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Olympus Corporation of the Americas recalls URF-P6 Uretero-reno fiberscope and URF-P6R Uretero-reno fiberscope
Recalled March 8, 2017 · FDA recall Z-1251-2017 · Olympus Corporation of the Americas
Hazard
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. · FDA Class II
Units
3461 units distributed to US consignees
Sold at
Distributed Nationwide
Description
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.
Product
URF-P6 Uretero-reno fiberscope and URF-P6R Uretero-reno fiberscope
Manufacturer(s)
Olympus Corporation of the Americas
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →