BEUDAMED
    FDA Enforcement Class II Terminated

    The da Vinci Xi and X surgical systems (IS4000 and IS4200) each consist of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The Patient Cart is the operative component of the system and its primary function is to support the instrument arms and camera arm. The X/Xi Instrument Arm Drape is intended to be used with the instrument arms of the PC as a sterile barrier during clinical procedures, and makes the instrument arms sterile and suitable for surgery. X/Xi Instrument Arm Drapes are sterile unless the package is opened or damaged, and are indicated for a single use. The drapes are placed onto the instrument arms by two users (one sterile and one non-sterile)in tandem, with the non-sterile user leading the placement via drape cuff pockets.

    Recall: Z-0275-2022 · Reported December 1, 2021

    Enforcement

    Recall Number
    Z-0275-2022
    Event ID
    88783
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Intuitive Surgical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 1, 2021
    Initiation Date
    September 21, 2021
    Classification Date
    November 23, 2021
    Termination Date
    January 25, 2024
    Address
    1266 Kifer Rd Bldg 101, Sunnyvale, CA, 94086-5304, United States

    Description

    The da Vinci Xi and X surgical systems (IS4000 and IS4200) each consist of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The Patient Cart is the operative component of the system and its primary function is to support the instrument arms and camera arm. The X/Xi Instrument Arm Drape is intended to be used with the instrument arms of the PC as a sterile barrier during clinical procedures, and makes the instrument arms sterile and suitable for surgery. X/Xi Instrument Arm Drapes are sterile unless the package is opened or damaged, and are indicated for a single use. The drapes are placed onto the instrument arms by two users (one sterile and one non-sterile)in tandem, with the non-sterile user leading the placement via drape cuff pockets.

    Reason

    Incorrect expiration date on its package labeling (shipper box and inner carton label).

    Code Info

    Part number: 470015-07; Lot number: DM4210309; REF: 470015; UDI # 00886874112199.

    Distribution

    Worldwide distribution - U.S. Nationwide distribution in the states of AL, CA, GA, IL, FL, CO, TX, MO, OH, MA, WI, NC, LA, UT and the country of South Korea.

    Quantity

    1,740 drapes (87 bobes)