Recall Z-1717-2017— Intuitive Surgical, Inc.

Name: FDA recall Z-1717-2017
Creator: U.S. Food and Drug Administration
Published: 2017-03-15

Class II · Terminated

Class II FDA medical device recall by Intuitive Surgical, Inc., initiated 2017-03-15, terminated 2018-12-10. It names one FDA 510(k) clearance: K140553. Product: STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi Dutch SRK General and Plastic Surgery: The Intuitive Surgical 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: Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result damage of the tool..

Recalling firm: Intuitive Surgical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-03-15
Terminated: 2018-12-10
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; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi Dutch SRK General and Plastic Surgery: The Intuitive Surgical 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

Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result damage of the tool.

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