| ||Class 2 Recall|
8mm Maryland Bipolar Forceps
||May 29, 2013
||8mm Maryland Bipolar Forceps used in conjunction with the da Vinci Surgical System, Model IS1200.
Multiple use electrosurgical endoscopic instruments.
||Model number: 400172-08;
|Intuitive Surgical, Inc.
1266 Kifer Rd Bldg 100
Sunnyvale, California 94086-5304
|For Additional Information Contact
|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.
||Intuitive Surgical sent an "Urgent Medical Device Correction" letter dated May 8, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact Customer Service at 800-876-1310 for questions regarding this notice.
|Quantity in Commerce
||697 - all products
||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.