Type of Product |
Medical Device |
TGA Recall Reference |
RC-2016-RN-00795-1 |
Product Name/Description |
Medtronic Midas Rex Sagittal Saws (used with the Medtronic Integrated Power Console (IPC) System)
Saw Sagittal Item Number: ES300
Saw Sagittal, Refurbished Item Number: ES300-R
Saw Sagittal, Finger Item Number: ES310
Saw Sagittal, Finger, Refurbished Item Number: ES310-R
All Serial Numbers affected
ARTG Number: 200336 |
Recall Action Level |
Hospital |
Recall Action Classification |
Class II |
Recall Action Commencement Date |
15/06/2016 |
Responsible Entity |
|
Reason/Issue |
This action is being taken to mitigate the risk of injury associated with the potential for leakage of fluid into the motor through the Rocker Housing Seal. The Seal is intended to prevent ingress of fluid into the Sagittal Microsaws during use and decontamination. Although there have been no reports of fluid leakage occurring in the field, engineering testing of the seal identified the potential for leakage to occur. In assessing the risk of this potential failure, testing was conducted that indicated the gravity displacement sterilisation cycle which is included in the IPC User Manual may not be adequate to ensure sterility of internal motor components if fluid ingress occurs beyond the Rocker Housing Seal. In the event that fluid leaks into the motor through the Rocker Housing Seal, and gravity displacement sterilisation method is used, if fluid leaks from the motor during use and this fluid contacts the patient surgical site, there is a potential for infection to occur. |
Recall Action |
Recall |
Recall Action Instructions |
Customers are advised to check their inventory for the affected products. A Medtronic Representative will be in touch with customers to organise the return of this product. This action has been closed-out on 17/02/2017. |
Contact Information |
02 9857 9243 - Medtronic |