| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00560-1 |
| Product Name/Description |
Da Vinci Xi Surgical System - Breakage of input disks of Endowrist instruments
Reprocessing Instruction: 551708-01
ARTG Number: 97348 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
23/07/2015 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer, Intuitive Surgical Inc, has determined that the use of the Getinge 88 Turbo Washer/Disinfector in combination with Getinge Clean MIS to reprocess instruments results in a higher chance of input disk breakage, rendering the instrument inoperable. The appendices in the reprocessing manuals incorrectly list the Getinge 88 Turbo Washer/Disinfector and the Getinge Clean MIS combination for reprocessing instruments. The Getinge combination of equipment and cleaning agents leaves a residual amount of detergent on the input disks resulting in disk breakage during sterilisation. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Device Technologies Australia (DTA) is requesting the customers to discontinue the use of the Getinge 88 Turbo Washer/Disinfector with Getinge Clean MIS for reprocessing da Vinci Xi instruments. DTA is suggesting alternative reprocessing methods. DTA is also instructing the customers to inspect the input disks of the Endowrist Instruments and identify any broken disks. Device Technologies representative will contact the customer to arrange the returns. This action has been closed-out on 10/08/2016. |
| Contact Information |
07 3623 1400 - Product Manager |