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U.S. Department of Health and Human Services

Class 2 Device Recall Intuitive Surgical EndoWrist Stabilizer Instrument

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  Class 2 Device Recall Intuitive Surgical EndoWrist Stabilizer Instrument see related information
Date Initiated by Firm February 16, 2015
Date Posted February 27, 2015
Recall Status1 Terminated 3 on July 01, 2015
Recall Number Z-1226-2015
Recall Event ID 70441
510(K)Number K060391  K080291  
Product Classification System,surgical,computer controlled instrument - Product Code NAY
Product Vacuum Source Tubing Set for the EndoWrist Stabilizer for da Vinci S (IS2000) and Si (IS3000);
Part number 420187-05.

The Intuitive Surgical EndoWrist Stabilizer Instrument is intended to be used with the fourth arm of the da Vinci S Surgical System. The Intuitive Surgical EndoWrist Stabilizer Instrument is intended to stabilize the epicardial surface of the non-arrested heart during coronary artery surgery.
Code Information all PN 410187-05
Recalling Firm/
Manufacturer		 Intuitive Surgical, Inc.
1266 Kifer Rd Bldg 100
Sunnyvale CA 94086-5304
For Additional Information Contact Shahbaz Kahn
408-523-2443
Manufacturer Reason
for Recall		 There is the possibility that the Vacuum Source Tubing set for the Endo Wrist Stabilizer may have the outer pouch compromised during shipping, resulting in small pinholes which compromise the sterility of the pouches outer surface.
FDA Determined
Cause 2		 Under Investigation by firm
Action Urgent Medical Device Recall letters were sent on February 16, 2015
Quantity in Commerce 706 units
Distribution US and Belgium, Brazil, Canada, China, Finland, France, Greece, India, Italy, Japan, Qatar, Russia, Saudi Arabia, South Korea, Spain, Switzerland, Taiwan, Turkey, 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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