The Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom posted a field safety notice concerning ENSEAL G2 Curved and Straight Tissue Sealer, manufactured by Ethicon Endo-Surgery (EES).
The affected products could be identified by the following product codes: NSLG2C14, NSLG2C25, NSLG2C35, NSLG2C45, NSLG2S14, NSLG2S25, NSLG2S35, NSLG2S45. All lot numbers with expiration date from October 2013 through September 2017 are impacted.
According to the manufacturer, there is a potential for self-activation while the device is in use, which could result in injury to patients or users (thermal damage). To date, the manufacturer has not received any reports of patient or user injuries.
The manufacturer advises all affected users to stop immediately the use of EES ENSEAL G2 Curved and Straight Tissue Sealer.
For details, please refer to MHRA website:
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/CON208680
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 4 December 2012