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U.S. Department of Health and Human Services

Class 2 Device Recall Intuitive Surgical Inc. Large Clip Applier instruments

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  Class 2 Device Recall Intuitive Surgical Inc. Large Clip Applier instruments see related information
Date Initiated by Firm June 13, 2014
Date Posted July 08, 2014
Recall Status1 Terminated 3 on December 01, 2014
Recall Number Z-2020-2014
Recall Event ID 68553
510(K)Number K050369  
Product Classification System,surgical,computer controlled instrument - Product Code NAY
Product Intuitive Surgical Inc. Large Clip Applier instruments used in conjunction with da Vinci S and da Vinci SI Surgical Systems

Intuitive Surgical Inc.,
'Sunnyvale, CA 94086
Code Information All product manufactured after May 16, 2014 with lot numbers starting with M10120516. Part number 420230-06; Batch numbers: M10131018 M10131022 M10131025 M10131105 M10131108 M10131112 M10131115 M10131122 M10131123 M10131126 M10131211 M10131218 M10140109 M10140113 M10140204 M10140224 M10140313 M10140509 M11140224 N10140117 N10140121 N10140227 N10140319 N10140325 N10140403 N10140429 N10140515. Part number 420230-04, Batch numbers: M10120516 M10120523 M10120529 M10120530 M10120607 M10120615 M10120627 M10120628 M10120629 M10120702 M10120704 M10120706 M10120712 M10120716 M10120718 M10120724 M10120727 M10120731 M10120803 M10120807 M10120813 M10120817 M10120827 M10120830 M10120911 M10120918 M10120925 M10121001 M10121009 M10121015 M10121025 M10121030 M10121105 M10121113 M10121116 M10121126 M10121128 M10121203 M10121205 M10121207 M10121213 M10130103 M10130109 M10130115 M10130122 M10130129 M10130131 M10130207 M10130212 M10130215 M10130225 M10130228 M10130305 M10130307 M10130314 M10130315 M10130321 M10130401 M10130403 M10130416 M10130418 M10130423 M10130429 M10130501 M10130508 M10130517 M10130521 M10130528 M10130529 M10130530 M10130606 M10130608 M10130627 M10130702 M10130724 M10130725 M10130806 M10130809 M10130819 M10130827 M10130904 M10130906 M10130918 M10130925 M10131002 M10131004 M10131010 N10130919 N11130925 S10121108 S10130109 S10130722. 
Recalling Firm/
Intuitive Surgical, Inc.
1266 Kifer Rd Bldg 100
Sunnyvale CA 94086-5304
For Additional Information Contact Mark Johnson
Manufacturer Reason
for Recall
Manufacturing variation in the grip assembly of the Large Clip applier which can lead to the instrument jamming during insertion when used with the 8 mm cannula or with certain reducer accessories..
FDA Determined
Cause 2
Process control
Action Urgent Medical Device Correction letters were sent on June 18, 2014 to all affected sites via trackable mail.
Quantity in Commerce 5290 for part 420230-04; 1964 for part 420240-06
Distribution Worldwide Distribution.
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.