—#133730

Product

Vacuum Source Tubing Set for the EndoWrist Stabilizer for da Vinci S (IS2000) and Si (IS3000); Part number 420187-05. The Intuitive Surgical EndoWrist Stabilizer Instrument is intended to be used with the fourth arm of the da Vinci S Surgical System. The Intuitive Surgical EndoWrist Stabilizer Instrument is intended to stabilize the epicardial surface of the non-arrested heart during coronary artery surgery.

FDA product code: NAY — System, Surgical, Computer Controlled Instrument
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K060391, K080291
Affected lot / code info: all PN 410187-05

Why it was recalled

There is the possibility that the Vacuum Source Tubing set for the Endo Wrist Stabilizer may have the outer pouch compromised during shipping, resulting in small pinholes which compromise the sterility of the pouches outer surface.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Urgent Medical Device Recall letters were sent on February 16, 2015

Recalling firm

Firm: Intuitive Surgical, Inc.
Address: 1266 Kifer Rd, Bldg 100, Sunnyvale, California 94086-5304

Distribution

Distribution pattern: US and Belgium, Brazil, Canada, China, Finland, France, Greece, India, Italy, Japan, Qatar, Russia, Saudi Arabia, South Korea, Spain, Switzerland, Taiwan, Turkey, United Kingdom

Timeline

Recall initiated: 2015-02-16
Posted by FDA: 2015-02-27
Terminated: 2015-07-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #133730. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.