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Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-01294-1
Product Name/Description	Large and Mega Needle Driver Endowrist Instruments for da Vinci Surgical Systems Large Needle Driver, da Vinci S and da Vinci Si Product Number: INS-420006 Mega Needle Driver, da Vinci S and da Vinci Si Product Number: INS-420194 Large Needle Driver, da Vinci Standard Product Number: INS-400006 Mega Needle Driver, da Vinci Standard Product Number: INS-400194. Multiple Lot Numbers affected Manufactured between July 2007 and October 2011 ARTG Number: 146826
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	9/12/2013
Responsible Entity	Device Technologies Australia Pty Ltd
Reason/Issue	Intuitive Surgical has become aware of the potential for detachment of the jaw insert for Large Needle Drivers and Mega needle Drivers. Only Large Needle Driver and Mega Needle Driver instruments manufactured between July 2007 and October 2011 are affected. If a jaw insert detaches during surgery, this could result in a device fragment falling into the patient.
Recall Action	Recall
Recall Action Instructions	Device Technologies is advising users to quarantine affected devices from use. Affected devices can be returned to Device Technologies.
Contact Information	1800 429 551 - Device Technologies Australia