BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TA 60-3.5 SINGLE USE RELOADABLE STAPLER

    MDR report key: 3170171 · Received June 7, 2013

    Report

    Report Number
    2647580-2013-00292
    Event Type
    Injury
    Date Received
    June 7, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 13, 2013
    Manufacturer
    COVIDIEN, FORMERLY USSC
    Product Code
    GDW
    PMA / PMN Number
    K013860
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: COLOSTOMY TAKEDOWN. ACCORDING TO THE REPORTER: THE CUSTOMER REPORTED THAT THE SURGEON WAS PERFORMING AN ILEOSTOMY CLOSURE. AFTER PERFORMING HIS SIDE BY SIDE ANASTOMOSIS, HE TOOK A TA6035S STAPLER TO CLOSE THE STAB WOUNDS OF THE ANASTOMOSIS. WHEN HE FIRED THE TA6035S STAPLER, HE NOTICED THAT ONLY A ¼ OF THE CARTRIDGE HAD APPLIED SOME STAPLES. IT APPEARED THAT ¾ OF THE RELOAD WAS EMPTY. HE THEN RESECTED A PORTION OF TISSUE THAT HAD THE STAPLES AND HE COMPLETED THE CLOSURE OF THE STAB WOUNDS USING A MANUAL SUTURE. THERE WAS NO UNANTICIPATED TISSUE LOSS OR TISSUE DAMAGE. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES. NOTHING FELL INTO THE PATIENT'S CAVITY. THERE WAS NO PATIENT INJURY OR ILL EFFECT AS A RESULT OF THIS PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253732 TA 60-3.5 SINGLE USE RELOADABLE STAPLER DISPOSABLE SURGICAL STAPLER GDW COVIDIEN, FORMERLY USSC P2K0437X

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other