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.
FDA Recall Z-0063-2015 · Posted 2014-10-10
Recalling FirmIntuitive Surgical, Inc.
Recall StatusTerminated
Product CodeNAY
Date Initiated2014-09-17
Date Terminated2015-06-01
Product Quantity1,483 devices
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.
Firm Action
Urgent medical device correction letter was sent to all consignees on 9/22/14 by trackable mail system.
Letters identified the issue and provides information for users should a error code be displayed.
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution-USA (nationwide) and the countries of Australia, Austria, Belgium, China, Chile, Colombia, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Japan, Netherlands, Norway, South Korea, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.