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U.S. Department of Health and Human Services

Class 2 Device Recall Encision AEM Suction Irrigation Electrode, Spatula

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 Class 2 Device Recall Encision AEM Suction Irrigation Electrode, Spatulasee related information
Date Initiated by FirmAugust 24, 2011
Date PostedAugust 30, 2011
Recall Status1 Terminated 3 on September 04, 2012
Recall NumberZ-3094-2011
Recall Event ID 59781
510(K)NumberK100711 
Product Classification Electrosurgical, Cutting; Coagulation; Accessories - Product Code GEI
ProductEncision 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.
Code Information Catalog: REF ES3882,  Lots: QI, RA, RD, RE and RF.
Recalling Firm/
Manufacturer		 Encision, Inc.
6797 Winchester Cir
Boulder CO 80301-3513
For Additional Information Contact
303-339-6917
Manufacturer Reason
for Recall		Electrode tips have been reported breaking off during use or cleaning.
FDA Determined
Cause 2		Device Design
ActionEncision 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 in Commerce604 units
DistributionWorldwide Distribution: Nationwide distribution, and the country of New Zealand.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = GEI
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