INTUITIVE Da Vinci Xi 8mm SureForm 30 Curved-Tip Stapler Da Vinci Xi|X REF 488530 INTUITIVE Da Vinci 8mm SureForm 30 Rel
FDA device recall Z-0340-2023 · posted 2022-11-30 · Open, Classified
Recall details
- Recalling firm
- Intuitive Surgical, Inc.
- Reason for recall
- Potential staple deployment failure and device fragment generation
- Action taken
- On 10/07/2022, Intuitive Surgical communicated an "Urgent Product Safety Notice" email to "STOP USE of da Vinci Xi 8mm SureForm 30 Stapler Instruments (488530-10) and Reloads (48230M-02, 48230W-02, 48230B-02)" and informing customers that there is a potential to transect targeted tissue without stapler formation that could result in bleeding and potential to generate fragments when using these products. On or about 10/25/2022, the firm sent an "Urgent Medical Device Removal" Letter via FedEx that informed their customers of the STOP USE. Customers are instructed to: Locate and return all affected products, as listed above, in their inventory via the standard RMA process by calling Intuitive Customer Service at (800) 876-1310, Option 3, 4 AM to 5 PM PST. If they have shared these products with other sites, make sure appropriate staff at that site receive and understanding this notification so that they locate and return their affected product. Customers may continue to use the da Vinci 12mm SureForm 45/60 instruments and reloads, as well as EndoWrist Stapler instruments and reloads, as these instruments are not impacted by this issue and use a different technology to effect stapler formation. For questions or further information: Contact their Clinical Sales Representative or contact Intuitive Customer Service at the numbers listed below: - US, Puerto Rico and Dominican Republic: (800) 876-1310, Option 3 (4 AM to 5 PM PST) or mail: customerservice@intusurg.com
- Root cause
- Nonconforming Material/Component
- Status
- Open, Classified
- Product code
- NAY
- Quantity affected
- 160 boxes of 488530-10 = 960 individual instruments 602 reload boxes = 7224 individual reloads
- Distribution
- U.S.: Arizona, California, Colorado, Florida, Illinois, Indiana, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Nevada, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, South Carolina
- Date initiated
- 2022-10-07
- Date posted
- 2022-11-30
- Location
- Sunnyvale, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 8 mm SureForm 30 Curved-Tip Stapler, 8 mm SureForm 30 Stapler, SureForm 30 Reloads (K211997) | Intuitive Surgical, Inc. | 2021-12-10 |