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U.S. Department of Health and Human Services

Class 2 Device Recall da Vinci SP Instrument Arm Drape

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 Class 2 Device Recall da Vinci SP Instrument Arm Drapesee related information
Date Initiated by FirmOctober 25, 2018
Create DateMay 06, 2020
Recall Status1 Terminated 3 on April 05, 2024
Recall NumberZ-1906-2020
Recall Event ID 83503
510(K)NumberK173906 
Product Classification System, surgical, computer controlled instrument - Product Code NAY
Productda Vinci SP Instrument Arm Drape. REF 430013-12 QTY 1 Pouch
Code Information Model Number: 430013-12 UDI Number: 00886874113486 Lot Numbers: All Lots
Recalling Firm/
Manufacturer		 Intuitive Surgical, Inc.
1266 Kifer Rd Bldg 101
Sunnyvale CA 94086-5304
For Additional Information ContactNicholas Pham
408-523-2100
Manufacturer Reason
for Recall		The instrument drape may tear while draping the Patient Side Cart presenting a breach in the sterile barrier.
FDA Determined
Cause 2		Device Design
ActionOn 10/25/2018, the firm sent an "Urgent Medical Device Correction" Notification Letter to Customers via FedEx (to OUS customers - emailed and hand-delivered) are asked to take actions during draping to avoid snagging the drape during installation and to continue following the instructions in the System User Manual. Representatives will be available by phone to answer questions related to the device correction. Acknowledgement form included with the recall letter is requested to be completed and returned to ISI asking that appropriate personnel be informed about the device correction.
Quantity in Commerce1818 pouches
DistributionUpdated information provided on 03/18/2020: FL, OH, TN, NJ, PA, MD, NY, CA, MN, NV, OR, HI, VA, TX, AL, CA, IL, CN, and NC. OUS: APAC (Asia Pacific) - South Korea
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = NAY
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