BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX45 ARTICULATING

    MDR report key: 2142626 · Received June 28, 2011

    Report

    Report Number
    3005075853-2011-02657
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 7, 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
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A MINIMALLY INVASIVE ESOPHAGECTOMY (MIE) PROCEDURE, THE SURGEON FIRED FOUR RELOADS ON THE STOMACH , IT WAS FOUND ONLY THE FIRST RELOAD AND LAST RELOAD WERE FORMED WELL, BUT THE SECOND AND THIRD RELOAD DID NOT. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON*FLEX45 ARTICULATING STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4), LOT#- H4317V