FDA-Device2019-11-06Class II
EndoWrist Suction Irrigator, Single Use Instrument. Part Number: 480299-04. An accessory to the EndoWrist Surgical System, used in endoscopic surgery.
Intuitive Surgical, Inc.
Hazard
The firm has identified the potential for a silicone particle to be generated within the Suction Irrigator device. If generated, a particle may be introduced into the patient with irrigation.
Sold states
Worldwide distribution. US nationwide, Australia, Italy, Switzerland, and United Kingdom.
Affected count
3108 units (518 boxes of 6 units)
Manufactured in
1266 Kifer Rd Bldg 101, Sunnyvale, CA, United States
Products
EndoWrist Suction Irrigator, Single Use Instrument. Part Number: 480299-04. An accessory to the EndoWrist Surgical System, used in endoscopic surgery.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0249-2020Don't want to check this manually?
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