BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EGIA ULTRA UNIVERSAL STAPLER

    MDR report key: 3232250 · Received July 8, 2013

    Report

    Report Number
    1219930-2013-00518
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 20, 2013
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K083519
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TRACKING NUMBER (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: THORACO/LOBECTOMY. ACCORDING TO THE REPORTER: AFTER THE FIRST FIRING, THE STAPLE LINE BURST OPEN. THE STAPLE LINE WAS TREATED WITH A NEW DEVICE. THERE WAS INFO ABOUT THE USE OF REINFORCEMENT MATERIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309098 EGIA ULTRA UNIVERSAL STAPLER DISPOSABLE STAPLE DEVICE GDW COVIDIEN, FORMERLY US SURGICAL N2L0248UMX

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability EGIA60AVM| EXPIRATION DATE: 09/30/2017, MFR DATE 09/2012,| K101444| EGIA 60 ARTICULATING VAS/MED SULU: LOT #N2J0384ULX