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Model Number SHAVER HP, APSII, HAND CONTROL |
Device Problem
Defective Device (2588)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/11/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
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Event Description
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On (b)(6) 2023, it was reported by a sales representative via sems that an ar-8330h shaver handpiece had a critical tool failure during a case, the patient was not affected.This occurred during use in an unspecified procedure with no patient harm.Additional information has been requested.
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Manufacturer Narrative
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(motor) the evaluation confirmed the reported event, "ar-8330h shaver handpiece had a critical tool failure during a case, the patient was not affected.This occurred during use in an unspecified procedure with no patient harm." and attributed it to a motor hall sensor malfunction.(refer to ncr-22401).
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Search Alerts/Recalls
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