Sigmoidovideoscope models recalled due to improper channel drying process
Aizu Olympus sigmoidovideoscope (model PCF-S) units are being recalled due to an unvalidated channel drying process. Some repaired units returned with water in channels, risking contamination and infection.
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 medical device recall with no reported illnesses or injuries. The hazard poses a risk of infection from contamination in surgical endoscopes, but no incidents have occurred. Per the severity rubric, this qualifies as 'High' for a risk-of-harm product without reported injury.
Plain-English summary
Aizu Olympus Co., Ltd. is recalling sigmoidovideoscope units (model PCF-S, UDI-DI 04953170339912). Sigmoidovideoscopes are medical devices used for endoscopy and endoscopic surgery in the lower digestive tract, including the anus, rectum, and sigmoid colon. Eight units distributed nationwide and worldwide are affected by this recall.
The channel air drying process used on these devices was not properly validated. Following servicing and repair, a small percentage of scopes returned to customers had water remaining in their channels. Water in the channels creates the potential for contamination, which could lead to infection.
Healthcare facilities and medical professionals using affected sigmoidovideoscopes should immediately discontinue use and contact Aizu Olympus Co., Ltd. for further guidance. Devices should not be used until they have been properly serviced to address the wet-channel issue.
The recalled product
- Product
- Signmoidovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum and sigmoid colon). Model Number: PCF-S.
- Manufacturer
- Aizu Olympus Co., Ltd.
- Category
- Medical Device — Endoscopy
- Hazard
- water-contamination
- infection-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)
- Model Number (UDI-DI): PCF-S (04953170339912).
Distribution
Distributed nationwide across the United States.
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