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Recall Observatory FDA recall evidence

Device product

8MM,BLACK DIAMOND MICRO FORCEPS,IS4000 ¿ REF 470033

Z-0851-2025

December 19, 2024

Class II

Product summary

Firm
Intuitive Surgical, Inc.
Event
Event 95938
Status
Ongoing
Classification
Class II
Quantity
1,111
Official record key
device-enforcement:Z-0851-2025

Official wording

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

Code information: Model Number: 470033 Part Number: 470033-09 UDI-DI code: 00886874112229 Batch Numbers: K10230219 K10230316 K10230511 K10230615 K10230706 K10230713 K10230824 K10230928 K10231005 K10231109 K10231218 K10240104 K10240229 K10240418 K10240613 Part Number: 470033-11 UDI-DI code: 00886874112229 Batch Number: K10230914

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.