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Model Number SHAVER HP, APSII, HAND CONTROL |
Device Problem
Defective Device (2588)
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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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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 06/27/2023, it was reported by a facility representative via sems that an ar-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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Additional information: h6: (motor) the evaluation confirmed the reported event, "ar-8330h hand control is not working.This occurred during a case, with a delay." and attributed it to normal wear and tear due to the age of the motor.
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Search Alerts/Recalls
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