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Class 2 Device Recall da Vinci Xi Surgical System |
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Date Initiated by Firm |
June 01, 2017 |
Date Posted |
June 06, 2017 |
Recall Status1 |
Terminated 3 on October 02, 2017 |
Recall Number |
Z-2630-2017 |
Recall Event ID |
77389 |
510(K)Number |
K131861
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Product Classification |
System,surgical,computer controlled instrument - Product Code NAY
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Product |
da Vinci Xi Surgical System
Product Usage: The da Vinci Xi Surgical System (IS4000) is designed to assist a surgeon in the accurate control of surgical instruments such as endoscopes, scissors, forceps, and retractors during endoscopic surgery. The system has four universal manipulators (arms) which allow the surgeon to control up to three instruments and an endoscope simultaneously to perform surgical tasks (e.g. cutting, suturing, tissue approximation) in a variety of procedures in the pelvic, abdominal, and thoracic cavities.
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Code Information |
Serial Numbers: SK0822, SK1154, SK1001, SK1170, SK1040, SK1176, SK1082, SK1180, SK1146, SK1190 |
Recalling Firm/ Manufacturer |
Intuitive Surgical, Inc. 1266 Kifer Rd Bldg 100 Sunnyvale CA 94086-5304
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For Additional Information Contact |
408-523-2100
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Manufacturer Reason for Recall |
da Vinci Xi(R) Surgical System Patient Side Carts (PSC) were shipped to the field with potentially under-torqued brake screws in a section of the system arms.
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FDA Determined Cause 2 |
Process control |
Action |
Intuitive Surgical sent an Field Safety Notice letter dated June 1, 2017 to customers. The letter was sent electronically via through our da Vinci customer portal via email to the affected sites on June 1, 2017. Letters are sent to the da Vinci Coordinator, Recall Coordinator and/or Risk Management. The customer will receive a hard copy of this letter on June 6, 2017 via Fed Ex. The letter identified the affected product, problem and actions to be taken. For questions contact your Clinical Sales Representative. |
Quantity in Commerce |
10 units |
Distribution |
Worldwide Distribution - US Nationwide in the states of TX, NY,FL, IL, OH, and countries of France, Ireland, Japan, and Taiwan |
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 and Original Applicant = INTUITIVE SURGICAL, INC.
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