Class 2 Device Recall da Vinci Si Surgical System

• Date Initiated by Firm: January 15, 2015
• Date Posted: February 03, 2015
• Recall Status: Terminated on March 03, 2015
• Recall Number: Z-1048-2015
• Recall Event ID: 70181
• 510(K)Number: K123463
• Product Classification: System,surgical,computer controlled instrument - Product Code NAY
• Product: da Vinci Si Surgical System, IS3000; - Wall chart for EndoWrist Stapler 45 System. Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
• Code Information: PN 410298-05, -06, -07, -08, -09
• Recalling Firm/ Manufacturer: Intuitive Surgical, Inc.; 1266 Kifer Rd Bldg 100; Sunnyvale CA 94086-5304
• For Additional Information Contact: Mark Johnson; 408-523-2100
• Manufacturer Reason for Recall: The Wall chart has been updated because it was noted that Wall Chart (PN 551524-03 Rev A) was inconsistent with the User Manual Adendum (PN 550986-07_B) with regards to neceassary sterilization dry time.
• FDA Determined Cause: Error in labeling
• Action: Medical Device Recall Replacement letters were sent to all customers on January 15, 2015. The letter identified the reason for the recall, the risk to health, affected products, and actions to be taken by the customer or user and the firm. Customers were asked to discard the existing EndoWrist Stapler Documentation and replace it with the new Documentation provided by the firm. Intuitive Surgical will ship replacement instruments at no charge to customers. Then customers were asked to reunite the replacement instruments with the additional components. The firm will retrain customers on the updated instructions for use. A Clinical Sales Representative or Intuitive Surgical Customer Service at 1-800-876-1310, should be contacted if further information or support is needed concerning the recall notification.
• Quantity in Commerce: 1,034
• Distribution: Nationwide Distribution
• Total Product Life Cycle: 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