Various Olympus Medical Systems Corp.'s Bronchofibervideoscope… — recall 58901
Health Canada — Medical Devices · Canada · 2018-11-30 · Type II
As described by Health Canada — Medical Devices: Various Olympus Medical Systems Corp.'s Bronchofibervideoscope, Bronchofiberscope and Laryngoscope products (2018-09-26)
🏛Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Reported risk: Olympus received a complaint outside of Canada claiming that patients were infected after a bronchoscopy procedure in which a BF-1T180 bronchoscope with a loosened instrument channel port was used. As a result of Olympus's investigation, it was discovered that the attachment of non-Olympus accessories to the bronchoscope's instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port. In an effort to maximize patient safety and mitigate any potential risk to patient health, Olympus is notifying users of this complaint and the need for careful inspection of the endoscope's instrument channel port prior to use in accordance with the instructions provided. Additionally, Olympus is providing updated Instruction For Uses (IFU).
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