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TGA Action ID	RC-2025-RN-00642-1
Type of Product	Medical Device
Product Name/Description	ESG-410 Electrosurgical Generator Model number: WA91307W Multiple serial numbers
ARTG Number	371561
Action Type	Product Correction
Action Level	Hospital
Hazard Classification	Class II
Reason for the Action	Following customer complaints, Olympus have identified the potential for the device to display the error message "E0662 System Error", which is then followed by either automatic single reboots of the device, or continuous reboot ‘loops’. Users reported that these reboots occurred both during and prior to clinical use. Olympus has identified that this problem is caused by a previous change to an electronic component. If a device unexpectedly reboots, this may cause a delay in starting surgical treatment or prolonged surgery due to the need to troubleshoot and/or replace the generator. There is the potential risk of bleeding which may require the clinician to use alternative surgical equipment (i.e., clamps, sutures, etc.) to maintain haemostasis. 43 complaints have been received related to this problem, with no adverse events reported.
Instructions for Customers/Users	Olympus will contact customers to arrange a mutually convenient time to correct the affected devices. Customers may continue to use their devices whilst they are waiting for Olympus to contact them to arrange the rework. Customers should continue to follow the IFU, including preparing a spare electrosurgical generator or an alternative procedure, in case of an interruption to a procedure due to an unexpected generator failure.
Action Commencement Date	22/07/2025
Responsible Entity	Olympus Australia Pty Ltd
Contact Information	1300 132 992 - Olympus Customer Operations