Catalog Number V041163000000 |
Device Problems
Mechanical Problem (1384); Therapeutic or Diagnostic Output Failure (3023)
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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.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 vdw silver motor stops during use.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) defective, replaced.Micro motor sm13236 during the examination of your device we discovered residues of liquids or oil in your motor.Excess oil that remains in the contra-angle handpiece after care is the most common cause of this defect.Additional info received indicating no injury resulted.
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Search Alerts/Recalls
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