FDA-Device2014-07-16Class II
Intuitive Surgical Inc. Large Clip Applier instruments used in conjunction with da Vinci S and da Vinci SI Surgical Systems Intuitive Surgical Inc., 'Sunnyvale, CA 94086
Intuitive Surgical, Inc.
Hazard
Manufacturing variation in the grip assembly of the Large Clip applier which can lead to the instrument jamming during insertion when used with the 8 mm cannula or with certain reducer accessories..
Sold states
Worldwide Distribution.
Affected count
5290 for part 420230-04; 1964 for part 420240-06
Manufactured in
1266 Kifer Rd Bldg 100, Sunnyvale, CA, United States
Products
Intuitive Surgical Inc. Large Clip Applier instruments used in conjunction with da Vinci S and da Vinci SI Surgical Systems Intuitive Surgical Inc., 'Sunnyvale, CA 94086
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2020-2014Don't want to check this manually?
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