Recall Z-3093-2011 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Encision, Inc.
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.
| Date | Aug 30, 2011 (initiated Aug 24, 2011) |
| Status | Terminated |
| Reason | Electrode tips have been reported breaking off during use or cleaning. |
| Root cause | Device Design |
| 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. |
| Quantity | 169 units |
| Distribution | Worldwide Distribution: Nationwide distribution, and the country of New Zealand. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100711 | SUCTION IRRIGATION ELECTRODES AND ADAPTERS Encision, Inc., Jun 9, 2010 |