BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA XL 25MM SINGLE-USE STAPLER

    MDR report key: 1910231 · Received November 22, 2010

    Report

    Report Number
    1219930-2010-00886
    Event Type
    Injury
    Date Received
    November 22, 2010
    Date of Event
    October 9, 2010
    Report Date
    October 27, 2010
    Manufacturer
    UNITED STATES SURGICAL
    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: ESOPHAGECTOMY. ACCORDING TO THE REPORTER: THE PT WAS BROUGHT IN FOR ESOPHAGECTOMY/GASTRIC TUBE ON OCTOBER 9TH. THE NEXT DAY, THE PT CONDITION GOT WORSE AND RE-OPERATION WAS DONE. DURING THE RE-OPERATION, TWO THIRDS OF THE STAPLER LINE ON ESOPHAGUS WAS FOUND NOT STAPLED. THE PT WAS BROUGHT INTO ICU TO BE OBSERVED. ADD'L INFO REGARDING PT'S STATUS HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EEA XL 25MM SINGLE-USE STAPLER DISPOSABLE STAPLER GDW UNITED STATES SURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R EEAORVIL25, DST SERIES EEA ORVIL 25MM DEVICE