Events

Field Safety Notices about da Vinci Surgical System Drapes

According to Ministry of Health, State Institute for Drug Control, Coordination Center for Departmental Medical Information Systems, this field safety notices involved a device in Czechia that was produced by Microtek Medical Inc..

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
  • Event ID
    336
  • Date
    2015-12-08
  • Event Country
    Czechia
  • Event Source
    MHSIDCCCDMIS
  • Event Source URL
    https://eregpublicsecure.ksrzis.cz/Registr/RZPRO/FSN
  • Notes / Alerts
    Czech data is current through July 2018. All of the data comes from the Czech Public Registry of Medical Devices, 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 data from the U.S. and the Czech Republic.
  • Extra notes in the data

Device

da Vinci Surgical System Drapes
  • Model / Serial
    Model Number: Affected product for Tear-Away Labels: 420015-03, 420022-02, 420256-01, 420258-01, 420279-03, 420291-03, 420290-03 Affected product for Cloudy / Waxy Appearance: 400015-03, 400016-04, 400027-04, 420015-03, 420017-03, 420022-02, 420026-01, 420256-01, 420258-01, 420273-02, 420279-03, 420281-02, 420290-03, 420291-03 Batch Number: All lot numbers greater than 066 as seen in the following format D15066xx or DA15066xx.
  • Product Description
    Medical devices for single use
  • Manufacturer
    Microtek Medical Inc.

Manufacturer

Microtek Medical Inc.
  • Manufacturer Parent Company (2017)
    Ecolab Inc
  • Source
    MHSIDCCCDMIS