—#53393

Product

da Vinci S Surgical System 8 mm Long instrument cannula, Part #:420004-01, Intuitive Surgical, Inc., Sunnvale, Ca. 94086,

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: Part #420004-01, Lot Numbers: SA054702, SA060504, SA062801, and SA062104

Why it was recalled

Devices may have a ridge on the side of the cannula, which has the potential to abrade instrument shafts and generate black particulate matter.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

The recalling firm issued an Important Device Recall Notification on 3/9/2007, announcing the recall and exchange program for device replacement. A toll free number of 1-800-876-1310 was given in the recall notice for questions.

Recalling firm

Firm: Intuitive Surgical, Inc.
Address: 950 Kifer Rd, Sunnyvale, California 94086

Distribution

Distribution pattern: Worldwide: 92 hospitals nationwide and abroad, as well as 6 distributors abroad, USA including the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, IL, IN, LA, MA, MD, MI, MN, MO, NC, NH, NJ, NV, NY, OH, OR, PA, SD, TN, TX, VA, WA, WI, and WV and countries of Belgium, China, France, Germany, India, Italy, Japan, Mexico, The Netherlands, Spain and Sweden.

Timeline

Recall initiated: 2007-03-09
Posted by FDA: 2008-01-31
Terminated: 2011-04-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #53393. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.