FDA-Device2017-03-08Class II
Uretero-reno videoscope URF-V2 and URF-V2R endoscope and accessories The URF-V2/V2R endoscopes are intended for use in endoscopic diagnosis and treatment within the ureter and kidney.
Olympus Corporation of the Americas
Hazard
Olympus has received complaints regarding the breakage of the endoscope's insertion tube bending section during surgical procedures. Some of these complaints are associated with tissue trauma, including perforation, and insertion tubes which were stuck inside the patient and had to be surgically removed.
Sold states
Worldwide distribution-US Nationwide and country of: Canada.
Affected count
1,627 units (769 URF-V2 and 858 URF-V2R)
Manufactured in
3500 Corporate Pkwy, PO Box 610, Center Valley, PA, United States
Products
Uretero-reno videoscope URF-V2 and URF-V2R endoscope and accessories The URF-V2/V2R endoscopes are intended for use in endoscopic diagnosis and treatment within the ureter and kidney.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1252-2017Don't want to check this manually?
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