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Type of Product Medical Device
TGA Recall Reference RC-2016-RN-00098-1
Product Name/Description TJF-Q180V Duodenoscope

ARTG Number: 210858
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 27/01/2016
Responsible Entity Olympus Australia Pty Ltd
Reason/Issue Olympus has received reports of patient infections associated with the elevator sealing mechanism of the TJF-Q180V Duodenoscope. Olympus is updating the existing TJF-Q180V Operation Manual, the TJF-Q180V Reprocessing Manual and will perform a correction to the forceps elevator mechanism. This is further to the Urgent Recall for Product Correction notification issued in June 2015 (TGA Ref: RC-2015-RN-00475-1).
Recall Action Recall for Product Correction
Recall Action Instructions Affected units can continued to be used, provided the leakage test as outlined in the revised Reprocessing Manual is performed before every use. Olympus is providing instructions for users to access the updated Operation and Reprocessing Manual. Olympus is undertaking a correction of all affected TFJ-Q180V elevator mechanisms and will provide users with loan units whilst the units are being repaired. This action has been closed-out on 27/02/2017.
Contact Information 1300 132 992 - Olympus Australia