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U.S. Department of Health and Human Services

Class 2 Device Recall da Vinci S Surgical System

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 Class 2 Device Recall da Vinci S Surgical Systemsee related information
Date Initiated by FirmMarch 16, 2016
Create DateApril 12, 2016
Recall Status1 Terminated 3 on July 01, 2016
Recall NumberZ-1376-2016
Recall Event ID 73649
510(K)NumberK050369 
Product Classification System,surgical,computer controlled instrument - Product Code NAY
Productda Vinci S Surgical System (IS1200/IS2000/IS3000) user manual, instrument & accessory. Product Usage: The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave ablation probes and accessories during urologic surgical procedures, general laparoscopic surgical procedures, gynecological laparoscopic surgical procedures, general noncardiovascular thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization.It is intended for use by trained physicians in an operating room environment in accordance with the representative specific procedures set forth in the Professional Instructions for Use.
Code Information Model 550675; IS1200/IS2000/IS3000 - User Manual, Instrument & Accessory - all languages.
Recalling Firm/
Manufacturer		 Intuitive Surgical, Inc.
1266 Kifer Rd Bldg 100
Sunnyvale CA 94086-5304
For Additional Information ContactMark Johnson
408-523-2100
Manufacturer Reason
for Recall		Intuitive Surgical has found that the use of instruments other than the Cardiac Probe Grasper (e.g. Large Needle Driver Instrument) to manipulate the ablation probes during cardiac surgery can result in an increase of microscopic metallic particulates generated from the contact with the probes.
FDA Determined
Cause 2		Device Design
ActionIntuitive 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.
Quantity in Commerce248 - all models
DistributionWorldwide 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.
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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