Health product recall

8mm, Tip-Up Fenestrated Grasper, IS4000

Last updated

Summary

Product
8mm, Tip-Up Fenestrated Grasper, IS40
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 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 and 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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