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.
This recall has been terminated (originally issued August 30, 2011).
- Company
- Encision, Inc.
- Recall Initiated
- August 24, 2011
- Posted
- August 30, 2011
- Terminated
- September 4, 2012
- Recall Number
- Z-3094-2011
- Quantity
- 604 units
- Firm Location
- Boulder, CO
- Official Source
- View on FDA website ↗
Reason for Recall
Electrode tips have been reported breaking off during use or cleaning.
Distribution
Worldwide Distribution: Nationwide distribution, and the country of New Zealand.
Lot / Code Info
Catalog: REF ES3882, Lots: QI, RA, RD, RE and RF.
Root Cause
Device Design
Action Taken
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.
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