Since incorrect measurement 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.Battery (voltage breaks down under load) defective, replaced.Lip clip cable (insulation broken) defective, replaced.Power supply unit, file clamp and file clamp cable were not included.Micromotor gmr1876559, contra-angle handpieces 60947, 25305 and foot control 86850 are not defective.
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In this event it was reported that a contra angle 6:1 for vdw.Gold/silver causes incorrect measurement results when used with an apex locator.According to customer, "during treatment with the device, the patient is injured again and again, as the lack of an apex stop causes over-instrumentation, which then leads to pain.".
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