Olympus HF Cable
Brand(s)
Last updated
Summary
Product
Olympus HF Cable
Issue
Medical devices - Performance
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 |
|---|---|---|
| HF Cable | More 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.
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Gastroenterology and urology
Companies
Olympus Winter & Ibe GmbH
Kuehnstrasse 61, Hamburg, Hamburg, Germany, 22045
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-81789
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