BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-1210-2022 · Initiated March 3, 2022

    Recall

    Recall Number
    Z-1210-2022
    Event Number
    89641
    Firm
    Intuitive Surgical, Inc.
    FEI Number
    3001675293
    Product Code
    GEI
    Status
    Open, Classified
    Root Cause
    Use error
    Initiated
    March 3, 2022
    Address
    1266 Kifer Rd, Bldg 101, Sunnyvale, CA, 94086-5304

    Description

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

    Reason

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

    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

    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.

    Quantity

    7,995 boxes (or 47,972 individual units ; 6 instruments/box)* The total amount will continue to grow until updated user documentation is distributed