8mm, Tip-Up Fenestrated Grasper, IS4000
Brand(s)
Last updated
Summary
Product
8mm, Tip-Up Fenestrated Grasper, IS40
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 |
|---|---|---|
8mm, Tip-Up Fenestrated Grasper, IS4000 |
All lots. |
470347-12 |
Issue
The tip-up fenestrated grasper has two versions on the approved product list (APL): 470347-11 and 470347-12. PN 470347-11 uses machined grips, while PN 470347-12 uses grips that have been manufactured via metal-injection molding (MIM). There have been complaints reported for a broken grip issue against the MIM grips. Grip breakage is observed on both upper and/or lower grips.
Recall start date: June 8, 2023
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Gastroenterology & Urology
Companies
Intuitive Surgical Inc.
1266 Kifer Road, Sunnyvale, California, United States, 94086
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-73855
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