BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GIA UNIVERSAL

    MDR report key: 1982229 · Received February 4, 2011

    Report

    Report Number
    MW5019309
    Event Type
    Injury
    Date Received
    February 4, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 28, 2011
    Manufacturer
    AUTO SUTURE
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    (B)(4) LEAD STAPLER WAS FIRED ACROSS THE BRONCHUS. SOME OF THE STAPLES DEPLOYED, BUT DID NOT CLOSE PROPERLY. THIS REQUIRED SUTURING THE AIRWAY AND PROLONGED THE OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GIA UNIVERSAL STAPLER GDW AUTO SUTURE GIA UNIVERSAL

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention