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Catalog Number V041163000000 |
Device Problems
Mechanical Problem (1384); Therapeutic or Diagnostic Output Failure (3023)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); Insufficient Information (4580)
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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 results are not available 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 turns to slow.The event outcome is unknown as of this mdr evaluation.
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Manufacturer Narrative
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Multiple unsuccessful attempts were made to obtain the patient outcome.Battery (breaks down under load) defective, replaced.Handpiece holder broken, replaced.Charger (adapter bracket broken) defective, replaced.Foot control and contra angle was not included.Housing cracked in several places (probably due to a fall), but has no effect on the function.Function test without errors.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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