—#165193

Product

da Vinci Xi EndoWrist Stapler 45 Reload Blue, Model 48645B-03, 12 reloads/box.

FDA product code: GDW — Staple, Implantable
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K140553
Affected lot / code info: UDI: 00886874112878. Device expiration: 10/14/2017 02/21/2020

Why it was recalled

Intuitive Surgical, Inc. (ISI) has recently become aware of an issue with the da Vinci Xi Stapler 45 Blue and Green Reloads that may be missing a component of the knife mechanism. Without this component, the reload knife will not move and cut tissue when the stapler is fired.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Intuitive Surgical, Inc. (ISI) conducted the recall and notified customers via letter "Field Safety Notice Urgent Medical Device Notification" sent the week of April 23, 2018. The letter notified customers of the recall, reason for field action, risk to health, affected products, Actions to be taken by the Customer/User, Actions to be taken by Intuitive Surgical, and Further Information and Support: If you need further information or support concerning this Medical Device Notification , please contact your Clinical Sales Representative or contact Intuitive Surgical Customer Service at the numbers listed below: "North and South America: (800) 876-1310, Option 3 (4 AM to 5 PM PST) or mail: customerservice@intusurg.com. "Europe, Middle East, Asia and Africa: +800 0821 2020 or +41 21 821 2020 (8AM to 6 PM CET) or ics@intusurg.com "South Korea: 02-3271-3200 (9 AM to 6 PM KSTJ) "Japan: 0120-56-5635 or 03-5575-1362 (9 AM to 6 PM JST).

Recalling firm

Firm: Intuitive Surgical, Inc.
Address: 1266 Kifer Rd, Bldg 101, Sunnyvale, California 94086-5304

Distribution

Distribution pattern: U.S., foreign and government accounts. Foreign: Australia, Austria, Belgium, Brazil, Canada, China (Hong Kong), Czech Republic, Denmark, Finland, France, Germany, Ireland, Italy, Japan, Luxembourg, Netherlands, Norway, Qatar, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom.

Timeline

Recall initiated: 2018-04-23
Terminated: 2020-07-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #165193. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.