Recall Z-0864-2025 ยท NAY System, Surgical, Computer Controlled Instrument
Intuitive Surgical, Inc.
8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000 REF 470296
| Date | Jan 10, 2025 (initiated Dec 19, 2024) |
| Status | Open, Classified |
| Reason | Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. |
| Root cause | Process change control |
| Action | On 12/19/2024, the firm send via email an "Urgent: Medical Device Correction" Letter informing customer that Intuitive Surgical has become aware of an increase in complaints regarding frayed or broken cables on some da Vinci X and Xi reusable instruments. Customer are instructed to: 1. Customers can continue using the products in accordance with the user manual. 2. As a reminder, when using da Vinci X and Xi reusable instruments, follow the Inspection Before Use and Warnings listed in the manual provided with your system to inspect for any broken cables. Refer to Figures C and D for examples. |
| Quantity | 784 |
| Distribution | U.S. - Nation-wide. Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebra |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150284 | IS4000 da Vinci EndoWrist Instruments Intuitive Surgical, Inc., May 15, 2015 |