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Type of Product	Medical Device
TGA Recall Reference	RC-2014-RN-00759-1
Product Name/Description	Large Clip Applier for use with the da Vinci STM and da Vinci SiTM ARTG number: 146826
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	7/07/2014
Responsible Entity	Device Technologies Australia Pty Ltd
Reason/Issue	Intuitive Surgical Inc. have become aware of the Larger Clip Applier instrument jamming or feeling friction during insertion into the 8mm cannula or into certain cannula reducer accessories. No adverse events have been reported due to this issue. If an instrument gets jammed in the cannula or reducer accessory during insertion this may prevent or delay the use of the instrument. As the type of clip applied by the clip applier is used to occlude controlled vessels rather than during episodes of active bleeding, a delay in clip application will have no immediate or long term health consequences for the patient.
Recall Action	Recall for Product Correction
Recall Action Instructions	A software update has been developed to correct the issue. The product may continue to be used while software upgrades are being made in the field. The software upgrade will reduce the degree to which the jaws on the Large Clip Applier Instrument open during insertion and will eliminate the occurrence of jamming.
Contact Information	1300 338 423 - Device Technologies