Medical device manufacturer, ETHICON Endo-Surgery, has issued a medical device safety alert concerning its Ethicon Generator Gen11 (Gen11).
The manufacturer has confirmed a cybersecurity software vulnerability and is issuing a field cybersecurity routine update and patch to address that vulnerability on the Gen11. The cybersecurity software vulnerability can exist when using the Gen11 system with certain non-OEM disposable devices as is it possible for these devices to bypass the Gen11 security authentication.
According to the manufacturer, the cybersecurity software vulnerability has been assessed to have a sufficiently low (acceptable) residual risk of patient harm because the Gen11 has additional safeguards in place to protect the patient even though it is possible for the Gen11 security authentication to be bypassed. The Gen11 neither has wireless connection nor connects to any IT networks. The generator does not store any patient record and there is no impact on patient privacy. Since the vulnerability represents a low risk of harm to patients, health care practitioners who have treated patients using the Gen11 may continue to follow those patients post-operatively in the usual manner.
After the update of the Gen11 to address the cybersecurity software vulnerability, some of the non-OEM products may no longer work on it. OEM Ethicon (including Sterilmed) devices will continue to function as designed on the Gen11 systems.
The users are strongly recommended to comply with the Gen11 product labeling and using only OEM devices on the Gen11. As referenced in the User Manual Warnings and Precaution section, Use of non-OEM devices may lead to unanticipated results and possible injury to the user or patient.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 1 March 2018