BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA 28MM SINGLE-USE STAPLER

    MDR report key: 4120882 · Received September 26, 2014

    Report

    Report Number
    2647580-2014-00810
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    September 6, 2014
    Report Date
    September 6, 2014
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO INC
    Product Code
    GAG
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: COLECTOMY. ACCORDING TO THE REPORTER: SURGEON FIRED THE DEVICE WITH BUTTRESS REINFORCEMENT, BUT THE STAPLER WOULD NOT RELEASE TISSUE UPON COMPLETION. THIS CAUSED A PARTIAL TEAR IN THE ANASTOMOSIS. THE SURGEON COULD NOT FIX THE PROBLEM WITH SUTURE SO ANOTHER DEVICE WITH REINFORCEMENT WAS USED TO REDO THE ANASTOMOSIS. SECOND ANASTOMOSIS WAS COMPLETED WITH NO ISSUES. THERE WAS NO UNANTICIPATED EXTENSION FOR THE INCISION MORE THAN ONE INCH. THERE WAS UNANTICIPATED TISSUE LOSS. THERE WAS UNANTICIPATED TISSUE TEARING. THERE WAS NO UNANTICIPATED BLOOD LOSS OF MORE THAN 500CC. THERE WAS A DELAY IN SURGERY TIME OF OVER 30 MINUTES. NO ADVERSE EVENT WAS REPORTED AS A RESULT OF THIS DELAY. NO DEVICE FRAGMENT FELL IN THE PATIENT CAVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601995 EEA 28MM SINGLE-USE STAPLER DISPOSABLE SURGICAL STAPLING DEVICE GAG COVIDIEN, FORMERLY USSC PUERTO RICO INC EEA28 P4F0485KX

    Patients

    Seq Age Sex Outcome Treatment
    1 Other