BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA XL 31MM SINGLE-USE STAPLER

    MDR report key: 3874814 · Received May 30, 2014

    Report

    Report Number
    2647580-2014-00433
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 16, 2014
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO, INC.
    Product Code
    GAG
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LOWER ANTERIOR RESECTION. ACCORDING TO THE REPORTER: WHILE THE EEA WAS BEING REMOVED, THERE WAS A HUGE LEAK FROM THE POSTERIOR PART OF THE ANASTOMOSIS. ALL INTESTINAL CONTENT CONTAMINATED THE LAPAROSCOPIC CAVITY. THE SURGEON PERFORMED A COLONOSTOMY TO CLOSE THE OPERATION. THERE WAS NO PATIENT INJURY. THE SURGICAL TIME WAS NOT EXTENDED BY MORE THAN 30 MINUTES. THERE WAS NO UNANTICIPATED TISSUE LOSS. THERE WAS NO TISSUE DAMAGE. THERE WAS NO BLOOD LOSS OF 500CC OR MORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318897 EEA XL 31MM SINGLE-USE STAPLER DISPOSABLE SURGICAL STAPLER GAG COVIDIEN, FORMERLY USSC PUERTO RICO, INC. P3J0453KX

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other