Health Products

EVIS EXERA III Duodenovideoscope

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Gastroenterology and urology
Product: EVIS EXERA III Duodenovideoscope
Issue: Medical devices - Labelling and packaging
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalogue number
EVIS EXERA III DuodenovideoscopeAll lots.TJF-Q190V

Issue

Olympus is conducting this recall following recent post-market surveillance data suggesting a possible association of higher microbial contamination levels from TJF duodenoscopes when manual cleaning was delayed beyond one hour and a presoak was performed, compared to those TJF duodenoscopes where manual cleaning began within one hour after patient procedure. the reprocessing manual for the TJF-Q190V has been updated to remove the presoak step and includes instructions that require manual cleaning to begin within one hour after patient procedure for the TJF duodenoscope. Recall start date: May 9, 2025

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