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Olympus tracheal intubation scopes
Official notice
4 Jul 2023
Last checked
4 Jul 2023
An official Health Canada notice concerns Olympus tracheal intubation scopes. The tracheal intubation scopes, LF-V and LF-P, have been listed as compatible with Olympus endoscope reprocessors (models OER-pro and OER-elite). The OER-pro endoscope reprocessor was the first Olympus model introduced among this series and was launched for the Americas in 2011. Olympus decided to remove these OER models as compatible for two tracheal intubation videoscopes, models LF-V and LF-P. As a result of an update to the "reprocessing medical devices in health care settings: validation methods and labeling" created by the FDA in 2015, Olympus conducted manual reprocessing validation according to the guidance. The LF-V and the LF-P are mainly used in an operating room and reprocessed in the central sterile supply department. Since OERs are not installed in the central sterile supply department / room, these scopes are rarely used after only high level disinfection with OERs. Therefore, Olympus decided not to pursue testing for LF-V and LF-P with OERs. In addition to removing the OERs from the compatible list of equipment, Olympus is also revising the instructions for use as a result of manual reprocessing validation to the updated guidance document. Recall start date: June 13, 2023 Published 2023-07-04.
What to do now
Contact the manufacturer if you require additional information.
Recall number
73892
Official notice
2023-07-04
The hazard
The hazard
The tracheal intubation scopes, LF-V and LF-P, have been listed as compatible with Olympus endoscope reprocessors (models OER-pro and OER-elite). The OER-pro endoscope reprocessor was the first Olympus model introduced among this series and was launched for the Americas in 2011. Olympus decided to remove these OER models as compatible for two tracheal intubation videoscopes, models LF-V and LF-P. As a result of an update to the "reprocessing medical devices in health care settings: validation methods and labeling" created by the FDA in 2015, Olympus conducted manual reprocessing validation according to the guidance. The LF-V and the LF-P are mainly used in an operating room and reprocessed in the central sterile supply department. Since OERs are not installed in the central sterile supply department / room, these scopes are rarely used after only high level disinfection with OERs. Therefore, Olympus decided not to pursue testing for LF-V and LF-P with OERs. In addition to removing the OERs from the compatible list of equipment, Olympus is also revising the instructions for use as a result of manual reprocessing validation to the updated guidance document. Recall start date: June 13, 2023
How to check if you're affected
How to check if you're affected
Compare the VIN on your vehicle against the official list. If your VIN is listed, follow the official notice.
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Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected vehicles were sold.
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Company & contacts
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Brand: Olympus Medical, Olympus Tracheal Intubation Scopes.
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Source & status
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Recall details
Recall details
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Documents, notices & source
See the official notice and source documents for full details.
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