BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON 60 ENDOPATH STAPLER

    MDR report key: 1080447 · Received July 24, 2008

    Report

    Report Number
    3005075853-2008-00406
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    May 24, 2008
    Report Date
    June 18, 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
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    H4, 6: INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTROPLASTY, THE DEVICE CUT ONLY A FEW CENTIMETERS AND DID NOT STAPLE. THE DEVICE WAS RELOADED AND FIRED AGAIN. THE DEVICE AGAIN CUT ONLY A FEW CENTIMETERS AND DID NOT STAPLE. ANOTHER SAME LIKE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS NO PT CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON 60 ENDOPATH STAPLER NONE GDW ETHICON ENDO-SURGERY, LLC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1