Events

Recall of Device Recall Intuitive Surgical da Vinci Si Surgical System (IS3000)

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
    59300
  • Event Risk Class
    Class 2
  • Event Number
    Z-2930-2011
  • Event Initiated Date
    2011-07-05
  • Event Date Posted
    2011-08-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-09-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102226
  • 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
    Potential failure of the retention component of the master tool manipulator (mtm) of the intuitive surgical da vinci si surgical system which could cause uncontrolled movement.
  • Action
    Intuitive Surgical sent an "URGENT- MEDICAL DEVICE CORRECTION" letter dated July 1, 2011 to all affected customers. Customers were asked to complete the attached response form and return as per the instructions. The letter identifies the product, problem, and actions to be taken by the customers. The letter reinforce to customers to follow the product labeling WARNING. The letter states that all affected customers sites will be receiving a call from a Customer Support staff to schedule a retrofit of the component. A letter was also sent to non affected customers to inform them of the urgent medical device correction and actions to be taken. If you have any questions, please contact Customer Service at 1-800-876-1310 or for Outside United States call +41 21 821 2020.

Device

Device Recall Intuitive Surgical da Vinci Si Surgical System (IS3000)
  • Model / Serial
    serial numbers: SH0019 SH0021 SH0028 SH0037 SH0039 SH0042 SH0059 SH0061 SH0062 SH0063 SH0071 SH0078 SH0082 SH0084 SH0085 SH0086 SH0095 SH0099 SH0103 SH0111 SH0112 SH0114 SH0116 SH0117 SH0118 SH0120 SH0125 SH0126 SH0127 SH0130 SH0131 SH0135 SH0143 SH0148 SH0150 SH0155 SH0156 SH0160 SH0176 SH0177 SH0180 SH0193 SH0208 SH0210 SH0220 SH0221 SH0222 SH0224 SH0225 SH0228 SH0246 SH0251 SH0252 SH0256 SH0258 SH0270 SH0271 SH0273 SH0285 SH0286 SH0291 SH0303 SH0305 SH0307 SH0308 SH0312 SH0314 SH0320 SH0328 SH0332 SH0335 SH0336 SH0340 SH0342 SH0343 SH0344 SH0363 SH0369 SH0373 SH0378 SH0380 SH0381 SH0388 SH0393 SH0408 SH0411 SH0412 SH0416 SH0434 SH0441 SH0443 SH0447 SH0448 SH0449 SH0463 SH0464 SH0465 SH0467 SH0469 SH0470 SH0482 SH0483 SH0491 SH0495 SH0497 SH0500 SH0506 SH0511 SH0516 SH0517 SH0518 SH0528 SH0531 SH0533 SH0534 SH0543 SH0547 SH0555 SH0557 SH0558 SH0560 SH0565 SH0570 SH0574 SH0579 SH0585 SH0589 SH0591 SH0600 SH0608 SH0618 SH0620 SH0625 SH0627 SH0630 SH0631 SH0639 SH0644 SH0653 SH0657 SH0658 SH0659 SH0660 SH0663 SH0664 SH0665 SH0668 SH0671 SH0672 SH0680 SH0687 SH0691 SH0692 SH0696 SH0697 SH0701 SH0705 SH0706 SH0708 SH0712 SH0713 SH0721 SH0729 SH0730 SH0741 SH0744 SH0747 SH0762 SH0764 SH0774 SH0798 SH0807 SH0813 SH0834 SH0900 USG172 USG317 USG484 USG702 USG713 USG718 USG775 USG806
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA (nationwide) and the countries of: Belgium, Czech Republic, Denmark, France, Germany, Greece, India, Ireland, Israel, Italy, Netherlands, Norway, Philippines, Portugal, Saudi Arabia, Singapore, South Korea, Spain, Switzerland, Turkey and United Kingdom.
  • Product Description
    Intuitive Surgical da Vinci Si Surgical System (IS3000); || Mfg by: Intuitive Surgical, Sunnyvale, CA 94086 || Product Usage: Intended to assist in the accurate control of Intuitive Surgical Endoscopic Endo Wrist Instruments and Accessories. The system is indicated for adult and pediatric use (except for transoral otolaryngology surgical procedures). It is intended for use for trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.
  • 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