My HPRA: Register

Gas Tamponades: EasyGas; SF6, C2F6, C3F8

Notice type: Advisory

Date: 13/06/2013

   

Product name or type:
Gas Tamponades: EasyGas; SF6, C2F6, C3F8

Reference:
SN2013(06)

Manufacturer Or Supplier:

Fluoron GmbH/Geuder AG/KD Surgical Ltd

Target Audience:
Opthalmic Surgeons 
Hospital CEOs 
Hospital Staff 
Clinical Risk Managers 
Clinical Nurse Managers 
General Practitioners 
Emergency Medicine Departments 

Problem Or Issue:
The effectiveness of the Fluoron EasyGas SF6, C2F6, C3F8 gas tamponade devices cannot be guaranteed. Despite correct handling and application, the gas volume may be below specification.

Background Information Or Related Documents:
In March 2013, Geuder AG, the international distributor of EasyGas SF6, C2F6, C3F8 advised customers that the effectiveness of these devices can no longer be guaranteed. Analysis has indicated that the designs of the syringe and the packaging may cause the gas volume to be below specification, despite correct handling and application. 

The international distributor has notified customers of the issue and has requested that they stop using these devices immediately and return any unused devices to them. 

The international distributor and local supplier for these devices have advised the Irish Medicines Board (IMB) that the majority of the potentially affected devices supplied to the Irish market, were provided as samples to medical professionals. As these samples were supplied to the market during various medical conferences and events, traceability of the devices is difficult. Although the local supplier has contacted hospitals who have used the devices, and is confident that all potentially affected devices have been either used or removed from the market, the IMB is issuing this safety notice out of a preponderance of caution to ensure all users of these devices are aware of this issue and to request users who may still have potentially affected devices to contact either the local supplier, international distributor or manufacturer and return devices to them. If users have any concerns regarding these devices please contact the manufacturer or international distributor for further guidance.

Gas Tamponades: EasyGas; SF6, C2F6, C3F8 Document

Actions To Be Taken:
The IMB recommends that: 

1. Relevant personnel in your organisation are made aware of this potential issue. 
2. If applicable, users contact either the local supplier, the international distributor or the manufacturer and return any unused affected devices. 
3. Ensure that this IMB Safety Notice and the attached Field Safety Notice is passed on to any organisation or end user where the potentially affected devices have been transferred. 

Further Information:

ENQUIRIES 

All adverse incidents relating to a medical device should be reported to the: 

Manufacturer 

Fluoron GmbH 
Magirus-Deutz-Straße 10 
89077 Ulm 
Germany 

Telephone: +49 731 205 5997 33 
Contact Person: Dr. Wilfried Kugler 
Email: wilfried.kugler@fluoron.de 

International Distributor 

Geuder AG 
Hertzstrasse 4 
69126 Heidelberg 
Germany 

Telephone: +49 6221 306-6 
Fax: +49 6221 303122 
Contact person: Mr. Julius Mueller-Albinus 
Email: easygas@geuder.de 

Local Supplier 

KD Surgical, Cloncleigh 
Two Mile Borris 
Thurles 
Co. Tipperary 

Telephone: +353 504 34866 
Fax: +353 504 60199 
Contact person: Mr. Killian Dunphy 
Email: office@kdsurgical.ie 

Competent Authority 

Health Products Regulatory Authority
Kevin O’Malley House 
Earlsfort Centre 
Earlsfort Terrace 
Dublin 2 

Telephone: +353-1-6764971 
Fax: +353-1-6344033 
E-mail: devicesafety@hpra.ie
Website: www.hpra.ie 

Click here to view a PDF version of this Safety Notice

Click here to view a copy of the Field Safety Notice

« Back