FDA-Device2026-03-04Class II
Olympus Inner Sheath. Model No. A2641. for endoscopic diagnosis and treatment in urological applications.
Olympus Corporation of the Americas
Hazard
Complaints of the ceramic tip of the resection sheath breaking have been received.
Sold states
US Nationwide Distribution.
Affected count
0 units
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
Olympus Inner Sheath. Model No. A2641. for endoscopic diagnosis and treatment in urological applications.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1455-2026Original summary
Olympus Inner Sheath. Model No. A2641. for endoscopic diagnosis and treatment in urological applications. Complaints of the ceramic tip of the resection sheath breaking have been received. Model No. A2641; UDI: 04042761004060; All Lots. Distribution: US Nationwide Distribution. Affected quantity: 0 units
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