Recalls / —
—#118081
Product
da Vinci 5 mm Instrument Cannulae for use with the da Vinci S and Si Surgical Systems. Used to establish a port of entry for Intuitive Surgical EndoWrist instruments,
- FDA product code
- NAY — System, Surgical, Computer Controlled Instrument
- Device class
- Class 2
- Medical specialty
- Gastroenterology, Urology
- 510(k) numbers
- K050369, K101743
- Affected lot / code info
- Model number 420011
Why it was recalled
Intuitive Surgical is implementing a voluntary Field Action to implement a modified inspection process for the 5 mm Cannula (PN 420011) and 5 mm Flared Cannula (PN 420262).
Root cause (FDA determination)
Use error
Action the firm took
Intuitive Surgical sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated May 14, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact Customer Service at 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: US (nationwide) and countries of: Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Netherlands, Norway, South Korea, Sweden, Switzerland, and United Kingdom.
Timeline
- Recall initiated
- 2013-05-06
- Posted by FDA
- 2013-06-05
- Terminated
- 2014-04-15
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #118081. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.