Recall Z-2675-2016— Intuitive Surgical, Inc.

Name: FDA recall Z-2675-2016
Creator: U.S. Food and Drug Administration
Published: 2016-07-14

Class II · Terminated

Class II FDA medical device recall by Intuitive Surgical, Inc., initiated 2016-07-14, terminated 2017-01-03. It names one FDA 510(k) clearance: K140553. Product: STAPLER,IS4000; Model number 470298; General and Plastic Surgery: The Intuitive Surgical da Vinci EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device can be used with staple line or tissue butressing material (natural or synthetic).. Reason: Field failures were reported related to the da Vinci Xi Surgical System EndoWrist Stapler 45 and 30 instruments having an interruption in shaft rotation and / or instrument jaws not opening..

Recalling firm: Intuitive Surgical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-07-14
Terminated: 2017-01-03
Firm location: Sunnyvale, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K140553 — ENDOWRIST STAPLER 45 AND STAPLER 45 RELOADSIntuitive Surgical, Inc.·cleared 2014-07-25

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

STAPLER,IS4000; Model number 470298; General and Plastic Surgery: The Intuitive Surgical da Vinci EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device can be used with staple line or tissue butressing material (natural or synthetic).

Reason for recall

Field failures were reported related to the da Vinci Xi Surgical System EndoWrist Stapler 45 and 30 instruments having an interruption in shaft rotation and / or instrument jaws not opening.

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