International Medical Devices Database

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
2018-03-07
Event Country
Netherlands
Event Source
IGJ
Event Source URL
https://www.igj.nl/onderwerpen/waarschuwingen-medische-hulpmiddelen/documenten/waarschuwingen/2018/03/07/cook-medical-europe-2018fa0004---stonebreaker-pneumatic-lithotripter-and-associated-accessories
Notes / Alerts

The data from the Netherlands is current through October 2018. All of the data comes from Inspectie Gezondheidszorg en Jeugd, 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 the Netherlands.
Extra notes in the data
Reason
We have found that the inside of the product may not be sterilized to the appropriate level for sterility assurance when following the reprocessing instructions in the instructions for use.

Device

StoneBreaker® Pneumatic Lithotripter and associated accessories

Model / Serial
Manufacturer
Cook Medical Europe

Manufacturer

Cook Medical Europe

Manufacturer Parent Company (2017)
Cook Group Incorporated
Manufacturer comment
Note published by the authorities from the Netherlands: This message is a warning from the manufacturer. After placing a medical device on the market, the manufacturer is obliged to follow the device and, where necessary, to improve it. When there is a risk for the user, the manufacturer must take action. The manufacturer informs users and the inspection of this action with a warning (Field Safety Notice). See also medical device warnings. This is part of the supervision of medical technology.
Source
IGJ

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Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers.

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Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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The International Medical Devices Database is licensed under the Open Database License and its contents under Creative Commons Attribution-ShareAlike license. Always cite the International Consortium of Investigative Journalists when using this data. You can download a raw copy of the database here.

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Field Safety Notices about StoneBreaker® Pneumatic Lithotripter and associated accessories

What is this?

Device

StoneBreaker® Pneumatic Lithotripter and associated accessories

Manufacturer

Cook Medical Europe