The da Vinci products should not be used in a clinical setting unless the institution has verified that these products are properly processed in accordance with the da Vinci System User's Manual. The EndoWrist ® Stapler for the da Vinci Xi ® System (IS4000) is not compatible for use with the da Vinci, da Vinci S ®, or da Vinci Si ® Surgical. Display search results with a default set of facets. Yes, but some documents can be ordered only as part of a set. To obtain a hard copy, submit a no-charge purchase order through the standard ordering process.
- Intuitive Surgical Da Vinci Xi User Manual Free
- Intuitive Da Vinci Si Catalog
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Intuitive Surgical Da Vinci Xi User Manual Free
![User User](/uploads/1/3/3/8/133867155/751576308.png)
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Intuitive sent a Field Safety Notice/Urgent Medical Device Correction letters dated March 22, 2016 by trackable mail method to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to 1. In addition to existing instructions for use, observe the following warning when manipulating the cardiac ablation probe, Use only the Cardiac Probe Grasper to manipulate a cardiac ablation probe. 2. Distribute a copy of this letter to all da Vinci S, Si, and Xi users at your facility. 3. Place a copy of this letter with your user manual. 4. Complete the attached Acknowledgement Form and return it to Intuitive Surgical as instructed. 5. Retain a copy of this letter and the Acknowledgement Form for your files. Intuitive Surgical will provide a user manual addendum to incorporate the warning related to this risk. For questions contact your Clinical Sales Representative or contact Intuitive Surgical Customer Service. | |||||||||||||||||||||||||||
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Worldwide Distribution - US Nationwide in the countries Australia, Belgium, Brazil, Canada, Chile, Finland, France, Germany, Greece, Iceland, India, Israel, Italy, Netherlands, Qatar, Russia, Singapore, South Korea, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, and United Kingdom. | |||||||||||||||||||||||||||
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. |
1Replya year ago | a year agointuitive davinci restoring lives of instruments Does any can restore lives on used instruments?Reply |
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Using the most advanced technology available today, theda VinciSurgical System enables surgeons to perform delicate and complex operations through a few tiny incisions with increased vision, precision, dexterity and control..