Events

Recall of Device Recall da Vinci Xi 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
    70705
  • Event Risk Class
    Class 2
  • Event Number
    Z-1303-2015
  • Event Initiated Date
    2015-03-03
  • Event Date Posted
    2015-03-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-09-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134525
  • 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
    Correction due to a fault that causes distal suj (dsuj) failures that indicates a mismatch between the positions reported by the redundant position sensors on one of the patient cart arm joints.
  • Action
    The firm, Intuitive Surgical, sent an "Urgent Medical Device Correction" letter dated March 11, 2015 to its consignees/customers on March 11, 2015 via Fed Ex. The letter described the product, problem and actions to be taken. The customers were instructed to ensure that all affected personnel are fully informed of this notice; forward this notice to your Risk Manager, OR Director, Purchasing Manager, biomedical Engineering staff and members of your medical staff who perform da Vinci Surgery procedures; Identify systems containing affected product at your site; if you encounter this error during a procedure and the fault cannot be recovered, disable the affected arm and contact dVStat; Contact Intuitive Surgical Customer Service; Complete and return the attached Acknowledgment Form to Intuitive Surgical via U.S. Fax +1 (408) 716-3040, or Scan and Email: isi.compliance@intusurg.com, ATTN: REGULATORY COMPLIANCE-Subject line for email: Pot to Encoder;and retain a copy of this notice for your records. An Intuitive Surgical representative will contact you to schedule a remote assessment to determine the health of your system and to schedule an appointment to replace the affected arm. 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: 800-876-1310, Option 3 (6 AM to 5 PM PST) -Japan: 0120-56-5635 or 03-5575-1362 (9 AM to 6 PM JST) -South Korea: 02-3271-3200 (9 AM to 6 PM KST) -Europe, Middle East, Asia and Africa: +800 0821 2020 or +41 21 821 2020 (8 AM to 6 PM CET) or ics@intusurg.com.

Device

Device Recall da Vinci Xi Surgical System
  • Model / Serial
    Material number: 380663-20; Serial numbers: 1311140532, 1311140035, 1311140475, 1311140424,  1311140196, 1311140146, 1311140252, 1311140010, 1311140289, 1311140578, 1311140435, 1311140349, 1311140411, 1311140389, 1311140156, 1311140198, 1311140452, 1311140186, 1311140554 1311140335, 1311140249. Material number 380663-21: Serial numbers: 1311140047, 1311140541, 1311140181, 1311140352 1311140023, 1311140165, 1311140159, 1311140126, 1311140571, 1311140397, 1311140130, 1311140318, 1311140180, 1311140151 1311140375, 1311140428, 1311140528, 1311140263, 1311140169 1311140443, 1311140537, 1311140544, 1311140419, 1311140006 1311140583, 1311140173, 1311140154.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) and countries of: Australia, Belgium, China, France, Germany, India, Israel, Italy, Norway, South Korea, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
  • Product Description
    da Vinci Xi Surgical System, IS4000; || ASSY,DISTAL SUJ,OUTER,IS4000, || Material number: 380663-20 and 380663-21. || The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endocopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, || endscopic retractors, electrocautery and accessories for edoscopic 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 labaroscopic surgical || procedures, general thorascopic surgical procedures and thorascopically-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