SEAL,IS4000 PORTS,5MM-8MM,BOX of 10; Model numbers: 470361-03, 470361-04, 470361-05, 470361-06; Part number: 470361. The
FDA device recall Z-1836-2016 · posted 2016-05-27 · Terminated
Recall details
- Recalling firm
- Intuitive Surgical, Inc.
- Reason for recall
- Potential for particulates in insufflation stopcocks on the da Vinci Xi Surgical System cannula seals. The particulates could be introduced into the cannula lumen when insufflation is connected during a surgical procedure.
- Action taken
- Upon discovery of the issue, Intuitive sent Urgent Product Safety Notices to all customers by e-mail to initially alert them of the situation. This will be followed by a formal letter that is scheduled to arrive on May 23, 2016. Both notification request that users Do NOT use the da Vinci Xi 5 mm8 mm Universal Cannula Seal or the da Vinci Xi 12 mm & Stapler Universal Cannula Seal for insufflation, or open the stopcock during intracardiac procedures.
- Root cause
- Manufacturing material removal
- Status
- Terminated
- Product code
- GCY
- Quantity affected
- 46, 191 boxes - total both sizes
- Distribution
- Worldwide distribution. US, Australia, Austria, Belgium, Chile, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Monaco, Netherlands, Norway,
- Date initiated
- 2016-05-09
- Date posted
- 2016-05-27
- Date terminated
- 2016-11-01
- Location
- Sunnyvale, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 8MM TROCAR KIT (K133845) | Intuitive Surgical | 2014-02-19 |