED. NO FUNCTIONAL TEST COULD BE PERFORMED DUE TO THE CONDITION OF THE DEVICE. THE DEVICE WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS AND THE FIRING SHUTTLE WAS FOUND DAMAGED, NOT ALLOWING THE FIRING MECHANISM TO PROPERLY FUNCTION. WHILE NO CONCLUSION COULD BE REACHED AS TO HOW THE FIRING SHUTTLE BECAME DAMAGED; IT SHOULD BE NOTED THAT A 100% INSPECTIONS TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRE SPECIFICATIONS PRIOR TO SHIPMENTS, IN ADDITION, A SAMPLE OF THE BATCH IS INSPECTED AT (B)(4). THE BATCH HISTORY RECORD WAS REVIEWED AND NO DEFECTS, NCR¿S OR PROTOCOLS RELATED TO THE COMPLAINT, WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A VIDEO-ASSISTED THORACOSCOPIC SURGERY (VATS) PROCEDURE, THE SURGEON FELT IT DIFFICULT TO SQUEEZE THE DEVICE ON THE FIRST FIRING WITH A GOLD RELOAD. ANOTHER GOLD RELOAD WAS RELOADED, BUT THE DEVICE STILL COULD NOT FIRE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755814 ECHELON ENDO LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA N90N50

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOAD ECR60D