FDA Recall Open, Classified

EndoWrist Suction Irrigator, Single Use Instrument. Part Number: 480299-04. An accessory to the EndoWrist Surgical System, used in endoscopic surgery.

Recall: Z-0249-2020 · Initiated June 4, 2018

Recall

Recall Number: Z-0249-2020
Event Number: 81073
Firm: Intuitive Surgical, Inc.
FEI Number: 3001675293
Product Code: NAY
Status: Open, Classified
Root Cause: Process change control
Initiated: June 4, 2018
Address: 1266 Kifer Rd, Bldg 101, Sunnyvale, CA, 94086-5304

Description

Reason

The firm has identified the potential for a silicone particle to be generated within the Suction Irrigator device. If generated, a particle may be introduced into the patient with irrigation.

Action

On 06/04/2018, Medical Device Recall notices (Field Safety Notice Urgent Medical Device Correction- ISIFA2018-09-C) were emailed to U.S. consignees, and on 06/07/2018 notices were mailed via FedEx. Additionally on 06/08/2018 two (2) distributors received the notices via email and on 06/15/2018 two (2) EMEIA consignees received the notices by mail. The firm posted information regarding the voluntary field recall on their US Customer Portal on 06/04/2018. Customers were asked to: 1. Stop-use of the affected products for intra-cardiac procedures until further notice from the Recalling Firm. 2. Ensure surgeons and patient side assistants using the products have read and understand the content of the notification letter. 3. Complete the attached Acknowledgement Form and return it via fax or email to U.S. FAX +1(408)523-0619, or Scan and Email [email protected] or for further questions contact Customer Service at: -North and South America: 800-876-1310 Option 3 (4 am to 5 pm PST) -Europe, Middle East, Asia and Africa: +800 0821 2020 or +41 21 821 2020 (8 am to 6 pm CET) 4. Please retain a copy of the Customer Notification and the Acknowledgement form on file.

Distribution

Worldwide distribution. US nationwide, Australia, Italy, Switzerland, and United Kingdom.

Quantity

3108 units (518 boxes of 6 units)