Health Products

Olympus HF Cable

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Gastroenterology and urology
Product: Olympus HF Cable
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalogue number
HF CableMore than 10 numbers, contact manufacturer.WA00014A

Issue

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.

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