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U.S. Department of Health and Human Services

Enforcement Report - Week of June 5, 2013

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Event Detail

Event ID 65083
Product Type Devices
Status Terminated
Recalling Firm Intuitive Surgical, Inc.
City Sunnyvale
State CA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2011-09-19
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Worldwide Distribution- USA Nationwide and countries of: Argentina, Australia,Canada, Chile, China, Czech Republic, Egypt, India, Israel, Italy,Korea-Republic of, Poland, Qatar, Romania, Saudi Arabia, Singapore, Spain, Thailand, Turkey, and Venezuela.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
da Vinci Si Surgeon Console. Intended to assist in the accurate Control of Intuitive Surgical Endoscopic Instruments. Model number: 314850, versions 1-6 Class II Clarification of existing labeling information and operating procedures. NA Z-1429-2013
Flush Port (used in almost all da Vinci instruments) Assists in cleaning the instrument. Model numbers: 340066-07 - straight; 340234-02 - extended taper; 340241-03 - 5mm; 340584-01 - Gemini 8mm straight; 340586-02 - Gemini 5mm; 340725-01 - Vespa straight; 340800-01 - Gemini ext taper; 340971-01 - IS1200 Grasping 340972-01 IS2000 Grasping. Class II Clarification of existing labeling information and operating procedures. NA Z-1428-2013
Cannula 8MM Regular. Provides the means of introduction and placement of an instrument or accessory into the human body. Model number 420002-07 Class II Clarification of existing labeling information and operating procedures. NA Z-1427-2013
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