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Model Number SHAVER HP, APSII, HAND CONTROL |
Device Problems
Defective Device (2588); Key or Button Unresponsive/not Working (4063)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/27/2023 |
Event Type
malfunction
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Event Description
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On (b)(6) 2023, it was reported by a facility representative via sems that an aar-8330h hand control is not working.This occurred during a case, with a delay.There was no additional information provided, 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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(no problem found) the evaluation did not reveal any issues relevant to the reported event, "aar-8330h hand control is not working.This occurred during a case, with a delay.".
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Search Alerts/Recalls
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