BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA XL 21MM SINGLE-USE STAPLER

    MDR report key: 2061201 · Received April 5, 2011

    Report

    Report Number
    1219930-2011-00267
    Event Type
    Injury
    Date Received
    April 5, 2011
    Date of Event
    March 21, 2011
    Report Date
    March 21, 2011
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: GASTRIC BYPASS. ACCORDING TO THE REPORTER: THE ANVIL OF THE (B)(4) WOULD NOT MATE WITH THE (B)(4). THEREFORE, THE PRODUCT WOULD NOT CONNECT AND CLOSE DOWN FOR FIRING. SURGEON HAD TO SURGICALLY CUT OUT ANVIL WITH CAUTERY AND PLACE ANVIL INCLUDED IN (B)(4) AND PURSE STRING AROUND THIS ANVIL IN ORDER TO FINISH THE CASE. EXTENDED OPERATING ROOM TIME BY 30 MINUTES. CAUTERY WAS USED AND ANVIL FROM (B)(4) WAS APPLIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EEA XL 21MM SINGLE-USE STAPLER DISPOSABLE SURGICAL STAPLING DEVICE GDW UNITED STATES SURGICAL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CATALOG#: EEAORVIL21, LOT NUMBER: UNK| DST SERIES EEA ORVIL 21MM DEVICE