CanadaThe Olympus HF Cable (model/catalogue number WA00014A; affected lot or serial numbers include more than 10 numbers — contact the manufacturer) is being recalled. A complaint reported a thermal event during a procedure causing a user burn; investigation found the device was used beyond its IFU-defined service life, resulting in insulation wear, corrosion and failure, and a four-year review identified 109 complaints including 17 minor burns and no serious injuries. Contact the manufacturer for additional information.
What's being recalled
Companies: Olympus Winter & Ibe GmbH, Kuehnstrasse 61, Hamburg, Hamburg, Germany, 22045.
How to identify it
Affected products: HF Cable; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: WA00014A
The hazard
Olympus received a complaint involving a thermal event with an HF cable during a procedure, causing a user burn. Investigation showed the device was used beyond IFU-defined service life, leading to insulation wear, corrosion, and failure. A four-year review identified 109 complaints, with no serious injuries and 17 minor burns.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)