| Class 2 Device Recall da Vinci S and Si Surgical System | |
Date Initiated by Firm | May 21, 2015 |
Date Posted | June 17, 2015 |
Recall Status1 |
Terminated 3 on July 02, 2018 |
Recall Number | Z-1812-2015 |
Recall Event ID |
71285 |
510(K)Number | K050369 |
Product Classification |
System,surgical,computer controlled instrument - Product Code NAY
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Product | Thoracic Grasper, 5 MM, for use with da Vinci S (IS2000) and SI (IS3000) Surgical Systems.
Intended for endoscopic manipulation of tissue, including grasping. |
Code Information |
version 420343-01 and 420323-02, all lots |
Recalling Firm/ Manufacturer |
Intuitive Surgical, Inc. 1266 Kifer Rd Bldg 100 Sunnyvale CA 94086-5304
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For Additional Information Contact | Mark Johnson 408-523-2100 |
Manufacturer Reason for Recall | The coating of the 5 mm Thoracic Grasper main tube may experience damage with the possibility of fragments of coating material dislodging and potentially falling into patient. |
FDA Determined Cause 2 | Nonconforming Material/Component |
Action | Urgent Medical Device Recall letters were sent to all consignees on May 21, 2015.
The letter describes the affected product and issue involved. Additionally, the risk to health, as well as the actions to be taken were also discussed in the letter. Customers are to ensure that all affected personnel were informed of the notice. All affected product are to be identified and returned by contacting Customer Service for a RMA. The Acknowledgment Form is to be completed and returned using the instructions provided. If further information or support concerning this recall is needed, customers are to contact their local Clinical Sales Representative or Intuitive Surgical Customer Service. |
Quantity in Commerce | 2,436 units |
Distribution | Worldwide Distribution -- US, Belgium, Brazil, Canada, Chile, Colombia,, Denmark, France, Germany, India, Netherlands, Panama, Singapore, South Korea, Switzerland, Taiwan, Turkey, and 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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