Recall Z-0406-2024 ยท NAY System, Surgical, Computer Controlled Instrument
Intuitive Surgical, Inc.
Da Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mm
| Date | Nov 28, 2023 (initiated Oct 6, 2023) |
| Status | Open, Classified |
| Reason | There is the potential for the needle drive to become dislodged and/or broken which could result in uncontrollable movement. |
| Root cause | Process control |
| Action | On October 24, 2023, Intuitive issued a "Urgent Medical Device Recall notification" to all affected consignees via E.Mail. Intuitive asked consignees to take the following actions: 1. Read and understand the contents of the letter. 2. Locate and return all affected lots of 478115-03 in your inventory via the standard RMA process by calling Intuitive Customer Service based on your region below. 3. Notify all surgeons, personnel, and sites using da Vinci X and da Vinci Xi Single Site Wristed Needle Driver, PN 478115-03 that they should review and understand the contents of this letter. 4. Compl |
| Quantity | 317 units |
| Distribution | US: IL, FL, ID, SC, MI, TX, TN, NY, OR, CO, CA, MS, NJ, Puerto Rico OUS: South Korea |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152448 | da Vinci Single-Site Instrument and Accessories Intuitive Surgical, Inc., Mar 9, 2016 |