BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA 28MM SINGLE USE STAPLER WITH 3.5MM STAPLES

    MDR report key: 4881667 · Received July 1, 2015

    Report

    Report Number
    2647580-2015-00470
    Event Type
    Injury
    Date Received
    July 1, 2015
    Date of Event
    May 6, 2015
    Report Date
    June 9, 2015
    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
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: SIGMOIDECTOMY FOR SIGMOID CANCER. ACCORDING TO THE REPORTER: THERE WAS A TILT OF THE ANVIL BEFORE THE COMPLETE CLOSING OF THE INSTRUMENT. THIS CAUSED A TEAR IN THE COLON, AND THE ANASTOMOSIS AND SUTURING WAS REDONE. THE INCISION WAS EXTENDED BY 2 INCHES AND THE SURGERY TIME WAS EXTENDED BY 30 MINUTES. THERE WAS NO UNANTICIPATED TISSUE LOSS OR BLEEDING REPORTED IN EXCESS OF 500CC. THERE WAS NO EXTENSION OF HOSPITAL STAY OR ADVERSE EVENT REPORTED DUE TO THE DELAY IN PROCEDURE. NO DEVICE FRAGMENT FELL INTO THE PATIENT'S CAVITY. NO REINFORCEMENT MATERIAL WAS USED WITH THE STAPLER. CURRENT PATIENT STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427581 EEA 28MM SINGLE USE STAPLER WITH 3.5MM STAPLES DISPOSABLE SURGICAL STAPLING DEVICE GAG COVIDIEN, FORMERLY USSC PUERTO RICO INC EEA2835 NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Other| R