8MM,HORIZON SMALL CLIP APPLIER,IS4000 REF 470401
Recall
- Recall Number
- Z-0870-2025
- Event Number
- 95938
- Firm
- Intuitive Surgical, Inc.
- FEI Number
- 3001675293
- Product Code
- NAY
- Status
- Open, Classified
- Root Cause
- Process change control
- Initiated
- December 19, 2024
- Posted
- January 10, 2025
- Address
- 1266 Kifer Rd, Sunnyvale, CA, 94086-5304
Description
8MM,HORIZON SMALL CLIP APPLIER,IS4000 REF 470401
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
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. In addition, please refer to Appendix B for additional images for detection of grip cable failures. 3. If you observe any failed (frayed or broken) grip cables prior to use, during procedure, or during reprocessing, please stop use of instrument, remove from use and inform Intuitive via the standard complaint process. 4. Inform Intuitive of any Adverse Events*/Serious Incidents** or quality problems concerning the use of the subject device via the standard complaint process. For Question and assistance - " North and South America: (800) 876-1310, Option 3 (4 am to 5 pm PST) or mail: [email protected]. " Europe, Middle East, Asia and Africa: +800 0821 2020 or +41 21 821 2020 (8 am to 6 pm CET) or [email protected] " South Korea: 02-3271-3200 (9 am to 6 pm KSTJ) or [email protected] " Japan: 0120-56-5635 or 03-5575-1362 (9 am to 6 pm JST) or [email protected] " India: +1-800-103-6952 (9 am to 6 pm IT) " Taiwan: +0800-86-8181 (9 am to 6 pm CT)
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