BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDIO GIA ROTICULATOR 45-3.5 SULU

    MDR report key: 3964852 · Received July 16, 2014

    Report

    Report Number
    1219930-2014-00540
    Event Type
    Injury
    Date Received
    July 16, 2014
    Report Date
    June 24, 2014
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K900129
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: VATS LOBECTOMY. ACCORDING TO THE REPORTER: AT THE FIRST FIRING WHEN THE JAW WAS CLOSED ON THE BRONCHIAL TUBE, CRACKING SOUNDS WERE HEARD. HOWEVER A DOCTOR CONTINUED USE AND FIRED. FOR SECURITY, AN ADDITIONAL FIRING WAS DONE ON THE PROXIMAL SIDE OF THE OPERATED SITE BY THE FIRST RELOAD. THIS TIME ALSO STRANGE SOUNDS WERE HEARD. ISSUES WERE OBSERVED WITH THE SECOND STAPLE LINE. IT WAS REPAIRED BY ADDITIONAL SUTURING. THERE WAS UNANTICIPATED TISSUE LOSS. THERE WAS TISSUE DAMAGE. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES. PATIENT IS CURRENTLY UNDER FOLLOW-UP. THE DOCTOR STATES THE CALCIFICATION OF BRONCHIAL TUBE COULD POSSIBLY MAKE THE TISSUE HARD TO BE GRASPED. NO REINFORCEMENT MATERIAL WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415925 ENDIO GIA ROTICULATOR 45-3.5 SULU DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY US SURGICAL N3J1425LX

    Patients

    Seq Age Sex Outcome Treatment
    1 Other