Print version of this report

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