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U.S. Department of Health and Human Services

Class 2 Device Recall Intuitive Surgical da Vinci Si Surgical System (IS3000)

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 Class 2 Recall
Intuitive Surgical da Vinci Si Surgical System (IS3000)
see related information
Date Posted August 03, 2011
Recall Status1 Terminated on September 02, 2011
Recall Number Z-2930-2011
Recall Event ID 59300
Premarket Notification
510(K) Number
K090993 
Product Classification System,Surgical,Computer Controlled Instrument - Product Code NAY
Product Intuitive Surgical da Vinci Si Surgical System (IS3000); Mfg by: Intuitive Surgical, Sunnyvale, CA 94086 Product Usage: Intended to assist in the accurate control of Intuitive Surgical Endoscopic Endo Wrist Instruments and Accessories. The system is indicated for adult and pediatric use (except for transoral otolaryngology surgical procedures). It is intended for use for trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.
Code Information serial numbers: SH0019 SH0021 SH0028 SH0037 SH0039 SH0042 SH0059 SH0061 SH0062 SH0063 SH0071 SH0078 SH0082 SH0084 SH0085 SH0086 SH0095 SH0099 SH0103 SH0111 SH0112 SH0114 SH0116 SH0117 SH0118 SH0120 SH0125 SH0126 SH0127 SH0130 SH0131 SH0135 SH0143 SH0148 SH0150 SH0155 SH0156 SH0160 SH0176 SH0177 SH0180 SH0193 SH0208 SH0210 SH0220 SH0221 SH0222 SH0224 SH0225 SH0228 SH0246 SH0251 SH0252 SH0256 SH0258 SH0270 SH0271 SH0273 SH0285 SH0286 SH0291 SH0303 SH0305 SH0307 SH0308 SH0312 SH0314 SH0320 SH0328 SH0332 SH0335 SH0336 SH0340 SH0342 SH0343 SH0344 SH0363 SH0369 SH0373 SH0378 SH0380 SH0381 SH0388 SH0393 SH0408 SH0411 SH0412 SH0416 SH0434 SH0441 SH0443 SH0447 SH0448 SH0449 SH0463 SH0464 SH0465 SH0467 SH0469 SH0470 SH0482 SH0483 SH0491 SH0495 SH0497 SH0500 SH0506 SH0511 SH0516 SH0517 SH0518 SH0528 SH0531 SH0533 SH0534 SH0543 SH0547 SH0555 SH0557 SH0558 SH0560 SH0565 SH0570 SH0574 SH0579 SH0585 SH0589 SH0591 SH0600 SH0608 SH0618 SH0620 SH0625 SH0627 SH0630 SH0631 SH0639 SH0644 SH0653 SH0657 SH0658 SH0659 SH0660 SH0663 SH0664 SH0665 SH0668 SH0671 SH0672 SH0680 SH0687 SH0691 SH0692 SH0696 SH0697 SH0701 SH0705 SH0706 SH0708 SH0712 SH0713 SH0721 SH0729 SH0730 SH0741 SH0744 SH0747 SH0762 SH0764 SH0774 SH0798 SH0807 SH0813 SH0834 SH0900 USG172 USG317 USG484 USG702 USG713 USG718 USG775 USG806
Recalling Firm/
Manufacturer
Intuitive Surgical, Inc.
1266 Kifer Rd Bldg 100
Sunnyvale, California 94086-5304
For Additional Information Contact William Nowlin, PhD.
408-523-2100
Manufacturer Reason
for Recall
Potential failure of the retention component of the Master Tool Manipulator (MTM) of the Intuitive Surgical da Vinci Si Surgical System which could cause uncontrolled movement.
FDA Determined
Cause 2
DESIGN: Device Design
Action Intuitive Surgical sent an "URGENT- MEDICAL DEVICE CORRECTION" letter dated July 1, 2011 to all affected customers. Customers were asked to complete the attached response form and return as per the instructions. The letter identifies the product, problem, and actions to be taken by the customers. The letter reinforce to customers to follow the product labeling WARNING. The letter states that all affected customers sites will be receiving a call from a Customer Support staff to schedule a retrofit of the component. A letter was also sent to non affected customers to inform them of the urgent medical device correction and actions to be taken. If you have any questions, please contact Customer Service at 1-800-876-1310 or for Outside United States call +41 21 821 2020.
Quantity in Commerce 183
Distribution Worldwide Distribution -- USA (nationwide) and the countries of: Belgium, Czech Republic, Denmark, France, Germany, Greece, India, Ireland, Israel, Italy, Netherlands, Norway, Philippines, Portugal, Saudi Arabia, Singapore, South Korea, Spain, Switzerland, Turkey and United Kingdom.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = NAY and Original Applicant = INTUITIVE SURGICAL, INC.
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