BEUDAMED
    FDA Enforcement Class II Terminated

    Patient Side Cart assembly, 4-arm, for use with Intuitive Surgical, Inc. da Vinci Surgical System IS 4000. The patient-side cart is positioned at the operating room table and contains four arms that are positioned over the target patient anatomy. The endoscope attaches onto any arm. The patient-side assistant attaches/detaches the endoscope and instrument intra-operatively.

    Recall: Z-1718-2014 · Reported June 11, 2014

    Enforcement

    Recall Number
    Z-1718-2014
    Event ID
    68358
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Intuitive Surgical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Other
    Report Date
    June 11, 2014
    Initiation Date
    May 9, 2014
    Classification Date
    June 4, 2014
    Termination Date
    June 4, 2014
    Address
    1266 Kifer Rd Bldg 100, Sunnyvale, CA, 94086-5304, United States

    Description

    Patient Side Cart assembly, 4-arm, for use with Intuitive Surgical, Inc. da Vinci Surgical System IS 4000. The patient-side cart is positioned at the operating room table and contains four arms that are positioned over the target patient anatomy. The endoscope attaches onto any arm. The patient-side assistant attaches/detaches the endoscope and instrument intra-operatively.

    Reason

    Torque wrenches used to tighten certain PSC bolts were out of calibration. This could lead to over- or under-tightening of bolts that may result in system faults, mechanical sound (e.g. scraping, squeaking, rattling), cracks or vibration in the system.

    Code Info

    lot 380652-20

    Distribution

    Medical facilities in TX and FL

    Quantity

    2