Recall Z-1251-2017 ยท FBN Choledochoscope And Accessories, Flexible/Rigid
Olympus Corporation of the Americas
URF-P6 Uretero-reno fiberscope and URF-P6R Uretero-reno fiberscope
| Date | Dec 12, 2016 |
| Status | Terminated |
| Reason | Olympus is recalling the URF-P6/P6R endoscopes due to a similar device (URF-V2/V2R endoscopes) but not identical, where adverse event complaints associated with tissue trauma, perforation and insertion tubes which were stuck inside of patients that had to be surgically removed. In an effort to mitigate a potential risk to patient health, Olympus is undertaking this action to notify users of these complaints and the need for careful inspection of the endoscope prior to use in accordance with the instructions provided int heir notification letter. |
| Root cause | Under Investigation by firm |
| Action | Olympus sent an Urgent Medical Device Safety Notice dated December 29, 2016, to those that were affected by this issue. The letter addressed the corrective actions Olympus that were taken to address the issue. Consignees were asked to inspect their inventory for the specified device, review the enclosed Instructions for Safe Use, which provided instructions to assist with understanding the Warnings and Cautions. You can contact our Technical Assistance Center (TAC) at 1-(800) 848-9024, option 1, to answer any questions. |
| Quantity | 3461 units distributed to US consignees |
| Distribution | Distributed Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K912120 | URF-P2 URETERORENOFIBERSCOPE/CHOLEDOCHOFIBERSCOPE Olympus Corp., Aug 7, 1991 |