Recall Z-1891-2020— Intuitive Surgical, Inc.

Name: FDA recall Z-1891-2020
Creator: U.S. Food and Drug Administration
Published: 2019-07-01

Class II · Ongoing

Class II FDA medical device recall by Intuitive Surgical, Inc., initiated 2019-07-01. It names one FDA 510(k) clearance: K173721. Product: daVinci XI Sureform 60 Reload, 60 mm black 6-Row 4.6 mm, Ref: 48360T-08 , UDI: 00886874113851, Rx only, SterileEO - Product Usage: are intended to be used with da Vinci Surgical Systems for resection, transection, and, or creation of anastomoses in General, Thoracic, Gynecologic, Urologic, and Pediatric surgery.. Reason: The firm became aware of a manufacturing variation in which black and green reloads in select Stapler Reloads may not deploy individual adjacent staples, which could result in an incomplete staple line. Failure of a incomplete staple like could potentially lead to an air leak or an anastomotic leak which may require an additional procedural intervention..

Recalling firm: Intuitive Surgical, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2019-07-01
Firm location: Sunnyvale, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K173721 — SureForm 60 and SureForm 60 ReloadsIntuitive Surgical·cleared 2018-07-05

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

daVinci XI Sureform 60 Reload, 60 mm black 6-Row 4.6 mm, Ref: 48360T-08 , UDI: 00886874113851, Rx only, SterileEO - Product Usage: are intended to be used with da Vinci Surgical Systems for resection, transection, and, or creation of anastomoses in General, Thoracic, Gynecologic, Urologic, and Pediatric surgery.

Reason for recall

The firm became aware of a manufacturing variation in which black and green reloads in select Stapler Reloads may not deploy individual adjacent staples, which could result in an incomplete staple line. Failure of a incomplete staple like could potentially lead to an air leak or an anastomotic leak which may require an additional procedural intervention.

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