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FDA-Device2022-06-22Class II

Olympus CYSTONEPHROFIBERSCOPE Model: CYF-5

Olympus Corporation of the Americas
Hazard

Incorrect adhesive used to secure the diopter ring and nameplate ring. Improperly connected diopter ring may result in the loss of adjustment function leading to a blurred field of vision and unintentional contact with the patients body and in rare cases perforation in the urinary tract/renal pelvis.

Sold states
CA FL MA MD MI NJ OH PR WI
Affected count
7 units
Manufactured in
3500 Corporate Pkwy, Center Valley, PA, United States
Products
Olympus CYSTONEPHROFIBERSCOPE Model: CYF-5

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1262-2022

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