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Catalog Number V041163000000 |
Device Problems
Mechanical Problem (1384); Loss of Power (1475)
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Patient Problems
No Consequences Or Impact To Patient (2199); 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.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.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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Event Description
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In this event it was reported that a silver reciproc motor suddenly stops during use; no injury resulted.
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Manufacturer Narrative
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Battery (voltage breaks down under load) defective, the micromotor smr113560, foot control 69065 and the sirona contra-angle 07776 are not defective.Note: the covid-19 pandemic caused a disruption in normal business activities, resulting in late submission of this report.
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Search Alerts/Recalls
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