Health product recall

Olympus Air/Water Valves

Last updated

Summary

Product
Olympus Air/Water Valves
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products Lot or serial number Model or catalog number
Air/Water Valves All lots. MAJ-1444

Issue

Olympus discovered the MAJ-1444 may become damaged and result in loss of the one-way valve functionality by repeated automated endoscope reprocessing in Olympus OER machines. Specifically, when the MAJ-1444 is put into the washing case with other accessories of the ultrasonic endoscope, such as suction valve MAJ-1443, which may collide against each other causing damage. If the MAJ-1444 loses one-way valve functionality, body fluid could backflow into the air/water channel of the ultrasonic endoscopes during the procedure. There is no check that can be performed by users which evaluates one-way valve functionality. Therefore, a risk to patient health exists: 1) if the body fluid remains in the channel of the ultrasonic endoscopes following reprocessing, and 2) if the contaminated ultrasonic endoscope is used for the next patient without realizing the body fluid during the inspection, then a contaminated ultrasonic endoscope channel can cause transmission of infection.

Recall Start Date: July 13, 2023

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Gastroenterology & Urology
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-74000