—#85088

Product

da Vinci S Surgical System IS2000 Endoscopic Instrument Control System, rev. A51_P7, manufactured by Intuitive Surgical, Sunnyvale, CA.

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: Code numbers between SG002 to SG836.

Why it was recalled

Gripper or Scissor jaws may close inadvertently, and will not open on command and various other reported modes of failure. Control by surgeon may fail and this failure may be difficult to detect.

Root cause (FDA determination)

Software design

Action the firm took

Recall initiated the recall on July 1, 2009. US consignee recall was initiated on July 7, 2009. All affected consignees have been notified via e-mail communication followed by a field service engineer visit. Customers with questions or with need for additional assistance regarding the notification, please contact the firm's Intuitive Surgical Customer Service Department at 1-800-876-1310 toll free.

Recalling firm

Firm: Intuitive Surgical, Inc.
Address: 1266 Kifer Rd, Bldg 100, Sunnyvale, California 94086-5304

Distribution

Distribution pattern: Product was distributed to 551 consignees throughout the US to AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WI, WV AND WY, as well as to Puerto Rico, and to Austria, Belgium, Bulgaria, Czech Republic, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Netherlands, Norway,Qatar, Romania, Spain, Sweden, Switzerland, Turkey, the United Kingdom, Argentina, Australia, Brazil, Canada, China, India, Israel, Japan, Korea, Mexico, Russia, Saudi Arabia, Singapore and South Korea.

Timeline

Recall initiated: 2009-07-15
Posted by FDA: 2010-04-05
Terminated: 2011-02-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #85088. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.