BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TA90 - 3.5 SINGLE USE RELOADABLE STAPLER

    MDR report key: 3800197 · Received April 28, 2014

    Report

    Report Number
    2647580-2014-00303
    Event Type
    Injury
    Date Received
    April 28, 2014
    Date of Event
    April 2, 2014
    Report Date
    April 4, 2014
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO, INC.
    Product Code
    GDW
    PMA / PMN Number
    K013860
    Adverse Event
    Yes
    Product Problem
    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: COLECTOMY FUNCTIONAL END TO END ANASTOMOSIS. ACCORDING TO THE REPORTER: AFTER THE FIRST FIRING WAS DONE AND THE TISSUE WAS RESECTED, THE DOCTOR CONFIRMED THAT THE STAPLE DID NOT FIRE ON TISSUE, WHICH FAILED TO CLOSE THE DESIRED PART OF TISSUE. THERE WAS NO PATIENT HARM. OPERATING TIME EXTENDED BY LESS THAN 30 MIN. THERE WAS NO ADD'L TISSUE RESECTION. THERE WAS NO TISSUE DAMAGE. NOTHING FELL INTO THE CAVITY. THERE WAS NO BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253936 TA90 - 3.5 SINGLE USE RELOADABLE STAPLER DISPOSABLE STAPLING DEVICES GDW COVIDIEN, FORMERLY USSC PUERTO RICO, INC. P3E0515X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other