Recall Z-1845-2016 ยท FDT Duodenoscope And Accessories, Flexible/Rigid
Olympus Corporation of the Americas
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.
| Date | Mar 15, 2016 |
| Status | Terminated |
| Reason | 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 | 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 th |
| Distribution | Nationwide: |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K024033 | XTJF-160AF DUODENOVIDEOSCOPE Olympus Optical Co., Ltd., Dec 20, 2002 |