BEUDAMED
    FDA Enforcement Class II Terminated

    INSTRUMENT ARM DRAPE IS2000, 20 PACK: Product Usage: The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci Surgical Systems.

    Recall: Z-2101-2012 · Reported August 8, 2012

    Enforcement

    Recall Number
    Z-2101-2012
    Event ID
    62553
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Intuitive Surgical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 8, 2012
    Initiation Date
    July 13, 2012
    Classification Date
    July 27, 2012
    Termination Date
    June 12, 2013
    Address
    1266 Kifer Rd Bldg 100, N/A, Sunnyvale, CA, 94086-5304, United States

    Description

    INSTRUMENT ARM DRAPE IS2000, 20 PACK: Product Usage: The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci Surgical Systems.

    Reason

    Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have difficulty engaging an instrument.

    Code Info

    Part number: 420015-03; Lot numbers: D120745A, D120765, D120795, D120845, D120895A, D120935, D120955. EXPANDED - added lot DA121075.

    Distribution

    Worldwide Distribution - US Nationwide and the countries of: Australia, Spain, India, Italy and Saudi Arabia.

    Quantity

    92390 total instrument Drapes