Olympus HF-Resection Electrode
Brand(s)
Last updated
Summary
Product
Olympus HF-Resection Electrode
Issue
Medical devices - Labelling and packaging
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 |
|---|---|---|
| HF-Resection Electrode | All lots. | WA22557C WA22657C |
| HF-Resection Electrode | All lots. | WA22538C WA22651C |
| HF-Resection Electrode | All lots. | WA22603S WA22742S WA22606S WA22702S WA22732S WA22643S WA22602S WA22637S WA22703S WA22705S WA22743S WA22706S WA22739S WA22607S WA22639S WA22737S WA22632S WA22642S WA22707S WA22605S |
| HF-Resection Electrode | All lots. | WA22723S WA22621S WA22721S WA22623S |
| HF-Resection Electrode | All lots. | WA22641S WA22666S WA22766S WA22741S |
| HF-Resection Electrode | All lots. | WA47760S |
| HF-Resection Electrode | All lots. | WA22521C WA22623C WA22621C WA22523C |
| HF-Resection Electrode | All lots. | WA22632D |
| HF-Resection Electrode | All lots. | WA22543S WA22305S WA22541S WA22566S WA22542S WA22544S WA22540S |
| HF-Resection Electrode | All lots. | WA22655C WA22355A WA22355C |
| HF-Resection Electrode | All lots. | A22221C A22224C A22255C A22201D A22259C WA22305D A22205D A22206C A22223C A22231C A22266C WA22351C A22251C A44728C WA22038C WA22302D A22206D A22207C WA22331D A22201C A22205C A22211C A22222C A22253C A22257C A22257D WA22037C A22202D A22250C WA22351A WA22539D A22202C A22231D A22258C WA22039C WA22301D A22203C |
| HF-Resection Electrode | All lots. | WA47705S WA47737S WA47732S WA47707S WA47739S WA47742S WA47743S WA47706S |
| HF-Resection Electrode | All lots. | WA22651S WA22751S WA22638S WA22738S |
| HF-Resection Electrode | All lots. | WA22760S WA22657S |
| HF-Resection Electrode | All lots. | WA47721S WA47723S |
| HF-Resection Electrode | All lots. | WA47738S WA47751S |
| HF-Resection Electrode | All lots. | WA47741S WA47766S |
| HF-Resection Electrode | All lots. | WA22332D WA22603D WA22507D WA22602D WA22306D WA22607D WA22537D WA22503D WA22558C WA22606D |
| HF-Resection Electrode | All lots. | WA47506S WA47540S WA47507S WA47560S WA47555S WA47505S WA47551S WA47566S |
| HF-Resection Electrode | All lots. | WA22740S WA22755S WA22644S WA22655S WA22640S WA22744S |
| HF-Resection Electrode | All lots. | WA47755S WA47740S WA47744S |
Issue
Olympus has initiated this recall after receiving complaints where the loop wire at the distal end of the HF resection electrode broke after getting in contact with metal objects, such as other endoscopic equipment, implants or stents. As a result, fragments can fall inside the patient and must be retrieved.
Recall start date: June 23, 2023.
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Gastroenterology and urology
Health products - Medical devices - General and plastic surgery
Health products - Medical devices - Ophthalmology
Companies
Olympus Winter & Ibe GmbH
Kuehnstrasse 61, Hamburg, Hamburg, Germany, 22045
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-73949
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