BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA XL 25MM SINGLE USE STAPLER WITH

    MDR report key: 2903623 · Received January 3, 2013

    Report

    Report Number
    2647580-2013-00003
    Event Type
    Injury
    Date Received
    January 3, 2013
    Date of Event
    December 4, 2012
    Report Date
    December 11, 2012
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: ROUX-EN-Y. ACCORDING TO THE REPORTER: THE ORVIL COULD NOT BE CONNECTED TO THE STAPLER. THE SURGEON TRIED FOR ABOUT 15 MINUTES, BUT COULD NOT CONNECT TO THE STAPLER. A NEW STAPLER WAS OPENED AND THE SAME ORVIL COULD BE CONNECTED TO IT. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER PROBLEM. THERE WAS OOZING AND TISSUE DAMAGE. THE TISSUE HAD TO BE EXCISED ADDITIONALLY TO REMOVE THE DEVICE. OPERATING ROOM TIME WAS EXTENDED BY MORE THAN 30 MINUTES. NO REINFORCEMENT MATERIAL USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3705 EEA XL 25MM SINGLE USE STAPLER WITH DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY USSC PUERTO RICO P2G0602X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other (B)(4), LOT #: N2K0311UX,| K062850| DST SERIES EEA ORVIL 25MM DEVICE,| MFG 07/01/2012, EXP 07/31/2017