Intuitive Surgical, Inc.: VESSEL SEALER EXTEND, Single-Use Instrument EndoWrist Instruments 8mm, da Vinci X' da Vinci Xi', REF 480422

Recall number

Z-1209-2022

Recalling firm

Intuitive Surgical, Inc.

Product

VESSEL SEALER EXTEND, Single-Use Instrument EndoWrist Instruments 8mm, da Vinci X' da Vinci Xi', REF 480422

Status

Open, Classified

Initiated

2022-03-03

Posted

not on file

Terminated

not on file

Reason

Placing excessive tissue in the instrument jaws of the devices prior to sealing and transection can result in an insufficient seal.

Root cause

Use error

Action

On 03/03/22, a Field Safety Notice was sent via courier service to customers. In section 4, "Actions to be taken by the Customer/User" of the Field Safety Notice includes the following: Place the customer communication with the User Manual. In addition, 1. Read and understand the contents of the letter. 2. Notify all surgeons and personnel using the System that they should reacquaint themselves by a. Reading the instructions, warnings, and cautions provided in the Instruments and Accessories User Manual Addendum /User Manual b. Contacting Sales Representatives for clarification of queries. 3. Complete the Acknowledgement Form immediately and return it via fax or email as instructed on the form. 4. Retain a copy of the letter and the acknowledgement form for your files. 5. Inform of any adverse events/serious incidents or quality problems concerning the use of the subject devices via the standard complaint process. 6. Additionally, if adverse events/serious incidents or quality problems are experienced, follow the standard reporting process to the health authority, if applicable. The use of the instruments may be continued by following instructions provided in Section 1 of the notice and warnings and cautions listed in the user manuals. There will be follow up with updated user documentation once available. If further information is needed or support concerning the Medical Device Correction, contact the Clinical Sales Representative or contact Customer Service at the numbers listed below: " US, Puerto Rico and Dominican Republic (800) 876-1310, Option 3 (4 AM to 5 PM PST) or mail: customerservice@intusurg.com " Europe, Middle East, Asia, South America and Africa: +800 0821 2020 or +41 21 821 2020 (8 AM to 6 PM CET) or EUCS@intusurg.com " South Korea: 02-3271-3200 (9 AM to 6 PM KSTJ) or support.korea@intusurg.com " Japan: 0120-56-5635 or 03-5575-1362 (9 AM to 6 PM JST) or csjapan@intusurg.com " Taiwan: 886-2-27008181 (7:30am to 5:30pm CT) or CS.Ta

Quantity

140,519 boxes (843,113 individual units)

Distribution

Worldwide distribution - US Nationwide and the countries/regions of Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Cyprus, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Greece, Guadeloupe, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mexico, Monaco, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, Vietnam.

Lot, serial or model codes

UDI: 00886874115664. All lots

510(k) numbers

["K173337"]

PMA numbers

not on file

Product code

NAY

Firm FEI

3001675293

Firm city

Sunnyvale

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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