Recall Z-1105-2020— Intuitive Surgical, Inc.

Name: FDA recall Z-1105-2020
Creator: U.S. Food and Drug Administration
Published: 2018-12-04

Class II · Terminated

Class II FDA medical device recall by Intuitive Surgical, Inc., initiated 2018-12-04, terminated 2022-08-24. It names one FDA 510(k) clearance: K131861. Product: Da Vinci Xi/X EndoWrist Monopolar Curved scissors (MCS), model number 470179-19, UDI: (00) 886874112298. Reason: This recall is being initiated because lots of EndoWrist Monopolar Curved Scissor instruments are not recognized by the integrated electrosurgical unit, which prohibits the activation of monopolar energy from the surgeon console..

Recalling firm: Intuitive Surgical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-12-04
Terminated: 2022-08-24
Firm location: Sunnyvale, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K131861 — DA VINCI SURGICAL SYSTEM, ENDOWRIST INSTRUMENTS AND ACCESSORIESIntuitive Surgical, Inc.·cleared 2014-03-28

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/X EndoWrist Monopolar Curved scissors (MCS), model number 470179-19, UDI: (00) 886874112298

Reason for recall

This recall is being initiated because lots of EndoWrist Monopolar Curved Scissor instruments are not recognized by the integrated electrosurgical unit, which prohibits the activation of monopolar energy from the surgeon console.

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