BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLUE RELOAD FOR ECHELON 60

    MDR report key: 1822367 · Received August 16, 2007

    Report

    Report Number
    1527736-2007-05435
    Event Type
    Malfunction
    Date Received
    August 16, 2007
    Date of Event
    August 6, 2007
    Report Date
    August 6, 2007
    Manufacturer
    ETHICON ENDO SURGERY, INC (CINCINNATI)
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE THE DEVICE DID NOT FIRE. ANOTHER CARTRIDGE WAS FIRED AND STAPLED, BUT THE STAPLES WERE NOT FORMED PROPERLY. SINCE THE CARTRIDGE STUCK ON THE SKIN,SOME BLEEDING OCCURRED. ANOTHER RELOAD WAS USED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLUE RELOAD FOR ECHELON 60 GDW ETHICON ENDO SURGERY, INC (CINCINNATI) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1