BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA XL 25MM STAPLER WITH 3.5MM STAPLES

    MDR report key: 1032867 · Received April 22, 2008

    Report

    Report Number
    1219930-2008-00312
    Event Type
    Injury
    Date Received
    April 22, 2008
    Date of Event
    March 25, 2008
    Report Date
    March 25, 2008
    Manufacturer
    NORTH HAVEN - USS
    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

    INITIAL REPORT SENT: 04/15/2008.

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAP GASTRIC BYPASS. ACCORDING TO THE REPORTER: THE WHITE TROCAR WOULD NOT STAY IN THE ANVIL SHAFT AND FELL OFF. THE SURGEON WAS ABLE TO ATTACH ANOTHER TROCAR AND WAS ABLE TO COMPLETE THE CASE. THE OPERATING TIME WAS DELAYED ABOUT 45 MINUTES TO 1 HR AS A RESULT. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EEA XL 25MM STAPLER WITH 3.5MM STAPLES DISPOSABLE SURGICAL STAPLER GDW NORTH HAVEN - USS U8B07H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention