—#144647

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.

FDA product code: FDT — Duodenoscope And Accessories, Flexible/Rigid
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K024033
Affected lot / code info: Models: TJF-160F and TJF-160VF, all serial numbers

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Olympus Corporation of the Americas
Address: 3500 Corporate Pkwy PO Box 610, Center Valley, Pennsylvania 18034-0610

Distribution

Distribution pattern: Nationwide:

Timeline

Recall initiated: 2016-03-15
Terminated: 2018-02-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #144647. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.