BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EGIA 45 ARTICULATING MED/THICK SULU

    MDR report key: 3973073 · Received July 9, 2014

    Report

    Report Number
    1219930-2014-00515
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 19, 2014
    Manufacturer
    COVIDIEN LP, FORMERLY US
    Product Code
    GDW
    PMA / PMN Number
    K083519
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORT SENT TO FDA ON (B)(4) 2014.

    Description of Event or Problem · 1

    PROCEDURE: ESOPHAGOGASTRECTOMY. ACCORDING TO THE REPORTER: AFTER LOADING EGIA45AMT ON IDRIVE AND TESTING THE CONDITIONS OF OPENING AND CLOSING THE JAW, THE STATUS INDICATOR LIGHTENING TURNED TO BLUE AND IT COULD NOT FIRE. NEW ONE WAS OPENED TO COMPLETE THE CASE WITH NO PROBLEM. NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400160 EGIA 45 ARTICULATING MED/THICK SULU DISPOSABLE SURGICAL STAPLER GDW COVIDIEN LP, FORMERLY US N4B0300KX

    Patients

    Seq Age Sex Outcome Treatment
    1 K121510| IDRIVE ULTRA POWERED HANDLE 1, IDRVULTRA1,