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U.S. Department of Health and Human Services

Class 2 Device Recall Mega Needle Driver, 8MM assembly of the da Vinci S IS1200 and da Vinci Si, IS2000

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  Class 2 Device Recall Mega Needle Driver, 8MM assembly of the da Vinci S IS1200 and da Vinci Si, IS2000 see related information
Date Initiated by Firm November 15, 2013
Date Posted December 16, 2013
Recall Status1 Terminated 3 on September 04, 2014
Recall Number Z-0520-2014
Recall Event ID 66918
510(K)Number K021036  K050369  
Product Classification System,surgical,computer controlled instrument - Product Code NAY
Product Mega Needle Driver, 8MM assembly of the da Vinci S IS1200 and da Vinci Si, IS2000.

Manufactured by Intuitive Surgical, Sunnyvale, CA.

EndoWrist Instruments, including scissors, scalpels, forceps, needle drivers and electrocautery are intended for endoscopic manipulation of tissue, including: grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery and suturing. Mega Needle Driver and Large Needle Driver instruments are part of the EndoWrist instrument family and are intended for use in endoscopic manipulation and suturing.
Code Information Part number 400194 on da Vinci IS1200; Lot numbers: 710191 M10110114 710197 M10110204 710261 M10110217 711061 M10110307 711121 M10110321 711191 M10110425 712071 M10110523 712171 M10110603 801041 M10110621 801151 M10110725 801171 M10110728 801301 M10110810 803171 M10110816 804121 M10110831 805091 M10110909 805271 M10110920 M10090320 S10080609 M10090512 S10080621 M10090709 S10080729 M10090731 S10080812 M10090812 S10080822 M10090824 S10080910 M10090909 S10080918 M10091020 S10081010 M10091110 S10081029 M10091130 S10081106 M10091211 S10081114 M10100114 S10081201 M10100216 S10081215 M10100218 S10090106 M10100428 S10090210 M10100526 S10090303 M10101026 S10090318 M10101103 S10090320 M10101125 S10090410 S10090715 S10110308. Part number 420194 - used on IS2000: lot numbers: 510071 M10090629 S10080802 710191 M10090706 S10080818 710261 M10090724 S10080822 711061 M10090727 S10080902 711121 M10090731 S10080910 711151 M10090810 S10080917 711191 M10090825 S10080926 712051 M10090828 S10080930 712131 M10090909 S10081002 712262 M10090916 S10081009 801021 M10091005 S10081014 801151 M10091008 S10081016 801181 M10091012 S10081029 801241 M10091030 S10081106 801301 M10091105 S10081114 802121 M10091123 S10081119 802201 M10091124 S10081202 802251 M10091130 S10081209 803121 M10091204 S10081218 803211 M10091211 S10081229 803261 M10091217 S10090106 804031 M10100105 S10090112 804111 M10100112 S10090114 804221 M10100114 S10090119 805121 M10100120 S10090121 805271 M10100122 S10090227 805301 M10100208 S10090302 M10090316 M10100216 S10090305 M10090324 S10080609 S10090312 M10090423 S10080618 S10090316 M10090505 S10080625 S10090318 M10090512 S10080708 S10090320 M10090528 S10080714 S10090327 M10090609 S10080723 S10090402 M10090624 S10080729 S10090406 M10100218 M10110112 M10110726 M10100224 M10110117 M10110802 M10100311 M10110131 M10110805 M10100318 M10110202 M10110809 M10100407 M10110208 M10110811 M10100412 M10110210 M10110817 M10100415 M10110218 M10110825 M10100429 M10110301 M10110901 M10100519 M10110302 M10110906 M10100526 M10110321 M10110913 M10100527 M10110323 M10110920 M10100531 M10110328 M10110923 M10100603 M10110330 S10110307 M10100615 M10110401 M10100713 M10110412 M10100714 M10110419 M10100722 M10110429 M10100723 M10110503 M10100802 M10110511 M10100809 M10110512 M10101001 M10110523 M10101008 M10110527 M10101019 M10110602 M10101026 M10110609 M10101029 M10110614 M10101104 M10110616 M10101109 M10110620 M10101115 M10110622 M10101117 M10110624 M10101122 M10110627 M10101127 M10110701 M10101206 M10110706 M10101215 M10110707 M10101217 M10110714 M10110107 M10110720                                  
Recalling Firm/
Intuitive Surgical, Inc.
1266 Kifer Rd Bldg 100
Sunnyvale CA 94086-5304
For Additional Information Contact Richard Reeves
Manufacturer Reason
for Recall
Firm has become aware of the potential for detachment of the jaw insert for Large Needle Drivers and Mega Needle Drivers.
FDA Determined
Cause 2
Software design (manufacturing process)
Action Intuitive Surgical sent a Field Safety Notice dated November 15, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to ensure all appropriate personnel are fully informed of the Notification. Discontinue use of affected product, Use the attached instructions to identify and segregate affected product. Return affected product to Intuitive Surgical following the established Returned Materials Authorization (RMA) process. Complete the Acknowledgement Form and return to Intuitive Surgical. Customers with questions were instructed to contact Intuitive Surgical Customer Service. Customers were asked to retain a copy of this letter and the acknowledgement form for their files. For questions regarding this recall call 800-876-1310, option 3. Japan 0120-56-5635 or 03-5575-1362 South Korea 02-3271-3200 Europe, Middle East, Asia and Africa +800 0821 2020 +41 21 821 2020 For questions regarding this recall call 408-523-2100. Urgent Medical Device Recall notification letters were sent to all affected sites on November 15, 2013.
Quantity in Commerce 15, 236 UPDATED 12/19/13 to 11,235
Distribution Worldwide Distribution - USA (nationwide and Puerto Rico) and Internationally to Finland, Belgium, Netherlands, UK, Czech Republic, Sweden, Germany, Austria, Switzerland, Norway, Denmark, South Korea, France, Ireland, and Slovakia.
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.