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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 April 01, 2019
Date Posted June 03, 2020
Recall Status1 Terminated 3 on December 16, 2021
Recall Number Z-2260-2020
Recall Event ID 85293
510(K)Number K173906  
Product Classification System, surgical, computer controlled instrument - Product Code NAY
Product da Vinci SP surgical system
Code Information Serial Numbers: SP0022, SP0031, SP0023, SP0032, SP0024, SP0034, SP0025, SP0035, SP0026, SP0036, SP0027, SP0037, SP0028, SP0038, SP0029, SP0039, SP0030
Recalling Firm/
Manufacturer		 Intuitive Surgical, Inc.
1266 Kifer Rd Bldg 101
Sunnyvale CA 94086-5304
For Additional Information Contact Intuitive Surgical Customer Service
408-523-2100
Manufacturer Reason
for Recall		 Intuitive has become aware that the da Vinci SP system may trigger a mechanical vibration of the instrument tips and endoscope due to a software anomaly. This issue has the potential to occur only under the following, extremely rare specific conditions: 1) the user is activating Adjust Mode, AND 2) the instrument Arm is near its vertical position limit, AND 3) the user is applying sustained force against the hand control haptic feedback.
FDA Determined
Cause 2		 Software design
Action The firm sent a letter to consignees on April 1, 2020 stating that an Intuitive representative will schedule a site visit to provide a software update as soon as possible. Firm representatives will be available by phone to answer any questions related to this Medical Device Correction. Actions taken by the customer are to: Inform all personnel who are involved with the affected device at your site of the following instructions: 1.If vibrations are sensed at the instrument and/or endoscope tips in Adjust Mode and the instrument arm is near its vertical limit: a.Cease applying sustained force against the hand control haptic feedback, b.Exit Adjust Mode by releasing the Endoscope Control pedal c.Exit following mode by removing your head from the Surgeon Console, or d.Press the Emergency Stop button. Any of these actions will stop the vibration. 2.If mechanical vibration persists, discontinue use of the system and contact Technical Support. 3.Inform affected personnel when the software update has been completed by the Intuitive representative. 4.Complete the attached Acknowledgment Form and return it via fax or email to Intuitive as instructed on the form. 5.Please retain a copy of this letter and the acknowledgment form for your files. Customers with additional questions: North and South America: (800) 876-1310, Option 3 (4 AM to 5 PM PST); South Korea: + 82-02-3271-3200, Opt. 3 (9 AM to 6 PM KSTJ)
Quantity in Commerce 17
Distribution U.S.: OH, PN, NY, MN, TN, TX, OR, IL, MD, NJ, AL. O.U.S.: South Korea
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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