BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60 ARTICULATING

    MDR report key: 2122890 · Received June 14, 2011

    Report

    Report Number
    3005075853-2011-02402
    Event Type
    Malfunction
    Date Received
    June 14, 2011
    Date of Event
    May 12, 2011
    Report Date
    May 23, 2011
    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
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC SPLENECTOMY PROCEDURE, THE DEVICE LOCKED ON TISSUE. THE SURGEON WAS UNABLE TO OPEN THE JAWS. THEY PULLED THE DEVICE OFF THE TISSUE. THERE WAS SOME BLEEDING. THE AREA WAS SUTURED. NO IMPACT TO THE PATIENT REPORTED. THE DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON*FLEX60 ARTICULATING STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1