| Class 2 Device Recall da Vinci Xi Surgical System | |
Date Initiated by Firm | March 03, 2015 |
Date Posted | March 20, 2015 |
Recall Status1 |
Terminated 3 on September 08, 2015 |
Recall Number | Z-1304-2015 |
Recall Event ID |
70705 |
510(K)Number | K131861 |
Product Classification |
System,surgical,computer controlled instrument - Product Code NAY
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Product | da Vinci Xi Surgical System, IS4000;
ASSY,USM,IS4000,
Material number: 380647-20 and 380647-22
The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endocopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders,
endscopic retractors, electrocautery and accessories for edoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximations, ligation, electrocautery, suturing and delivery and placement of microware and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic labaroscopic surgical procedures, general thorascopic surgical procedures and thorascopically-assisted cardiotomy procedures. |
Code Information |
Material number: 380647-20; Serial numbers: 1311140430, 1311140586, 1311140058, 1311140392. 1311140277, 1311140307, 1311140094, 1311140100, 1311140569, 1311140102, 1311140421, 1311140092, 1311140009, 1311140070, 1311140267, 1311140333, 1311140492, 1311140391, 1311140057, 1311140294, 1311140508, 1311140565, 1311140105, 1311140122, 1311140469, 1311140521, 1311140378, 1311140456, 1311140230 1311140573, 1311140065, 1311140164, 1311140194, 1311140511, 1311140291, 1311140304, 1311140212, 1311140222, 1311140001, 1311140137, 1311140344, 1311140381, 1311140341, 1311140538, 1311140168, 1311140523, 1311140274, 1311140033, 1311140091 1311140248, 1311140141, 1311140436, 1311140418, 1311140548 1311140320, 1311140170, 1311140346. Material number 380746-22: Serial numbers: 1311140486 1311140539, 1311140174, 1311140183, 1311140327, 1311140347 1311140482, 1311140145, 1311140066, 1311140302, 1311140477 1311140084, 1311140211, 1311140103, 1311140083, 1311140050, 1311140488, 1311140365, 1311140207, 1311140459, 1311140557, 1311140423, 1311140045, 1311140440, 1311140231. |
Recalling Firm/ Manufacturer |
Intuitive Surgical, Inc. 1266 Kifer Rd Bldg 100 Sunnyvale CA 94086-5304
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For Additional Information Contact | Mark Johnson 408-523-2100 |
Manufacturer Reason for Recall | Correction due to a fault that causes distal SUJ (DSUJ) failures that indicates a mismatch between the positions reported by the redundant position sensors on one of the patient cart arm joints. |
FDA Determined Cause 2 | Under Investigation by firm |
Action | The firm, Intuitive Surgical, sent an "Urgent Medical Device Correction" letter dated March 11, 2015 to its consignees/customers on March 11, 2015 via Fed Ex. The letter described the product, problem and actions to be taken. The customers were instructed to ensure that all affected personnel are fully informed of this notice; forward this notice to your Risk Manager, OR Director, Purchasing Manager, biomedical Engineering staff and members of your medical staff who perform da Vinci Surgery procedures; Identify systems containing affected product at your site; if you encounter this error during a procedure and the fault cannot be recovered, disable the affected arm and contact dVStat; Contact Intuitive Surgical Customer Service; Complete and return the attached Acknowledgment Form to Intuitive Surgical via U.S. Fax +1 (408) 716-3040, or Scan and Email: isi.compliance@intusurg.com, ATTN: REGULATORY COMPLIANCE-Subject line for email: Pot to Encoder;and retain a copy of this notice for your records.
An Intuitive Surgical representative will contact you to schedule a remote assessment to determine the health of your system and to schedule an appointment to replace the affected arm.
If you need further information or support concerning this Medical Device Correction, please contact your Clinical Sales Representative or Intuitive Surgical Customer Service at the numbers listed below:
-North America and South America: 800-876-1310, Option 3 (6 AM to 5 PM PST)
-Japan: 0120-56-5635 or 03-5575-1362 (9 AM to 6 PM JST)
-South Korea: 02-3271-3200 (9 AM to 6 PM KST)
-Europe, Middle East, Asia and Africa: +800 0821 2020 or +41 21 821 2020
(8 AM to 6 PM CET) or ics@intusurg.com. |
Quantity in Commerce | 167 total affected da Vinci Xi systems |
Distribution | Worldwide Distribution: US (nationwide) and countries of: Australia, Belgium, China, France, Germany, India, Israel, Italy, Norway, South Korea, Spain, Sweden, Switzerland, Turkey, and United Kingdom. |
Total Product Life Cycle | TPLC Device Report |
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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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510(K) Database | 510(K)s with Product Code = NAY
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