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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 06/29/2023 |
Event Type
malfunction
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Event Description
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On 6/29/2023, it was reported by a facility representative via sems that an ar-8330h shaver handpiece was not responding.No patient was affected, and there was no delay in completing the procedure.This occurred during use with no patient harm.Additional information has been requested.
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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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Manufacturer Narrative
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(motor) the evaluation confirmed the reported event, "ar-8330h shaver handpiece was not responding.No patient was affected, and there was no delay in completing the procedure."; and attributed it to normal wear and tear due to the age of the device.
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Search Alerts/Recalls
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