BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA 31MM SINGLE-USE STAPLER

    MDR report key: 4071283 · Received September 5, 2014

    Report

    Report Number
    2647580-2014-00748
    Event Type
    Injury
    Date Received
    September 5, 2014
    Date of Event
    August 11, 2014
    Report Date
    August 15, 2014
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO, INC.
    Product Code
    GDW
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LOW ANTERIOR RESECTION. ACCORDING TO THE REPORTER: THE SURGEON REMOVED THE SAFETY AND FIRED THE STAPLER BUT FELT SOMETHING STRANGE. HE REMOVED THE STAPLER AND DISCOVERED THAT IT HAD NOT CUT BUT HAD DEPLOYED STAPLES. THERE WERE ALSO SOME UNFORMED STAPLES THAT DEPLOYED. THE SURGEON USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE WITHOUT FURTHER CONSEQUENCE. THERE WAS UNANTICIPATED TISSUE LOSS. THERE WAS NO UNANTICIPATED TISSUE DAMAGE. THERE WAS NO BLEEDING OF OVER 500CC. THERE WAS NO DELAY IN SURGERY TIME OF MORE THAN 30 MINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543568 EEA 31MM SINGLE-USE STAPLER DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY USSC PUERTO RICO, INC. P4B0322KX

    Patients

    Seq Age Sex Outcome Treatment
    1 Other