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Recall Observatory FDA recall evidence

Device product

8MM,RESANO FORCEPS,IS4000 ¿ REF 470181

Z-0857-2025

December 19, 2024

Class II

Product summary

Firm
Intuitive Surgical, Inc.
Event
Event 95938
Status
Ongoing
Classification
Class II
Quantity
373
Official record key
device-enforcement:Z-0857-2025

Official wording

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

Code information: Model Number: 470181 Part Number: 470181-09 UDI-DI code: 00886874112304 Batch Numbers: K10230601 K10230608 K10230824 K10230928 K10231012 K10231027 K10240118 K10240222 K10240516 K10240711 K10240725 K10240801

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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