Thoracic Grasper, 5 MM, for use with da Vinci S (IS2000) and SI (IS3000) Surgical Systems. Intended for endoscopic manip
FDA device recall Z-1812-2015 · posted 2015-06-17 · Terminated
Recall details
- Recalling firm
- Intuitive Surgical, Inc.
- Reason for recall
- The coating of the 5 mm Thoracic Grasper main tube may experience damage with the possibility of fragments of coating material dislodging and potentially falling into patient.
- Action taken
- Urgent Medical Device Recall letters were sent to all consignees on May 21, 2015. The letter describes the affected product and issue involved. Additionally, the risk to health, as well as the actions to be taken were also discussed in the letter. Customers are to ensure that all affected personnel were informed of the notice. All affected product are to be identified and returned by contacting Customer Service for a RMA. The Acknowledgment Form is to be completed and returned using the instructions provided. If further information or support concerning this recall is needed, customers are to contact their local Clinical Sales Representative or Intuitive Surgical Customer Service.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- NAY
- Quantity affected
- 2,436 units
- Distribution
- Worldwide Distribution -- US, Belgium, Brazil, Canada, Chile, Colombia,, Denmark, France, Germany, India, Netherlands, Panama, Singapore, South Korea, Switzerland, Taiwan, Turkey, and United Kingdom.
- Date initiated
- 2015-05-21
- Date posted
- 2015-06-17
- Date terminated
- 2018-07-02
- Location
- Sunnyvale, CA
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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 |