• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall da Vinci S and Si Surgical System

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall da Vinci S and Si Surgical Systemsee related information
Date Initiated by FirmMay 21, 2015
Date PostedJune 17, 2015
Recall Status1 Terminated 3 on July 02, 2018
Recall NumberZ-1812-2015
Recall Event ID 71285
510(K)NumberK050369 
Product Classification System,surgical,computer controlled instrument - Product Code NAY
ProductThoracic 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
For Additional Information ContactMark 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
ActionUrgent 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 Commerce2,436 units
DistributionWorldwide 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 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
-
-