Recalls / —

—#117856

Product

Flush Port (used in almost all da Vinci instruments) Assists in cleaning the instrument.

FDA product code

NAY — System, Surgical, Computer Controlled Instrument

Device class

Class 2

Medical specialty

Gastroenterology, Urology

510(k) numbers

K050369

Affected lot / code info

Model numbers: 340066-07 - straight; 340234-02 - extended taper; 340241-03 - 5mm; 340584-01 - Gemini 8mm straight; 340586-02 - Gemini 5mm; 340725-01 - Vespa straight; 340800-01 - Gemini ext taper; 340971-01 - IS1200 Grasping 340972-01 IS2000 Grasping.

Why it was recalled

Clarification of existing labeling information and operating procedures.

Root cause (FDA determination)

Labeling False and Misleading

Action the firm took

Intuitive Surgical sent an "IMPORTANT PRODUCT NOTIFICATION" letter dated October 17, 2011 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact Customer Service at 1-800-876-1310 for questions regarding this notice.

Recalling firm

Firm

Intuitive Surgical, Inc.

Address

1266 Kifer Rd, Bldg 100, Sunnyvale, California 94086-5304

Distribution

Distribution pattern

Worldwide Distribution- USA Nationwide and countries of: Argentina, Australia,Canada, Chile, China, Czech Republic, Egypt, India, Israel, Italy,Korea-Republic of, Poland, Qatar, Romania, Saudi Arabia, Singapore, Spain, Thailand, Turkey, and Venezuela.

Timeline

Recall initiated

2011-09-19

Posted by FDA

2013-05-29

Terminated

2013-05-30

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #117856. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.