BEUDAMED
    FDA Enforcement Class II Ongoing

    EndoWrist Suction Irrigator, Single Use Instrument. Part Number: 480299-04. An accessory to the EndoWrist Surgical System, used in endoscopic surgery.

    Recall: Z-0249-2020 · Reported November 6, 2019

    Enforcement

    Recall Number
    Z-0249-2020
    Event ID
    81073
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Intuitive Surgical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Other
    Report Date
    November 6, 2019
    Initiation Date
    June 4, 2018
    Classification Date
    October 30, 2019
    Address
    1266 Kifer Rd Bldg 101, Sunnyvale, CA, 94086-5304, United States

    Description

    EndoWrist Suction Irrigator, Single Use Instrument. Part Number: 480299-04. An accessory to the EndoWrist Surgical System, used in endoscopic surgery.

    Reason

    The firm has identified the potential for a silicone particle to be generated within the Suction Irrigator device. If generated, a particle may be introduced into the patient with irrigation.

    Code Info

    Lots: T10180226 and onward; Part Numbers: 480299-04 (UDI 00886874114810)

    Distribution

    Worldwide distribution. US nationwide, Australia, Italy, Switzerland, and United Kingdom.

    Quantity

    3108 units (518 boxes of 6 units)