Health product recall

Evis Exera III Video System - Gastrointestinal Videoscope

Last updated

Summary

Product
Evis Exera III Video System - Gastrointestinal Videoscope
Issue
Medical devices - Sterility
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

Evis Exera III Video System - Gastrointestinal Videoscope

All lots

GIF-1TH190

Issue

The GIF-1TH190 reprocessing manual has instructions for either High Level Disinfection (HLD) reprocessing or Ethylene Oxide Gas (EOG) sterilization after endoscope cleaning. As a result of testing, Olympus discovered EOG sterilization failures in which the GIF-1TH190 failed to achieve sterilization following the GIF-1TH190's reprocessing manual. As a result of the subsequent investigation, Olympus determined that changes are required to the endoscope's channel drying steps following cleaning and prior to EOG sterilization in order to ensure effective endoscope sterilization. Accordingly, Olympus has updated the instructions for the endoscope channel's drying process and validated that the new, updated channel drying steps will result in GIF-1TH190 endoscope EOG sterilization. The revised instructions for the "dry the endoscope" in chapter 5.7 of the GIF-1TH190 reprocessing manual are provided in a supplied addendum.

Recall start date: October 11, 2023

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
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-74508

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