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Catalog Number 792430 |
Device Problems
Fitting Problem (2183); Detachment of Device or Device Component (2907)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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Though no medical/surgical intervention was required to preclude a serious injury in this event, there have been previously reported events involving a similar device that resulted in the need for medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function.Therefore, 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 was reported that the cap unscrewed from a stylus plus handpiece while in use.The reported complaint did not result in an injury or need for intervention.
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Manufacturer Narrative
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Received the handpiece in pieces, both bearings were off of the turbine shaft, cap was off also.The only visible damage was to the turbine which with both bearings in pieces.The cap was sticking, did not press in and out consistently, evenly.There was no thread damage to either the cap or the inside of the head.I tightened down the cap and it was not cross threaded either.The chuck pusher may have been pressed in and not released.
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Search Alerts/Recalls
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