BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON 60

    MDR report key: 2153076 · Received July 7, 2011

    Report

    Report Number
    3005075853-2011-02790
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Report Date
    April 20, 2011
    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
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): SHROUD. THE ANALYSIS RESULTS FOUND THAT ONE EC60 DEVICE WAS RETURNED WITH THE HANDLES OPEN AND WITHOUT A RELOAD PRESENT. NO FUNCTIONAL TEST COULD BE PERFORMED DUE TO THE CONDITION OF THE DEVICE. WHILE NO CONCLUSION COULD BE REACHED AS TO HOW THE SHROUDS 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP SIGMA PROCEDURE, THE DEVICE DID NOT FIRE AT ALL. NO FURTHER INFORMATION IS AVAILABLE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON 60 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK E4L94

    Patients

    Seq Age Sex Outcome Treatment
    1