There has been a previous report received with a similar device where this malfunction resulted in a serious injury.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 21 cfr part 803.The device is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.
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Nc073949/gr21703/ca-sn:(b)(6):the battery (breaks down under load) defective.The mainboard (measuring socket, file clamp, loose contact) is defective.The contra-angle 87175 (2015) (worn head drive) is defective.The case has broken in several places (probably due to a fall), but has no effect on the function.The charger, the foot control 117302, the motor gmr1556205, the motor cable and the measuring cable set after thorough inspection, no fault could be found.All complaints are monitored through the monthly product surveillance committee and a corrective action could be determined by the committee.
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