BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTICULATOR 55-4.8 TITANIUM STAPLER

    MDR report key: 3854947 · Received May 28, 2014

    Report

    Report Number
    2647580-2014-00389
    Event Type
    Injury
    Date Received
    May 28, 2014
    Date of Event
    April 24, 2014
    Report Date
    May 21, 2014
    Manufacturer
    COVIDIEN, FORMERLY, USSC PUERTO RICO, INC.
    Product Code
    GDW
    PMA / PMN Number
    K855047
    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: LOW ANTERIOR RESECTION. ACCORDING TO THE REPORTER: THERE WAS NO PROBLEM IN MANIPULATION OF THE DEVICE WHEN FIRING. UPON INSPECTING THE CONDITIONS OF FIRED STAPLES BY TOUCH AFTER RELEASE OF DEVICE FROM TISSUE, A DOCTOR CONFIRMED THAT THE INTESTINAL TRACT WAS NOT CLOSED SUCCESSFULLY. CONFIRMED THERE WAS NO PROOF THAT THE DOCTOR CUT THE TISSUE ON THE OTHER SIDE BY MISTAKE. CONSIDERING PT HISTORY OF DIABETIC DISEASE AND CEREBRAL INFARCTION, THE PROCEDURE WAS TRANSFERRED TO MILES INSTEAD OF RECOVERY BY SUTURING. NO X RAY IMAGE WAS TAKEN DURING OPERATIONS. THE PT IS CURRENTLY UNDER FOLLOW-UP. OPERATING TIME WAS EXTENDED BY MORE THAN 30 MINUTES. THERE WAS NO EXTENSION IN HOSPITAL STAY. NO BUTTRESS MATERIAL WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314991 ROTICULATOR 55-4.8 TITANIUM STAPLER DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY, USSC PUERTO RICO, INC. P2E0708X

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other