BEUDAMED
    FDA Recall Terminated

    da Vinci S / Si Surgical System IS2000 / IS3000, Instrument Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.

    Recall: Z-1387-2015 · Initiated March 16, 2015

    Recall

    Recall Number
    Z-1387-2015
    Event Number
    70777
    Firm
    Intuitive Surgical, Inc.
    FEI Number
    3001675293
    Product Code
    KKX
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    March 16, 2015
    Posted
    April 6, 2015
    Terminated
    December 3, 2015
    Address
    1266 Kifer Rd, Bldg 100, Sunnyvale, CA, 94086-5304

    Description

    da Vinci S / Si Surgical System IS2000 / IS3000, Instrument Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.

    Reason

    Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.

    Action

    Firm issued field safety notice to all customers on March 16, 2015. Field safety notice includes acknowledgement form to be returned to recalling firm. A second letter was sent on May 12, 2015 to inform users that the date that the drape product unaffected by the issue will not be availalble untisl October/November 2015, not May 2015 as stated in the original communication.

    Distribution

    Worldwide Distribution-Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China (including Hong Kong), Colombia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, France, Germany, Greece, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Mauritius, Mexico, Monaco, Netherlands, New Zealand, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, Venezuela, Vietnam.

    Quantity

    442,475 total for all drape models