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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 Instrumentsee related information
Date Initiated by FirmFebruary 16, 2015
Date PostedFebruary 27, 2015
Recall Status1 Terminated 3 on July 01, 2015
Recall NumberZ-1226-2015
Recall Event ID 70441
510(K)NumberK060391 K080291 
Product Classification System,surgical,computer controlled instrument - Product Code NAY
ProductVacuum 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 ContactShahbaz 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
ActionUrgent Medical Device Recall letters were sent on February 16, 2015
Quantity in Commerce706 units
DistributionUS 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 CycleTPLC 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) Database510(K)s with Product Code = NAY
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