There has been a previous report received where stalling has caused file separation.Since separation of a file could necessitate medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function, this malfunction would be likely to cause/contribute to a serious injury should it recur.As such, this event meets the criteria for reportability per 21 cfr part 803.Contra angle 19797 (bearing damaged, resistance too high, head drive needs to be replaced completely), battery (was charged 81 times with an operating time of 50:01:11 hours, whereby 25 charging cycles would have been sufficient) defective.Motor connection cable (cable break) defective, membrane keyboard (no led display) defective.Micromotor sm15578 and foot control 81558 checked, without error.Note: the covid-19 pandemic caused a disruption in normal business activities, resulting in late submission of this report.
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