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Recall Observatory FDA recall evidence

Device product

8MM,LONG TIP FORCEPS,IS4000 REF 471048

Z-0872-2025

December 19, 2024

Class II

Product summary

Firm
Intuitive Surgical, Inc.
Event
Event 95938
Status
Ongoing
Classification
Class II
Quantity
1,562
Official record key
device-enforcement:Z-0872-2025

Official wording

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

Code information: Model Number: 471048 Part Number: 471048-09 UDI-DI code: 00886874115930 Batch Numbers: K10230330 K10230420 K10230515 K10230706 K10230720 K10230810 K10230907 K10230921 K10231005 K10231019 K10231102 K10231123 K10231207 K10240229 K10240314 K10240321 K10240411 K10240418 K10240509 K10240516 K10240718 K10240725 K10240822

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.