This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
DA VINCI SI SURGICAL SYSTEM (2016-03-24)
- Starting date:
- March 24, 2016
- Posting date:
- April 22, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-58002
Affected Products
A. DA VINCI SI SURGICAL SYSTEM
Reason
Intuitive Surgical is initiating a voluntary correction regarding the use of certain da Vinci EndoWrist instruments with a cardiac cryoablation probe. Intuitive Surgical has determined that microscopic metallic particulate can be generated during both robotic and non-robotic intra-cardiac surgery. The use of da Vinci instruments other than the cardiac probe grasper (e.g. large needle driver) to manipulate a cardiac cryoablation probe during da Vinci cardiac surgery has been shown to increase the amount of microscopic metallic particulate.
Affected products
A. DA VINCI SI SURGICAL SYSTEM
Lot or serial number
ALL Lots
Model or catalog number
550675
Companies
- Manufacturer
-
Intuitive Surgical
1266 Kifer Road, Building 101,
Sunnyvale
94086
California
UNITED STATES