| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00890-1 |
| Product Name/Description |
Endowrist Instruments and Accessories for the da Vinci Surgical Systems (Used in endoscopic procedures)
Part Numbers of Affected Reprocessing Instructions: 550874-02 and 550882-05
ARTG Number: 132451 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
22/08/2013 |
| Responsible Entity |
|
| Reason/Issue |
Device Technologies Australia are implementing a revised Reprocessing Instructions for Endowrist instruments and accessories.
The changes include:
- To allow the use of mildly alkaline enzymatic cleaners, instead of only pH-neutral enzymatic cleaners.
- To clarify soaking prior to active scrubbing and rinsing in order to soften soil and make pre-cleaning easier.
- To augment scrubbing by spraying water through the ISI-supplier Luer nozzle at 2 bar pressure onto the tip of the instrument.
- To add magnification to the visual inspection of instruments to make it easier to ensure that instruments are free of visible soil prior to automated reprocessing. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Device Technologies Australia is providing on site training for the revised instructions, review updated content and provide a Cleaning and Sanitation kit (including the revised instructions) for all users. |
| Contact Information |
1800 429 551 - Device Technologies Australia |