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Recall Observatory FDA recall evidence

Device product

8MM,CURVED BIPOLAR DISSECTOR,IS4000¿ REF 470344

Z-0868-2025

December 19, 2024

Class II

Product summary

Firm
Intuitive Surgical, Inc.
Event
Event 95938
Status
Ongoing
Classification
Class II
Quantity
141
Official record key
device-enforcement:Z-0868-2025

Official wording

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

Code information: Model Number: 470344 Part Number: 470344-17 UDI-DI code: 00886874112489 Batch Numbers: K10230405 K10230413 K10230420 K10230504

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.