BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON LINEAR CUTTER

    MDR report key: 3865020 · Received June 10, 2014

    Report

    Report Number
    3005075853-2014-03917
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    April 24, 2014
    Report Date
    April 24, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K081146
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS; DAMAGED YOKE. THE ANALYSIS FOUND THAT ONE EC60A DEVICE WAS RETURNED WITH THE CLAMPING MECHANISM DAMAGED AND WITHOUT RELOAD PRESENT. NO FUNCTIONAL TEST WAS PERFORMED DUE THE CONDITION OF THE DEVICE. THE DEVICE WAS DISASSEMBLED TO VERIFY THE INTERNAL COMPONENTS AND THE YOKE WAS NOTED TO BE BROKEN. ALTHOUGH NO CONCLUSION COULD BE REACHED AS TO HOW THE YOKE BECAME BROKEN, THIS DAMAGE CAN OCCUR WHEN EXCESSIVE FORCE IS APPLIED TO THE CLOSING TRIGGER WHEN THE JAWS ARE CLAMPED OVER AN EXCESS OF TISSUE. IT SHOULD BE NOTED THAT A 100% INSPECTIONS TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRE SPECIFICATIONS; IN ADDITION, A SAMPLE OF THE BATCH IS INSPECTED AT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE WOULD NOT FIRE. A SECOND DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340767 ECHELON LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA L90L02

    Patients

    Seq Age Sex Outcome Treatment
    1