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Catalog Number V041163000000 |
Device Problem
Mechanical Problem (1384)
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Patient Problem
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 this malfunction 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 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 is reported that vdw silver reciproc stops during treatment.No injury occurred.
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Manufacturer Narrative
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Device inspected and found: battery (voltage collapses under load) defective.Root cause - battery defective (example: low battery life, internal resistance too high).Overcharged.Micromotor smr 117458, contra-angle 29425 (2011) and foot control 199343 checked, no errors.Sent without power supply.
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Search Alerts/Recalls
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