| TGA Action ID |
RC-2025-RN-01057-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
The ShockPulse-SE Lithotripsy System
ShockPulse Lithotripsy Transducer
Model/SKU: SPL-T
ShockPulse Lithotripsy Generator
Model/SKU: SPL-G
ShockPulse-SE Lithotripsy System
Model/SKU: SPL-SR
All serial numbers |
| ARTG Number |
343651 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Olympus recently informed users through a Market Action letter, dated 21 October 2025 (RC-2025-RN-00862-1) of complaints received for the ShockPulse Lithotripsy Transducer either failing to start up, or the transducer starting up briefly and then stopping, accompanied by an error light on the generator. In addition, the body of the transducer handpiece may gradually increase in temperature during clinical use. The investigation indicated that the transducer may fail in the field before reaching its expected 100 reprocessing cycles.
Olympus’ investigation has additionally identified instances of the ShockPulse Generator remaining in a blinking phase waiting to recognise the transducer. Assessment of complaints has determined that damage to the transducer plug and/or to the generator receptacle may cause the ShockPulse Transducer to not startup, the ShockPulse Generator to display an error light, and of the ShockPulse Generator to not recognise the transducer.
Since June 2021, globally Olympus has received reports of six (6) serious injuries for prolonged procedures resulting from the ShockPulse device not working or working inconsistently. |
| Instructions for Customers/Users |
Due to the potential for these problems to impact the functionality of the ShockPulse Transducer, it is increasingly important that a back-up transducer and probe are sterilised and available prior to beginning a procedure.
Customers are to add a copy of the Customer Letter and Appendices to their existing IFU.
Olympus continues to investigate these issues and potential mitigations. Olympus will communicate the outcome to customers in subsequent communication. In the interim, supplemental guidance has been developed to assist users in preventing and identifying damage to the ShockPulse Transducer and ShockPulse Generator receptacle. |
| Action Commencement Date |
15/12/2025 |
| Responsible Entity |
|
| Contact Information |
1300 132 992 - Olympus Customer Operations |