| Class 2 Device Recall Intuitive Surgical EndoWrist | |
Date Initiated by Firm | April 13, 2007 |
Date Posted | January 24, 2008 |
Recall Status1 |
Terminated 3 on August 01, 2008 |
Recall Number | Z-0258-2008 |
Recall Event ID |
38312 |
510(K)Number | K061260 |
Product Classification |
Dissecting Forceps - Product Code NAY
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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 CA 94086-5206
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For Additional Information Contact | 408-523-2100 |
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 | Device 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 |
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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.
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510(K) Database | 510(K)s with Product Code = NAY
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