Health product recall

Olympus Pulmonary Endoscopes

Last updated

Summary

Product
Olympus Pulmonary Endoscopes
Issue
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

Tracheal Intubation Fiberscopes

All lots.

LF-DP
LF-P
LF-GP
LF-TP

Evis Exera II Ultrasonic Bronchofibervideoscope

All lots.

BF-UC180F

Tracheal Intubation Fiberscope

All lots.

LF-P

Evis Exera III Bronchofibervideoscope

All lots.

BF-MP190F

Airway Mobilescope

All lots.

MAF-DM2
MAF-GM2

Evis Eus Ultrasound Bronchofibervideoscope

All lots.

BF-UC190F

Airway Mobilescope- General

All lots.

MAF-GM

Airway Mobilescopetherapeautic

All lots.

MAF-TM

Evis Exera III Video System - Bronchovideoscope

All lots.

BF-1TQ180
BF-P180
BF-Q180-AC
BF-Q180
BF-1T180

Evis Exera Video System - Bronchofibervideoscopes

All lots.

BF-MP160F
BF-XP160F

Visera Trachael Intubation Videoscope

All lots.

LF-V

Evis Exera Video Sytem - Bronchovideoscope

All lots.

BF-3C160
BF-XT160

Oes Bronchofiberscopes

All lots.

BF-P60
BF-N20
BF-1T60
BF-XP60
BF-MP60
BF-3C40

Evis Exera III Video System - Bronchovideoscope

All lots.

BF-XT190
BF-P190
BF-1TH190
BF-H190
BF-Q190
BF-XP190

Airway Mobilescope

All lots.

MAF-TM2

Issue

Olympus has received three complaints, including one that was associated with an injury, that upon trying to use an Olympus pulmonary endoscope model with an endotracheal tube, the tip became lodged (entrapped) inside the endotracheal tube connector. As a result of the complaint investigation, it was determined that the scope (bending section) was too large for the endotracheal tube connector. Selection of an endotracheal tube where the size is incompatible with the Olympus airway mobilescope can result in delayed procedures, foreign body obstruction, failure to ventilate the patient, hemorrhage, upper airway tract injury, esophageal perforation, and/or airway mobilescope damage.

In an effort to maximize patient safety and mitigate any potential risk to patient health, Olympus is providing the following information related to using an endotracheal tube:

• before inserting the airway mobilescope with an endotracheal tube into the patient, slide the tube along the entire length of the airway mobilescope insertion section to confirm that the insertion section of the airway mobilescope can be inserted smoothly into the endotracheal tube. If it cannot be inserted smoothly, the covering material of the bending section of the airway mobilescope or the external surface of the insertion section may be damaged. When using a lubricant, make the above confirmation before applying the lubricant.

In the event the endotracheal tube cannot slide smoothly over the insertion section of the airway mobilescope, select another size tube, or inspect scope for damage.

Olympus  is undertaking this action to provide an IFU addendum which specify the correct maximum scope diameter information.

Recall start date: July 28, 2023

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Anaesthesiology
Health products - Medical devices - Ear, nose and throat
Health products - Medical devices - Gastroenterology and urology
Health products - Medical devices - General and plastic surgery
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-74122

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