Intuitive brand da Vinci S, 5 mm Instrument Cannula Model/Part Number: 420011-02, Product is manufactured and distribute
FDA device recall Z-0669-2008 · posted 2008-01-31 · Terminated
Recall details
- Recalling firm
- Intuitive Surgical, Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- NAY
- Quantity affected
- 89 units
- Distribution
- 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
- Date initiated
- 2007-11-19
- Date posted
- 2008-01-31
- Date terminated
- 2008-08-27
- Location
- Sunnyvale, CA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS2000 (K050369) | Intuitive Surgical, Inc. | 2005-04-29 |