Recalls / —
—#66936
Product
Intuitive brand da Vinci S, 5 mm Instrument Cannula Model/Part Number: 420011-02, Product is manufactured and distributed by Intuitive Surgical , 950 Kifer Road, 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
- Lot Numbers Affected: SA070902, SA071101, and SA071401
Why it was recalled
Sharp Edges: the 5mm Cannula may have a sharp edge on the inner diameter of the Cannula. The defective cannulae may cause particulate shavings to be skive (scraping) from the instrument shafts during surgery.
Root cause (FDA determination)
Other
Action the firm took
On 11/19/07, the firm issued Urgent Device Recall Notification letters via Federal Express to all its direct consignees, informing them of the affected product and providing instructions on the recall.
Recalling firm
- Firm
- Intuitive Surgical, Inc.
- Address
- 950 Kifer Rd, Sunnyvale, California 94086-5206
Distribution
- Distribution pattern
- Worldwide: USA including states of AZ, CA, CT, DC, GA, lA, MI, MN, NC, NJ, NV, OH, PA, SD, TX, and VA and country of Hong Kong
Timeline
- Recall initiated
- 2007-11-19
- Posted by FDA
- 2008-01-31
- Terminated
- 2008-08-27
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #66936. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.