| Class 2 Device Recall da Vinci S Surgical System 8 mm Long instrument cannula | |
Date Initiated by Firm | March 09, 2007 |
Date Posted | January 31, 2008 |
Recall Status1 |
Terminated 3 on April 19, 2011 |
Recall Number | Z-0658-2008 |
Recall Event ID |
38315 |
510(K)Number | K050369 |
Product Classification |
Cannula - Product Code NAY
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Product | da Vinci S Surgical System 8 mm Long instrument cannula, Part #:420004-01, Intuitive Surgical, Inc., Sunnvale, Ca. 94086, |
Code Information |
Part #420004-01, Lot Numbers: SA054702, SA060504, SA062801, and SA062104 |
Recalling Firm/ Manufacturer |
Intuitive Surgical, Inc. 950 Kifer Rd Sunnyvale CA 94086
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For Additional Information Contact | 408-523-2100 |
Manufacturer Reason for Recall | Devices may have a ridge on the side of the cannula, which has the potential to abrade instrument shafts and generate black particulate matter. |
FDA Determined Cause 2 | Nonconforming Material/Component |
Action | The recalling firm issued an Important Device Recall Notification on 3/9/2007, announcing the recall and exchange program for device replacement. A toll free number of 1-800-876-1310 was given in the recall notice for questions. |
Quantity in Commerce | 206 units |
Distribution | Worldwide: 92 hospitals nationwide and abroad, as well as 6 distributors abroad, USA including the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, IL, IN, LA, MA, MD, MI, MN, MO, NC, NH, NJ, NV, NY, OH, OR, PA, SD, TN, TX, VA, WA, WI, and WV and countries of Belgium, China, France, Germany, India, Italy, Japan, Mexico, The Netherlands, Spain and Sweden. |
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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