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U.S. Department of Health and Human Services

Class 2 Device Recall Intuitive Surgical EndoWrist

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 Class 2 Recall
Intuitive Surgical EndoWrist
see related information
Date Posted January 24, 2008
Recall Status1 Terminated on August 01, 2008
Recall Number Z-0258-2008
Recall Event ID 38312
Premarket Notification
510(K) Number
K061260 
Product Classification System,Surgical,Computer Controlled Instrument - Product Code NAY
Product Intuitive Surgical EndoWrist, 8 mm, PK Dissecting Forceps for use with the da Vinci and da Vinci S Surgical systems, Part Numbers: 400214-02, 400214-03, 420214-02 and 420214-03, Intuitive Surgical, Inc., Sunnyvale, CA
Code Information All instruments manufactured till 03/21/07
Recalling Firm/
Manufacturer
Intuitive Surgical, Inc.
950 Kifer Rd
Sunnyvale, California 94086-5206
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
Mislabeling-electrical isolation requirements: devices were incorrectly labeled with a CF symbol not their proper BF Symbol on the instrument housing. (All instruments meeting the CF isolation requirements are suitable for direct cardiac application, while instruments meeting BF isolation requirements are not suitable for direct cardiac application)
FDA Determined
Cause 2
DESIGN: Labeling Design
Action On January 9, 2008, via an Urgent Device Recall Letter the recalling firm notifed users of the defect (mislabeling with heart symbol) and to Immediately Discontinue any direct cardiac applications. The recalling firm will arrange with each consignee a time to relabel their devices. Customers on April 17, 2007 had earlier been warned of the device defect via letter but no correction was indicated.
Quantity in Commerce 1,136 units
Distribution Worldwide Distribution --- USA including states of MN, PA, AK, NY, CA, MD, IN, AZ, CO, AR, TX, TN, FL, VA, MA, NE, NC, IL, OH, ME, WI, MD, NJ, MN, MI, VA, IA, OR, MO, NC, MS, AL, WA, GA, KY, LA, AK, AR, SD, SC, DE, NV, HI, NH, WV, and CT, and countries of Canada, Australia, Belgium, Spain, Hong Kong, Italy, Switzerland, and Sweden. ( 192 USA hospitals, 3 foreign hospitals and 5 foreign distributors)
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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