Events

Field Safety Notices about da Vinci® Standard ™, S ™ and Si ™

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Intuitive Surgical.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Date
    2015-11-13
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
  • Extra notes in the data
  • Reason
    You do not need to return any covers that may have problems with tear-off labels, as stated in past notices. containers that may have problems with tear-off labels can continue to be used if the covers are inspected according to the instructions given in past messages. .

Device

da Vinci® Standard ™, S ™ and Si ™
  • Model / Serial
    420290-03 D152085A 420291-03 D152085A 420256-01 D152125 420258-01 D152125 420015-03 DA152095 420279-03 DA152095 420022-02 D152115
  • Manufacturer
    Intuitive Surgical

Manufacturer

Intuitive Surgical