PlainRecalls
FDA Devices Moderate Class II Terminated

URF-P6 Uretero-reno fiberscope and URF-P6R Uretero-reno fiberscope

Reported: March 8, 2017 Initiated: December 12, 2016 #Z-1251-2017

Product Description

URF-P6 Uretero-reno fiberscope and URF-P6R Uretero-reno fiberscope

Reason for Recall

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.

Details

Units Affected
3461 units distributed to US consignees
Distribution
Distributed Nationwide
Location
Center Valley, PA

Frequently Asked Questions

What product was recalled?
URF-P6 Uretero-reno fiberscope and URF-P6R Uretero-reno fiberscope. Recalled by Olympus Corporation of the Americas. Units affected: 3461 units distributed to US consignees.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on March 8, 2017. Severity: Moderate. Recall number: Z-1251-2017.