BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60 LONG

    MDR report key: 1832357 · Received September 13, 2010

    Report

    Report Number
    3005075853-2010-05221
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    August 19, 2010
    Report Date
    August 20, 2010
    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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. WE DID NOT RECEIVE A BATCH OR LOT NUMBER FOR THE PRODUCT INVOLVED IN THIS COMPLAINT. THEREFORE, WE WERE UNABLE TO CHECK MANUFACTURING RECORDS FOR ANY RELATED NON-CONFORMANCES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS USED DURING A LAPAROSCOPIC GASTRIC BYPASS. THE STAPLE LINE IS BLEEDING MORE THAN USUAL. THE DEVICE WAS FIRED AS USUAL, HELD FOR FIFTEEN SECOND. THE FIRST COUPLE OF FIRINGS WERE GOOD. AT THE END, WHEN THE SCOPE WAS USED, THERE WAS SO MUCH BLOOD COULDN'T TELL WHERE IT WAS COMING FROM. AT THE DISTAL END, THE LAST STAPLE WAS NOT FORMED. THE STAPLE LINE WAS OVERSEWN AND THE CASE WAS COMPLETED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. THE DEVICE WAS DISCARDED. (B)(4)

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4)