Tip Cover Accessory, 8 MM, MCS, box of 10 Product Usage: The disposable Tip cover accessory is used in conjunction with

FDA device recall Z-1425-2013 · posted 2013-05-29 · Terminated

Recall details

Recalling firm

Intuitive Surgical, Inc.

Reason for recall

Clarification of existing labeling and related cautions for the tip cover accessory of the da Vinci Surgical System.

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

NAY

Quantity affected

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, Malays

Date initiated

2011-09-23

Date posted

2013-05-29

Date terminated

2013-05-30

Location

Sunnyvale, CA

Related 510(k) clearances