Olympus Updates Manual Cleaning Instructions for Cysto-Nephro Videoscope
Olympus has updated cleaning instructions for the Model CYF-VH Cysto-Nephro Videoscope. Reusable cleaning brushes are no longer recommended for manual cleaning; single-use brushes remain compatible.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II FDA recall for a surgical videoscope used in invasive urological procedures. As a risk-of-harm medical device, it meets the High severity criterion. No illnesses or injuries have been reported in the source material.
Plain-English summary
Shirakawa Olympus Co., Ltd. has issued updated instructions for the Model CYF-VH Cysto-Nephro Videoscope, a reusable endoscope used in urological procedures. This change affects all units with UDI-DI numbers 04953170310461 and 04953170411250, regardless of serial number. Approximately 4,780 units are distributed in the United States.
The updated instructions specify that reusable cleaning brushes are no longer to be used for manual cleaning of this device. Single-use brushes remain compatible and should be used instead for manual cleaning.
This update has been classified as a Class II recall by the U.S. Food and Drug Administration. Healthcare facilities and medical professionals using this videoscope should obtain and implement the updated cleaning procedure immediately.
For questions or additional information about the updated instructions, contact Shirakawa Olympus Co., Ltd. directly.
The recalled product
- Product
- Model No. CYF-VH, CYSTO-NEPHRO VIDEOSCOPE
- Manufacturer
- Shirakawa Olympus Co., Ltd.
- Hazard
- improper-cleaning
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI-DI: 04953170310461
- 04953170411250 All serial numbers
Distribution
Distributed nationwide across the United States.
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