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Type of Product	Medical Device
TGA Recall Reference	RC-2023-RN-01059-1
Product Name/Description	Single Use Distal Cover MAJ-2315 ALL lot numbers ARTG 119797 (OLYMPUS AUSTRALIA PTY LTD - Endotherapy device, non-active, single use)
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	15/12/2023
Responsible Entity	Olympus Australia Pty Ltd
Reason/Issue	In April 2023, Olympus recalled Single Use Distal Cover MAJ-2315 that could cause mucosal injury and/or become cracked and/or detached from the endoscope during use and a new distal cover design was introduced. Olympus has now become aware that the new design Single Use Distal Cover MAJ-2315 may also unexpectedly detach from the duodenoscope during use.
Recall Action	Product Defect Alert
Recall Action Instructions	The investigation to determine the root cause is ongoing and further updates will be provided when available. In the interim, customers are reminded to follow the IFU, noting that it is important to ensure that the distal cover is attached correctly, and checked carefully, before a procedure. Illustrations are also provided as part of the IFU on how to correctly attach the MAJ-2315 distal cover and confirm distal cover attachment. Also, a reminder, do not apply anti-fogging products, such as olive oil or products containing petroleum-based substances to the distal cover or the endoscope. These products may cause cracks in the distal cover, which could contribute to distal cover detachment, thermal injury from electric current leaks when performing high-frequency cauterisation treatment, or mucosal injury from the sharp edges due to cracks on the distal cover. Olympus is offering an in-service (on site) training on MAJ-2315 distal cover attachment.
Contact Information	1300 132 992 - Olympus Customer Operations