FDA Medical Device Recalls (openFDA)
Intuitive Surgical, Inc.: Tip Cover Accessory, 8 MM, MCS, box of 10 Product Usage: The disposable Tip cover accessory is used in conjunction with the 8mm Monopolar Curved Scissors Instruments to cut and coagulate tissue. The tip cover is intended to provide electrical insulation over a section of the Monopolar Curved Scissors instrument so that FR energy is only available at the scissors blades.
- Recall number
- Z-1425-2013
- Recalling firm
- Intuitive Surgical, Inc.
- Product
- Tip Cover Accessory, 8 MM, MCS, box of 10 Product Usage: The disposable Tip cover accessory is used in conjunction with the 8mm Monopolar Curved Scissors Instruments to cut and coagulate tissue. The tip cover is intended to provide electrical insulation over a section of the Monopolar Curved Scissors instrument so that FR energy is only available at the scissors blades.
- Status
- Terminated
- Initiated
- 2011-09-23
- Posted
- 2013-05-29
- Terminated
- 2013-05-30
- Reason
- Clarification of existing labeling and related cautions for the tip cover accessory of the da Vinci Surgical System.
- Root cause
- Device Design
- Action
- Intuitive Surgical sent an Important Product Notification letters dated October 10, 2011 to all affected customers. A second letter was sent to those that had not responded on December 4, 2011. The letters identified the affected product, problem, and actions to be taken, The letter included recommendations and suggestions for proper use and prevention of damage to the Tip cover during surgery. Also attachments include recommendations and further information for the following areas: avoid instrument collisions; carefully install tip cover; straighten wrist prior to removal; inspect cannula prior to use and do not exceed maximum monopolar cautery settings. Attached is a list of validated ESU settings and suggestions and instruction on being aware of critical anatomy in contact with the instrument and to change the tip cover in cases with extended cautery use. Questions may be referred to Customer service at 1-800-876-1310 in the US and at + 41 21 821 2020 or +800-0821-2010.
- Quantity
- 50,000 boxes of 10 tip covers
- Distribution
- Worldwide distribution - USA Nationwide and the countries of Australia, Austria, Belgium, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, New Zealand, Norway, Pakistan, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom.
- Lot, serial or model codes
- Model numbers: 400180-10 and prior versions 400180-01, 400180-02, 400180-03, 400180-04, 400180-05, 400180-05, 400180-06. 400180-07, 400180-08 and 400180-09.
- 510(k) numbers
- ["K050005"]
- PMA numbers
- not on file
- Product code
- NAY
- Firm FEI
- 3001675293
- Firm city
- Sunnyvale
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28