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U.S. Department of Health and Human Services

Class 2 Device Recall EVIS EXERA Duodenovideoscope OLYMPUS TJF 160F/VF

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  Class 2 Device Recall EVIS EXERA Duodenovideoscope OLYMPUS TJF 160F/VF see related information
Date Initiated by Firm March 15, 2016
Create Date May 31, 2016
Recall Status1 Terminated 3 on February 06, 2018
Recall Number Z-1845-2016
Recall Event ID 73640
510(K)Number K024033  
Product Classification duodenoscope and accessories, flexible/rigid - Product Code FDT
Product EVIS EXERA Duodenovideoscope Olympus TJF Type 160F/VF
used with an Olympus video system center, light source, documentation equipment monitors, Endo Therapy accessories and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.
Code Information Models: TJF-160F and TJF-160VF, all serial numbers
Recalling Firm/
Manufacturer		 Olympus Corporation of the Americas
3500 Corporate Pkwy
PO Box 610
Center Valley PA 18034-0610
Manufacturer Reason
for Recall		 New reprocessing instructions for the Olympus TJF-160/VF duodenoscopes, consisting of revised manual cleaning and high level disinfection procedures they plan to implement as well as a new cleaning brush (MAJ-1534), which is enclosed with the notification.
FDA Determined
Cause 2		 Under Investigation by firm
Action Olympus notified customers on 03/14/2016 via an Urgent Safety Notification letter that referenced discontinuation of previously distributed copies of the TJF-160F/VF Reprocessing Manual. Customers were asked to inspect their inventory and discard any existing inventory of TJF-160F/VF Reprocessing Manuals. They were asked to update their information with the enclosed TJF-160F/VF Reprocessing Manual, which contains new brushing and flushing steps for the TJF-160F/VF elevator mechanisms and the forceps elevator recesses. Instuctions for cleaning and a new cleaning brush (used for cleaning the device) was included with the notification. Customers were asked to ensure all reprocessing personnel are completely knowledgeable and throughly training on the new reprocessing instructions in the new Reprocessing Manual.
Distribution Nationwide:
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 OPTICAL CO., LTD.
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