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U.S. Department of Health and Human Services

Class 2 Device Recall da Vinci Xi EndoWrist Stapler 45 Reload Green, Model 48445G03

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  Class 2 Device Recall da Vinci Xi EndoWrist Stapler 45 Reload Green, Model 48445G03 see related information
Date Initiated by Firm April 23, 2018
Create Date July 06, 2018
Recall Status1 Terminated 3 on July 15, 2020
Recall Number Z-2381-2018
Recall Event ID 80318
Product Classification Staple, implantable - Product Code GDW
Product da Vinci Xi EndoWrist Stapler 45 Reload Green, Model
48445G-03, 12 reloads/box.
Code Information UDI: 00886874112823. Device expiration: 10/14/2017 02/21/2020
Recalling Firm/
Manufacturer		 Intuitive Surgical, Inc.
1266 Kifer Rd Bldg 101
Sunnyvale CA 94086-5304
For Additional Information Contact
408-523-2100
Manufacturer Reason
for Recall		 Intuitive Surgical, Inc. (ISI) has recently become aware of an issue with the da Vinci Xi Stapler 45 Blue and Green Reloads that may be missing a component of the knife mechanism. Without this component, the reload knife will not move and cut tissue when the stapler is fired.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Intuitive Surgical, Inc. (ISI) conducted the recall and notified customers via letter "Field Safety Notice Urgent Medical Device Notification" sent the week of April 23, 2018. The letter notified customers of the recall, reason for field action, risk to health, affected products, Actions to be taken by the Customer/User, Actions to be taken by Intuitive Surgical, and Further Information and Support: If you need further information or support concerning this Medical Device Notification , please contact your 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 (8AM to 6 PM CET) or ics@intusurg.com "South Korea: 02-3271-3200 (9 AM to 6 PM KSTJ) "Japan: 0120-56-5635 or 03-5575-1362 (9 AM to 6 PM JST).
Quantity in Commerce 6816
Distribution U.S., foreign and government accounts. Foreign: Australia, Austria, Belgium, Brazil, Canada, China (Hong Kong), Czech Republic, Denmark, Finland, France, Germany, Ireland, Italy, Japan, Luxembourg, Netherlands, Norway, Qatar, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom.
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.
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