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Type of Product Medical Device
TGA Recall Reference RC-2013-RN-00280-1
Product Name/Description PROSTIVA RF Model 8930 Generator (Used for minimally invasive treatment for patients with lower urinary tract symptoms due to benign prostatic hyperplasia (BPH))

ARTG Number: 137006
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 28/03/2013
Responsible Entity Medtronic Australasia Pty Ltd
Reason/Issue Medtronic has found through device testing that if the foot switch is not connected to the Model 8930 RF generator, there is the potential for an electrostatic discharge on the foot switch connector port to toggle the generator RF output on or off. This behaviour mimics the performance of operation of the footswitch.
Recall Action Recall for Product Correction
Recall Action Instructions Medtronic is sending an insulating cap for placing over the foot switch connector port located on the rear panel of the Model 8930 RF Generator. The insulating cap is not necessary if the foot switch is connected.
Contact Information 02 9857 9306 - Medtronic Australasia