BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA XL 28MM SINGLE-USE STAPLER

    MDR report key: 2980916 · Received February 19, 2013

    Report

    Report Number
    2647580-2013-00096
    Event Type
    Injury
    Date Received
    February 19, 2013
    Date of Event
    January 23, 2013
    Report Date
    January 24, 2013
    Manufacturer
    COVIDIEN, FORMERLY USSC
    Product Code
    GDW
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LOW ANTERIOR RESECTION. ACCORDING TO THE REPORTER: THE POSTERIOR WALL OF THE ANASTOMOSIS WASN'T STAPLED. THE TISSUE DONUTS WERE COMPLETE BUT THE ANASTOMOSIS WAS NOT. AS A RESULT, THERE WAS A HOLE IN THE POSTERIOR WALL OF THE ANASTOMOSIS. THERE WAS ALSO A MALFORMED STAPLE RECOVERED FROM THE RECTUM. UPON FURTHER INSPECTION OF THE DEVICE, IT APPEARED THAT HALF OF THE STAPLES WERE NOT DEPLOYED WHEN THE DEVICE WAS FIRED. THE SAFETY WAS REMOVED AND THE SURGEON BEGAN TO SQUEEZE THE HANDLE AND NOTICED WHAT APPEARED TO BE STAPLE LEGS ADVANCING FORWARD. AT THAT POINT, THE SAFETY WAS REPLACED. A NEW STAPLER WAS OPENED AND USED. BUTTRESS MATERIAL WAS NOT USED. THERE WAS UNANTICIPATED TISSUE LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72189 EEA XL 28MM SINGLE-USE STAPLER DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY USSC P2F0149H

    Patients

    Seq Age Sex Outcome Treatment
    1 Other