—#117872

Product

User Manual addendum, TORS for da Vinci Surgical System IS 1200, IS 2000 and IS 3000. Product Usage: The user manual for Transoral Surgery (TORS) provided information to update and replace the Indications for Use and Representative uses section and add the section Warnings for Transoral Otolaryngology Surgery.

FDA product code: NAY — System, Surgical, Computer Controlled Instrument
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K090993
Affected lot / code info: Model number 552002-01

Why it was recalled

Change to User Manual to remove one indication for use and amend warnings to emphasize restrictions for use.

Root cause (FDA determination)

Labeling False and Misleading

Action the firm took

Intuitive sent an Important Medical Device Correction letters dated January 24, 2013 via Federal Express to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to locate and discard the existing TORS addendum, place the new TORS addendum included with this letter with your System User Manual, and complete and return the attached Acknowledgement Form to Intuitive Surgical. For questions call Intuitive Surgical Customer Service at 1-800-876-1310.

Recalling firm

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

Distribution

Distribution pattern: US Distribution Only

Timeline

Recall initiated: 2013-01-24
Posted by FDA: 2013-05-29
Terminated: 2013-05-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #117872. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.