| ||Class 2 Device Recall 8mm Fenestrated Bipolar Forceps |
||May 29, 2013
||Terminated on February 18, 2014
|Recall Event ID
System,surgical,computer controlled instrument -
||8mm Fenestrated Bipolar Forceps used in conjunction with the da Vinci Surgical System, Model IS1200.
Multiple use electrosurgical endoscopic instruments.
||Model number: 400205-04;
Intuitive Surgical, Inc.
1266 Kifer Rd Bldg 100
|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.
|Total Product Life Cycle
TPLC Device Report
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K)s with Product Code = NAY and Original Applicant = INTUITIVE SURGICAL, INC.