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U.S. Department of Health and Human Services

Class 2 Device Recall KIT,DISPOSABLE ACCESSORY

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  Class 2 Device Recall KIT,DISPOSABLE ACCESSORY see related information
Date Initiated by Firm July 13, 2012
Date Posted July 27, 2012
Recall Status1 Terminated 3 on June 12, 2013
Recall Number Z-2103-2012
Recall Event ID 62553
510(K)Number K050369  
Product Classification System,surgical,computer controlled instrument - Product Code NAY
Product KIT,DISPOSABLE ACCESSORY,4ARM,IS2000,5 PACK;


Product Usage:
The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci Surgical Systems.
Code Information Part number: 420258-01 Lot numbers: D120755 ,D120755A , D120825.
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		 Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have difficulty engaging an instrument.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Intuitive Surgical sent an Urgent Medical Device Correction letters dated July 16, 2012 via Fed Ex to all affected customers in the US. The customers outside of the US were notified starting July 17, 2012. The letter identified the affected products, problem and actions to be taken. Customers were instructed to Identify affected lots, order replacement products and return both full and partial boxes of the affected products for credit as soon as unaffected products are available. All staff should be made aware of the issue. Customers were instructed to complete and return the acknowledgement form immediately. Questions and concerns should be directed to Intuitive Customer Service at 1-800-876-1310. EXPANSION: Intuitive discovered an additional lot (Lot DA121075) of Instrument Arm Drape IS2000, 20 pack that should have been included in the recall and expanded the recall on September 4, 2012. Letters to customers were sent by Fed Ex on September 5, 2012.
Quantity in Commerce 92390 total instrument Drapes
Distribution Worldwide Distribution - US Nationwide and the countries of: Australia, Spain, India, Italy and Saudi Arabia.
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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