Catalog Number V041163000000 |
Device Problems
Loss of Power (1475); Self-Activation or Keying (1557); Power Problem (3010); Unexpected Shutdown (4019)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Information (3190)
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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 (b)(4).
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Event Description
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In this event it was reported that a silver reciproc motor turns off suddenly.The event outcome is unknown as of this mdr evaluation.
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Manufacturer Narrative
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Battery, voltage breaks down under load, replaced.Power supply defective, replaced.Handpiece holder defective, replaced.Without contra angle.Function test without error.Additional information was received indicating that there was no injury to the patient.
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Search Alerts/Recalls
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