BEUDAMED
    FDA Recall Terminated

    Encision AEM Suction Irrigation Electrode, L-Diamond, REF ES3881. Encision Inc., Boulder, CO 80301. The Suction Irrigation Electrodes and Adapters combine AEM shielding technology with suction and irrigation of fluids during laparoscopic electrosurgery to cut and coagulate tissue. The electrodes connect to a compatible electrosurgical generator via an adapter on the Encision AEM Monitor.

    Recall: Z-3093-2011 · Initiated August 24, 2011

    Recall

    Recall Number
    Z-3093-2011
    Event Number
    59781
    Firm
    Encision, Inc.
    FEI Number
    1000117361
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    August 24, 2011
    Posted
    August 30, 2011
    Terminated
    September 4, 2012
    Address
    6797 Winchester Cir, Boulder, CO, 80301-3513

    Description

    Encision AEM Suction Irrigation Electrode, L-Diamond, REF ES3881. Encision Inc., Boulder, CO 80301. The Suction Irrigation Electrodes and Adapters combine AEM shielding technology with suction and irrigation of fluids during laparoscopic electrosurgery to cut and coagulate tissue. The electrodes connect to a compatible electrosurgical generator via an adapter on the Encision AEM Monitor.

    Reason

    Electrode tips have been reported breaking off during use or cleaning.

    Action

    Encision Inc. sent out an "Urgent Product Recall" letter dated August 24, 2011 to all affected customers. The letter included: affected product, problem and instructed customers to discontinue use and return all affected electrodes to Encision. An enclosed reply form was to be faxed back to Encision indicating status of firm's inventory. For information on this recall call Encision at (303) 339-6917.

    Distribution

    Worldwide Distribution: Nationwide distribution, and the country of New Zealand.

    Quantity

    169 units