While no serious injury resulted in this event, calibration related issues in endo motors have led to file separation in the past.Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such.As such, this event is reportable per 21cfr part 803.Mainboard (motor control interrupted) defective.As part of the review, we will also offer you a new battery.Micromotor smr (b)(4), contra-angle handpiece (b)(4) (2017) and foot control (b)(4) checked, without errors.
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