Colonoscope Repair Defect May Cause Device Malfunction and Contamination Risk
Aizu Olympus colonoscopes with improperly repaired light guide connectors may experience loss of image or suction failure. This could delay treatment and expose patients to contaminated material.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: FDA Class II recall affecting a medical device used in invasive procedures. While no illnesses or injuries have been reported, the defect poses a risk of patient contamination and infection through improper reprocessing and potential device malfunction.
Plain-English summary
Twenty-four units of the PCF-H190DL EVIS EXERA III colonovideoscope have been recalled due to improper repair. The devices have a defect in the light guide connector where missing adhesive fails to properly secure the suction channel mouthpiece to the scope connector.
This defect can result in loss of image, decreased suction, and inability to effectively reprocess the device. These issues may lead to unanticipated delays in treatment and patient exposure to contaminated material, which may result in infection.
The affected units were distributed domestically to Florida, Kentucky, Massachusetts, New Jersey, New York, and Pennsylvania. The recalled devices have serial numbers 2942716, 2604497, and 2502056.
The recalled product
- Product
- PCF-H190DL, EVIS EXERA III COLONOVIDEOSCOPE
- Manufacturer
- Aizu Olympus Co., Ltd.
- Category
- Medical Device — Endoscope
- Affected units
- 24
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 (3)
- UDI-DI 04953170363672 Serial Numbers 2942716
- 2604497
- 2502056
Distribution
Part of a larger recall action
This product is one of 5 recalled by Aizu Olympus Co., Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 5 products in this recall →Related recalls
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