BEUDAMED
    FDA Recall Terminated

    Da Vinci Xi/X EndoWrist Monopolar Curved scissors (MCS), model number 470179-19, UDI: (00) 886874112298

    Recall: Z-1105-2020 · Initiated December 4, 2018

    Recall

    Recall Number
    Z-1105-2020
    Event Number
    83994
    Firm
    Intuitive Surgical, Inc.
    FEI Number
    3001675293
    Product Code
    NAY
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    December 4, 2018
    Terminated
    August 24, 2022
    Address
    1266 Kifer Rd, Bldg 101, Sunnyvale, CA, 94086-5304

    Description

    Da Vinci Xi/X EndoWrist Monopolar Curved scissors (MCS), model number 470179-19, UDI: (00) 886874112298

    Reason

    This recall is being initiated because lots of EndoWrist Monopolar Curved Scissor instruments are not recognized by the integrated electrosurgical unit, which prohibits the activation of monopolar energy from the surgeon console.

    Action

    On 12/4/2018 date, the firm provided consignees a "Urgent Medical Device Recall" letter. The letter informed customers about the recall. In addition to providing information about the recall, the letter asked customers to do the following: 1.Locate and return all affected instruments in your inventory via the standard Intuitive RMA process as soon as possible. 2. Inform affected personnel when the return has been completed. 3. Please log into the da Vinci Online Community Field Action resource to read or complete any requested actions related to this issue, at this link: https://www.davincisurgerycommunity.com/ 4. In the case where the da Vinci online resource cannot be used, complete the attached Acknowledgement Form and return it via fax to Intuitive Surgical as instructed on the form. 5. Please retain a copy of this letter and the acknowledgement form for your files. 6.If you need further information or support concerning this Medical Device Recall, please contact your Clinical Sales Representative or contact Intuitive Surgical Customer Service at the numbers listed below: North and South America: (800) 876-1310, Option 3 (4 AM to 5 PM PST) or mail: [email protected].

    Distribution

    US National Distribution Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Illinois, Indiana, Iowa, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming OUS:None

    Quantity

    286 Monopolar curved scissors