Health product recall

Single Use Distal Cover and EVIS EXERA III Duodenovideoscope

Last updated

Summary

Product
Single Use Distal Cover and EVIS EXERA III Duodenovideoscope
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

Single Use Distal Cover

All lots.

MAJ-2315

EVIS EXERA III Duodenovideoscope

All lots.

TJF-Q190V

Issue

The Single Use Distal Cover has been designed to be attached to Olympus duodenovideoscope to cover the distal end of the insertion tube and around the forceps elevator. The duodenovideoscope TJF-Q190V is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, endotherapy accessories and other ancillary equipment for endoscopy and endoscopic surgery.

Olympus has become aware that the single use distal cover MAJ-2315 may unexpectedly detach from the duodenoscope during use.

Recall Start Date: December 27, 2023

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Gastroenterology & Urology
Health products - Medical devices - Orthopaedics
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-74893

Get notified

Receive notifications for new and updated recalls and alerts by category.

Subscribe