Z-1210-2022Class II

DAVINCI | Energy SynchroSeal da Vinci X' da Vinci Xi', Single Use Instrument 8mm, REF 480440

Name: Z-1210-2022 DAVINCI | Energy SynchroSeal da Vinci X' da Vinci Xi', Single Use Instrument 8mm, REF 480440
Creator: Intuitive Surgical, Inc.
Published: 2022-03-03
License: https://open.fda.gov/license/

Intuitive Surgical, Inc. / initiated 2022-03-03 / Open, Classified

FDA source

Intuitive Surgical, Inc. began a recall of DAVINCI | Energy SynchroSeal da Vinci X' da Vinci Xi', Single Use Instrument 8mm, REF 480440 on 2022-03-03. FDA classified it as Class II and gives the reason as "Placing excessive tissue in the instrument jaws of the devices prior to sealing and transection can result in an insufficient seal". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1210-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-03-03
Posted: 2022-05-31
Recalling firm: Intuitive Surgical, Inc.
Product: DAVINCI | Energy SynchroSeal da Vinci X' da Vinci Xi', Single Use Instrument 8mm, REF 480440
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Placing excessive tissue in the instrument jaws of the devices prior to sealing and transection can result in an insufficient seal.
FDA 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: [email protected] " Europe, Middle East, Asia, South America and Africa: +800 0821 2020 or +41 21 821 2020 (8 AM to 6 PM CET) or [email protected] " South Korea: 02-3271-3200 (9 AM to 6 PM KSTJ) or [email protected] " Japan: 0120-56-5635 or 03-5575-1362 (9 AM to 6 PM JST) or [email protected] " Taiwan: 886-2-27008181 (7:30am to 5:30pm CT) or CS.Ta
Quantity in commerce: 7,995 boxes (or 47,972 individual units ; 6 instruments/box)* The total amount will continue to grow until updated user documentation is distributed
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.
Product codes and lots: UDI: 00886874117309. All lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1210-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1209-2022	Class II	Completed	Voluntary: Firm initiated	2022-06-08	2022-05-31
Z-1210-2022	Class II	Completed	Voluntary: Firm initiated	2022-06-08	2022-05-31

Product code GEI

K191280Class IIE-100 Electrosurgical Generator, SynchroSealIntuitive Surgical, Inc. / cleared 2019-11-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)