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Large Needle and Mega Needle Drivers for Da Vinci systems (2013-11-15)
- Starting date:
- November 15, 2013
- Posting date:
- March 18, 2014
- 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-38277
Recalled Products
Large Needle and Mega Needle Drivers for Da Vinci systems
Reason
A potential performance issue has been identified with the product from certain lots in which the carbide insert may break or become detached from the instrument.
Affected products
A. Large Needle Driver, Da Vinci Standard
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
400006
Companies
- Manufacturer
-
Intuitive Surgical
1266 Kifer Road, Building 101
Sunnyvale
94086
California
UNITED STATES
B. Mega Needle Driver, Da Vinci Standard
Lot or serial number
M10090724
M10100429
M10100527
M10100713
M10101217
M10110117
M10110208
M10110811
M10110913
Model or catalog number
400194
Companies
- Manufacturer
-
Intuitive Surgical
1266 Kifer Road, Building 101
Sunnyvale
94086
California
UNITED STATES
C. Mega Needle Driver, Da Vinci S And Da Vinci Si
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
420194
Companies
- Manufacturer
-
Intuitive Surgical
1266 Kifer Road, Building 101
Sunnyvale
94086
California
UNITED STATES
D. Large Needle Driver, Da Vinci And Da Vinci Si
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
420006
Companies
- Manufacturer
-
Intuitive Surgical
1266 Kifer Road, Building 101
Sunnyvale
94086
California
UNITED STATES