Product Wiki · Recalls · Health Canada — Medical Devices

DA VINCI SI SURGICAL SYSTEM (2016-03-24) — recall 54787

Health Canada — Medical Devices · Canada · 2016-04-22 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
54787
Date of alert
2016-04-22
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: Intuitive Surgical is initiating a voluntary correction regarding the use of certain da Vinci EndoWrist instruments with a cardiac cryoablation probe. Intuitive Surgical has determined that microscopic metallic particulate can be generated during both robotic and non-robotic intra-cardiac surgery. The use of da Vinci instruments other than the cardiac probe grasper (e.g. large needle driver) to manipulate a cardiac cryoablation probe during da Vinci cardiac surgery has been shown to increase the amount of microscopic metallic particulate.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/da-vinci-si-surgical-system-20

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