Events

Recall of Device Recall IS3000 da Vinci Si" Surgical System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Intuitive Surgical, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    69902
  • Event Risk Class
    Class 2
  • Event Number
    Z-0940-2015
  • Event Initiated Date
    2014-12-05
  • Event Date Posted
    2015-01-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-03-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131929
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System,surgical,computer controlled instrument - Product Code NAY
  • Reason
    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.
  • 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

Device

Device Recall IS3000 da Vinci Si" Surgical System
  • Model / Serial
    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.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Product Description
    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.
  • Manufacturer
    Intuitive Surgical, Inc.

Manufacturer

Intuitive Surgical, Inc.
  • Manufacturer Address
    Intuitive Surgical, Inc., 1266 Kifer Rd Bldg 100, Sunnyvale CA 94086-5304
  • Manufacturer Parent Company (2017)
    Intuitive Surgical Inc
  • Source
    USFDA