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U.S. Department of Health and Human Services

Class 2 Device Recall da Vinci SP Surgical System

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  Class 2 Device Recall da Vinci SP Surgical System see related information
Date Initiated by Firm October 23, 2018
Create Date January 24, 2020
Recall Status1 Terminated 3 on January 21, 2022
Recall Number Z-0845-2020
Recall Event ID 83192
510(K)Number K173906  
Product Classification System, surgical, computer controlled instrument - Product Code NAY
Product The da Vinci SP surgical system is made of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The Patient Cart is the operative component of the SP system and its primary function is to support the positioning of the surgical port (cannula) and to manipulate the surgical instruments and camera. The Model Number is SP 1098.
Code Information The Affected Systems are : SP0022, SP0023, SP0024, SP0025 and SP0026.
Recalling Firm/
Manufacturer		 Intuitive Surgical, Inc.
1266 Kifer Rd Bldg 101
Sunnyvale CA 94086-5304
For Additional Information Contact Nicholas Pham
408-523-2100
Manufacturer Reason
for Recall		 The firm became aware of a problem with the surgical system where the cannula mount button may be damaged when the user releases the button abruptly.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action On 10/23/2018, the firm sent a "Medical Device Correction" Letter informing them about the cannula mount button issue and informing all personnel who are involved with da Vinci SP Surgery at their site of the following instructions. 1. Release the cannula mount button in a slow and controlled manner. This will prevent the button from snapping back potentially causing button damage. 2. If button damage occurs prior to procedure, discontinue use of the affected SP system. 3. If button damage occurs during a procedure, call dVSTAT for instructions to complete the procedure. ------------ 4. Complete the attached Acknowledgement Form and return it via fax to Intuitive Surgical as instructed on the form. 5. Please retain a copy of this letter and the acknowledgement form for your files. The firm will: 1. Have a Surgical Representative schedule a site visit to repair your system as soon as possible. 2. Surgical representatives will be available by phone to answer any questions related to this Medical Device Correction. If you need further information or support concerning this Field Safety Notice, customer can contact their Clinical Sales Representative or contact Intuitive Surgical Customer Service at the numbers listed below: ¿ North and South America: (800) 876-1310, Option 3 (4 AM to 5 PM PST) or mail: customerservice@intusurg.com. ¿ Europe, Middle East, Asia and Africa: +800 0821 2020 or +41 21 821 2020 (8 AM to 6 PM CET) or ics@intusurg.com
Quantity in Commerce 5 PSCs (Units)
Distribution Product distributed in the US to the following states: Minnesota, New York, Ohio, and Pennsylvania.
Total Product Life Cycle TPLC Device Report
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.
510(K) Database 510(K)s with Product Code = NAY and Original Applicant = Intuitive Surgical, Inc.
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