BEUDAMED
    FDA Recall Terminated

    IS4000 da Vinci Xi - Endoscope accessory; 0 Degree, 8mm Endoscope. Intuitive Surgical Inc.

    Recall: Z-1871-2014 · Initiated June 11, 2014

    Recall

    Recall Number
    Z-1871-2014
    Event Number
    68531
    Firm
    Intuitive Surgical, Inc.
    FEI Number
    3001675293
    Product Code
    NAY
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    June 11, 2014
    Posted
    June 25, 2014
    Terminated
    July 2, 2014
    Address
    1266 Kifer Rd, Bldg 100, Sunnyvale, CA, 94086-5304

    Description

    IS4000 da Vinci Xi - Endoscope accessory; 0 Degree, 8mm Endoscope. Intuitive Surgical Inc.

    Reason

    In some procedures when using the endoscope in conjunction with the IS4000 (da Vinci Xi) System, the surgical view has an orange-yellow tint which can make it hard to differentiate between tissue

    Action

    Medical Device Recall notifications were sent to the 4 affected sites on June 11, 2014. Letters describe the problem and the potential health risk. The two model numbers of the endoscope are listed and the statement that ISI will perform a software upgrade to the da Vinci System and replace the endoscopes. Letters request that the following actions take place: - Ensure that all appropriate personnel are fully informed of the information provided in the notification letter. - Complete and return the acknowledgement form using instructions provided. - Retain a copy of The letter for your records. Intuitive representatives will schedule a site visit to provide the re-calibrated endoscope, update the software and ensure that it is properly integrated with the da Vinci Xi Surgical System. Questions or concerns may be directed to Intuitive Customer Service at 800-876-1310.

    Distribution

    Distributed in the states of FL, TX, and NY.

    Quantity

    19 units