BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX45 COMPACT

    MDR report key: 2170515 · Received July 21, 2011

    Report

    Report Number
    3005075853-2011-02927
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 22, 2011
    Report Date
    June 24, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC LOBECTOMY PROCEDURE, THE DEVICE COULD BE FIRED PROPERLY AT THE 1ST FIRING. THE SURGEON CLOSED THE JAW AND HANDED THE DEVICE TO THE NURSE. WHEN THE NURSE PUSHED THE RELEASE BUTTON TO LOAD THE CARTRIDGE FOR THE SECOND FIRING, THE JAW COULD NOT BE OPENED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. THE CUSTOMER DISPOSED OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON*FLEX45 COMPACT STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK G4TG8C

    Patients

    Seq Age Sex Outcome Treatment
    1