| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00034-2 |
| Product Name/Description |
Fujifilm ED-530XT Duodenoscope
Serial Numbers: MD102A129, MD102A130
ARTG Number: 139172 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
11/04/2016 |
| Responsible Entity |
|
| Reason/Issue |
The Operation Manuals have been revised to reflect newly validated manual cleaning and high-level disinfection procedures. This action is being taken as a result of reports of multi-drug resistant bacteria on endoscopes
used for Endoscopic Retrograde Cholangiopancreatogram (ERCP) procedures.
Revisions have been made to the ED-530XT Operation Manuals, “Preparation and Operation” and “Cleaning, Disinfection and Storage.” These revisions modify the cleaning and disinfection processes and require the use of a new disposable distal end cleaning brush to be used for the cleaning of the duodenoscope’s distal tip, forceps elevator and elevator recess, in addition to use of the existing Fujifilm valve cylinder cleaning brush. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
FujiFilm is providing users with updated instructions manuals and samples of the new disposable distal end cleaning brush. All previous versions of the IFU should be discarded.
This action has been closed-out on 01/03/2018. |
| Contact Information |
02 9466 2600 - FujiFilm Australia Pty Ltd |