BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TA 60-3.5 SINGLE USE RELOADABLE STAPLER

    MDR report key: 2020197 · Received March 7, 2011

    Report

    Report Number
    2647580-2011-00153
    Event Type
    Injury
    Date Received
    March 7, 2011
    Date of Event
    February 11, 2011
    Report Date
    February 25, 2011
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GDW
    PMA / PMN Number
    K013860
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: SIGMOIDECTOMY. ACCORDING TO THE REPORTER: DURING TRANSACTION OF SIGMOID COLON THE TA 60 STAPLER IS USED DISTAL ON THE SIGMOID, HOWEVER THE COLON IS NOT CLOSED DUE TO NO STAPLES IN THE CARTRIDGE - ONLY THE YELLOW PUSHERS ARE VISUAL IN THE CARTRIDGE AFTER FIRING. FOLLOWING THE SURGEON HANDLE WAS FULLY SQUEEZED. THE MISSING STAPLES ARE FIRST DISCOVERED AFTER TRANSACTION AND WHEN INSTRUMENT IS REMOVED LEAVING THE SIGMOID COLON OPEN. THERE WAS NO TISSUE DAMAGE. AS A SOLUTION THE SIGMOID COLON WAS CLOSED MANUALLY WITH SUTURE AND THE CASE HAD NO FURTHER CONSEQUENCES FOR THE OPERATION. THE PATIENT CONDITION IS POST-OP POSITIVE AT CURRENT STAGE. THE ADDITIONAL BLEEDING WAS MINIMAL, AND THERE WAS NO TISSUE DAMAGE OR UNANTICIPATED TISSUE LOSS. THE OPERATIVE TIME WAS EXTENDED OVER 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TA 60-3.5 SINGLE USE RELOADABLE STAPLER DISPOSABLE SURGICAL STAPLER GDW USSC PUERTO RICO UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other