BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EGIA ULTRA UNIVERSAL SHORT STAPLER

    MDR report key: 2548472 · Received April 18, 2012

    Report

    Report Number
    1219930-2012-00365
    Event Type
    Injury
    Date Received
    April 18, 2012
    Date of Event
    November 12, 2011
    Report Date
    April 10, 2012
    Manufacturer
    COVIDIEN, FORMERLY US SUR
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). K083519.

    Description of Event or Problem · 1

    PROCEDURE: THORACOTOMY. ACCORDING TO THE REPORTER: WHEN THE CARTRIDGE WAS ATTACHED TO THE HANDLE, THE JAWS WOULD NOT OPEN, THE DOCTOR USED ANOTHER HANDLE AND RELOAD AND WAS ABLE TO CONTINUE THE CASE. INVESTIGATION REVEALED THAT ADDITIONAL TISSUE WAS RESECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EGIA ULTRA UNIVERSAL SHORT STAPLER DISPOSABLE STAPLER GDW COVIDIEN, FORMERLY US SUR

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability EGIA 60 ARTICULATING VAS/MED SULU: EGIA60AVM