Class 2 Device Recall ASSEMBLY, PATIENT SIDE CART, PS4000

• Date Initiated by Firm: September 11, 2014
• Date Posted: September 30, 2014
• Recall Status: Terminated on October 23, 2014
• Recall Number: Z-2731-2014
• Recall Event ID: 69213
• 510(K)Number: K131861
• Product Classification: System,surgical,computer controlled instrument - Product Code NAY
• Product: ASSEMBLY, PATIENT SIDE CART, PS4000 used with the da Vinci Xi Surgical System.; ; Product Usage: The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximations, ligation, electrocautery, suturing and delivery and placement of microware and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use. It is intended to be used 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: PATIENT SIDE CART, PS4000. Part Number: 380652 Serial Numbers: 353668 351929 354943 351749 354389 351849 355824 363594 361993 360419 358104 357083 351852 351845 361323 358107 364412 364505 361994 364001 349166 364112 358774 359361 357082 363784 353632 364343 358109 358848 351052 354234 354552 356258 363752 354233 358775 364200 359222 364619 363868 354714 361989 361391 361094 351853 353410 355206 357698 358480 365395 359223 355996 363681 360417 355623 365465 365839 356530 364620 365928 365862 356532 366904 366884 367674 368046 367426 356683 360413 356533 368071 368681 358930 357081.
• 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: Correction due to the detection of a motor sensor failure in the Patient Cart instrument arms of the da Vinci Xi (IS4000) Surgical Systems after a mid-procedure restart.
• FDA Determined Cause: Other
• Action: Intuitive sent an Urgent Medical Device Correction letter dated September 11, 2014 to all consignees via trackable mail system. Letters identified the issue and provides information for users should a error code be displayed. For questions contact your Clinical Sales Representative or Intuitive Surgical Customer Service
• Quantity in Commerce: 75 devices
• Distribution: Worldwide Distribution - US nationwide and the countries of: Belgium, Germany, China(Hong Kong), India, Israel, Italy, and the United Kingdom.
• 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 and Original Applicant = INTUITIVE SURGICAL, INC.