Sunnyvale, Calif.-based Intuitive Surgical initiated its recall of 17 versions of device on April 1, 2019. According to the FDA database, the company became aware that the da Vinci SP system may trigger a mechanical vibration of the instrument tips and endoscope because of a software anomaly.
If this vibration occurs, it could only do so under rare, specific conditions, including when the user is activating “Adjust Mode,” when the instrument arm is near its vertical position limit and when the user is applying sustained force against the hand control haptic feedback.
Intuitive Surgical sent a letter to consignees on April 1, 2019, to confirm that a company representative will schedule an on-site visit to provide a software update as soon as possible.
Customers are urged to inform all personnel involved with the affected device that if vibrations are sensed at the instrument and/or endoscope tips in “Adjust Mode” and the instrument arm is near its vertical limit, they are to stop applying sustained force against the hand control haptic feedback, exit “Adjust Mode,” exit following mode or press the “Emergency Stop” button.
If mechanical vibration persists beyond the user taking these actions, customers were told to discontinue use of the system and contact technical support.