Catalog Number 663100 |
Device Problems
Break (1069); Unraveled Material (1664)
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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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While no serious injury resulted in this event, if this malfunction recurred, it could cause or contribute to a serious injury or require medical or surgical intervention to preclude such.This event, therefore, 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 was reported that automate tool broke.This occurred during a simple filling that was being performed when the wrench broke.The coil unraveled during patient use and the tip broke off.The instrument was sterilized in an autoclave then sent back.No one was harmed and no medical attention was required.
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Manufacturer Narrative
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While no serious injury resulted in this event, if this malfunction recurred, it could cause or contribute to a serious injury or require medical or surgical intervention to preclude such.This event, therefore, 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 was reported that automate tool broke.This occurred during a simple filling that was being performed when the wrench broke.The coil unraveled during patient use and the tip broke off.The instrument was sterilized in an autoclave then sent back.No one was harmed and no medical attention was required.
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Manufacturer Narrative
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A capa has been opened to address weld failures, coil / spring tears / deformation and "broken tip" for product manufactured by sarasota since (b)(6) 2020.Complaint is considered substantiated.
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Search Alerts/Recalls
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