BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA31

    MDR report key: 5042076 · Received August 31, 2015

    Report

    Report Number
    2647580-2015-00613
    Event Type
    Injury
    Date Received
    August 31, 2015
    Report Date
    August 26, 2015
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO INC
    Product Code
    GDW
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS AN EEA31MM SINGLE-USE STAPLER. 510(K) K062850.

    Additional Manufacturer Narrative · 1

    AS NO LOT NUMBER WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED. ALL PROCESS AND TEST CRITERIA ARE VERIFIED AS COMPLYING WITH THE FINISHED PRODUCT SPECIFICATIONS FOR ALL RELEASED LOTS. A REVIEW OF HISTORICAL COMPLAINT DATA DISPLAYED NO INCREASE IN TRENDS.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, A CIRCULAR STAPLER WAS USED ON A PATIENT DURING A LOW ANTERIOR RESECTION. THE ANASTOMOSIS WAS CHECKED FOR LEAKS AND NONE WERE DETECTED. THE PATIENT WAS SENT TO RECOVERY. A FEW DAYS LATER, THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL FOLLOWING AN ANASTOMOSIS FAILURE. THE PATIENT WAS RE-ADMITTED AND UNDERWENT REOPERATION. THE SURGERY WAS AN OPEN PROCEDURE AND THE STAPLE LINE WAS INCOMPLETE. THE ANASTOMOSIS WAS REDONE AND THERE WAS UNANTICIPATED TISSUE LOSS. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. NO REINFORCEMENT MATERIAL WAS USED. PATIENT STATUS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574751 EEA31 IMPLANTABLE STAPLE GDW COVIDIEN, FORMERLY USSC PUERTO RICO INC CEEA31 NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R