BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA XL 21MM STAPLER WITH 3.5MM STAPLES

    MDR report key: 1192770 · Received October 8, 2008

    Report

    Report Number
    1219930-2008-00734
    Event Type
    Injury
    Date Received
    October 8, 2008
    Date of Event
    September 15, 2008
    Report Date
    September 17, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GDW
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAP GASTRIC BYPASS. ACCORDING TO THE REPORTER: AFTER APPLYING THE DEVICE IT WAS NOTED THAT THE DONUTS WERE NORMAL BUT STAPLES DID NOT FORM. THE ANASTOMOSIS WAS HAND SEWN TO COMPLETE THE PROCEDURE. NO BLOOD LOSS OCCURRED BUT SURGERY TIME WAS EXTENDED THIRTY FIVE MINUTES AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EEA XL 21MM STAPLER WITH 3.5MM STAPLES DISPOSABLE SURGICAL STAPLER GDW NORTH HAVEN - USS U8F19H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PRODUCT ID: EEAORVIL21| DST SERIES EEA ORVIL 21MM DEVICE| EXP. DATE: UNK