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Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-01265-1
Product Name/Description	da Vinci Xi instrument & accessories Affected instruments: 0 deg, 8mm Endoscope, IS4000 Part numbers: 470026-34, 470026-40, 470026-41 DT ordering code: INS-470026 30 deg, 8mm Endoscope, IS4000 Part numbers: 470027-34, 470027-40, 470027-41 DT ordering code: INS-470027 Affected User Manual: Part number: 551706 Language: English ARTG: 99242
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	24/12/2015
Responsible Entity	Device Technologies Australia Pty Ltd
Reason/Issue	The manufacturer Intuitive Surgical has identified specific configurations in which monopolar energy has the potential to be transmitted from the da Vinci Xi endoscope shaft to tissue it is contacting. Although there have been no reported complaints related to this issue, these configurations have the potential to result in unintended thermal injury.
Recall Action	Recall for Product Correction
Recall Action Instructions	The sponsor is advising users to follow the instructions given in the customer letter to mitigate the risk of thermal injury, specifically: • Monopolar energy should not be used when the da Vinci Xi 8 mm endoscope is introduced via the 12 mm da Vinci cannula. This is the case whether or not the da Vinci 12 mm to 8 mm cannula reducer is used. • Never insert a da Vinci Xi cannula into another cannula placed in the patient’s body wall (i.e. double cannulation). • Use caution when using monopolar energy during da Vinci Xi procedures in which contact between the endoscope cannula and the body wall is not assured. This action has been closed-out on 28/02/2018.
Contact Information	07 3623 1400 - Product Manager