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U.S. Department of Health and Human Services

Class 2 Device Recall 8mm Maryland Bipolar Forceps

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  Class 2 Device Recall 8mm Maryland Bipolar Forceps see related information
Date Initiated by Firm May 08, 2013
Date Posted May 29, 2013
Recall Status1 Terminated 3 on February 18, 2014
Recall Number Z-1432-2013
Recall Event ID 65194
510(K)Number K012833  
Product Classification System,surgical,computer controlled instrument - Product Code NAY
Product 8mm Maryland Bipolar Forceps used in conjunction with the da Vinci Surgical System, Model IS1200.

Multiple use electrosurgical endoscopic instruments.
Code Information Model number: 400172-08; Lot numbers: M10120815 M10120817 M10120831 M10120913 M10120918 M10121008 M10121024 M10121120 M10121123 M10121203 M10121210 M10121215 M10130220 M10130222 M10130311 M10130315 M10130327 M10130411. 
Recalling Firm/
Manufacturer		 Intuitive Surgical, Inc.
1266 Kifer Rd Bldg 100
Sunnyvale CA 94086-5304
For Additional Information Contact Richard Reeves
408-523-2244
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Device Design
Action 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
Distribution 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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = NAY and Original Applicant = INTUITIVE SURGICAL, INC.
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