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U.S. Department of Health and Human Services

Class 2 Device Recall daVinci Harmonic ACE Curved Shears

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  Class 2 Device Recall daVinci Harmonic ACE Curved Shears see related information
Date Initiated by Firm January 16, 2019
Create Date February 15, 2019
Recall Status1 Open3, Classified
Recall Number Z-0841-2019
Recall Event ID 81972
510(K)Number K093217  K112584  
Product Classification System, surgical, computer controlled instrument - Product Code NAY
Product daVinci Harmonic ACE Curved Shears
Code Information All Lots
Recalling Firm/
Manufacturer		 Intuitive Surgical, Inc.
1266 Kifer Rd Bldg 101
Sunnyvale CA 94086-5304
For Additional Information Contact
408-523-2100
Manufacturer Reason
for Recall		 During an internal inspection, Intuitive found that the sterile packaging of the da Vinci S/Si Harmonic ACE Inserts may become damaged during transit. The potential damage includes pinholes and /or small openings (less than a few millimeters) on the pouch leading to a potential breach in sterility.
FDA Determined
Cause 2		 Under Investigation by firm
Action A Stop Use Notification was sent to affected customers on December 19, 2018. This notification requested customers to return the device. The formal customer recall letter was sent on January 16, 2019.
Quantity in Commerce 43755 inserts
Distribution US and Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, Finland, France, Germany, India, Israel, Italy, Japan, Kuwait, Lebanon, Mexico, Monaco, Netherlands, Pakistan, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, South Korea, Spain, Taiwan, Turkey, United Kingdom
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = NAY and Original Applicant = INTUITIVE SURGICAL, INC.
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