Da Vinci Xi/X Sureform 45/60 Stapler
Brand(s)
Last updated
Summary
Product
Da Vinci Xi/X Sureform 45/60 Stapler
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 |
|---|---|---|
| Da Vinci Xi/X Sureform 60 Stapler | Multiple lots, contact manufacturer. | 480460-09 |
| Da Vinci Xi/X Sureform 45 Stapler | Multiple lots, contact manufacturer. | 480445-04 480545-04 |
Issue
Intuitive has observed an increase in complaints regarding engagement failures associated with Da Vinci x/xi Sureform 45 and 60 stapler instruments. This is related to specific lots and as a precautionary measure, this notice is being sent to raise awareness that there may be increased occurrences of these instruments failing to engage to the system.
Recall start date: October 18, 2022
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General and plastic surgery
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-72140
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