Events

Recall of Device Recall 8 mm Monopolar Curved Scissors

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
    65216
  • Event Risk Class
    Class 2
  • Event Number
    Z-1442-2013
  • Event Initiated Date
    2013-05-08
  • Event Date Posted
    2013-05-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-05-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118292
  • 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 has identified a potential for some units of the monopolar curved scissors version 09 and 10 instruments to develop very small cracks near the distal end. this may create a pathway for electrosurgical energy to leak to tissue and potentially cause thermal injury.
  • Action
    Intuitive Surgical sent an Urgent Medical Device Recall letter dated May16, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised that they did not need to quarantine or return the affected device at that time. a Intuitive Surgical representative would contact them to arrange for replacement of the affected product once they became available. In the interim customers were instructed to follow the precautions and warnings outlined in Attachment A in the letter as well as the Instructions for Use. Customers were also asked to ensure all affected personnel were fully informed of the contents of the Recall Notification. The letter should be forwarded to other surgeons and/or managers within their facility. Customers were also asked to complete and return the attached Acknowledgement Form. For further questions customers were instructed to contact Customer Service: North and South America: 800-876-1310 Option 3 Japan: 0120-56-5635 or 003-5575-1362 Korea: 02-3271-3200 Europe, Middle East, Asia and Africa +800 0821 2020 or +41 21 821 2020 For questions regarding this recall call 408-523-2244.

Device

Device Recall 8 mm Monopolar Curved Scissors
  • Model / Serial
    Model Numbers 420179-09 and -10 and 400179-09 and -10.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution - USA (nationwide) Foreign Distribution to Argentina, Austria, Australia, Belgium, Brazil, Bulgaria, Canada, China, Chile, Czech Republic, Denmark, Finland, France, Germany, Cyprus- Greece, Egypt, Guadeloupe, Israel, Ireland, India, Indonesia, Italy, Japan, Kuwait, Lebanon, Malaysia, Mexico, Monaco, Netherlands, New Zealand, Norway, Pakistan, Philippines, Portugal, Poland, Qatar, Russia, Romania, Slovenia, South Korea, Spain, Sweden, Switzerland, Thailand, Taiwan, Turkey, United Kingdom, Saudi Arabia, Singapore, South Korea, and Venezuela.
  • Product Description
    8 mm Monopolar Curved Scissors (a.k.a. Hot Shears) || Manufactured and Distributed by: || Intuitive Surgical || Sunny vale, CA || The EndoWrist Monopolar Curved Scissors Instrument is a multiple-use endoscopic instrument utilizing a single use, tip cover accessory, to be used in conjunction with the Intuitive Surgical Endoscopic Instrument Control System.
  • 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