Disposable Rotatable Clip Fixing Device
Brand(s)
Last updated
Summary
Product
Disposable Rotatable Clip Fixing Device
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 catalog number |
|---|---|---|
| Disposable Rotatable Clip Fixing Device | Contact the manufacturer. | HX-201LR-135 HX-201UR-135 |
Issue
Olympus has received complaints that the clip did not come out of the tube sheath during the procedure. investigation by Olympus confirmed the tube sheath is longer than specifications which prevents the clip from being extended. Absence of treatment, prolonged episode of care, and unexpected medical intervention are the potential harms associated with clip nondeployment.
Recall start date: February 23. 2023
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General and plastic surgery
Companies
Olympus Medical Systems Corp.
2951 Ishikawa-Cho, Hachioji-Shi, Tokyo-To, Japan, 192-8507
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-73339
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