BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA 31MM SINGLE-USE STAPLER

    MDR report key: 3030652 · Received March 25, 2013

    Report

    Report Number
    2647580-2013-00156
    Event Type
    Injury
    Date Received
    March 25, 2013
    Date of Event
    February 25, 2013
    Report Date
    February 25, 2013
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO
    Product Code
    GAG
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: COLECTOMY. ACCORDING TO THE REPORTER: THE CUSTOMER REPORTS THAT THE STAPLER ONLY STAPLED ON HALF THE CIRCUMFERENCE, THEN STAYED STUCK IN THE PATIENT. THE SURGEONS HAD TO RECUT AND REDO THE ANASTOMOSIS LOWER ON THE COLON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121515 EEA 31MM SINGLE-USE STAPLER DISPOSABLE SURGICAL STAPLER GAG COVIDIEN, FORMERLY USSC PUERTO RICO P2J0338X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other