BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOEGIA 60 ARTICULATING MED/THICK SULU

    MDR report key: 4251532 · Received September 3, 2014

    Report

    Report Number
    1219930-2014-00774
    Event Type
    Malfunction
    Date Received
    September 3, 2014
    Report Date
    August 12, 2014
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K083519
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: LAPAROSCOPIC DISTAL GASTRECTOMY. ACCORDING TO THE REPORTER: IDRIVE SIGNAL BLINKED GREEN LIGHT AFTER SURGEON PUSHED THE GREEN BUTTON. SURGEON PUSHED BLUE BUTTON FOR FIRING BUT CARTRIDGE WAS NOT FIRED. IDRIVE STATUS SIGNAL SHOWED BLUE WITHOUT FIRING. THE TISSUE WAS NOT DAMAGED. THE PT DID NOT GET INJURED AND THERE WAS MINIMAL BLOOD LOSS. NO REINFORCEMENT MATERIAL WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535851 LOEGIA 60 ARTICULATING MED/THICK SULU DISPOSABLE SURGICAL STAPLER GDW COVIDIEN, FORMERLY US SURGICAL N4C0854KX

    Patients

    Seq Age Sex Outcome Treatment
    1 K121510| LOT #:N3M0712UX, (B)(4), MFG: 12/2013,| IDRIVE ULTRA POWERED HANDLE 1: IDRVULTRA1,