BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON 45 ENDOPATH STAPLER

    MDR report key: 2833796 · Received November 15, 2012

    Report

    Report Number
    3005075853-2012-05166
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    October 19, 2012
    Report Date
    October 24, 2012
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    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.ADDITIONAL INFORMATION HAS BEEN REQUESTED; NO RESPONSE HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE AFFILIATE THAT DURING A LUNG BIOPSY PROCEDURE, THE STAPLER DID NOT FIRE, WAS THE SECOND FIRING WITH A GOLD RELOAD. IT WAS USED IN THE LUNG. THE SURGEON DOES NOT USED REINFORCING MATERIAL, NO STAPLES CROSSED ANOTHER LINE, AND I DID NOT HEAR ANY UNEXPECTED NOISE. THE SURGEON HAD TO CONVERT TO OPEN AND USE A NTLC. ONE DEVICE WAS DISCARDED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON 45 ENDOPATH STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK J4C73K

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention