Intuitive—da Vinci X and Xi Surgical Systems: May Have Manufacturing Variation in Arm, Potentially Resulting in Persistent Fault
December 5, 2018 | Risk Management News
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In a November 21, 2018, Field Safety Notice Urgent Medical Device Correction letter, Intuitive states that the above systems were shipped with a manufacturing variation in the arm that may result in a persistent recoverable fault (error 23087). Intuitive also states that this problem could occur before a procedure or during a procedure. Intuitive further states that the problem results in an inoperable arm, presenting the user with the option to disable the arm and continue the procedure with the remaining arms. Intuitive states that if the problem occurs during a procedure, it may lead to a minor delay in continuation of the da Vinci procedure if the affected arm is disabled and the procedure is continued with the remaining arms, or the user may convert to another surgical approach. Intuitive also states that it has received no reports of adverse events related to this problem and...