Recall Z-0063-2015— Intuitive Surgical, Inc.

Name: FDA recall Z-0063-2015
Creator: U.S. Food and Drug Administration
Published: 2014-09-17

Class II · Terminated

Class II FDA medical device recall by Intuitive Surgical, Inc., initiated 2014-09-17, terminated 2015-06-01. It names one FDA 510(k) clearance: K130266. Product: EndoWrist One Vessel Sealer used in conjunction with the da Vinci Si Surgical System IS3000. The Endo Wrist One Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Si Surgical System and the ERBE VIO 300 D electrosurgical generator. It is intended for grasping and blunt dissection of tissue and for bipolar coagulation and mechanical transection of vessels up to 7 mm in diameter and tissue bundles that fit in the jaws of the instrument.. Reason: Intuitive Surgical is initiating a voluntary correction relating to the labeling and software associated with the EndoWrist. One Vessel Sealer for the da Vinci Si (IS3000) Surgical System..

Recalling firm: Intuitive Surgical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-09-17
Terminated: 2015-06-01
Firm location: Sunnyvale, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K130266 — ENDOWRIST ONE VESSEL SEALERIntuitive Surgical, Inc.·cleared 2013-08-29

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 One Vessel Sealer used in conjunction with the da Vinci Si Surgical System IS3000. The Endo Wrist One Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Si Surgical System and the ERBE VIO 300 D electrosurgical generator. It is intended for grasping and blunt dissection of tissue and for bipolar coagulation and mechanical transection of vessels up to 7 mm in diameter and tissue bundles that fit in the jaws of the instrument.

Reason for recall

Intuitive Surgical is initiating a voluntary correction relating to the labeling and software associated with the EndoWrist. One Vessel Sealer for the da Vinci Si (IS3000) Surgical System.

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