Medical device manufacturer, Olympus, has issued a medical device safety alert concerning its ENDOEYE HD II Video Telescope [Product code: W WA50040A and WA50042A; Serial number: all].
The manufacturer has initiated this FSCA after discovering that the ENDOEYE distal end can become abnormally hot if the temperature sensor at the device's tip is damaged. Although no customer complaints have been received referring to this issue and thus no patient or user injury has occurred, excessive heating of the ENDOEYE distal end could result in patient or user injury. In an effort to prevent a potential risk to patient or user health, the manufacturer is undertaking the action to remove the model and serial numbers identified above and to modify and return the devices.
According to the manufacturer, disabling a specific feature on the video telescope (i.e. fog-free function) will prevent excessive heating of the ENDOEYE distal end in case of certain faults. The manufacturer will provide an addendum to the instructions for use with the modified devices.
Affected users are advised to take the following actions:-
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 06 February 2017