Health product recall

Video Telescope - Endoeye HD II

Last updated

Summary

Product
Video Telescope - Endoeye HD II
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 catalogue number
Video Telescope - Endoeye HD II All lots. WA50040A WA50042A

Issue

Olympus has identified a total of 1003 complaints, including 372 adverse events (since September 2020 to August 2023) related to pink or green coloration of the image, including cases with reported delays of treatments and/or prolonged surgery. Olympus investigated the complaints and identified that the CCD chip that produces the image became damaged. The CCD chip is sensitive to heat and mechanical shocks. Olympus's risk management is taking this into account, and the instructions for use mention necessary steps to prepare the video telescope prior to usage. This medical device recall has been launched to remind customers to follow the steps in the instructions for use, especially to inspect the image prior to a clinical procedure, and always have a spare laparoscope available. 

Recall start date: November 8, 2023

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General and plastic surgery
Companies
Olympus Winter & Ibe Gmbh
Kuehnstrasse 61, Hamburg, Hamburg, Germany, 22045
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-74656