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Model Number SHAVER HP, SYNERGY, HANDCONTROL |
Device Problems
Defective Device (2588); Unexpected Shutdown (4019)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/21/2023 |
Event Type
malfunction
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Event Description
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On (b)(6) 2023, it was reported by a distributor via sems that an ar-8332h shaver handpiece stopped during surgery on (b)(6) 2023.This occurred during use with no patient harm.Additional information has been requested.On (b)(6) 2023, the distributor provided the following information via email: this occurred during an lca procedure.Another piece of equipment was used to complete the case.
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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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(no problem found) the evaluation did not reveal any issues relevant to the reported event, "ar-8332h shaver handpiece stopped during surgery on (b)(6) 2023.This occurred during use with no patient harm.".
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Search Alerts/Recalls
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