| Class 2 Device Recall da Vinci Si Surgical System IS3000, Disposable Accessory Kit | |
Date Initiated by Firm | March 16, 2015 |
Date Posted | April 06, 2015 |
Recall Status1 |
Terminated 3 on December 03, 2015 |
Recall Number | Z-1392-2015 |
Recall Event ID |
70777 |
510(K)Number | K050322 |
Product Classification |
Drape, surgical - Product Code KKX
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Product | da Vinci Si Surgical System IS3000, Disposable Accessory Kit, 3 ARM, 5 Pack.
Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting. |
Code Information |
Product number 420290-03; da Vinci Si Disposable Accessory Kit, 3 ARM, 5 Pack. Lot Numbers for Cloudy/Waxy issue: ALL lot numbers Lot Numbers for Tear issue: D142175, D142175A, D142185, D142185A, D142235, D142235A, D142245, D142245A, D142255, D142305, D142305A, D142315, D142315A, D142345, D142375, D142375A, D142385, D142385A, D142395, D142455, D142465, D142465A, D142475, D142475A, D142485, D142515, D142515A, D142525, D142525A, D142535, D142535A, D142605, D142605A, D142615, D142615A, D142625, D142635, D142655, D142655A, D142665, D142665A, D142725, D142725A, D142735, D142735A, D142745, D142755, D142755A, D142795, D142795A, D142825, D142825A, D142835, D142885, D142885A, D142885A, D142895, D142905, D142945, D142955, D142955A, D142965, D142965A, D143005, D143015, D143015A, D143025, D143025A, D143035, D143045, D143045A, D143095, D143095A, D143105, D143105A, D143155, D143155A, D143165, D143165A, D143175, D143175A, D143185, D143185A, D143215, D143215A, D143225, D143225A, D143235, D143235A, D143295, D143295A, D143305, D143305A, D143315, D143325, D143325A, D143365, D143375, D143375A, D143385, D143395, D143395A, D143435, D143445, D143445A, D143455, D143455A, D143465, D143465A, D150075, D150085, D150125, D150125A, D150135, D150165, D150195, D150195A, D150205, D150205A, D150275, D150275A, D150285, D150305, D150345, D150345A, D150355, D150355A, D150415, D150415A, D150425, D150425A, D150435, D150475, D150475A, D150485, D150485A, D150495, D150545, D150545A, D150555, D150555A, D150635, D150635A, D150645, D150645A, D150685, D150685A, D150695, D150695A, DA142235, DA142305, DA142515, DA142615, DA142795, DA142885, DA142885, DA143025, DA150125, DA150275, DA150475, DA150545, DA150645, DA150685 |
Recalling Firm/ Manufacturer |
Intuitive Surgical, Inc. 1266 Kifer Rd Bldg 100 Sunnyvale CA 94086-5304
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For Additional Information Contact | 800-876-1310 |
Manufacturer Reason for Recall | Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear. |
FDA Determined Cause 2 | Packaging process control |
Action | Firm issued field safety notice to all customers on March 16, 2015. Field safety notice includes acknowledgement form to be returned to recalling firm. A second letter was sent on May 12, 2015 to inform users that the date that the drape product unaffected by the issue will not be availalble untisl October/November 2015, not May 2015 as stated in the original communication. |
Quantity in Commerce | 442,475 total for all drape models |
Distribution | Worldwide Distribution-Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China (including Hong Kong), Colombia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, France, Germany, Greece, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Mauritius, Mexico, Monaco, Netherlands, New Zealand, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, Venezuela, Vietnam. |
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 = KKX
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