Videoscope Cleaning Instructions Updated: Reusable Brushes No Longer Compatible
Shirakawa Olympus updated cleaning instructions for VISERA Cysto-Nephro Videoscopes, recommending removal of reusable brushes from manual cleaning procedures. Single-use brushes remain compatible.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This FDA Class II device recall consists of an instruction update with no reported illnesses, injuries, or hospitalization. The hazard is theoretical—improper cleaning could compromise device function—making this a voluntary precautionary measure, which falls under Moderate severity.
Plain-English summary
Shirakawa Olympus Co., Ltd. is updating the instructions for use for the Model CYF-V2R VISERA Cysto-Nephro Videoscope, a reusable medical device used in urological and nephroscopic procedures.
The updated instructions specify that reusable cleaning brushes should no longer be used in manual cleaning procedures for this device. Single-use brushes remain compatible and should be used instead. This change applies to all devices distributed in the United States and overseas.
Approximately 608 units were distributed nationwide in the United States, with an additional 1,264 units distributed outside the United States. Healthcare facilities and medical professionals using this device should implement the updated cleaning protocol immediately.
Facilities should review the updated instructions for use and transition to single-use brushes for manual cleaning procedures. Devices currently in use should be cleaned according to the new protocol going forward.
The recalled product
- Product
- Model No. CYF-V2R, VISERA Cysto-Nephro Videoscope
- Manufacturer
- Shirakawa Olympus Co., Ltd.
- Hazard
- improper-cleaning
- contamination-risk
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 (1)
- UDI-DI: 04953170339523 04953170411212 All serial numbers
Distribution
Distributed nationwide across the United States.
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