| TGA Action ID |
RC-2025-RN-00376-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
DORO Easy-Connect Navigation Adaptor, BRAINLAB
Item No: 1204.002
UDI Code: 04250435506738 |
| ARTG Number |
336215 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
It has been determined that in certain instances the compatibility of the DORO Easy-Connect Navigation Adaptor with the BRAINLAB with the Brainlab’s Patient Reference Array for Skull Clamp (item No. 41725) or Brainlab’s VV Mayfield Reference Clamp 2.0 (item No. 41730A), might be compromised. This might have an influence on the positioning of the reference array.
The DORO Easy-Connect Navigation Adaptor, BRAINLAB is used to connect Brainlab Navigation Reference Arrays to the DORO Headrest System. The DORO Headrest System is a mechanical support system which is used in head and neck surgery when rigid cranial stabilisation is desired.
If the navigation accuracy is lost after the standard replacement of the navigation reference, serious injuries to the patient cannot be ruled out (if the shift is not detected by the surgeon). If the deviation is identified, it is also possible that the procedure will be continued by the surgeon without navigation or that surgery will have to be repeated due to an unsuccessful operation - delay in operation time >15 min.
No known complaints or incidents relating to a loss of navigation when using the adapter have been reported to date. |
| Instructions for Customers/Users |
Customers are to:
- Quarantine any DORO for Brainlab array adapter.
- If needed use another array adapter as outlined in customer letter.
- Return the adapter to Innovative Medcare Instruments for correction of the device.
This action has been closed out on 20/06/2025. |
| Action Commencement Date |
10/04/2025 |
| Responsible Entity |
|
| Contact Information |
1300 690 998 - Imedcare Customer Care |