Olympus Corporation of the Americas recalls URF-P6 Uretero-reno fiberscope and URF-P6R Uretero-reno fiberscope

Recall date

December 12, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1251-2017

FDA classification

Class II

Brand / firm

Olympus Corporation of the Americas

Sold / distributed

Distributed Nationwide

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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