Recall Z-1819-2017— Intuitive Surgical, Inc.

Name: FDA recall Z-1819-2017
Creator: U.S. Food and Drug Administration
Published: 2017-03-31

Class II · Terminated

Class II FDA medical device recall by Intuitive Surgical, Inc., initiated 2017-03-31, terminated 2017-07-28. It names one FDA 510(k) clearance: K162973. Product: da Vinci Xi EndoWrist Suction Irrigator, 8 mm instrument; PN 480299-03; and SOFTWARE, EMBEDDED RLS, IS4000, A70_P6_B440; PN 610092-440. General and Plastic Surgery: The EndoWrist¿ Suction Irrigator is designed to be used in conjunction with an Intuitive Surgical da Vinci Surgical System and compatible suction and irrigation sources and tubing sets for delivering fluid to the surgical site and for evacuation and aspiration of fluids. The instrument may also be used for retraction and blunt dissection of tissue. The instrument tip is blunt and intended to contact tissue.. Reason: Intuitive Surgical has become aware that in specific scenarios with system software P6 and the da Vinci Xi Suction Irrigator (PN 480299-03), users can experience unexpected motion of a system arm..

Recalling firm: Intuitive Surgical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-03-31
Terminated: 2017-07-28
Firm location: Sunnyvale, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K162973 — EndoWrist Suction IrrigatorIntuitive Surgical, Inc.·cleared 2017-02-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

da Vinci Xi EndoWrist Suction Irrigator, 8 mm instrument; PN 480299-03; and SOFTWARE, EMBEDDED RLS, IS4000, A70_P6_B440; PN 610092-440. General and Plastic Surgery: The EndoWrist¿ Suction Irrigator is designed to be used in conjunction with an Intuitive Surgical da Vinci Surgical System and compatible suction and irrigation sources and tubing sets for delivering fluid to the surgical site and for evacuation and aspiration of fluids. The instrument may also be used for retraction and blunt dissection of tissue. The instrument tip is blunt and intended to contact tissue.

Reason for recall

Intuitive Surgical has become aware that in specific scenarios with system software P6 and the da Vinci Xi Suction Irrigator (PN 480299-03), users can experience unexpected motion of a system arm.

Data sourced from openFDA. This site is unofficial and independent of the FDA.