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TGA Action ID	RC-2025-RN-01073-1
Type of Product	Medical Device
Product Name/Description	Olympus THUNDERBEAT hand instruments TB-0520FCS THUNDERBEAT 5mm, 20cm SKU: N5423930 TB-0545FCS THUNDERBEAT 5mm, 45cm SKU: N5423330 TB-0535FCS THUNDERBEAT 5mm, 35cm SKU: N5423630 TB-0520FCS THUNDERBEAT 5mm, 20cm SKU: N5424030 TB-0535FCS THUNDERBEAT 5mm, 35cm SKU: N5423730 TB-0545FCS THUNDERBEAT 5mm, 45cm SKU: N5423430
ARTG Number	319986
Action Type	Recall
Action Level	Hospital
Hazard Classification	Class I
Reason for the Action	Olympus was made aware of reports where probe tips of the THUNDERBEAT hand instruments are becoming damaged and/or breaking. There are also instances of tissue pad damage or detachment. Investigations by Olympus demonstrated that these problems could occur when the instructions and warnings in the Instructions for Use (IFU) are not followed. There have been multiple accounts of serious patient injury and one reported death. Due to a continuation of occurrences of this problem, Olympus is removing potentially affected models of THUNDERBEAT hand instruments from the market.
Instructions for Customers/Users	Customers are to: • Inspect stock immediately for affected THUNDERBEAT hand instrument models. • Immediately cease use of all affected devices and quarantine the products to prevent further use. • Complete the attached Customer Response Form even if you do not have any affected stock and return it to oaz-fca@olympus.com. • An Olympus representative will reach out to coordinate the return of the affected device and process the corresponding credit.
Action Commencement Date	19/12/2025
Responsible Entity	Olympus Australia Pty Ltd
Contact Information	1300 132 992 - Olympus