FDA-Device2013-06-05Class II
8mm Maryland Bipolar Forceps used in conjunction with the da Vinci Surgical System, Model IS1200. Multiple use electrosurgical endoscopic instruments.
Intuitive Surgical, Inc.
Hazard
Reports of dislodging of the Cautery Plug Insert from the Cautery Plug Riser, preventing a bipolar cautery cable from being properly connected which results in loss of cautery function of Bipolar Instruments.
Sold states
Worldwide Distribution-USA (nationwide) including the states of AL, CA, CO, FL, IL, KY, MI, MS, NJ, NY, PA, TX, UT, VA, WA, and WI, and the countries of Austria, Australia, Belgium, Canada, Czech Republic, Denmark, France, Germany, Italy, Netherlands, Norway, Qatar, Romania, Spain, Sweden, Switzerland, Taiwan, United Kingdom, Saudi Arabia, Singapore, and Venezuela.
Affected count
697 - all products
Manufactured in
1266 Kifer Rd Bldg 100, N/A, Sunnyvale, CA, United States
Products
8mm Maryland Bipolar Forceps used in conjunction with the da Vinci Surgical System, Model IS1200. Multiple use electrosurgical endoscopic instruments.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1432-2013Don't want to check this manually?
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