Device product
URF-P6 Uretero-reno fiberscope and URF-P6R Uretero-reno fiberscope
Z-1251-2017
Product summary
- Event
- Event 75990
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3461 units distributed to US consignees
- Official record key
device-enforcement:Z-1251-2017
Official wording
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.
Code information: All serial numbers are affected.
Distribution pattern: Distributed Nationwide
Derived failure modes
-
Unknown
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.