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U.S. Department of Health and Human Services

Class 2 Device Recall 8mm Fenestrated Bipolar Forceps

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 Class 2 Device Recall 8mm Fenestrated Bipolar Forceps see related information
Date Posted May 29, 2013
Recall Status1 Terminated on February 18, 2014
Recall Number Z-1433-2013
Recall Event ID 65194
510(K)Number K012833 
Product Classification System,surgical,computer controlled instrument - Product Code NAY
Product 8mm Fenestrated Bipolar Forceps used in conjunction with the da Vinci Surgical System, Model IS1200.

Multiple use electrosurgical endoscopic instruments.



Code Information Model number: 400205-04;
Lot numbers:
M10120816
M10120820
M10120903
M10120910
M10120912
M10120921
M10121008
M10121024
M10121120
M10121130
M10121206
M10121213
M10121215
M10130124
M10130131
M10130213
M10130218
M10130222
M10130313
M10130319
M10130402.
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 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) Database 510(K)s with Product Code = NAY and Original Applicant = INTUITIVE SURGICAL, INC.
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