| TGA Action ID |
RC-2025-RN-01094-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Olympus resection/inner sheaths of resectoscopes
Name: Resection Sheath
Model: A22014A, A22041A, A22041T, A22042A, A22042T, A22043A, A22043T, A2666, A42011A
All lot numbers
Name: Inner Sheath
Model: A22040A, A2660, A4741, WA22017A, WA22017T
All lot numbers
Name: Sheath
Model: A37004A
All lot numbers |
| ARTG Number |
146203 |
| Action Type |
Product Correction / Product Alert |
| Action Level |
Hospital |
| Hazard Classification |
Class I |
| Reason for the Action |
Olympus has identified complaints related to the ceramic tip of the resection/inner sheath breaking. Over the past three years, there were 146 reports globally of serious injuries, where the tip fell off during the procedure. In most events, the clinician identified and retrieved the fragment during the procedure.
A broken or fractured ceramic tip may cause patient harm, including retention of a foreign body, prolonged operative time, and the need for additional interventions such as imaging or an additional procedure to locate and remove the fragment. Exposed sharp edges could result in tissue trauma and bleeding. If a fractured tip is not recognised and a fragment remains in the patient, this could potentially lead to an inflammatory reaction, dysuria, haematuria, pain, urinary retention, and/or a requirement for post-procedure removal.
No reports of death have been associated with these events. |
| Instructions for Customers/Users |
Customers are to carefully read the content of the letter. Ensure all personnel are fully familiar with the contents of the notification including:
a. the importance of strictly adhering to the ‘Inspection and Testing’ and ‘Caution’ sections of the Instructions for Use (IFU) for both the resection/inner sheath, as well as the ‘Inspection Before Each Use’ section in the Resectoscope System Manual.
b. the additional instructions to have an extra resection sheath available and to inspect the resection sheath during and after the procedure for damage or device fragments.
c. supplemental guidance on how to prevent or minimise the likelihood of distal tip damage during surgical procedure.
Customers are to add a copy of the letter and additional instructions with their existing IFU.
Olympus is currently investigating this problem and will update the IFU to include these additional instructions, as well as clarify the lifetime of the resection sheath is limited to 2 years or 400 uses. |
| Action Commencement Date |
9/01/2026 |
| Responsible Entity |
|
| Contact Information |
1300 132 992 - Olympus Customer Operations |