Events

Field Safety Notices about Soluscope Serie 4 PA endoscope washer-disinfectors (EWD)

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 Soluscope SAS.

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
    2015-09-30
  • 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
    We have detected failures in the traceability of processed endoscopes; the data are not properly retrieved in certain cases. these malfunctions are not systematic. they have no consequence whatsoever on medical device performances related to cleaning and disinfection of endoscopes.

Device

Soluscope Serie 4 PA endoscope washer-disinfectors (EWD)
  • Model / Serial
    00022342 00021985 00021993 00022302 00021995
  • Manufacturer
    Soluscope SAS

Manufacturer

Soluscope SAS
  • Manufacturer Parent Company (2017)
    Ecolab Inc
  • Source
    AMPMDRS