BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA XL 25MM SINGLE USE STAPLER WITH

    MDR report key: 3030636 · Received March 25, 2013

    Report

    Report Number
    2647580-2013-00151
    Event Type
    Injury
    Date Received
    March 25, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 27, 2013
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO
    Product Code
    GDW
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: ANVIL AND STAPLER COULD NOT BE CONNECTED. THE SURGEON TRIED SEVERAL TIMES, BUT THE RESULT WAS THE SAME. THE SMALL UMBILICAL INCISION WAS EXTENDED BY AROUND 2 CM AND CDH25 (ETHICON) WAS USED TO PERFORM THE PROCEDURE. THERE WAS OOZING AND TISSUE DAMAGE. THERE WAS UNANTICIPATED TISSUE LOSS. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES. BUTTRESS MATERIAL WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122155 EEA XL 25MM SINGLE USE STAPLER WITH DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY USSC PUERTO RICO P2K0850X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other EXP. DATE 10/31/2017, K062850| DST SERIES EEA ORVIL 25MM DEVICE, (B)(4),| LOT #: N2M0465UX, MANUFACTURE DATE 10/01/2012,