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Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-00539-1
Product Name/Description	8 mm Fenestrated Bipolar Forceps used with da Vinci Standard System (IS1200) Product code: INS-400172 Lot numbers: M10120815, M10120817, M10120831, M10120913, M10120918, M10121008, M10121024, M10121120, M10121123, M10121203, M10121210, M10121215, M10130220, M10130222, M10130311, M10130315, M10130411 ARTG Number: 132451
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	29/05/2013
Responsible Entity	Device Technologies Australia Pty Ltd
Reason/Issue	The manufacturer has received customer complaints regarding dislodged cautery plug inserts which prevents a bipolar cautery cable from being properly connected to the instrument, resulting in loss of cautery function of the bipolar instrument. The dislodged Cautery Plug Insert most commonly occurs prior to the commencement of a procedure, but may be noticed when connecting or disconnecting the bipolar cautery cable during the procedure.
Recall Action	Recall
Recall Action Instructions	Customers are asked quarantine any affected stock and return them.
Contact Information	02 9975 5755 - Device Technologies