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U.S. Department of Health and Human Services

Class 2 Device Recall System,surgical,computer controlled instrument

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  Class 2 Device Recall System,surgical,computer controlled instrument see related information
Date Initiated by Firm May 09, 2016
Date Posted May 27, 2016
Recall Status1 Terminated 3 on November 01, 2016
Recall Number Z-1837-2016
Recall Event ID 74188
510(K)Number K140553  
Product Classification System,surgical,computer controlled instrument - Product Code NAY
Product SEAL,IS4000 PORTS,12MM&STAPLER,BOX of 10; Model numbers: 470380-04, 470380-05, 470380-06; Part number:470380. The da Vinci Xi Surgical System cannula seal is used with the cannula accessory and provides sterile 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 during a surgical procedure.
Code Information All lots
Recalling Firm/
Manufacturer		 Intuitive Surgical, Inc.
1266 Kifer Rd Bldg 100
Sunnyvale CA 94086-5304
For Additional Information Contact Mark Johnson
408-523-2100
Manufacturer 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 2		 Manufacturing material removal
Action 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.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = NAY and Original Applicant = INTUITIVE SURGICAL, INC.
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