| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00695-1 |
| Product Name/Description |
VueOptic Visualisation Source & Flexor Vue Deflecting Endoscopic System
VueOptic Visualisation Source
Catalogue Identifier: FVO-150
Part Number: G25343
Flexor Vue Deflecting Endoscopic System
Catalogue Identifiers: FV-090075-150 & FV-090045-150
Part Numbers: G50972 & G34306 (respectively)
All Lot Numbers
ARTG Numbers: 211575 and 211572 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
30/05/2017 |
| Responsible Entity |
|
| Reason/Issue |
The reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection and sterilisation of these products. In addition, the monitoring of chemical residues was not considered in the reprocessing validation. Preliminary investigation indicates that validation data related to the reprocessing of these devices do not meet the current guidelines.
Potential adverse events that may occur if the products are not adequately reprocessed include urological infections and systemic infections from a urological origin as well as events resulting from chemical residual exposure. To date, there have been no reports of adverse reactions related to inadequate cleaning, disinfection, sterilisation or chemical residual exposure associated with these devices.
(Please note that for the Endoscopic System, the reprocessing instructions apply to the VueOptic Visualisation Source as the Flexor 180 is intended for one-time use only). |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Cook Medical will be updating the reprocessing instructions in the Instructions For Use (IFU). In the interim, users are advised to quarantine any affected products. Use of the affected products can be continued if the updated "Reprocessing Instructions" provided is adhered to. (Users are to note that the reprocessing instructions apply to the VueOptic Visualisation Source as the Flexor 180 is intended for one-time use only).
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
1800 777 222 - Cook Medical Customer Service |