| Class 2 Device Recall Intuitive Surgical EndoWrist Stabilizer Instrument |  |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = NAY
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