Recall Z-1425-2013 ยท NAY System, Surgical, Computer Controlled Instrument
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.
| Date | May 29, 2013 (initiated Sep 23, 2011) |
| Status | Terminated |
| 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 |
| 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, Roman |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050005 | INTUITIVE SURGICAL MONOPOLAR CURVED SCISSORS, MODEL 400179; TIP COVER ACCESSORY, MODEL 400180 Intuitive Surgical, Inc., Jan 25, 2005 |