BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON 60 ENDOPATH STAPLER

    MDR report key: 1210242 · Received October 21, 2008

    Report

    Report Number
    3005075853-2008-02497
    Event Type
    Malfunction
    Date Received
    October 21, 2008
    Date of Event
    September 25, 2008
    Report Date
    October 1, 2008
    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
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 10/21/2008. INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A VATS PROCEDURE, THE DEVICE FULLY CUT AND PARTIALLY STAPLED WITH THE RELOAD. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THEY DID NOT HAVE TO CONVERT TO OPEN. THE PT WAS SCHEDULED TO GO HOME, BUT THE PT WAS STILL IN THE HOSP. IT WAS REPORTED THAT THE HOSP STAY WILL NOT BE EXTENDED. THERE WAS NO ADVERSE PT CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON 60 ENDOPATH STAPLER GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1