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U.S. Department of Health and Human Services

Class 2 Device Recall EVIS EXERA II Duodenovideoscope OLYMPUS TJF TypeQ180V

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  Class 2 Device Recall EVIS EXERA II Duodenovideoscope OLYMPUS TJF TypeQ180V see related information
Date Initiated by Firm March 26, 2015
Date Posted September 22, 2015
Recall Status1 Terminated 3 on February 01, 2017
Recall Number Z-2807-2015
Recall Event ID 70858
510(K)Number K080403  
Product Classification duodenoscope and accessories, flexible/rigid - Product Code FDT
Product EVIS EXERA II Duodenovideoscope OLYMPUS TJF TypeQ180V.

This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitors, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.
Code Information Model: TJF-Q180V, all sold units
Recalling Firm/
Manufacturer		 Olympus America Inc.
3500 Corporate Pkwy.
P.O. Box 610
Center Valley PA 18034-0610
For Additional Information Contact Customer Support
800-848-9024 Ext. 1
Manufacturer Reason
for Recall		 New and validated reprocessing procedures have been issued for the Olympus TJF-Q180V duodenoscope ("TJF-Q180V"), consisting of revised manual cleaning and high level disinfection procedures.
FDA Determined
Cause 2		 Labeling design
Action The firm, Olympus, sent an "Urgent Safety Notification" dated March 26, 2015, to direct consignees/customers. The notification described the product, problem and actions to be taken. The notification contained new reprocessing procedures. The customers were instructed to immediately implement new precleaning and high level disinfection procedure; ensure that all personnel involved in the reprocessing are completely knowledgeable and thoroughly trained on the new reprocessing instructions; complete and return the enclosed questionnaire via fax to (484) 896-7128 and implement the new cleaning instructions when the new brushes arrive on/about May 8, 2015. If you have question, contact our Technical Assistance Center (TAC) at 1-800-848-9024, option 1, Monday-Friday between 7 AM EST - 8 PM EST. For additional information on this matter, contact V.P., Regulatory/Clinical Affairs & Quality Assurance at (484) 896-5688 or by email at laura.storms@olympus.com.
Quantity in Commerce 6109
Distribution Worldwide Distribution: US (nationwide) and countries of: Canada and Mexico.
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 = FDT and Original Applicant = OLYMPUS MEDICAL SYSTEMS CORPORATION
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