Health product recall

Olympus Tracheal Intubation Scopes

Last updated

Summary

Product
Olympus Tracheal Intubation Scopes
Issue
Medical devices - Device compatibility
Medical devices - Labelling and packaging
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalogue number

Endoscope Reprocessor Oer-Elite

All lots.

OER-ELITE

Endoscope Reprocessor Oer-Pro

All lots.

OER-PRO

Visera Tracheal Intubation Videoscope Olympus Lf Type V

All lots.

LF-V

Tracheal Intubation Fiberscope Olympus Lf-P

All lots.

LF-P

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

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Anaesthesiology
Health products - Medical devices - Gastroenterology and urology
Health products - Medical devices - General hospital and personal use
Companies
Olympus Medical Systems Corp.
2951 Ishikawa-Cho, Hachioji-Shi, Tokyo-To, Japan, 192-8507
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-73892

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