da Vinci Xi Surgical System, IS4000; ASSY,DISTAL SUJ,OUTER,IS4000, Material number: 380663-20 and 380663-21. The Intuiti

FDA device recall Z-1303-2015 · posted 2015-03-20 · Terminated

Recall details

Recalling firm

Intuitive Surgical, Inc.

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.

Action taken

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.

Root cause

Under Investigation by firm

Status

Terminated

Product code

NAY

Quantity affected

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.

Date initiated

2015-03-03

Date posted

2015-03-20

Date terminated

2015-09-08

Location

Sunnyvale, CA

Related 510(k) clearances