Recall Z-0249-2020— Intuitive Surgical, Inc.

Name: FDA recall Z-0249-2020
Creator: U.S. Food and Drug Administration
Published: 2018-06-04

Class II · Ongoing

Class II FDA medical device recall by Intuitive Surgical, Inc., initiated 2018-06-04. It names one FDA 510(k) clearance: K162973. Product: EndoWrist Suction Irrigator, Single Use Instrument. Part Number: 480299-04. An accessory to the EndoWrist Surgical System, used in endoscopic surgery.. Reason: The firm has identified the potential for a silicone particle to be generated within the Suction Irrigator device. If generated, a particle may be introduced into the patient with irrigation..

Recalling firm: Intuitive Surgical, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2018-06-04
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

EndoWrist Suction Irrigator, Single Use Instrument. Part Number: 480299-04. An accessory to the EndoWrist Surgical System, used in endoscopic surgery.

Reason for recall

The firm has identified the potential for a silicone particle to be generated within the Suction Irrigator device. If generated, a particle may be introduced into the patient with irrigation.

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