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 please note that while this product is not sold in the us, it is considered similar to products that are marketed in the us by dentsply sirona.Battery (was charged with an operating time of 70:09:15 hours, 157 x, whereby 35 charging cycles would have been sufficient) defective, replaced.Micromotor smr118275 and contra-angle handpiece 31054 (2011) with no recognizable errors.Sent in without power supply and foot control.Function test and test measurements without errors.
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