Recall Z-1142-2015— Intuitive Surgical, Inc.

Name: FDA recall Z-1142-2015
Creator: U.S. Food and Drug Administration
Published: 2015-02-11

Class II · Terminated

Class II FDA medical device recall by Intuitive Surgical, Inc., initiated 2015-02-11, terminated 2015-06-01. It names one FDA 510(k) clearance: K140189. Product: EndoWrist One Vessel Sealer, 8MM, IS4000, 6 pack used in conjunction with the da Vinci Surgical System Xi IS4000. The EndoWrist Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Xi Surgical System and the ERBE VIO dV 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 has identified the potential for a certain, small portion of Vessel Sealers to exhibit interference in the back of the instrument grips due to manufacturing variability in some jaws..

Recalling firm: Intuitive Surgical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-02-11
Terminated: 2015-06-01
Firm location: Sunnyvale, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K140189 — ENDOWRIST VESSEL SEALERIntuitive Surgical, Inc.·cleared 2014-06-05

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, 8MM, IS4000, 6 pack used in conjunction with the da Vinci Surgical System Xi IS4000. The EndoWrist Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Xi Surgical System and the ERBE VIO dV 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 has identified the potential for a certain, small portion of Vessel Sealers to exhibit interference in the back of the instrument grips due to manufacturing variability in some jaws.

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