Recall Z-1210-2022— Intuitive Surgical, Inc.

Name: FDA recall Z-1210-2022
Creator: U.S. Food and Drug Administration
Published: 2022-03-03

Class II · Ongoing

Class II FDA medical device recall by Intuitive Surgical, Inc., initiated 2022-03-03. It names one FDA 510(k) clearance: K191280. Product: DAVINCI | Energy SynchroSeal da Vinci X' da Vinci Xi', Single Use Instrument 8mm, REF 480440. Reason: Placing excessive tissue in the instrument jaws of the devices prior to sealing and transection can result in an insufficient seal..

Recalling firm: Intuitive Surgical, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2022-03-03
Firm location: Sunnyvale, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K191280 — E-100 Electrosurgical Generator, SynchroSealIntuitive Surgical, Inc.·cleared 2019-11-14

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

DAVINCI | Energy SynchroSeal da Vinci X' da Vinci Xi', Single Use Instrument 8mm, REF 480440

Reason for recall

Placing excessive tissue in the instrument jaws of the devices prior to sealing and transection can result in an insufficient seal.

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