BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EGIA ULTRA UNIVERSAL STAPLER

    MDR report key: 3894101 · Received June 20, 2014

    Report

    Report Number
    2647580-2014-00464
    Event Type
    Injury
    Date Received
    June 20, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 30, 2014
    Manufacturer
    COVIDIEN, FORMERLY USSC
    Product Code
    GDW
    PMA / PMN Number
    K083519
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: ATYPICAL RESECTION OF LEFT LOWER LUNG LOBE FOR LEFT PULMONARY NODULE. ACCORDING TO REPORTER: DURING PULMONARY RESECTION OF THE LEFT LOWER LOBE STAPLER JAMMED, PREVENTING THE SECTION OF THE LUNG PARENCHYMA AND REMAINING ATTACHED. CONVERSION PROCEDURE FROM LAPARA TO OPEN. STAPLER HAD ALREADY BEEN USED WITH A PREVIOUS RELOAD WITH NO PROBLEM. EXTENSION OF THE SURGERY TIME AND EXTENSION OF THE HOSP STAY. SAMPLES ARE NOT AVAILABLE SINCE THEY WERE DISCARDED AFTER USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364052 EGIA ULTRA UNIVERSAL STAPLER DISPOSABLE SURGICAL STAPLER GDW COVIDIEN, FORMERLY USSC NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PRODUCT LOT #: N4C0600KX, MFG DATE: 03/2014| EGIA 60 ARTICULATING MED/THICK SULU, EGIA60AMT,| EXP. DATE: 03/31/2019