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Catalog Number V041163000000 |
Device Problem
Mechanical Problem (1384)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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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 handpiece 2060 (no apex function, head part is depressed) defective, battery (which breaks down under load) defective, the housing has broken a several place (possibly due to impact) has no function.Micromotor (b)(4) and foot control (b)(4) read without errors.
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Event Description
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In this event it was reported that a silver reciproc motor stops during use; no injury resulted.
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Manufacturer Narrative
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Contra-angle 2060 (2016) (no apex function, head part is depressed) defective, battery (voltage breaks down under load) defective, the housing is on broken into several places (presumably due to a collision) has no effect on the function.Micromotor smr113118 and foot control 100502 tested without errors.Delivered without power supply.
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Search Alerts/Recalls
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