Z-0877-2025Class II
8Mm,cobra Grasper,is4000 Ref 471190
Intuitive Surgical, Inc. / initiated 2024-12-19 / Open, Classified
Intuitive Surgical, Inc. began a recall of 8MM,COBRA GRASPER,IS4000 REF 471190 on . FDA classified it as Class II and gives the reason as "Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws". As of , the recall status on record is Open, Classified.
Recall record
- Recall number
- Z-0877-2025
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Intuitive Surgical, Inc.
- Product
- 8Mm,cobra Grasper,is4000 Ref 471190
- Product code
- NAY System, Surgical, Computer Controlled Instrument
- Reason for recall
- Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- FDA 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. 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)
- Quantity in commerce
- 2,472
- 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, 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
- Product codes and lots
- Model Number: 471190 Part Number: 471190-04 UDI-DI code: 00886874121481 Batch Numbers: K10230226 K10230405 K10230413 K10230420 K10231005 K10231019 K10231130 K10240104 K10240111 K10240118 K10240327 K10240418 K10240502 K10240606 K10240725
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0847-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0848-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0849-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0850-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0851-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0852-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0853-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0854-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0855-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0856-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0857-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0858-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0859-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0860-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0861-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0862-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0863-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0864-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0865-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0866-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0867-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0868-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0869-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0870-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0871-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0872-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0873-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0874-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0875-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0876-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0877-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0878-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0879-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0880-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0881-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0882-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0883-2025 | Class II | Ongoing | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.