BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AEM SUCTION IRRIGATION ELECTRODE, SPATULA

    MDR report key: 2253295 · Received August 3, 2011

    Report

    Report Number
    1722040-2011-00013
    Event Type
    Malfunction
    Date Received
    August 3, 2011
    Date of Event
    July 18, 2011
    Report Date
    August 2, 2011
    Manufacturer
    ENCISION INC.
    Product Code
    GEI
    PMA / PMN Number
    K100711
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE TIP OF THE SUCTION IRRIGATION ELECTRODE CAME OFF DURING A PROCEDURE, BUT NOT IN PT. NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AEM SUCTION IRRIGATION ELECTRODE, SPATULA ELECTROSURGICAL INSTRUMENT GEI ENCISION INC. ES3882 QI

    Patients

    Seq Age Sex Outcome Treatment
    1