BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EGIA 60 ARTICULATING MED/THICK SULU

    MDR report key: 3131388 · Received May 13, 2013

    Report

    Report Number
    1219930-2013-00371
    Event Type
    Injury
    Date Received
    May 13, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 29, 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
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LUNG RESECTION. ACCORDING TO THE REPORTER: DURING THE PROCEDURE, THE TWO PINS AT THE AREA OF THE JOINT FELL INTO THE PATIENT CAVITY. IT IS NOT CLEAR IF BOTH PINS WERE ABLE TO BE REMOVED FROM THE PATIENT CAVITY. THERE WAS NO UNANTICIPATED TISSUE LOSS OR TISSUE DAMAGE AS A RESULT OF THIS PROBLEM. NO REINFORCEMENT MATERIAL WAS USED IN CONJUNCTION WITH THE STAPLING DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211815 EGIA 60 ARTICULATING MED/THICK SULU DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY US SURGICAL N2L0331ULX

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Other LOT # N2J0466UMX, K083519| MAN. DATE: 11/2012, EXP DATE: 11/30/2017| EGIAUSTND, EGIA ULTRA UNIVERSAL STAPLER