Duodenoscopes recalled after continued reports of positive cultures and infections
Olympus is recalling 7,023 EVIS EXERA III TJF-Q190V duodenovideoscopes after continued reports of positive cultures and infections, and is updating the reprocessing materials.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: Scored 4 under the significant injury criterion: the record states continued reports of positive cultures and infections have already occurred.
Plain-English summary
The Olympus EVIS EXERA III Duodenovideoscope, model TJF-Q190V, is being recalled across all serial numbers. The instrument is used with an Olympus video system centre, light source and documentation equipment.
Continued reports of positive cultures and infections have identified updates to the reprocessing materials to minimise potential deviations in TJF duodenoscope reprocessing. Olympus is informing users of these changes, reminding users to closely follow the operation and reprocessing instructions, and providing updated materials to users.
The recall covers 7,023 units carrying UDIs 04953170405563 and 04953170452024. The product was distributed nationwide in the United States. The FDA has classified the action as Class II.
Facilities using an affected duodenoscope should adopt the updated reprocessing materials and follow Olympus' instructions.
The recalled product
- Product
- Brand Name: EVIS EXERA III Duodenovideoscope Product Name: Olympus TJF-Q190V Model/Catalog Number: TJF-Q190V Product Description: This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy…
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Endoscope
- Affected units
- 7,023
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)
- Model/Catalog Number: TJF-Q190V
- UDI: 04953170405563 / 04953170452024
- Serial Numbers: All
Distribution
Distributed nationwide across the United States.
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