Recall Z-2059-2023— Intuitive Surgical, Inc.

Name: FDA recall Z-2059-2023
Creator: U.S. Food and Drug Administration
Published: 2023-06-12

Class II · Ongoing

Class II FDA medical device recall by Intuitive Surgical, Inc., initiated 2023-06-12. It names one FDA 510(k) clearance: K131861. Product: da Vinci Xi/X Tip-Up Fenestrated Grasper, REF: 470347, VER: 12. Reason: Fenestrated Graspers have a manufacturing issue has the potential to cause breakage on both upper and/or lower grips, which could lead to stainless steel fragments falling into the patient that may be either detected or undetected..

Recalling firm: Intuitive Surgical, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-06-12
Firm location: Sunnyvale, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K131861 — DA VINCI SURGICAL SYSTEM, ENDOWRIST INSTRUMENTS AND ACCESSORIESIntuitive Surgical, Inc.·cleared 2014-03-28

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

da Vinci Xi/X Tip-Up Fenestrated Grasper, REF: 470347, VER: 12

Reason for recall

Fenestrated Graspers have a manufacturing issue has the potential to cause breakage on both upper and/or lower grips, which could lead to stainless steel fragments falling into the patient that may be either detected or undetected.

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