Encision AEM Suction Irrigation Electrode, Spatula, REF ES3882, 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.
FDA Recall Z-3094-2011 · Posted 2011-08-30
Recalling FirmEncision, Inc.
Recall StatusTerminated
Product CodeGEI
Date Initiated2011-08-24
Date Terminated2012-09-04
Product Quantity604 units
Reason for Recall
Electrode tips have been reported breaking off during use or cleaning.
Firm 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.
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution: Nationwide distribution, and the country of New Zealand.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.