Catalog Number A066000000300 |
Device Problem
Break (1069)
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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 resulted in a serious injury.Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such.As such, this event is reportable per 21cfr 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 is reported that a start-x tip satelec insert 3 lot# broke during use.No injury.
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Manufacturer Narrative
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Summary: a start-x tip satelec insert 3 was returned in loose.The instrument is broken in the middle of the active part.No material defect was found during analysis of the rupture pattern.No unused device is available for further evaluation.Nothing unusual to report was found during dhr review (batch #1832285).No information was provided by customer regarding satelec scaler power setting.We cannot rule on the compliance of the customer's setting with the ones recommended by maillefer.Root causes are not identified.We will track this kind of event and monitor the trend.Generally speaking, several other factors may contribute to breakage issue, such as usury, pressure or incorrect technique.All of these factors may affect the longevity of the tip.For information, we noted that the returned device had a active part strongly worn out.
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Search Alerts/Recalls
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