Terminated

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

FDA Recall Z-1161-2010 · Posted 2010-04-05

Recalling FirmIntuitive Surgical, Inc.

Recall StatusTerminated

Product CodeNAY

Date Initiated2009-07-15

Date Terminated2011-02-11

Product Quantity782 units

Reason for Recall

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.

Firm Action

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.

Root Cause

Software design

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K050369INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS2000Intuitive Surgical, Inc. · 2005-04-29

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.