BEUDAMED
    FDA Recall Open, Classified

    da Vinci X (IS4200) and Xi (IS4000) systems, which consists of finished devices Surgeon Console (SSC), Patient Cart (PSCART), Vision System (VSS)

    Recall: Z-0133-2023 · Initiated September 20, 2022

    Recall

    Recall Number
    Z-0133-2023
    Event Number
    90826
    Firm
    Intuitive Surgical, Inc.
    FEI Number
    3001675293
    Product Code
    NAY
    Status
    Open, Classified
    Root Cause
    Software Design Change
    Initiated
    September 20, 2022
    Posted
    October 25, 2022
    Address
    1266 Kifer Rd, Bldg 101, Sunnyvale, CA, 94086-5304

    Description

    da Vinci X (IS4200) and Xi (IS4000) systems, which consists of finished devices Surgeon Console (SSC), Patient Cart (PSCART), Vision System (VSS)

    Reason

    Inadvertent energy delivery from surgical system instrument if 1) Force bipolar and bipolar instruments installed on system 2) Force bipolar connected to Force Triad generator, bipolar not connected to generator 3) Yellow pedal associated with force bipolar is pressed, released with head in surgeon console 4) Blue pedal associated with bipolar is pressed, resulting in force bipolar energy delivery

    Action

    On 09/20/22, correction notices were mailed to customers. Customers were advised of the following: 1) The system software version can be located on the Vision Cart Touchscreen in the Troubleshooting Tab. 2) Ensure all device users read and understand this notice. 3) Notice should be passed on to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. 4) Ensure proper instrument connections to the generator(s) and continue to follow all existing warnings and cautions found in user manuals 551400-15, USER MANUAL,SYS,P10,US,IS4000, 553873-07, USER MANUAL,I-A,MDR P10,IS4000-IS4200 and 554070-04, ADD,I-A,FORCE BIPOLAR,IS4000,IS4200. 5) Complete and return the acknowledgement form. 6) The recalling firm will follow-up with customers and schedule a software upgrade. 7) After the upgrade, inform all personnel that the software update/upgrade was completed. 8) If you have experienced this issue or require additional assistance, contact Technical Support: 800-876-1310, Option 1 (24/7) or [email protected]

    Distribution

    US: MS, PA, WI, KY, TN, MI, FL, GA, NC, NV, LA, OH, IL, MO, IN, CA, AK, MD, TX, IA, MA, NE, AZ, WA, CO, AL, SC

    Quantity

    162