Class 2 Device Recall IS3000 da Vinci Si" Surgical System

• Date Initiated by Firm: December 05, 2014
• Date Posted: January 07, 2015
• Recall Status: Terminated on March 03, 2015
• Recall Number: Z-0940-2015
• Recall Event ID: 69902
• 510(K)Number: K081137
• Product Classification: System,surgical,computer controlled instrument - Product Code NAY
• Product: IS3000 Vision Side Cart (VSC) used in conjunction with the da Vinci Si Surgical System IS3000.; Product number 371683-05/Model Number VS3000; ; The Intuitive Surgical Endoscopic Instrument Control System (Intuitive Surgical da Vinci Surgical System Model IS3000) 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 and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general cardiovascular and noncardiovascular thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures.
• Code Information: Product number 371683-05/Model Number VS3000 Serial numbers - USA: SH0018, SH0057, SH0097, SH0132, SH0165, SH0235, SH0019, SH0058, SH0098, SH0133, SH0167, SH0248, SH0021, SH0059, SH0099, SH0134, SH0168, USG015, SH0024, SH0060, SH0100, SH0135, SH0169, USG072, SH0025,SH0064, SH0101, SH0136, SH0170, USG146, SH0026, SH0065, SH0102, SH0137,SH0171, USG213, SH0029, SH0066, SH0103, SH0138, SH0172, USG317, SH0030, SH0067, SH0104, SH0139, SH0175, USG352, SH0031, SH0068, SH0105, SH0140, SH0177, USG353, SH0032, SH0069, SH0106 ,SH0141, SH0179 ,USG445, SH0033, SH0070, SH0107, SH0142, SH0180, USG519, SH0035, SH0071, SH0109, SH0143, SH0182, USG559, SH0036, SH0072, SH0110, SH0144, SH0184, USG631,SH0038, SH0073, SH0112, SH0145, SH0185, USG700, SH0039, SH0076, SH0113, SH0146, SH0186, USG701,SH0040, SH0077, SH0115, SH0147, SH0187, USG702, SH0041, SH0078, SH0117, SH0149, SH0188 ,USG703, SH0042, SH0079, SH0118, SH0150, SH0189, USG721, SH0044, SH0080, SH0119, SH0151, SH0190 ,USG728, SH0045, SH0081, SH0120, SH0152, SH0194, USG748, SH0046, SH0082, SH0121, SH0153, SH0196, USG750, SH0047, SH0085, SH0123, SH0154, SH020,2 USG764, SH0048, SH0088, SH0124, SH0155, SH0203, USG769, SH0050, SH0089, SH0125, SH0156, SH0204, USG770, SH0051 SH0090 SH0126 SH0157 SH0206 USG775, SH0052, SH0091, SH0127, SH0158, SH0211, USG786, SH0053, SH0092, SH0128, SH0159, SH0215,, USG787, SH0054, SH0094, SH0129, SH0160, SH0216, USG788, SH0055, SH0095, SH0130, SH0163, SH0223, SH0056, SH0096, SH0131, SH0164, SH0224, Out of US: SH0034,USG217, SH0086, SH0087, SH0028,SH0084,SH0111, SH0191, USG754, SH0114, SH0116, SH0063, SH0148, USG484, USG727, SH0161, SH0162, SH0061, SH0093, SH0238, USG726, SH0062, SH0037, USG806.
• 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: Intuitive Surgical is initiating a voluntary correction related to da Vinci Si System (IS3000) Vision Side Carts, with threaded-in caster wheels, which can result in the caster wheel bolts gradually unthreading and the wheels loosening.
• FDA Determined Cause: Device Design
• Action: The firm, Intuitive Surgical, sent an "Urgent Medical Device Correction" letter dated December 5, 2014 to all customers on December 5, 2014 by trackable method. The letter described the product, problem and actions to be taken. The customers were instructed to: ensure all affected personnel are fully informed of this notice; identify affected product, and retain a copy of this notice with your da Vinci Si user manual. Please note: the da Vinci Si Vision Side Cart can continue to be used safely. Ensure that all wheels are fully unlocked before attempting to move the Vision Side Cart. Avoid rolling the Vision Side Cart over uneven surfaces (i.e., over cables or a threshold). Intuitive Surgical is working on a newly designed wheel assembly. Upon availability, Field Service will retrofit the wheel assembly of the affected Vision Side Carts with the new design. If you need further information or support concerning this Medical Device Correction, please contact your Clinical Sales Representative or Intuitive Surgical Customer Service at the numbers listed below: ¿¿ North America and South America: 8008761310 Option 3 (6 a.m. to 5 p.m. PST) ¿¿ Japan: 0120565635 or 0355751362 (9 a.m. to 6 p.m. JST) ¿¿ South Korea: 0232713200 (9 a.m. to 6 p.m. KST) ¿¿ Europe, Middle East, Asia and Africa: +800 0821 2020 or +41 21 821 2020 (8 a.m. to 6 p.m.) or ics@intusurg.com
• Quantity in Commerce: 202
• Distribution: Worldwide Distribution: US (nationwide) and countries of: Belgium, France, Germany, Romania, India, Israel, Italy, South Korea, Norway, Slovak Republic, Spain, Sweden, Turkey, and 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.