| TGA Action ID |
RC-2026-RN-00441-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
MAJ-2315 Single Use Distal Cover
SKU: N6192000
Multiple lot numbers |
| ARTG Number |
119797 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class I |
| Reason for the Action |
Olympus has received complaints of the distal cover unexpectedly detaching from the duodenoscope during use.
To address this problem, Olympus has developed a newly designed version of the Distal Cover (MAJ-2315), which contains a new attachment tool to help mitigate the risk of incorrect attachment of the distal cover to the scope.
In the past 12 months, Olympus has received 96 complaints globally pertaining to the MAJ-2315 distal cover falling off within or outside patients. This included 36 events considered to be Serious Injury, which involved foreign body retrieval and/or additional treatment.
|
| Instructions for Customers/Users |
Customers should:
· Note that all older versions of this product should be returned to Olympus and replaced with the newly designed version.
· Examine their inventory for the previous design of the Single Use Distal Covers, model MAJ-2315 using the list of models and lot numbers in the customer letter.
· Once customers have received the new design of the MAJ-2315, they must stop using the old design and set aside for return.
· Once Olympus has received your response form, an Olympus representative will reach out to coordinate the return of your affected device and process the corresponding credit or replacement. |
| Action Commencement Date |
11/06/2026 |
| Responsible Entity |
|
| Contact Information |
1300 132 992 Olympus Customer Operations or oaz-fca@olympus.com |