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U.S. Department of Health and Human Services

Class 2 Device Recall Olympus Endoscopic Electrosurgical Unit working elements

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  Class 2 Device Recall Olympus Endoscopic Electrosurgical Unit working elements see related information
Date Initiated by Firm December 27, 2011
Date Posted January 20, 2012
Recall Status1 Terminated 3 on December 21, 2013
Recall Number Z-0829-2012
Recall Event ID 60772
510(K)Number K030194  
Product Classification Unit, electrosurgical, endoscopic (with or without accessories) - Product Code KNS
Product Olympus Endoscopic Electrosurgical Unit working elements, model numbers WA22366A, and WA22367A.

Working element for cutting, coagulation, and vaporization in conductive irrigation fluid or conductive distension medium in the Saline mode.
Code Information Lot numbers 118W, 119W, and 11XW for new inventory
Recalling Firm/
Manufacturer
Olympus America Inc.
3500 Corporate Pkwy.
P.O. Box 610
Center Valley PA 18034-0610
For Additional Information Contact Laura Storms-Tyler
484-896-5688
Manufacturer Reason
for Recall
Less than optimal thickness in the plastic housing holding the electrode in the Olympus Working Elements
FDA Determined
Cause 2
Component design/selection
Action Olympus America Inc. sent an "URGENT: MEDICAL DEVICE WITHDRAWAL" letter dated December 27, 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to inspect their inventory for the affected product and discontinue use of any affected product discovered. Customers should contact the Gyrus ACMI Customer Service Department at 1-888-524-7266 for credit or replacement of the product. Additionally, an Olympus Working Elements Withdrawal form was enclosed for customers to complete and fax to 484-896-7128. Contact the firm at 484-896-5688 for questions regarding this notice.
Distribution Nationwide Distribution-including Washington, D.C. and the states of AL, AK, AZ, AR, CA, CO, CT, FL, GA, IL, IN, IA, KS, KY, LA, ME, MD, MI, MN, MO, MT, NV, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, TN, TX, UT, VA, WA, and WI.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = KNS and Original Applicant = THE OLYMPUS OPTICAL CO.
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