Olympus Tracheal Intubation Scopes

Issue

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

What you should do

• Contact the manufacturer if you require additional information.