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Catalog Number V041163000000 |
Device Problems
Mechanical Problem (1384); Failure to Auto Stop (2938)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); 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 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 does not stop when the value is reached.The event outcome is unknown as of this mdr evaluation.
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Manufacturer Narrative
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Battery defective, replaced, motor smr 1456553 ( includes oil and liquid) defective, replaced with smr 1980907.Power supply, foot control and contra angle were not delivered.Function test without errors.Multiple unsuccessful attempts were made to obtain the patient outcome.
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Search Alerts/Recalls
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