| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00120-1 |
| Product Name/Description |
Pentax ED-3490TK Video Duodenoscope
ARTG Number: 234951 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
16/10/2017 |
| Responsible Entity |
|
| Reason/Issue |
PENTAX Medical is informing customers about a potential issue associated with the distal cap of the ED-3490TK and offer recommendations intended to reduce the potential risk for contamination and subsequent patient infection. Pentax is also reminding customers to follow the validated manual reprocessing instructions that PENTAX issued to all PENTAX Model ED-3490TK duodenoscope customers in April 2016.
This action was undertaken prior to consultation with the Therapeutic Goods Administration (TGA). |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Pentax is advising users that the validated manual reprocessing procedures included in the current Instructions for Use (RIFU 6217001 S059 R01, April 2016) remain the same. PENTAX reminds its customers of the importance of using the ED-3490TK according to its current labelling. Customers must ensure that all reprocessing personnel are knowledgeable and thoroughly trained on the current Instructions for Use for manual reprocessing of these devices. Meticulous cleaning of the elevator recesses and attention to following all reprocessing instructions are required.
Additionally, PENTAX recommends that users immediately remove from use any ED-3490TK duodenoscope that shows visible signs of wear or physical damage.
PENTAX will provide annual inspection and servicing to all customers with ED-3490TK duodenoscopes. During on-site inspections, PENTAX fie
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
1300 736 829 - Pentax Medical Customer Support |