BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EGIA 45 ARTICULATING MED/THICK SULU

    MDR report key: 3761146 · Received December 31, 2013

    Report

    Report Number
    1219930-2013-01090
    Event Type
    Malfunction
    Date Received
    December 31, 2013
    Date of Event
    November 13, 2013
    Report Date
    December 2, 2013
    Manufacturer
    COVIDIEN
    Product Code
    GDW
    PMA / PMN Number
    K083519
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAP COLECTOMY. ACCORDING TO THE REPORTER: RELOAD CANNOT FIRE ON TISSUE. PT INVOLVED WITHOUT INJURY. NO REINFORCEMENT MATERIAL WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682518 EGIA 45 ARTICULATING MED/THICK SULU DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN N3B0522LX

    Patients

    Seq Age Sex Outcome Treatment
    1 LOT # C3C0347UX, SERIAL # (B)(4)| IDRVULTRA1, IDRIVE ULTRA POWERED HANDLE 1,| MFR DATE:03/2013, K121510