Recall Z-1836-2016
Intuitive Surgical, Inc. · initiated May 9, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
SEAL,IS4000 PORTS,5MM-8MM,BOX of 10; Model numbers: 470361-03, 470361-04, 470361-05, 470361-06; Part number: 470361. The da Vinci Xi Surgical System cannula sterile single use disposable cap for each cannula . When attached to the cannula, the seal maintains insufflation when the cannula is empty and when the instrument is inserted in the patient during a surgical procedure.
Codes / lots: All lots
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.
FDA-determined cause: Manufacturing material removal
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.
Details
- Recall number
- Z-1836-2016
- Initiated
- May 9, 2016
- Posted by FDA
- May 27, 2016
- Terminated
- November 1, 2016
- Product code
- GCY – Apparatus, Suction, Single Patient Use, Portable, Nonpowered
- Quantity
- 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, Puerto Rico, Portugal, Qatar, Romania, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, and United Kingdom.
- Recalling firm
- Intuitive Surgical, Inc., Sunnyvale, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1837-2016 Class II | SEAL,IS4000 PORTS,12MM&STAPLER,BOX of 10; Model numbers: 470380-04, 470380-05…Potential for particulates in insufflation stopcocks on the da Vinci Xi Surgical System cannula seals. The… | 05/09/2016Terminated |