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Open, Classified

8MM,COBRA GRASPER,IS4000 REF 471190

FDA Recall Z-0877-2025 · Posted 2025-01-10

Recalling FirmIntuitive Surgical, Inc.
Recall StatusOpen, Classified
Product CodeNAY
Date Initiated2024-12-19
Product Quantity2,472

Reason for Recall

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

Firm 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. 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)

Root Cause

Process change control

Distribution Pattern

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, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and Puerto Rico. O.U.S: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, French Guiana, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mexico, Monaco, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and Vietnam

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K214095da Vinci X/Xi (IS4200/IS4000) 8mm Reusable InstrumentsIntuitive Surgical, Inc. · 2022-08-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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