BEUDAMED
    FDA Enforcement Class II Terminated

    8MM, MEGA SUTURECUT ND; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.

    Recall: Z-0444-2015 · Reported December 3, 2014

    Enforcement

    Recall Number
    Z-0444-2015
    Event ID
    69638
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Intuitive Surgical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 3, 2014
    Initiation Date
    November 3, 2014
    Classification Date
    November 25, 2014
    Termination Date
    February 3, 2015
    Address
    1266 Kifer Rd Bldg 100, N/A, Sunnyvale, CA, 94086-5304, United States

    Description

    8MM, MEGA SUTURECUT ND; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.

    Reason

    Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.

    Code Info

    Part number; 470309-04; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.

    Distribution

    US Distribution -- FL, TX, NY, NV, OR, IN, UT, and MA.

    Quantity

    509 units, total all devices