BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH THOR ENDO LIN CUT THK

    MDR report key: 1080394 · Received July 24, 2008

    Report

    Report Number
    3005075853-2008-00385
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    June 9, 2008
    Report Date
    June 17, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 07/10/2008. INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A VATS THE DEVICE WAS CLAMPED ON THE LUNG AND FIRED. THE DEVICE CUT, BUT THE STAPLES DID NOT CLOSE. THE DEVICE MADE A POPPING SOUND UPON FIRING. THIS OCCURRED ON THE FIRST FIRING AND NO BUTTRESSING MATERIAL WAS USED. THERE WAS EXCESSIVE BLEEDING THAT THE SURGEON HAD NOT EXPECTED AFTER THE FIRING. ANOTHER STAPLER WAS USED TO COMPLETE THE CASE. THE PT WAS FINE AND DID NOT REQUIRE ANY BLOOD PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH THOR ENDO LIN CUT THK NONE GDW ETHICON ENDO-SURGERY, LLC NA E4K72Y

    Patients

    Seq Age Sex Outcome Treatment
    1